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<a href="https://www.businessinsider.com/category/future-of-healthcare"></a><div type="image" title="Two scientists working in a laboratory" height="1285" width="1713" msid="86616895" hostid="261"></div><ul class="summary-list"><li>The pandemic's <keyword id="12003791" type="UNKNOWN" weightage="60" keywordseo="telehealth" source="Orion">telehealth</keyword> boost has spurred investments in startups making <keyword id="12204817" type="UNKNOWN" weightage="60" keywordseo="clinical-trials" source="Orion">clinical trials</keyword> virtual.</li><li>The goal is to open trials for experimental medicines to people who can't trek to a medical center. </li><li>These companies and experts agree it'll be years before decentralized clinical trials are the norm.</li></ul>Companies selling technology aiming to bring clinical trials online have raised more than $150 million in the past few months, but even they agree we're years away from widespread virtual clinical trials. Riding on the pandemic's rapid transition to virtual care, startups like Thread, Florence, Hawthorne Effect, and Castor are hawking tech they hope will decentralize clinical trials for vaccines, drugs, and treatments that have traditionally been concentrated near large academic medical centers in metropolitan areas. In a bid to open trials up to people who can't afford the trek, they offer services that vary from software to collates data from disparate sources to gig-economy clinicians who can go directly into homes to gather samples. <a href="https://hawthorne-effect.com/hawthorne-effect-raises-20-million-series-a-round-of-financing-to-decentralize-clinical-trials/">Their teams</a> and investors have pitched the technology as a means for diversifying clinical trials, which have <a href="https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00228-4/fulltext">historically underrepresented racial minorities</a>. But these companies tell Insider that the technology required for widespread virtual clinical trials, including standards for gathering data from disparate data sources, is far from established. The rush to develop vaccines and treatments for <a href="https://www.pfizer.com/science/clinical-trials/diversity-clinical-trials">COVID-19 spotlighted the issue</a>, prompting the Food and Drug Administration to recommend <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial">researchers enroll underrepresented groups in their trials.</a>But "nobody in the industry has arrived," said John Reites, CEO of clinical-trial data company Thread. Lack of standards in the way the data is stored and reported makes it harder to link new sites up to clinical trials, Reites said. <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial"></a>Thread, <a href="https://www.businessinsider.com/reviews/out?u=https%3A%2F%2Fwww.wsj.com%2Farticles%2Fwater-street-and-jll-partners-add-50-million-to-thread-commitments-11597273200">which raised $50 million from private-equity backers in August</a>, sells a software platform that pharmaceutical companies and academic research centers use to gather data that's collected from sites across the country, whether they're retail pharmacies or commercial labs like Labcorp.<h2>Where the tech falls short</h2>Companies are raising millions to disrupt how clinical trials are conducted at a time when others are working at the beginning of the process to recruit underrepresented patients using sophisticated advertising. There, too, <a href="https://www.businessinsider.com/clinical-trials-have-a-diversity-problem-is-tech-the-solution-2021-8">equity experts agree that technology alone</a> won't address the social barriers keeping underserved patients out of clinical trials.<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial"></a>The software company Florence recruits patients, obtains their consent virtually, and aims to make the enrollment process easier. The startup <a href="https://florencehc.com/press-release/florence-supports-pfizers-covid-19-vaccine-clinical-trials/">worked with Pfizer</a> to gather data from patients across the country about COVID-19 vaccine response.But Blake Adams, Florence's marketing vice president, told Insider that the lack of data sharing even among the companies managing different parts of clinical trials makes it harder to expand them virtually."There's not really a lot of standards in the space right now," he said. Florence raised $80 million in a Series C round in May. Jodi Akin, who founded Hawthorne Effect, agreed that these types of services alone won't address larger systemic barriers keeping underserved patients out of clinical trials. Hawthorne Effect, which <a href="https://www.prnewswire.com/news-releases/hawthorne-effect-completes-20-million-series-a-round-of-financing-to-decentralize-clinical-trials-301309184.html">raised $20 million in June,</a> hires thousands of clinicians on a contract basis modeled after the gig economy to gather specimens directly from patients' homes. And though backers are eager to fund decentralized clinical-trial technology because of its potential to diversify research, some startups and investors are overhyping its ability to meaningfully change it in the short term, Akin said.

Startups are raising tens of millions to make clinical trials virtual. But experts say we're still years away.

