Patient centric trial design- The new success model

The clinical trial industry is currently in the midst of a fundamental cultural change, with patient centricity being the primary area of focus. The intent is to give patients access to their medical data on demand and at will. Patient-centric Trial Design, a futuristic participatory approach, is a key method to establish this kind of patient empowerment. Not only does it promote a more collaborative relationship between patients and healthcare, it also creates active, participatory ‘e-patients. Researchers, regulatory agencies, policy makers and payers are increasingly recognizing the impact of a more patient-centric approach towards health outcomes research, including the development and validation of clinical outcome assessments, and patient participation in clinical trials.

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The selection process for utilizing electronic data capture (EDC) is thorough, challenging, and time consuming. It is conducted with qualified individuals and teams reviewing systems that appear to meet various functional requirements and display the necessary performance on...

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