Industry sponsors, human research participants, and the public need assurance that clinical trials are overseen and regulated by experienced and competent professionals, in an ethical manner, and at well-qualified sites that have the necessary resources to ensure human research protection.
Worldwide, there is tremendous variation in the skills and experience of clinical research personnel, including ethics boards, regulators, investigators, coordinators, and Data Monitoring Committees. Lack of adequate training and support for clinical research and ethical review boards can threaten research integrity.
MRCT Center Projects
Training is one of the MRCT Center’s core strengths. We have conducted in-country, dynamic trainings in eight countries. Our training model to-date has been to identify an in-country local partner to work with us to identify the appropriate topics that are of highest need, the appropriate trainees for the course, and to arrange the on-site specific location and arrangements. Attendees of our trainings have included regulators, investigators, site staff, local industry and ethics committee members.
Current projects in this area include:
Clinical Research Professional Competency Framework
The MRCT Center led an effort to convene a group of diverse stakeholders for this project. The group agreed to work toward aligning and harmonizing the many focused statements relating to core competency for clinical research professionals into a single, high-level set of standards which could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. Read more
Assignment of causality of adverse drug reactions during a clinical trial is routinely performed to determine the relationship of a safety event to an investigational agent. Fair compensation for injury occurring 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. Recent Indian rules directly link trial participant compensation for injury or death to causality assessment. Read more
Data Monitoring Committee Training
Countries in which global trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee safety for these trials. Recognizing the need for more engagement from emerging economies, the MRCT Center created a training program in 2012 with the aim to transform motivated individuals into DMC champions within their home country and participate in DMCs for multi-regional clinical trials. Read more
Good Clinical Practice (GCP)
We have trained in ICH GCP as applied to international settings.
Multi-Regional Clinical Trials
We have focused on the more challenging aspects of training for MRCT implementation, including providing scientific justification to support the utilization of an MRCT to demonstrate its sufficiency for safety and efficacy determinations in a particular population.
Pilot APEC Center of Excellence
The MRCT Center has received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE). The aim of this project is ultimately to become certified as an APEC Training Center of Excellence for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection to train regulators from APEC economies. Read more