As an investigational compound progresses from early phase randomized clinical trials to being approved for prescribing to patients in physician practice, the research focus shifts from ‘Does the drug work’ to ‘Does the drug work in real world settings?’ Ideally, data collection on observational study designs should reflect standard of practice care at physician visits since the setting provides opportunities to study the drug in real world settings, rather than in a controlled environment, as is the case with early phase randomized clinical trials.
Zia Haque, Senior Director of Data Management, Real-World Late Phase Research, and Arshad Mohammed, Senior Director, Clinical Data Management, Real-World Late Phase Research at Quintiles addressed, among other topics:
- Defining the Observational studies in this arena
- Approaches to designing precise eCRFs
- Considerations for data collection technologies and data validation levels selection
- ePROs and their value on Observational studies