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 MRCT Center 2016 Annual Meeting was held on December 7, 2016 and was attended by about 80 stakeholders, including representatives from academia, governmental agencies, institutional review boards, the pharmaceutical industry, and non-profit organizations.
The major themes of the MRCT Center 2016 Annual Meeting included the draft ICH E17 guidelines, data sharing and data transparency, and individual return of results (IRR). The draft ICH E17 guidelines, which delineates guidelines for the development of multi-regional clinical trials (MRCTs) for drug development and approval in regulatory authorities around the world were addressed, and a dynamic group discussion followed. Next, data sharing and data transparency were addressed, including the MRCT Center’s work to create Vivli, an independent non-profit center for global research data and invited speakers shared their insights on this pivotal topic. Dr. Murray Stewart (GlaxoSmithKline), the keynote speaker, addressed the current state of data transparency, and the value of global clinical trial data sharing. Finally, the Individual Return of Results (IRR) Working Group presented two major deliverables, the IRR Recommendation Document and IRR Toolkit, and outlined the eight principles the group has drafted. Invited speakers offered their perspectives and suggested revisions on the MRCT Center’s IRR documents.
Proceedings from this meeting are available and presentations are available for sponsors below.
The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.
The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency. The Post-Trial Responsibilities (PTR) Working Group developed an Ethics Framework with two main deliverables: a PTR Guidance Document and a PTR Toolkit. Invited speakers shared their perspectives and suggestions for revisions. The Data Sharing and Data Transparency Initiative’s current progress on developing a blueprint for a new, not-for-profit entity was presented. Invited speakers shared their perspectives on the project vision to date.
MRCT Center at Harvard 2014 Annual Meeting was held on 3 December 2014 and was attended by by more than 60 stakeholders from governmental agencies, pharmaceutical industry, academia, patient advocates, media representatives and others. MRCT Center at Harvard’s Annual Progress Report 2014 was released at the meeting.
The meeting focused on returning aggregate results to research participants. MRCT Center at Harvard faculty co-directors presented drafts of the Return of Results Guidance Document and Toolkit which was followed by perspectives from various stakeholders. In addition, the faculty co-directors gave an overview of MRCT Center at Harvard’s work in India addressing regulatory issues, causality determination, and compensation calculation. Presentations and Proceedings from this meeting are now available
The Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions Conference, held on May 17th, 2013, drew close to 200 participants and proved to be an exceptional platform to discuss matters surrounding clinical trial data sharing.
Harvard MRCT is grateful to all the Conference Speakers, Panelists, and attendees who made this a stimulating and productive day.