<ul class="summary-list"><li>The National Institutes of <keyword id="6354750" type="UNKNOWN" weightage="100" keywordseo="health">Health</keyword> (NIH) said in a press release on Saturday that it has halted a <keyword id="122283" type="PERSON" weightage="60" keywordseo="Clinical-trial">clinical trial</keyword> of <keyword id="4751090" type="PERSON" weightage="60" keywordseo="Hydroxychloroquine">hydroxychloroquine</keyword> for the treatment of adults hospitalized with COVID-19.</li><li>Though the NIH said that the drug poses "no harm" to those who have taken it, the drug is ultimately "very unlikely to be beneficial."</li><li>The clinical trial is said to have been held in Nashville, Tennessee, starting in April, and had more than 470 people enrolled before it was halted.</li><li>Just a few days earlier, the World Health Organization announced that its dropping hydroxychloroquine from its tests of <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> drugs after it was found to be ineffective.</li></ul>A clinical trial of hydroxychloroquine for the treatment of hospitalized adults with COVID-19 has been halted after the drug was found to be ineffective, the National Institutes of Health (NIH) announced on Friday.According to <a href="https://www.nih.gov/news-events/news-releases/nih-halts-clinical-trial-hydroxychloroquine">the NIH's press release</a>, the drug poses "no harm" to those who have taken it, but has still been deemed "very unlikely to be beneficial" to those being treated for coronavirus.As a result, the NIH halted its trial of the drug that it says began in April at Vanderbilt University Medical Center in Nashville, Tennessee.<div type="image" title="hydroxychloroquine" height="1333" width="1777" msid="76487480" hostid="261"></div>The study aimed to enroll "more than 500 adults who are currently hospitalized with COVID-19," and had enrolled more than 470 patients before it was halted, according to the NIH.Those involved in the trial were "randomly assigned" to receive 400 milligrams of hydroxychloroquine twice daily on their first day of the trial, and then 200 milligrams of the drug twice daily on their second, third, fourth, and fifth days.Though hydroxychloroquine is typically used to treat malaria and rheumatoid conditions like arthritis, according to the NIH, it had been tested to treat COVID-19 because "the drug had demonstrated antiviral activity, an ability to modify the activity of the immune system."Just three days before the NIH shared its press release, the World Health Organization (WHO) announced that <a href="https://www.businessinsider.com/who-is-stopping-the-hydroxychloroquine-arm-of-the-solidarity-trial-2020-6">it's dropped hydroxychloroquine from its tests of coronavirus drugs</a> after it also found the drug to be ineffective in treating COVID-19 patients.As Business Insider's <a href="https://www.businessinsider.com/author/anna-medaris-miller">Anna Medaris Miller</a> reported, the WHO's test had been paused once before after it was reported that the drug "might be linked to an increased risk of death for coronavirus patients." However, a safety review didn't confirm those reports, and the tests were later restarted.<div type="image" title="hydroxychloroquine trump" height="1333" width="2000" msid="76487482" hostid="261"></div>In recent months, hydroxychloroquine has been provided to a wide range of people across the US — including <a href="https://www.businessinsider.com/us-veterans-affairs-hydroxychloroquine-coronavirus-patients-2020-5">1,300 veterans infected with COVID-19</a>.Donald Trump has also taken hydroxychloroquine, though he says he's routinely tested negative for COVID-19. <a href="https://www.businessinsider.com/president-trump-says-hes-been-taking-hydroxychloroquine-2020-5">The President first discussed his use of the drug on May 18</a>, at which point he said he had been taking it "every day" for a week and a half because he had heard "very good things" about it. "I take it," he said at the time. "I would've told you that three, four days ago, but we never had a chance because you never asked me the question." More recently at the start of June, White House physician <a href="https://www.businessinsider.com/white-house-physician-trump-is-healthy-took-hydroxychloroquine-2020-6">Sean Conley confirmed in a memo that Trump had been prescribed hydroxychloroquine</a>, zinc, and vitamin D, for a two-week period. The note also stated that Trump "remains healthy" with "no findings of significance or changes to report" from his annual physical, as Business Insider's <a href="https://www.businessinsider.com/author/grace-panetta">Grace Panetta</a> previously reported.Read more:<ul class="read-more-links"><li><a href="https://www.insider.com/woman-took-hydroxychloroquine-19-years-still-got-covid-19-2020-5">A Wisconsin woman with lupus has taken hydroxychloroquine for 19 years and still got COVID-19</a></li><li><a href="https://www.insider.com/doctor-charged-for-selling-fake-covid-19-cure-pack-2020-4">A California doctor was charged for selling a fake COVID-19 cure priced at '$3,995 for a family of four'</a></li><li><a href="https://www.insider.com/bureau-of-prisons-buys-60000-worth-of-hydroxychloroquine-2020-4">The Bureau of Prisons just bought $60,000 worth of hydroxychloroquine, the unproved coronavirus treatment touted by Trump</a></li><li><a href="https://www.insider.com/trump-stopped-fauci-hydroxycholoroquine-coronavirus-2020-4">Trump stopped Fauci from answering a question about the anti-malaria drug Trump is hyping despite it being unproven against the coronavirus</a></li></ul>

A clinical trial of hydroxychloroquine has been halted after the drug was deemed 'very unlikely to be beneficial' to COVID-19 patients

