Published in:National Center for Biotechnology Information, NIH
Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.
DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.
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.
Description: The MRCT Center and Medable convened a multi-stakeholder group to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs) and presented a joint webinar titled “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices” on June 20, 2023.
During the webinar, Dr. Barbara Bierer (MRCT Center) and Dr. Pam Tenaerts and Leanne Madre (Medable) presented guidance and tools organized around 12 key elements. These elements are grouped into three domains: People, Remote Data Collection, and Data Oversight. The aim is to provide IRBs, ethics committees (ECs), and sponsors with the necessary framework, tools, and recommendations for conducting ethical reviews. Robert Ramanchuk provided insights into the real-world, practical implications of the recommendations.
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
