Clinical Researcher

Trial participation for a patient with a rare disease that has significant medical needs, as in the case of Dravet syndrome, can be challenging and adds to the already overwhelming caregiver burden on parents. An organized, informed, and connected patient community can ease some of these challenges.

Identifying eligible patients, obtaining consent, executing the study, capturing data, and complying with all reporting and regulatory obligations take time and vital resources away from other important responsibilities at study sites. That’s where new clinical research technology comes in.

The FDA has released final guidance on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” One relatively minor difference from the draft version actually represents a major step forward in statistical analyses for randomized controlled trials (RCTs).

Taken as a whole, in one way or another the pieces of this issue are all about not just the need for, but the inevitability of, ongoing change in the clinical research enterprise—not just change for the sake of change, but change for the better.

Although there are challenges and drawbacks to implementing artificial intelligence (AI) in clinical trials, it has potential benefits that make it a viable tool for the pharmaceutical industry.