Washington, A clinical trial to evaluate the safety and effectiveness of <keyword id="4751090" type="PERSON" weightage="20" keywordseo="Hydroxychloroquine">hydroxychloroquine</keyword>, an antimalarial drug, for the treatment of adults hospitalized with COVID-19 has begun in the <keyword id="6356955" type="LOCATION" weightage="20" keywordseo="united-states">United States</keyword>, according to a release of the <keyword id="190126" type="COMPANY" weightage="20" keywordseo="National-Institutes-of-Health">National Institutes of Health</keyword> (NIH) on Thursday. The first participants have enrolled in the trial at <keyword id="1244379" type="LOCATION" weightage="20" keywordseo="Vanderbilt-University-Medical-Center">Vanderbilt University Medical Center</keyword>, Tennessee, reported Xinhua news agency. The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. All participants in the study will continue to receive clinical care as indicated for their condition. Those randomized to the experimental intervention will also receive hydroxychloroquine, according to the NIH. "Effective therapies for COVID-19 are urgently needed," said James Kiley, director of the Division of Lung Diseases of the National Heart, Lung, and Blood Institute, part of the NIH. "Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19," he said. While COVID-19 usually presents as an acute respiratory infectious illness, it can damage multiple organ systems, including heart, lung, and blood. Currently, no therapies have been demonstrated to prevent the progression of COVID-19 to severe illness, but several medicines available in the United States have been proposed as potential therapies, said the NIH. Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. In various studies, the drug has demonstrated antiviral activity, an ability to modify the activity of the immune system, said the NIH. The drug has an established safety profile at appropriate doses, leading to the hypothesis that it may also be useful in the treatment of COVID-19, according to the NIH. SEE ALSO:<a href="https://www.businessinsider.in/topic/coronavirus">Coronavirus News and Updates</a> <a href="https://www.businessinsider.in/india/news/how-to-check-coronavirus-symptoms-at-home/articleshow/74960334.cms">What are the Coronavirus symptoms and how to check for them at home</a>

US starts clinical trial of hydroxychloroquine for Coronavirus treatment

The <keyword id="6365231" type="COMPANY" weightage="20" keywordseo="all-india-institute-of-medical-sciences">All India Institute of Medical Sciences</keyword> (<keyword id="40458" type="COMPANY" weightage="20" keywordseo="AIIMS">AIIMS</keyword>) is learnt to have started screening of children aged 6-12 years for the clinical trials of <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>'s first indigenously developed Covid-19 vaccine, <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>. Sources said that the recruitment and clinical trials of the children aged 6-12 years will start from Tuesday. The trial on children aged 6-12 has already started at AIIMS Patna. Participants would be given the vaccine after their screening report comes. The trial would ensure if the Bharat Biotech jab is suitable for children. Delhi AIIMS has decided to start the trial drive after the recruitment and <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> for single-dose Covaxin for 12-18 age group is over. After the recruitment of 6-12 year-old children, AIIMS Delhi will be conducting trials for the age group 2-6 years of children. The trials are taking place at 525 centres. The screening of children for the trial of single-dose Covaxin among those aged between 2 and 18 years started at the AIIMS in <keyword id="6358777" type="LOCATION" weightage="20" keywordseo="New-Delhi">New Delhi</keyword> on June 7 after India's drug regulator had granted permission for conducting the Phase 2 and 3 clinical trials of Covaxin in the age group 2 to 18 years on May 12. AIIMS Patna, Mysore Medical College and Research Institute in Karnataka have also been selected to conduct clinical trials on children. Covaxin is being used on adults in India's ongoing Covid-19 vaccination drive since January 16 this year. The government last week cautioned that even though Covid-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in virus behaviour or epidemiology dynamics, and said preparations are being strengthened to deal with any such situation. A national expert group has been formed to review Covid-19 infections in children and approach the pandemic in a renewed way to strengthen the nation's preparedness, <keyword id="2665691" type="COMPANY" weightage="20" keywordseo="Niti-Aayog">NITI Aayog</keyword> Member (Health) V.K. Paul had said at a press conference. "The group has examined signs which were not available four-five months before." SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/sona-comstar-ipo-price-gmp-should-you-subscribe/articleshow/83505013.cms">Sona Comstar IPO worth ₹5,550 crore opens today – find out if this EV battery player has enough juice for a long ride</a> <a href="https://www.businessinsider.in/business/news/why-dodla-dairy-has-no-plans-to-expand-beyond-southern-india/articleshow/83503817.cms">Here’s why Dodla Dairy has no plans to expand beyond southern India for at least the next two years even with its IPO</a> <a href="https://www.businessinsider.in/stock-market/news/adani-group-under-sebi-scanner-on-market-manipulation/articleshow/83501698.cms">Gautam Adani loses over $7 billion in net worth after questions over the meteoric rise in group stocks</a>

AIIMS Delhi to start clinical trial of Covaxin on children aged 6-12 years from Tuesday

<ul><li>Mexico has agreed to help produce a Covid-19 vaccine for Latin America developed by the UK's Oxford University and pharmaceutical company <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword>, said Ebrard.</li><li>Mexico has been offered at least 2,000 doses of a <keyword id="9598578" type="UNKNOWN" weightage="20" keywordseo="Russian-COVID-19-Vaccine">Russian Covid-19 vaccine</keyword> and is to take part in its clinical trials, said Foreign Minister Marcelo Ebrard.</li></ul>Mexico has been offered at least 2,000 doses of a Russian Covid-19 vaccine and is to take part in its clinical trials, said Foreign Minister Marcelo Ebrard. This is "very good news because once again we are gaining time", Xinhua news agency quoted Ebrard as saying on Thursday. The Minister and Russian Ambassador to Mexico Viktor Koronelli met on Wednesday to discuss the country's participation in testing the "Sputnik V" vaccine developed by Russia's Gamaleya National Center of Epidemiology and Microbiology. "It will arrive in Mexico to begin testing. I will announce the date very soon, but yesterday both the offer and the acceptance were formalized," Ebrard said. Mexico has agreed to help produce a Covid-19 vaccine for Latin America developed by the UK's Oxford University and pharmaceutical company AstraZeneca, said Ebrard. Phase three trials of a vaccine developed by US pharmaceutical firm <keyword id="92247" type="COMPANY" weightage="20" keywordseo="Johnson-Johnson">Johnson &amp; Johnson</keyword> are likely to begin in September, he added. Mexico has so far reported a total of 543,806 <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> cases with 59,106 deaths, according health authorities. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/economy/news/these-are-the-20-countries-with-the-highest-gold-reserves/articleshow/77605753.cms">These are the 20 countries with the highest gold reserves</a> <a href="https://www.businessinsider.in/science/environment/news/these-are-the-top-20-cleanest-cities-in-india-in-2020/articleshow/77650052.cms">These are the top 20 cleanest cities in India— Indore tops the list for fourth year in a row</a>

