Human research participants, the public, sponsors and funders need assurance that clinical trials are ethical and overseen and regulated by experienced and competent professionals and at qualified sites that have the necessary resources to ensure human research protections.
Worldwide, the skills and experience of investigators and study staff, research ethics boards, regulators, coordinators, and data monitoring committees vary widely. Appropriate training and support for clinical research personnel, research ethics boards, regulators and others can help ensure the ethical conduct of research and research integrity.
MRCT Center Training Projects
Training is one of the core strengths of the MRCT Center. Complementary approaches are employed:
1) We conduct in-country, in-person dynamic trainings using a training model in which we partner with a local collaborator (e.g. academic leader, regulator, institution) to identify the appropriate topics that are of highest need, to select the trainees for the course, and to arrange the on-site location.
2) We conduct trainings at Brigham and Women’s Hospital and Harvard, inviting key international leaders and regulators for on-site training.
3) We create on-line training resources and develop eLearning courses.
Attendees of our trainings have included regulators, investigators, site staff, local industry and ethics committee members.
Examples of past international trainings, in collaboration with local partners, have included:
|May 2013||Boston, US||Society of Clinical Trials||DMC||30|
|Oct 2013||Daegu, Korea||Daegu Catholic University Medical Center||DMC||70|
|Jan 2014||Bangalore, India||ISCR||DMC||50|
|April 2014||Tokyo, Japan||JPMA||DMC||150|
|May 2014||Shanghai, China||DIA||DMC||20|
|Nov 2014||Gurgeon, India||Biogen||Causality training||35|
|Jan 2015||Bangkok, Thailand||HIV-NAT||DMC||62|
|Feb 2015||Delhi, India||Indian Society of Clinical Research||Causality training||60|
|Oct 2015||Beijing, China||Peking U.||ICH/GCP MRCTs||30|
|Nov 2015||Johannesburg & |
Cape Town, South Africa
|Univ. of Witwatersrand & Univ. of Cape Town|
Global Health Network
|Causality Training Pharmacovigilance Vaccine development||100|
|April 2016||Sao Paolo, Brazil||Sociedade Brasileira de|
Medicina Farmacêutica, Lilly
|MRCT Post-trial responsibilities||40|
|Sept 2016||New Haven, USA||Yale, Novartis, CFDA||MRCTs||30|
|Oct 2017||Cambridge, USA||International Council for Harmonisation (ICH)||ICH Good Clinical Practice (GCP)||25|
Current projects in this area include:
MRCT Training Assets (in alphabetical order)
Assignment of causality of adverse drug reactions during a clinical trial is performed routinely to determine the relationship of a safety event to use of an investigational product. Safety assessments of an investigational product depend upon understanding of causality. Furthermore, Indian regulations directly link trial participant compensation for injury or death to causality assessment. 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. Read more
Clinical Research Professional Competency Framework
The MRCT Center convened diverse stakeholders to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards that could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. 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 developed a training program to promote diverse participation in DMCs for multi-regional clinical trials. Read more
Good Clinical Practice (GCP) Training
APEC Pilot Center of Excellence
The MRCT Center is an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspections, aiming to train regulators from APEC economies. Read more
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently endorsed a training effort to help ensure greater adoption of ICH guidelines by regulators and industry. The MRCT Center was selected to conduct training on ICH E6 and E6 (R2). Read more
Multi-Regional Clinical Trials
We focus on challenging aspects of training for MRCT implementation, including providing scientific justification to support the utilization of an MRCT to demonstrate sufficiency for safety and efficacy determinations in a particular population. We are developing training resources for ICH E17 to pilot in early 2018.