| While there are reasons inherent to research that can cause failures, including protocol design, lack of intrinsic activity of the compound, and poor tolerability and toxicity, most studies fail due to site-based issues, such as placebo response, poor enrollment, and poor patient retention. CCT addresses these site limitations to achieve superior sensitivity and discrimination between placebo and active therapies.
Learn more about CCT’s strategies for reducing study failure:
PLACEBO VIDEO TRAINING
PATIENT SELECTION
DIAGNOSTIC ASSESSMENTS
Placebo Video Training
CCT conducts placebo video training for staff and patients about the 'placebo' effect, a powerful tool for researchers and subjects to understand their 'role' in the conduct of a study. Our staff shows all patients in Phase II-IV placebo-controlled studies (following consent) a short videotape describing the role of placebo in psychiatry. They are instructed to be honest and complete in their reporting of all possible side effects from a medication.
Most importantly, patients are provided information that further explains the implications of being maintained on a placebo for a psychiatric condition. Our patients understand that there is a chance they are on a sugar pill, and that we want to know about subtle changes in symptoms and behavior. Pilot data suggests that we generate 25-35% differences between placebo and active drug in depression and anxiety trials, an area where placebo effect is particularly dramatic.
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Patient Selection
Successful trials must have the foundation of properly selected patients and well-trained staff. CCT's marketing is conducted in a region of the United States that is approaching 20 million people amongst our four sites from Los Angeles to San Diego. While we use our proprietary database, STEPS, to find many patients, we continually market to new patients through advertising, working with community-based care groups and facilities, and interacting with local physicians, all to assists in keeping placebo response under control.
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Diagnostic Assessments
All patients are assessed by licensed senior clinical staff. We look specifically for historic and family information that indicates a biological basis for patients' conditions. We identify confounding factors that might reduce patient response to drug therapy including substance abuse or psychosocial stressors, and exclude such patients from studies. For proof of concept and Phase IIa studies, CCT applies more rigorous criteria and proposes strategies that maintain enrollment rates when specific Sponsor concerns need to be addressed.
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