Mexico to participate in clinical trials of Russian COVID-19 vaccine

<ul class="summary-list"><li><keyword id="3103584" type="PERSON" weightage="60" keywordseo="CureVac">CureVac</keyword> lost more than half its value after its <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> jab showed 47% effectiveness.</li><li>Results were based on <keyword id="83911" type="ORGANIZATION" weightage="60" keywordseo="Clinical-trials">clinical trials</keyword> conducted in Latin America and Europe on about 40,000 volunteers.</li><li>The company attributed its results to 29 virus strains in the 10 countries where its trials took place. </li></ul><a href="https://markets.businessinsider.com/stocks/cvac-stock">CureVac's</a> shares tumbled by as much as 50% on Thursday after the German pharmaceutical firm said its <a href="https://www.businessinsider.com/curevac-vaccine-efficacy-late-stage-trial-covid-bill-gates-2021-4">COVID-19 vaccine candidate failed</a> in a <keyword id="122283" type="PERSON" weightage="60" keywordseo="Clinical-trial">clinical trial</keyword>.Interim analysis of data from about 40,000 volunteers showed the biotech's jab is only 47% effective, falling short of the study's criteria and the minimum <a href="https://www.nbcnews.com/health/health-news/fda-s-cutoff-covid-19-vaccine-effectiveness-50-percent-what-n1245506">50% effectiveness threshold</a> required by US regulators.Data for the late-stage clinical trials that were conducted in Latin America and Europe was released after the US close on Wednesday. The company, backed by the Bill &amp; Melinda Gates Foundation, attributed its disappointing results to the fact there are at least 29 COVID-19 strains circulating in the 10 countries where its trials took place.The Gates foundation owns about 1.7% of CureVac, or 3.1 million shares, according to Bloomberg.CureVac's US shares are listed on the Nasdaq and plunged after hours from $94.79 at Wednesday's close to $49.54 at Thursday's market open.The 47% efficacy estimate is based on 134 COVID-cases that occurred at least two weeks after the administration of the second dose, the company <a href="https://www.curevac.com/en/2021/06/16/curevac-provides-update-on-phase-2b-3-trial-of-first-generation-covid-19-vaccine-candidate-cvncov/">said in a statement</a>."While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging," CureVac CEO Franz-Werner Haas said.CureVac said last year that it was working with <a href="https://markets.businessinsider.com/stocks/tsla-stock">Tesla</a> on a vaccine printer, which <a href="https://www.bloomberg.com/news/articles/2021-04-10/curevac-could-win-covid-shot-approval-in-may-augsburger-says">Elon Musk reportedly called</a> "an important product for the world." Musk said in a tweet about the biotech in April that it "sounds like they're a few months away from regulatory approval." This tweet was later deleted.The company will continue trials of its two-dose messenger RNA vaccine and expects to publish final analysis within the next few weeks.Read More: <a href="https://www.businessinsider.com/investing-strategy-advice-playbook-stocks-commodities-crypto-after-fed-meeting-2021-6" target="_blank" rel="noopener noreferrer">The Fed has left rates steady while signaling 2 potential hikes by the end of 2023. Here is what to do with your stocks, bonds, and digital assets, according to top Wall Street and crypto investors.</a>

German biotech CureVac's stock plunges 50% after its COVID-19 vaccine candidate failed a clinical trial

