As we celebrate Health Literacy Month , we invite you to join us on October 23, 2023, from 12-1 PM ET to explore actionable strategies to incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand — the key tenets of health literacy. This approach enhances engagement, empowers patients, improves communication, and addresses knowledge gaps, paving the way for improved health outcomes and enriched participant experiences.
Topics: 1) Update on the GDPR, including discussion of the EU/US data privacy framework; 2) Considerations for ensuring accurate clinical trials data
OPEN TO THE PUBLIC
GDPR: This session will involve a panel discussion exploring developments occurring in the past year related to the effect of the European Union’s privacy law, the General Data Protection Regulation (“GDPR”), on clinical research. GDPR was the topic of a one-day meeting held in conjunction with the MRCT Center annual meeting in December 2022, and the intent of this panel is to explore what has changed in the intervening 12-month period. Topics to be addressed will include the Trans-Atlantic Data Privacy Framework, the UK-US Data Bridge, ongoing litigation in the EU regarding the definition of anonymization, and the latest relevant European Data Protection Board guidance. The panel will include representatives from leading life sciences companies who advise on data privacy issues as well as a representative of the U.S. Department of Commerce who worked on the Trans-Atlantic Data Privacy Framework.
Ensuring Integrity of Clinical Trial Data:Clinical trials are most often conducted at sites contracted to perform clinical trials. Historically, trials have most often been sited at organized clinics or hospitals, which have reliable systems of ensuring quality of care and creating and maintaining accurate medical records. Yet in recent years, clinical trials have been sited at stand-alone, for-profit research sites that lack the quality assurance infrastructure of clinics or even physician group practices; and in the wake of COVID, clinical trials have often become “remote” or “decentralized.” This session will explore the challenges in this new clinical trial environment to ensuring accurate recording and retention of data, and whether and how monitoring processes should be revised and enhanced.
This meeting is part of the MRCT Center’s 2023 Annual Meeting in Boston on December 13-14 and is open to all registrants at no cost. Guests are welcome to attend the entire program or individual sessions. While in-person attendance is encouraged, virtual participation is welcome.
The provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization
Description: Since the updated Individual Return of Results toolkit was released last year, the MRCT Center has continued collaborating with leaders from academia, patient advocacy groups, and industry to create a series of case studies. These cases detail the experiences of five organizations planning and implementing procedures to return individual research results and data to participants, highlighting ethical, scientific, operational, regulatory, and technical considerations that should be considered. In this webinar, case study authors shared their experiences, successes, and challenges in a moderated conversation.
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar.
Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning related to returning individual results.
The series will feature conversations with Pfizer, Yale University, and the National Cancer Institute representatives. Please register for one, two, or all by clicking the links below.
The third of the three sessions in this series will feature a moderated conversation with Megan Frone at the National Cancer Institute about considerations when returning genetic/genomic results.
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar.
Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning related to returning individual results.
The series will feature conversations with Pfizer, Yale University, and the National Cancer Institute representatives.
The second webinar on August 17 will feature a moderated conversation with Yale University’s Linda Coleman and Madelon Baranoski about navigating IRB/HRPP responsibilities when returning individual results.
Please register for one, two, or all by clicking the links below.
Session 1: Pfizer’s Participant Data Return Solution:
Thursday, July 27: Paula Boyles, Pfizer Click here for the webinar recording, slides, and related materials.
Session 2: IRB and HRPP Responsibilities
Thursday, August 17, 12 – 1:00 PM EST – Linda Coleman and Madelon Baranoski, Yale University Click here for the webinar recording, slides, and related resources.
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar.
Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning related to returning individual results.
The series will feature conversations with Pfizer, Yale University, and the National Cancer Institute representatives.
The first webinar on July 27 will feature a moderated conversation with Paula Boyle about Pfizer’s Patient Data Return Solution.
Please register for one, two, or all by clicking the links below.
Description: Please join us on May 4 from 11:00 AM – 12:00 PM ET as we launch the Accessibility by Design (AbD) in Clinical Research Toolkit, a product developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
Click here to register for the webinar and here for the webinar resources.
Click here to view the Accessibility by Design (AbD) toolkit.
Speakers: Willyanne DeCormier Plosky, DrPH, MRCT Cecile González-Cerimele, PMP, Eli Lilly Duke Morrow, M.Div, D.Min
