Sharing Clinical Trial Data: Challenges and a Way Forward – A Workshop : Health and Medicine Division

“An ad hoc planning committee under the auspices of the National Academies of Sciences, Engineering, and Medicine, will plan and conduct a two-day public workshop to discuss advances, challenges, and opportunities in clinical trial data sharing efforts since the release of the 2015 Institute of Medicine report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. This workshop is co-sponsored by the Wellcome Trust.

WORKSHOP OBJECTIVES:

Consider the value and potential risks/costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, primary and secondary researchers, and patients;
Review the current landscape of clinical trial data sharing and reuse across public and private sectors (e.g. policies, platforms, collaborations, data sharing culture, published research output);
Examine use cases and trends from across public and private sectors when it comes to success, failure, lessons learned, and value;
Consider the perspectives and expectations of primary and secondary researchers, clinical trial participants, patient organizations, research sponsors (pharmaceutical companies and nonprofit organizations), journals, institutions, and federal agencies; and
Discuss next step opportunities for stakeholders to better harmonize incentives, policy, data standards, and governance to encourage the sharing and reuse of clinical trial data.

The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines….”

Data sharing from clinical trials: lessons from the YODA Project – STAT

“This week, the National Academies of Science, Engineering, and Medicine are convening the workshop “Sharing Clinical Trial Data: Challenges and a Way Forward” just shy of five years after the Institute of Medicine released its seminal report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.”

During this time, the scientific culture regarding data sharing has shifted. Just last week, the National Institutes of Health requested public comments on its draft “Policy for Data Management and Sharing.” In 2018, the International Committee of Medical Journal Editors began requiring data-sharing plans for clinical trials as a condition for publication in member journals. And platforms such as ClinicalStudyDataRequest.com, Project Data Sphere, and BioLINCC have emerged or grown. These platforms use a variety of different governance structures and models for data access, developed both with and without the support of industry or government….

The Yale Open Data Access (YODA) Project, which two of us (J.S.R. and H.M.K.) co-direct, launched in 2011 and formed a partnership with Johnson & Johnson in 2014. This five-year partnership offers an opportunity to reflect on some of the questions about sharing clinical trial data that may inform ongoing and future efforts….”

Characteristics of mental health trials registered in ClinicalTrials.gov – ScienceDirect

Abstract:  The ClinicalTrials.gov registry was established in 2000 to address concerns about publication bias and public access to information about clinical trials. We aimed to evaluate differences between for-profit and non-profit sponsors of efficacy mental health trials registered in ClinicalTrials.gov on key trial characteristics that relate to data integrity. We also sought to evaluate whether the registry is fulfilling its purpose as a means of promoting transparency between researchers and the public by providing complete and quality information about the trials it contains. We found that trials tend to be small, use a placebo instead of an active comparator, and employ randomization and blinding. We discuss the implications of these design characteristics and the limitations of the registry.

 

Frequency and format of clinical trial results dissemination to patients: a survey of authors of trials indexed in PubMed

Abstract:  Objective Dissemination of research findings is central to research integrity and promoting discussion of new knowledge and its potential for translation into practice and policy. We investigated the frequency and format of dissemination to trial participants and patient groups. Design Survey of authors of clinical trials indexed in PubMed in 2014–2015. Results Questionnaire emailed to 19 321 authors; 3127 responses received (16%). Of these 3127 trials, 2690 had human participants and 1818 enrolled individual patients. Among the 1818, 498 authors (27%) reported having disseminated results to participants, 238 (13%) planned to do so, 600 (33%) did not plan to, 176 (10%) were unsure and 306 (17%) indicated ‘other’ or did not answer. Of the 498 authors who had disseminated, 198 (40%) shared academic reports, 252 (51%) shared lay reports, 111 (22%) shared both and 164 (33%) provided individualised study results. Of the 1818 trials, 577 authors (32%) shared/planned to share results with patients outside their trial by direct contact with charities/patient groups, 401 (22%) via patient communities, 845 (46%) via presentations at conferences with patient representation, 494 (27%) via mainstream media and 708 (39%) by online lay summaries. Relatively few of the 1818 authors reported dissemination was suggested by institutional bodies: 314 (17%) of funders reportedly suggested dissemination to trial participants, 252 (14%) to patient groups; 333 (18%) of ethical review boards reportedly suggested dissemination to trial participants, 148 (8%) to patient groups. Authors described many barriers to dissemination. Conclusion Fewer than half the respondents had disseminated to participants (or planned to) and only half of those who had disseminated shared lay reports. Motivation to disseminate results to participants appears to arise within research teams rather than being incentivised by institutional bodies. Multiple factors need to be considered and various steps taken to facilitate wide dissemination of research to participants.

Can an open drug discovery model find a solution for rare brain cancers in children? « OICR News

“OICR-funded drug discovery project’s unique ‘open science’ business model is accelerating the search for a solution to lethal pediatric brain cancers Diffuse intrinsic pontine glioma (DIPG) is a lethal and inoperable brain cancer with a median survival of less than a year from diagnosis. Finding solutions to this disease is challenging due to its rarity, scientific complexity and its presentation in pediatric populations. An OICR-funded team of researchers, led by Dr. Aled Edwards from M4K Pharma, have developed new potential drug candidates for DIPG that they will test in animal models in the coming months. They’ve reached this milestone ahead of schedule, with fewer resources required than anticipated, by using an ‘open drug discovery’ approach – sharing their methods and data with the greater research community to streamline the drug discovery process….”

Laura and John Arnold Foundation contributes funding to launch Vivli, the Center for Global Clinical Research Data – Vivli

“Vivli, a Massachusetts-based nonprofit, has received $2 million from the Laura and John Arnold Foundation to build a first-of-its-kind data sharing platform for clinical trial research. The innovative platform will include a data repository, analysis tools and a dynamic search engine. It will provide transparency and access to clinical research data from around the globe, break data out of existing silos, and accelerate scientific discovery to improve human health.”

Clinical trials revolution could change the future of medical research | Science | The Guardian

“In tumultuous times, it is easy to miss the fact that science is undergoing a quiet revolution. For several years now, concerns have been peaking in biomedicine about the reliability of published research – that the results of too many studies cannot be reproduced when the methods are repeated. Alongside growing discontent, the scientific community has answered by driving forward a raft of open science reforms. From initiatives to making research data publicly available, to ensuring that all published research can be read by the public, the aim of these reforms is simple: to make science more credible and accessible, for the benefit of other scientists and the public who fund scientific research.”

WHO | Major research funders and international NGOs to implement WHO standards on reporting clinical trial results

“Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.”

Journal of Health Psychology

Abstract: “Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.”

Journal of Health Psychology

Abstract: “Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.”