Understanding Regulatory Expectations for Diversity in Clinical Trials

Diversity of the subjects that are part of a clinical trial is a very important dynamic in the study. This is because ethnicity and genetics, along with age, gender and lifestyle, are among the factors that determine our response to medicine.


Diversity of the subjects that are part of a clinical trial is a very important dynamic in the study. This is because ethnicity and genetics, along with age, gender and lifestyle, are among the factors that determine our response to medicine.

Despite the US having one of the most diverse collection of ethnicities and the fact that nearly three in every four Americans are willing to be a subject of a clinical trial if the physician assented to it; it is a historic fact that minorities have consistently been underrepresented at clinical trials. Ironically, it has been known since at least a century that individual vary in their response to medication.

Diversity is a factor in the effectiveness of a clinical trial

Diversity in Clinical Trials1

A proper and judicious mix of the ethnic groups makes the clinical study well represented, well-rounded and diverse, leading to a higher level of effectiveness. A clinical trial in which there is heavy representation of only one or a handful of ethnic groups is not a complete representation of the effects of a drug, medical device or any other product that the trial seeks to produce.

The FDA has taken note of this fact, and for over two decades, has been issuing guidances to the industry to make clinical trials more inclusive. It has issued many directives on the age, gender and ethnic composition of the trials. The FDA Safety and Innovation Act (FDASIA 907) that the American Congress passed in 2012 required the FDA to not only report on the diversity of the subjects of a clinical trial, but also on the quality of the outcomes, meaning the extent to which ethnicity, age and sex of the patient determined the outcomes.

Accordingly, asked to produce an action plan in this regard, the FDA released the Action Plan to Enhance the Collection and Availability of Subgroup Data in 2014. This plan consisted of many as 27 recommendations for addressing the diversity aspect of clinical trials.

Get to understand the dynamics of diversity in clinical trials

Clinical Trials1

So, organizations carrying out a clinical trial have to comply with all these and other existing regulatory requirements relating to the diversity element of these trials. How do they understand these regulatory requirements, and what do they need to do to be compliant? This is the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

This webinar is being organized to offer complete understanding of this very vital aspect of clinical trials. As we have seen, a clinical trial at which the subjects are of a diverse makeup is considered more reflective in determining the outcome of the research. A clinical trial that does not have the recommended mix in the diversity of its subjects is not likely to produce optimal result. The consequence of this gap is that the program could be imperiled, leading to inferior or subpar findings.

Lauren Neighbours, Head of Regulatory Affairs, North America at PSI, will be the speaker at this very valuable webinar. Dr. Neighbours leads regulatory strategy at her organization in the US and Canada. Dr. Neighbours has over 10 years of scientific research experience within industry, government, and academic settings. Also having experience in coordinating and overseeing the strategy and operations of full-service Phase 1-4 clinical studies spanning many therapeutic areas and product types; Dr. Neighbours has authored a variety of clinical and regulatory documents, and has contributed as an author to multiple IND/CTA and marketing application dossiers.

Dr. Neighbours will offer clarity into the current regulatory landscape surrounding diversity inclusion in clinical trials. She will show how organizations can adapt their clinical study designs to comply with regulatory agency expectations and achieve success at their program. During the course of this webinar, Dr. Neighbours will cover the following areas:

  • FDA and other regulatory authority guidance on diversity of clinical trial participants
  • Current trends on clinical trial participation by patient demographic
  • Best practices on developing clinical studies to meet regulatory expectations
  • Resources on diversity inclusion in clinical trials.

Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

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