As the launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today.
Dr. Robert Califf, former Commissioner of FDA, delivered the opening keynote entitled, ‘New Possibilities for Medical Product Safety in the Digital Revolution.’ The conversation that followed was expansive, thought-provoking, and dynamic. Diverse perspectives on many topics were considered, including the sources, curation, and use of data; the importance of understanding the benefit to risk and not simply a safety risk; communication of the balance of benefit and risk to patients; and communication between stakeholders, regulators, and the global population. The MRCT Center will continue to explore the themes identified during the meeting to develop a concrete plan for the future.
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.
Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. A limited number of surveillance systems have utilized innovative analytical and statistical techniques, including data mining, machine learning, and artificial intelligence, to interrogate real-world data. While these approaches are important and complementary, they fail to harness the full power of cooperation across stakeholders and of global inclusivity. In collaboration with others, the MRCT Center is launching the Proactive Safety Surveillance initiative which aims to improve upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s).
As the official launch to the project, on May 3, 2019, MRCT Center will invite stakeholders from industry, government and academia to participate in an invitation-only small meeting or Visioning Session in order to identify the salient issues, the challenges, the opportunities and to further explore the need for and characteristics of such an approach. The session will be a partnership of best minds with diverse perspectives to enable the evaluation and adaptation of new technologies, methodologies, and insights to better support the determination of the medical importance and validity of safety signals for the global community. While inevitably challenging, we believe exploration of such questions holds the promise of increasing the timely detection, validation, and communication of important safety information.
Plain Language for Health. A Writing and Design Workshop for Health Research and Practice (March 28-29)
The MRCT Center co-sponsored a two-day workshop held by Tufts on March 28th-29thfocused on how to use plain language principles to improve research-related communications. Approximately 70 attendees from academic medical centers, the public health field and pharmaceutical companies attended.
Our very own Health Literacy in Clinical Research workgroup co-chair, Christopher Trudeau, focused an entire day of the workshop on how to develop informed consent forms using health literacy principles given the recent Common Rule revisions. In addition, Sarah White and Sylvia Baedorf Kassis sat on two separate panels to share their perspectives on how health literacy can be integrated into consent processes and clinical trials at large, respectively.
NASEM Roundtable on Health Literacy. A Workshop on Health Literacy in Clinical Trials: Practice and Impact (April 11)
On April 11, Barbara Bierer gave the opening keynote at the National Academies of Science, Engineering, and Medicine Roundtable on Health Literacy “Workshop on Health Literacy in Clinical Trials: Practice and Impact.” The need for health literacy in clinical research was described as an ethical imperative and a practice that could benefit participants andresearch studies. The connection between health literacy and diversity efforts was made even more evident over the course of the day’s discussions. Inclusive community engagement and research education at various points of an individual’s healthcare journey, were identified as critical to supporting research awareness, understanding, and participation. A repeated theme of the day was the need for greater sensitivity when considering the context within which research information is presented and discussed. A summary report of the workshop will be released by the Roundtable on Health Literacy later this year.
The third Research, Development, and Regulatory Roundtable (R3) was held at the Washington, D.C. offices of Ropes & Gray LLP on March 7, 2019. Stakeholders convened to discuss Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguity. Afterward, attendees were updated on developments related to the application of the EU General Data Protection Regulation (GDPR) to research.
The use for clinical trial recruitment purposes of data that were originally collected for another business purpose raises several legal and regulatory questions, including whether the companies have authority to use health care data for these secondary purposes; whether health care providers may receive payment for permitting secondary uses of their data or for the results of these secondary use; the extent to which third-party payors, or agents of those payors, may be involved in research recruitment; and which entities may contact patients directly to discuss possible enrollment in a clinical trial. During this session, roundtable participants discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.
The MRCT Center recently authored ‘Universal Funder Responsibilities That Advance Social Value’ in the American Journal of Bioethics.
This article outlines the responsibilities of, and specific recommendations for, research funding organizations to promote the novelty, significance, rigor, and impact of research they fund.
The use for clinical trial recruitment purposes of data that were originally collected for another business purpose raises several legal and regulatory questions, including whether health care providers may receive payment for permitting secondary uses of their data, the extent to which third-party payors, or agents of those payors, may be involved in research recruitment, and which entities may contact patients directly to discuss possible enrollment in a clinical trial. During this session, roundtable participants discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.
The R3 meeting took place on Thursday, March 7, from 10:00am – 3:00pm at the Washington, D.C. offices of Ropes & Gray LLP.
In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project.
The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
Roundtable attendees considered the advantages and drawbacks of the two pathways by which patients may request access to investigational therapies.
Among other things, participants explored the impact of each pathway on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies on Right to Try and Expanded Access.
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research.
For additional information about sponsoring and participating in the R3, please contact the MRCT Center.
