Kohkan Shamsi, MD, PhD, and Richard Patt, MD, have launched the Blinded Reader and Investigator Training Institute (BRITI) to facilitate training for medical imaging in clinical trials.
BRITI will provide clinical trial personnel with formalized training and testing modules on a variety of topics related to the use of medical imaging in clinical trials, which previously did not exist in a single solution, according to Shamsi and Patt.
The institute can track training parameters on each participant, providing certification of completion of specific curricula, online or locally, individually or in groups. Modules include introductory lectures on clinical development, blinded reading process and various evaluation criteria, the physicians noted.
Medical imaging in clinical trials is increasingly used as a surrogate marker of drug and device efficacy.
“With the explosion of the use of medical imaging in clinical trials, there [is] a greater need for formalized training of clinical trial personnel involved in image acquisition and evaluations,” said Patt. “A clear understanding of the clinical development process, specific knowledge of various evaluation criteria, and pertinent regulatory requirements is critical for clinical trial professionals who are participating as site investigators or are performing independent evaluations of imaging trial data.”
BRITI said it is initially marketing the training modules to:
- Radiologist and cardiologists blinded readers;
- Oncologist and other clinical panel evaluators;
- Pathologists performing independent histology reviews;
- Site investigators/technologists responsible for imaging protocols; and
- Pharmaceutical/biotechnology/CRO research professionals using medical imaging in clinical trials (clinicians, project managers, CRAs, biostatisticians, data management and regulatory).