Human research participants, the public, sponsors, and funders are comforted by the knowledge that clinical trials are not only ethical but overseen and regulated by experienced and competent professionals and conducted at qualified sites that have the necessary resources to ensure human research protections.
The skills and experience of investigators and study staff, research ethics boards, regulators, coordinators, and data monitoring committees vary widely across the globe. Appropriate training and support for clinical research personnel, research ethics boards, regulators and others help ensure the ethical conduct of research and research integrity.
Training is one of the core strengths of the MRCT Center. Complementary approaches are employed:
- 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 on-site logistics
- On-site trainings at Brigham and Women’s Hospital and Harvard, inviting key international leaders and regulators to participate.
- On-line training resources and development of eLearning courses.
Attendees of our trainings have included regulators, investigators, site staff, local industry and ethics committee members.
The MRCT Center continues to build capacity for training on many different topics.
Current projects in this focus area include:
Safety assessments of an investigational product depend upon understanding of causality and the differentiation from correlation or association. 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 and a consequence of the investigational product. The MRCT Center has developed causality training to improve accuracy and uniformity in causality determination for clinical trials. Read more
Clinical Research Professional Competency Framework
The MRCT Center co-led an effort to convene a group of diverse stakeholders to align and harmonize the many focused statements relating to 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. The MRCT Center is now leading the Joint Task Force for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally. Read more
Data Monitoring Committee Training
Countries in which global trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee these trials. Recognizing the need for more engagement from emerging economies, the MRCT Center developed a training program to promote inclusion on DMCs with oversight responsibilities for multi-regional clinical trials. Read more
Good Clinical Practice (GCP) and Multi-Regional Clinical Trial (MRCT) Training
Countries in which global trials are conducted benefit from experienced and trained regulatory authorities. The MRCT Center has been endorsed as a Training Partner of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and as an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Good Clinical Practice (GCP) and to facilitate review and oversight of Multi-Regional Clinical Trials (MRCTs). Read more.
Examples of Training Assets
Past international trainings, in collaboration with local partners, have included:
|Since Nov 2014||Online||The Global Health Network||Essential Elements of Ethics|
|Training on Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT)|
|April 2018||Cambridge, USA||Asia-Pacific Economic Cooperation (APEC) Harmonization Center (AHC)||GCP and MRCTs|
|Oct 2017||Cambridge, USA||International Council for Harmonisation (ICH)||ICH Good Clinical Practice (GCP)|
|Sept 2016||New Haven, USA||Yale, Novartis, CFDA||MRCTs|
|Oct 2015||Beijing, China||Peking U.||ICH/GCP MRCTs|
|Causality Training and Post-Trial Responsibilities|
|April 2016||Sao Paolo, Brazil||Sociedade Brasileira de|
Medicina Farmacêutica, Lilly
|MRCT Post-trial responsibilities|
|Nov 2015||Johannesburg & Cape Town, South Africa||U. of Witwatersrand & U. of Cape Town|
Global Health Network
|Causality Training Pharmacovigilance
|Feb 2015||Delhi, India||Indian Society of Clinical Research||Causality training|
|Nov 2014||Gurgeon, India||Biogen||Causality training|
|Data Monitoring Committee Training|
|Jan 2015||Bangkok, Thailand||HIV-NAT||DMC|
|May 2014||Shanghai, China||DIA||DMC|
|April 2014||Tokyo, Japan||JPMA||DMC|
|Jan 2014||Bangalore, India||ISCR||DMC|
|Oct 2013||Daegu, Korea||Daegu Catholic University Medical Center||DMC|
|May 2013||Boston, US||Society of Clinical Trials||DMC|