Moscow, Jun 17 (AP) Clinical trials of a Russian coronavirus vaccine have started Wednesday, the Health Ministry said in a statement. Two forms of the vaccine developed by the Moscow-based Gamaleya research institute - liquid and powder for injections - will be tested on two groups of volunteers, 38 people each, the statement said. The participants will be isolated in two Moscow hospitals. "Running clinical trials in the midst of a pandemic is a unique situation. So unprecedented measures have been taken - all potential participants of the trial ... spent two weeks (quarantined) in a sanatorium for observation," the ministry said, adding that the first injections are scheduled for Thursday and Friday. The Gamaleya institute made headlines last month when its director, professor Alexander Gintsburg, made a statement that he and other researchers had tried the vaccine on themselves before the start of human studies. He didn't clarify how many people injected themselves with the substance, but told the Interfax news agency that no one experienced any side effects: "Everyone is alive and well and cheerful." In comments to RIA Novosti, Gintsburg insisted that he and others hadn't intended to test the vaccine - they were merely looking to "protect themselves (from the virus) with the vaccine." "It's not a trial. It's self-defense in order for us to continue working (on the vaccine). Losing a staffer (to the virus) would delay the work. Knowing what they're developing, they consciously took this step. And so did I," Gintsburg said. Gintsburg's comments sparked criticism in the Russian medical community. The country's Association of Clinical Research Organizations issued a statement condemning the actions of the researchers as a "crude violation of the very foundations of clinical research, Russian law and universally accepted international regulations." The association accused Russian authorities of rushing researchers to finish clinical trials of COVID-19 vaccines, saying "an unattainable bar has been set. Many scientists understand that, yet they got involved in the crazy race, hoping to please those in power." Days before Gintsburg revealed trying the vaccine, Kremlin spokesman Dmitry Peskov extended "words of admiration" to scientists testing the vaccine on themselves. "Let's not name the facility, the people. But these are people that are fanatics in what they do in the best sense of the word," Peskov told the Kommersant newspaper in an interview in mid-May. According to Russian media, at least seven research facilities are currently working on coronavirus vaccines. (AP) RS RS

Russia starts clinical trials of COVID-19 vaccine

<a href="https://www.businessinsider.com/covid-19-booster-shots-likely-administered-after-6-months-wsj-2021-8"></a>Hello, and welcome to <keyword id="11894896" type="UNKNOWN" weightage="60" keywordseo="insider-healthcare" source="Orion">Insider Healthcare</keyword>. I'm Mohana Ravindranath, and I cover digital health and the future of <keyword id="11897506" type="UNKNOWN" weightage="100" keywordseo="healthcare" source="Orion">healthcare</keyword>. Today in healthcare news:<ul><li><a href="https://www.businessinsider.com/covid-booster-shot-jj-johnson-second-vaccine-dose-antibody-2021-8">Johnson &amp; Johnson says a second dose of its COVID-19 vaccine boosted antibodies in a small study;</a></li><li><a href="https://www.businessinsider.com/covid-19-booster-shots-likely-administered-after-6-months-wsj-2021-8">The Biden administration is reportedly poised to recommend booster shots after six months instead of eight;</a> </li><li><a href="https://www.businessinsider.com/clinical-trials-have-a-diversity-problem-is-tech-the-solution-2021-8">Companies hawking tech to recruit diverse clinical-trial candidates could be focused on the wrong problem</a>.</li></ul>If you're new to this newsletter, <a href="http://newsletter.businessinsider.com/join/4np/newsletter.businessinsider.com/join/4np/insider-healthcare">sign up here.</a> Send tips, gripes, comments and predictions for healthcare's future to <a href="mailto:adeangelis@insider.com">mravindranath@insider.com</a> or tweet <a href="https://www.twitter.com/ravindranize">@ravindranize</a>. On to the news...<a href="https://www.businessinsider.com/covid-booster-shot-jj-johnson-second-vaccine-dose-antibody-2021-8"><div type="image" title="johnson &amp; johnson vaccine" height="2045" width="4090" msid="85657193" hostid="261"></div></a><h3><a href="https://www.businessinsider.com/covid-booster-shot-jj-johnson-second-vaccine-dose-antibody-2021-8">J&amp;J says a booster shot of its single-dose COVID-19 vaccine raises antibody levels and could be given eight months after the first dose</a></h3><ul><li>A second dose of Johnson &amp; Johnson's single-dose COVID-19 vaccine boosted antibodies in a small study</li><li>Antibody levels were nine times higher after the second dose than after the original.</li><li><a href="https://www.businessinsider.com/covid-booster-shot-jj-johnson-second-vaccine-dose-antibody-2021-8">The company plans to meet with US health officials to discuss the possibility of administering the booster eight months after the first dose. </a></li></ul><a href="https://www.businessinsider.com/covid-booster-shot-jj-johnson-second-vaccine-dose-antibody-2021-8">Read more&gt;&gt;</a><a href="https://www.businessinsider.com/covid-19-booster-shots-likely-administered-after-6-months-wsj-2021-8"><div type="image" title="covid vaccine cards" height="3655" width="4888" msid="85657195" hostid="261"></div></a><h3><a href="https://www.businessinsider.com/covid-19-booster-shots-likely-administered-after-6-months-wsj-2021-8">Report: The Biden administration is likely to recommend COVID-19 booster shots after six months instead of eight</a></h3><ul><li>The Biden administration will likely approve COVID-19 booster shots for fully vaccinated adults six months after they're immunized, The Wall Street Journal <a href="https://www.businessinsider.com/reviews/out?u=https%3A%2F%2Fwww.wsj.com%2Farticles%2Fbiden-administration-plans-covid-19-vaccine-boosters-at-six-months-instead-of-eight-11629919356">reported.</a></li><li>The administration previously said it would call for boosters eight months people got their shots. </li><li><a href="https://www.businessinsider.com/covid-19-booster-shots-likely-administered-after-6-months-wsj-2021-8">The move is based on data from vaccine manufacturers running on a six-month booster shot schedule. </a></li></ul><a href="https://www.businessinsider.com/covid-19-booster-shots-likely-administered-after-6-months-wsj-2021-8">Get the news&gt;&gt;</a><h3><a href="https://www.businessinsider.com/clinical-trials-have-a-diversity-problem-is-tech-the-solution-2021-8"><div type="image" title="Clinical trial lab research drug medicine" height="4125" width="5500" msid="85657197" hostid="261"></div></a></h3><h3><a href="https://www.businessinsider.com/clinical-trials-have-a-diversity-problem-is-tech-the-solution-2021-8">Clinical trials have a diversity problem, but tech might not be the answer</a></h3><ul><li>Startups are raising millions to use sophisticated marketing and messaging tech to reach more racially and socioeconomically diverse patients. </li><li>Clinical trials generally underrepresent racial minorities, though COVID-19 vaccine development has highlighted the issue for major drug companies. </li><li><a href="https://www.businessinsider.com/clinical-trials-have-a-diversity-problem-is-tech-the-solution-2021-8">Equity experts say the tech likely won't move the needle on the real issues keeping minorities out of clinical trials, including lack of access to health care.</a></li></ul><a href="https://www.businessinsider.com/clinical-trials-have-a-diversity-problem-is-tech-the-solution-2021-8">Read the full story&gt;&gt;</a>More stories we're reading: <ul><li><a href="https://www.businessinsider.com/pfizer-vaccine-name-comirnaty-explained-mashup-community-immunity-mrna-covid-2021-8">The Pfizer vaccine's full name - Comirnaty - is a mashup of 'Covid-19', 'mRNA', and more</a> (Insider) </li><li><a href="https://www.statnews.com/2021/08/25/headspace-ginger-merger-mental-health/">Mental health-focused tech companies Headspace and Ginger are merging</a> (Stat)</li><li><a href="https://www.mobihealthnews.com/news/study-finds-95-patients-were-able-complete-medication-abortion-telehealth-services">A new study in JAMA Network Open finds telehealth-facilitated medication abortions to be safe and effective</a> (MobiHealthNews)</li><li><a href="https://www.wired.com/story/social-media-algorithms-are-controlling-how-i-grieve/">Steven Blum explores how social media changes the "digital afterlife" and grieving</a> (Wired)</li></ul>-Mohana

