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Online portal of thousands of clinical trials could aid disease research

first_img By Jocelyn KaiserJul. 19, 2018 , 10:00 AM Sign up for our daily newsletter Get more great content like this delivered right to you! Country Country * Afghanistan Aland Islands Albania Algeria Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Cote d’Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People’s Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People’s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Norway Oman Pakistan Palestine Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Qatar Reunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Vietnam Virgin Islands, British Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Online portal of thousands of clinical trials could aid disease research Under pressure to be more transparent about the results of drug testing studies, some companies have begun to share anonymized patient data from clinical trials with approved researchers on secure websites. An online platform launched today aims to expand such efforts by offering a one-stop clearinghouse for those seeking to mine these data for new insights.The platform, created by Vivli, a nonprofit based in Cambridge, Massachusetts, debuts with access to more than 4000 clinical trial data sets from eight companies and nonprofits. It also features tools for combining and analyzing the data. “This is the first time it’s all going to be available in one place,” Vivli Executive Director Rebecca Li says.Vivli, which spun out of a policy think tank at Harvard University–affiliated Brigham and Women’s Hospital in Boston, is part of a push to encourage drug developers to share trial data—even negative results, findings that show a treatment has no benefit. Companies seeking U.S. regulatory approval for a drug, as well as investigators funded by the National Institutes of Health, must post limited, summary results on ClinicalTrials.gov. But many researchers and policy analysts believe sharing detailed raw data on individual patients, stripped of identifying information, would be valuable. Researchers could confirm that a drug works, look for side effects, or explore new questions. Starting this month, the International Committee of Medical Journal Editors—which includes the leaders of many major journals—will ask submitting authors to include a data sharing plan that can include patient data. Such sharing remains controversial. In 2016, Jeffrey Drazen, editor of The New England Journal of Medicine, worried in an editorial that it would embolden “research parasites”—scientists who request others’ data and quickly publish papers, preempting the scientists who generated the data. But Drazen ultimately endorsed the committee’s plan.Some companies have already responded. Drug giant Johnson & Johnson allows researchers to request patient data at a 5-year-old site called YODA, sponsored by Yale University, whereas GlaxoSmithKline and 13 other firms share data at ClinicalStudyDataRequest.com.Vivli aims to streamline researchers’ ability to find, request, and combine data from these and other sites, Li says. It will both list data deposited elsewhere and eventually host data sets. (Of the more than 4000 studies, about 2500 data sets are listed on the Vivli site and the rest can be accessed from the site.) GlaxoSmithKline, for example, is allowing Vivli to list more than 2000 of its data sets. Vivli will have an independent panel review some requests, but refer others to the sites that hold the data. Because of patient privacy concerns, users often won’t be able to download the data to their own computers, but will use the Vivli platform.Companies can purchase memberships to have Vivli share their data. Academic researchers will pay $2000 to $4500 per study for storage and sharing services. Data miners can freely use the site’s basic tools for a year, but after that will pay a daily fee of $12. Both the Bill & Melinda Gates Foundation and Harvard plan to help researchers cover data submission costs.At the Gates Foundation in Seattle, Washington, officials anticipate that many grantees will deposit their clinical trial results in Vivli in order to meet the foundation’s data-sharing requirements. And Harvard officials will be encouraging faculty to add their clinical data sets, including hundreds from already completed studies.Some data sharing advocates are pleased by Vivli’s arrival. “We need to get everyone behind one platform instead of having a proliferation of these things,” says epidemiologist Evan Mayo-Wilson of Johns Hopkins University in Baltimore, Maryland. There is uncertainty about demand, however. A 2016 study by researchers at Duke University in Durham, North Carolina, found that scientists had requested access to just 16% of more than 3200 patient data sets available on three platforms. One obstacle was the difficulty finding the data, says Duke cardiologist Eric Peterson, an author. Vivli could resolve that problem, he says, by serving as a clinical data “card catalog.”With reporting by Elizabeth Gamillo.center_img A new online platform will make it easier for researchers to request anonymized clinical trial data for individual patients. Email Click to view the privacy policy. Required fields are indicated by an asterisk (*) Colin McPherson/Alamy Stock Photo last_img

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