Dr. Barbara E. Bierer and MRCT Center Program Manager, Laura G. Meloney, co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to consider to address the problem.
MRCT Center Senior Advisors, Luke Gelinas and David Strauss, MRCT Center Faculty Director, Barbara E. Bierer, and others co-authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making.
As more states move to legalize marijuana, the regulatory landscape is becoming increasingly complex. The number of sponsors and researchers inquiring about these regulations has also increased. Clinical research involving cannabis is subject to both federal and state regulations. Key regulatory frameworks include DEA regulations on the use of controlled substances in research studies, FDA IND regulations, and state law. Proposed federal legislation may also affect the conduct of research involving cannabis. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of DEA and FDA regulations relating to research involving cannabis, reviewed recent legislative developments, and discussed state-level policies and challenges using New York state as an example.
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The objective of this workshop was to agree on a consensus list of “key selection standards or criteria for sites and Principal Investigators,” to propose methods to quantify the importance of these criteria, and to make recommendations for the MRCT Center’s role moving these issues forward
The objective of this meeting was to provide an update to all stakeholders regarding current initiatives and progress, engage regulators in the MRCT Center initiatives and mission, obtain feedback from regulators and stakeholders on MRCT Center’s ongoing and planned initiatives, and discuss the 2013 Budget and Proposed Goals.
The MRCT Center Annual Meeting provided an opportunity to update stakeholders on current initiatives and discuss key Clinical Data Sharing Projects including, Practical Implementation of Clinical Trial Data Sharing and Return of Individual Results to Patients.