How clinical trial recruitment tech falls short

<div class="image-container display-table float_right"><div><div class="image"><keyword id="6360409" type="ORGANIZATION" weightage="60" keywordseo="NASA">NASA</keyword>Participants in NASA's bed <keyword id="6355244" type="ORGANIZATION" weightage="60" keywordseo="Study">study</keyword> can watch movies, play video games, and read book, so long as they don't get out of bed for 70 days.</div></div></div>Need some extra cash? If you want to help the <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">science</keyword> community (and potentially save some lives) there are some unconventional ways to make money by selling your body.
Below is a short list:
Sell your blood plasma Payout (per donation): $20-$50
Plasma is the largest component of the human blood. It's a clear liquid that contains mostly water but is also filled with enzymes, antibodies, and other proteins. The plasma is used to create therapies that treat people with blood clotting disorders, autoimmune diseases, and even burn victims. <a href="http://www.donatingplasma.org/" target="_blank">According to DonatingPlasma.org</a>, donating plasma is often called "the gift of life," since in most cases synthetic therapies are not available.
During plasma donation, blood is drawn and an automated machine separates the plasma from other blood components, which are returned to the donor. Most plasma collection facilities set their own compensation rate, but the average payout <a href="http://moneysavingmom.com/2012/11/31-ways-to-earn-extra-income-before-christmas-donate-plasma-day-28.html" target="_blank">ranges from $20-$50 per donation</a>. You can donate roughly once a month, according to the <a href="http://www.redcrossblood.org/donating-blood/types-donations/plasma-donation" target="_blank">American Red Cross</a>. To find a licensed and certified plasma center, <a href="http://www.donatingplasma.org/donation/find-a-donor-center" target="_blank">click here.</a>
Donate your sex cells Payout for eggs (per donation): $5,000-$10,000; Payout for sperm (per donation): $30-$200
Egg donation allows women whose ovaries do not produce healthy eggs to become pregnant using another woman's donated eggs. In the United States, eggs donors can net anywhere from $5,000 to $10,000 (the upper-limit recommended by The American Society of Reproductive Medicine). At Weill Cornell, the compensation per egg donation cycle is <a href="http://eggdonorcornell.com/about_us/faq.html" target="_blank">$8,000</a>, including a free medical screening. The medical college <a href="http://eggdonorcornell.com/whats_involved/" target="_blank">outlines the standard steps for egg donation</a>, which requires about a four-week time commitment.
During the egg donation cycle, patients are injected with fertility drugs so that the ovaries make more mature eggs than normal. (Eligible women are generally between the ages of 21 and 35 sine older women's eggs don't respond as well to fertility drugs). The actual egg retrieval procedure takes about 20 minutes, but may require several days of recovery. Donors should be aware of the risks involved in the egg donation process (largely related to the hormones used) before signing up.
Men can donate their sperm, although this isn't quite as lucrative as egg donation given that it's much easier process. Men are paid anywhere from $30 to $200 per donation, <a href="http://www.fertilitycommunity.com/fertility/sperm-donor-basics.html" target="_blank">according to FertilityCommunity.com</a>, but that can add up to more than pocket change if you donate hundreds of samples (many programs require a six-month or one-year donation commitment).
Lie in bed for 70 days straight Payout: $18,000
NASA will pay you to stay in bed for 70 days, 24 hours a day, to simulate some of the changes that an astronaut's body goes through in weightlessness during space flight. To apply for the bed rest study, <a href="https://bedreststudy.jsc.nasa.gov/apply.aspx" target="_blank">fill out this form</a>. If you think this sounds like an easy task, keep in mind that the selection committee is looking for participants that possess the physical and psychological traits of a real astronaut. Roni Cromwell, a senior scientist for the study <a href="http://www.forbes.com/sites/crossingborders/2013/09/18/nasa-will-pay-18000-to-watch-you-rest-in-bed-for-real/" target="_blank">told Forbes</a>: "We want to make sure we select people who are mentally ready to spend 70 days in bed. Not everyone is comfortable with that. Not every type of person can tolerate an extended time in bed."
Donate a testical Payout: $35,000
