Are research participants truly representative of the patients?

The Maxwell J. Mehlman Lecture
Wednesday, October 18, 2017
4:30-5:30 PM
Moot Courtroom (A59)
Paula Taylor Whitfield (’83)
Senior Director, Assistant General Counsel, Eli Lilly and Company, Retired 

Diversity in Clinical Trials ~ Why it is Especially Crucial Today? 

Adequate and well-controlled clinical trials are the holy grail and the sole bases used to evaluate whether any medicine is safe and effective before it is approved for marketing to health care professionals. The big challenge for companies, FDA and international regulatory authorities is ensuring that research participants are truly representative of the patients that will benefit from the medicine.  The composition of the population enrolled in a clinical trial should help; but, getting the right clinical subjects to participate is a complex and often difficult prospect.  The speaker will discuss why increasing diversity in clinical research is important for 1) improving patient outcomes, 2) decreasing overall cost of therapy and 3) enhancing the knowledge of pharma companies and regulators and, through them, physicians, on which patient will benefit, or not, from a given medicine to enable better patient care and improve customer's overall satisfaction with therapy.

 

 

The Maxwell J. Mehlman Lecture
Wednesday, October 18, 2017
4:30-5:30 PM
Moot Courtroom (A59)
Paula Taylor Whitfield (’83)
Senior Director, Assistant General Counsel, Eli Lilly and Company, Retired

Diversity in Clinical Trials ~ Why it is Especially Crucial Today?

Adequate and well-controlled clinical trials are the holy grail and the sole bases used to evaluate whether any medicine is safe and effective before it is approved for marketing to health care professionals. The big challenge for companies, FDA and international regulatory authorities is ensuring that research participants are truly representative of the patients that will benefit from the medicine.  The composition of the population enrolled in a clinical trial should help; but, getting the right clinical subjects to participate is a complex and often difficult prospect.  The speaker will discuss why increasing diversity in clinical research is important for 1) improving patient outcomes, 2) decreasing overall cost of therapy and 3) enhancing the knowledge of pharma companies and regulators and, through them, physicians, on which patient will benefit, or not, from a given medicine to enable better patient care and improve customer's overall satisfaction with therapy.