Pharma Veterans Launch Blinded Reader And Investigator Training Institute
Medical imaging experts Kohkan Shamsi, MD, PhD, and Richard Patt, MD, recently 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.
Each training module discusses a topic in detail, and is followed by an examination. BRITI tracks training parameters on each participant, and provides certification of completion of specific curricula. The training can be provided online or locally, individually or in groups. Modules include introductory lectures on clinical development, blinded reading process, and various evaluation criteria.
BRITI's formalized training addresses an exploding market for medical imaging in clinical trials, which is increasingly used as a surrogate marker of drug and device efficacy. According to CenterWatch, approximately 80,000 clinical trials are conducted in the U.S. each year, requiring the work of an estimated 200,000 research professionals and the involvement of millions of study participants. Industry analysts estimate the worldwide CRO market was $17.8B in 2007, and predict demand for CRO services will continue to grow at a rate of 15 percent annually (Goldman Sachs; Frost & Sullivan)
"With the explosion of the use of medical imaging in clinical trials, there has come a greater need for formalized training of clinical trial personnel involved in image acquisition and evaluations," said Dr. Patt, Co-founder of BRITI. "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. With BRITI's new training modules, the industry now has a central and reliable resource for acquiring this critical training." BRITI 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
- Pharmaceutical/biotechnology/CRO research professionals using medical imaging in clinical trials (clinicians, project managers, CRA's, biostatisticians, data management, regulatory, etc.)
About BRITI
BRITI is the only organization dedicated to providing standardized training of both blinded readers and imaging site investigators. The company originated from the demand for specialized education of blinded readers, and from an understanding of the complexities involved in training imaging clinical site physicians. BRITI was founded by radiologists with more than 25 years' experience in medical imaging in clinical development.
SOURCE: Blinded Reader and Investigator Training Institute