Training & Education

• Improve regulatory capacity to provide a unified standard for conducting and oversight of clinical trials
• Improve capacity of those planning and reviewing clinical trials to conduct effective multi-regional trials
• Improve capacity of those planning, reviewing, and conducting clinical trials to ultimately lead to participant safety

• Barbara Bierer, MD. Faculty Director, MRCT Center
• Sarah White, MPH. Executive Director, MRCT Center
• Carmen Aldinger, PhD, MPH, PMP. Senior Administrative and Training Manager, MRCT Center
• Samjhana Bogati, BSN, RN. Program Manager
• Lauren Otterman, MBE. Project Manager, MRCT Center

Safety assessments of an investigational product depends upon understanding of causality and the differentiation from correlation or association. Assignment of causality of adverse drug reactions during a clinical trial is predicated on an accurate causality assessment and determination of whether the injury or death is related to participation in the trial and a consequence of the investigational product. This training enables clinicians and ethics committee members to follow best practice procedures in determining causality for participant injuries or illnesses occurring in the course of a clinical trial.

The curriculum is designed to introduce the audience to the process of drug development and clinical research, including research and development, bioethics, good clinical practice, regulatory requirements, as well as post-market surveillance and real world evidence. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local regional context.

Countries in which global clinical trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee these trials. Recognizing the need for greater engagement from emerging economies, the MRCT Center created a training program in 2012 aiming to engage motivated individuals to become DMC champions within their home country and to participate in DMCs for multi-regional clinical trials.

The participant population enrolled in clinical trials ideally reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. The MRCT Center training is intended to aid attendees in improving their ability to enroll underrepresented participants in clinical research and develop mechanisms for ongoing sustainability of DEI in clinical research.

Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide wish to ensure that drugs, biologics and devices are developed by processes that uphold the highest ethical standards and scientific principles. The MRCT Center has been designated as an ICH Associate and as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence in the area of Multi-Regional Clinical Trials and Good Clinical Practice (GCP) and offers onsite, in-country and online training on this topic.

Since 2018, the MRCT Center has focused on the importance of clear communication through the development of health literacy resources as part of the MRCT Center’s Health Literacy in Clinical Research Program. Online, virtual and in person capacity building activities that provide research professionals with practical guidance and tools to integrate health literacy best practices into their roles are available.

Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a participant’s time on the trial has completed. The MRCT Center has provided training to clarify terms and interpretations related to “post-trial responsibilities” and to suggest standards with regard to the practical application of those directives.

“Research Ethics” refers to addressing ethical issues in the design of clinical trials and documenting their rationale in a section of the study protocol. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local/regional Ethics Committee context.
The MRCT Center offers an online course that guides the development of a dedicated “Ethics section” of the protocol and offers virtual training of ethics committees and those reviewing clinical research applications, with a focus on Africa.