On an episode of <a href="http://www.tlc.com/tv-shows/extreme-cheapskates/videos/meet-thrifty-mark.htm" target="_blank">TLC's "Extreme Cheapskates</a>" a Las Vegas man, Mark Parisi, has figured out a way to live a cheap life by signing up for medical trials, saving himself $750 or more, according to a trailer for the show. Most recently, Parisi agreed to donate one of his testicles, which will be replaced by an artificial one, for $35,000. During an appearance on <a href="http://www.youtube.com/watch?v=sgg4-1lVuFo" target="_blank">CBS' "The Doctors,"</a> Parisi revealed that he would us the money to buy a Nissan 370Z.
Sign up for a paid clinical trials Payout: Varies by program 
The National Institute for Health runs a searchable database, <a href="http://clinicaltrials.gov/" target="_blank">ClincalTrials.gov</a>, for human clinical studies around the world. Participants may be a guinea pig for new medical products, like drugs to treat high blood pressure, or be a part of observational research, like a study that records the effects of different lifestyles on heart health. Subjects are generally paid to be a part of clinical trials, and in general, the bigger the risk, the bigger the reward. According to the <a href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm121345.htm#fda" target="_blank">U.S. Food and Drug Administration</a>: "The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of discomfort that might be associated with medical or surgical procedures related directly to the study."
Enroll in a psychological study Payout: Varies by program 
Paid psychological studies, such as those that examine behavior and brain function, may not generate as high of a return as clinical trials, but they are generally lower risk and require a shorter time commitment. Most research universities keep an online database of studies so people can easily sign up. For example, here's a list of the most recent <a href="http://www.psych.nyu.edu/research/paidstudies.html" target="_blank">paid research studies offered by New York University</a>. You <a href="http://www.psych.nyu.edu/research/paid-studies/Film%20Facts%20Exp%207-25-14%20approved%20flyer.pdf" target="_blank">can make $10 to watch a movie</a> or <a href="http://www.psych.nyu.edu/research/paid-studies/An%20fMRI%20Study%20Exp%2010-03-14.pdf" target="_blank">$50 to get your brain scanned</a>.

6 Ways To Make Money By Selling Your Body To Science

<div class="image-container float_right" style="width:400px"><div class="image"></div><a href="http://en.wikipedia.org/wiki/File:%22_12_-_ITALY_-_Italia_cuisine_-_aglio_pomodorini_e_prezzemolo_%28_garlic,_tomatoes,_parsley_%29_su_tagliere_-_wooden_chopping_board.JPG">Wikimedia Commons</a></div>The results of a five-year-long <keyword id="122283" type="UNKNOWN" weightage="60" keywordseo="Clinical-trial">clinical trial</keyword> appear to prove once and for all that we should all be eating like the Greeks. 
The study, published this week in the <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1200303?query=featured_home&amp;#t=article">New England Journal of Medicine</a>, found that while people ages 55-80 on the Mediterranean <keyword id="6358230" type="PERSON" weightage="60" keywordseo="diet">diet</keyword> did not lose any weight, their risk of heart disease and stroke decreased by almost 30 percent compared to those on a typical low-fat diet.
The study took place in Spain, where scientists randomly assigned 7,447 people who were either overweight, smokers, diabetic, or had any other heart disease risk factors to follow the Mediterranean diet or a low-fat one.
It was particularly significant because it was <a href="http://www.nytimes.com/2013/02/26/health/mediterranean-diet-can-cut-heart-disease-study-finds.html?pagewanted=all&amp;_r=1&amp;" target="_blank">considered to be the first major clinical trial to measure the diet's effect on heart risks</a>. The results were so clear that by the end of five years, it was thought "unethical" to continue the study.
Research supporting the effectiveness of the Mediterranean diet is nothing new, and it has long been <a href="http://www.mayoclinic.com/health/mediterranean-diet/CL00011" target="_blank">associated with reduced risk for heart attack, cancer, Parkinson's and Alzheimer's diseases</a>. Most analysis, however, has focused on the health of those living in Mediterranean countries (such as <keyword id="6357856" type="COUNTRY" weightage="60" keywordseo="greece">Greece</keyword> and Southern Italy) who were already on the diet. 
Mediterranean diets are heavy on fruits, vegetables, whole grains, legumes, and nuts, and replace butter with olive and canola oils. Instead of using salt to flavor foods, the Mediterranean diet uses herbs and spices, and dieters are encouraged to eat fish and poultry at least twice a week and limit red meat to no more than a few times a month.
But it's all about being balanced — the diet also allows you to enjoy sweets in moderation, an occasional glass of red wine, and to try to eat as many meals as possible with family and friends.

