By Ray Tobey, Chief Medical Officer on Apr 25, 2018 9:00:00 AM
In an effort to make drug development more patient centric, the FDA encourages pharma and biotech companies to use real world evidence throughout all clinical trial phases. Real world evidence can be defined as any information on patient health and health care from sources within or outside of the clinical setting. But what types of real world evidence should you use? We’ve list the top four real world evidence types and briefly describe how you many manipulate data from these sources to drive your drug through the development process faster and, importantly, safer.
Health plans claims and billing data:Claims and billing data can provide vital information on the conditions that people have, the stage of their disease, and the treatments they are receiving. Occasionally these types of evidence will allow insight into how your patient is responding to your drug due to the various follow up tests administered.
Medical product and disease registries:Large patient networks for example, PatientsLikeMe, provide information from patients themselves discussing conditions they have, experience with therapies, etc.
Data generated from personal devices:Personal devices, like fitness trackers, can give immediate information on vital health measures, like blood pressure and heart rate, allowing a real-time picture of the overall health of your patient.
Search engine data mining:With search engines, like Google, you can identify whether web search logs can identify and evaluate previously unreported adverse reactions and detect safety signals earlier than current FDA reporting methods, such as MedWatch.
Having access to the exhaustive data set to learn about patients and your drugs effect on them will allow a more efficient clinical trial process and a safer drug development process. Moreover, real world evidence can also help support new indications for existing drugs and help demonstrate how a drug works in populations that weren’t studied in the initial clinical trial.