In this video blog, Dr. Nicholas Robert, chief medical officer, and Dr. Paul Conkling, senior medical director, discuss the role that real-world evidence plays in supporting clinical trials from the viewpoint of a principal investigator.
Here is an outline of the questions they discuss (and corresponding timestamps) so that you can follow along in their conversation:
- Can you describe the clinical trial process and the role of a principal investigator (PI) in a study? (0:35)
- The role of real-world data (RWD) and real-world evidence (RWE) are becoming increasingly important. A lot of our RWD comes from electronic health records, such as Ontada’s iKnowMedSM. As a former practicing physician, can you comment on the process of taking care of patients and recording RWD in an EHR? (3:30)
- One of the challenges we face in research is in dealing with a small patient subset (e.g., an uncommon cancer or mutation). In your experience as a PI, can you tell us about how we can conduct single-arm trials in this setting and some of the associated challenges? (6:15)
- What information is needed to determine if a patient is eligible for a clinical trial? (9:15)
- The utility of RWE: Example 1 – using RWD to expand eligibility criteria. (10:59)
- The utility of RWE: Example 2 – understanding how an approved therapy is performing in the real world. (12:48)