Even More Proof That People Should Embrace The Mediterranean Diet

<ul><li>In its draft guidelines published in February 2018, India’s drug regulator mandated the upfront payment of 60% of <keyword id="6356362" type="UNKNOWN" weightage="20" keywordseo="compensation">compensation</keyword> fee if a human subject was found to have suffered a permanent disability or death as a result of a <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword>. </li><li>The payment was to be made within 15 days after a decision was taken by a pre-appointed ‘Ethics Committee’ overseeing the trial, with the remaining 40% of the compensation fee coming within 30 days of the decision. </li><li>However, after backlash from pharmaceutical companies and even the World Health Organisation (WHO), the Indian government is considering a plan to scrap the compensation clause. </li></ul> When India’s <keyword id="589469" type="COMPANY" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organization">Central Drugs Standard Control Organization</keyword> (CDSCO), the national drug regulator, released the draft guidelines for laws on <a href="http://www.cdsco.nic.in/writereaddata/Draft%20CT%20Rules%20sent%20for%20Publication.pdf">new drugs and clinical trials </a>in February 2018, it included an important compensation clause to protect human subjects. The clause mandated that a sponsor of a clinical trial would have to pay upfront 60% of the compensation fee if a human subject was found to have suffered a permanent disability or death as a result of the trial. The payment was to be made within 15 days after a decision was taken by a pre-appointed Ethics Committee overseeing the trial, with the remaining 40% of the compensation fee coming within 30 days of the decision. However, after backlash from pharmaceutical companies and even <a href="https://www.livemint.com/Industry/pdHu6zfNmDDCnHDbh1svVP/WHO-tells-govt-strict-clinical-trial-rules-will-drive-away-d.html">the World Health Organisation (WHO</a>), the Indian government is considering a plan to scrap the compensation clause, an official <a href="https://indianexpress.com/article/business/govt-may-ease-compensation-clause-in-clinical-trial-rules-5464128/">told Indian Express</a>. In July, the WHO asked India’s health ministry to reconsider the compensation rule because if approved, it would discourage pharmaceutical companies as well as the WHO from conducting clinical trials in India. The agency explained that the appointment of the seven-member ethics committee by the Indian government was not in line with international best practices, and would raise questions about their competence. Similar sentiments were also echoed by the Indian Council of Medical Research (ICMR). The issue of speedy compensation for people affected in drug trials is a particularly contentious one. Out of the nearly 5,000 deaths that have resulted from clinical trials between January 2006 and November 2017, compensation has been afforded to the kin of only <a href="https://www.thenational.ae/world/asia/thousands-of-indians-die-in-unethical-clinical-trials-1.770992">187 </a>participants, according to an RTI request filed by the Swasthya Adhikar Manch, an Indore-based NGO. The Indian government knows that clinical trials are key to supporting homegrown research and innovation in the <keyword id="6363818" type="UNKNOWN" weightage="20" keywordseo="Pharma">pharma</keyword> sector. However, if it eventually scraps the compensation clause, it will have to introduce an adequate clause that protects the rights of trial participants. If not, this will likely be seen as another case of the government giving into the pressure from big business at the expense of its citizens’ interests. SEE ALSO: <a href="https://www.businessinsider.com/r-indias-drug-regulator-expects-to-finalize-new-clinical-trial-rules-in-two-months-2018-5">India’s drug regulator expects to finalize new clinical trial rules in two months</a> <a href="https://www.businessinsider.in/india-spends-just-1-2-of-its-gdp-on-healthcare-but-a-policy-can-change-that/articleshow/64665303.cms">India spends just 1.2% of its GDP on healthcare, but a policy can change that</a>

You Searched For "Clinical trial" and got 11 results

Startups are raising tens of millions to make clinical trials virtual. But experts say we're still years away.

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A clinical trial of hydroxychloroquine has been halted after the drug was deemed 'very unlikely to be beneficial' to COVID-19 patients

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US starts clinical trial of hydroxychloroquine for Coronavirus treatment

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AIIMS Delhi to start clinical trial of Covaxin on children aged 6-12 years from Tuesday

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Mexico to participate in clinical trials of Russian COVID-19 vaccine

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German biotech CureVac's stock plunges 50% after its COVID-19 vaccine candidate failed a clinical trial

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Russia starts clinical trials of COVID-19 vaccine

PTI

How clinical trial recruitment tech falls short

Mohana Ravindranath

6 Ways To Make Money By Selling Your Body To Science

Dina Spector

Even More Proof That People Should Embrace The Mediterranean Diet

Megan Willett

India’s government may scrap an important compensation rule for human subjects in clinical trials in a bid to placate pharma companies

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