By Deborah Borfitz
August 4, 2008 | Up till now, there has been no standardized training program for professionals who work with medical images in clinical trials. As industry groups such as Metrics Champion Consortium and Pharmaceutical Research and Manufacturers of America discuss the influence of training on blinded reader performance, they might want to pay attention to how a pair of Pennsylvania radiologists is tackling the issue.
Medical imaging experts Kohkan Shamsi, MD, PhD, and Richard Patt, MD, have just launched the Blinded Reader and Investigator Training Institute (BRITI) to facilitate the training of clinical trial personnel on a diversity of topics ranging from responsibilities of imaging investigators to properly measuring a tumor’s response to drugs, says Patt.
Each training module is followed by an examination. BRITI tracks training parameters on each participant and provides certification of completion of specific curricula.
The training is expected to be done primarily online via pre-recorded, audiovisual presentations where users control the learning pace, Patt says. But online training programs can be customized to include a real-time question-and-answer session. Live, on-site training is also available.
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| Richard Patt |
BRITI was initially created to train blinded readers who work for RadMD, another company started by Shamsi and Patt. As training was getting under way for those doctors earlier this year, Patt says, inquiries began pouring in from sponsors and clinical research organizations about training their clinical trial personnel.
Interpreting images in a medical clinic is considerably different than doing so for a clinical trial, which is guided by specific measurement criteria and “doesn’t look at [everything] that may be abnormal in patients, like kidney stones in patients in an oncology trial,” says Patt. Most radiologists haven’t learned the difference between a Phase II and Phase IV trial, let alone how to quantify drug efficacy via imaging studies.
Imaging investigators generally get only trial-specific training about the mechanics of image acquisition, continues Patt, but also need to understand basic regulatory issues and measurement criteria in order to better understand their role and responsibilities.
BRITI’s core curriculum covers how imaging is used in clinical trials and is useful for training physicians and other investigative site personnel as well as clinical research associates, biostatisticians, and project managers, says Patt. The focus of the more advanced training modules depends on the trial type and disease process. It will appeal primarily to blinded readers and clinical panel evaluators, as well as site personnel responsible for completing imaging portions of case report forms. “The vast majority of imaging today is on the oncology side, so [in addition to the primer courses], those modules will be most heavily used.”
The information in the modules exists in a variety of locations, says Patt. BRITI pulls it all into one convenient place. Patt and Shamsi, who each have more than 15 years of experience in medical imaging clinical development, oversee content along with selected experts on specific topics.
For now, BRITI modules are accessible only to groups on a negotiated per-use basis, says Patt. Pricing is based largely on training needs and size of the group. Over the next year, BRITI will also train at least 200 of the 500 independent radiologists that RadMD contracts with across the globe.
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