Institute of Good Manufacturing Practices India

Global accredited training & certification provider

IGMPI Approvals & Accreditation : Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India, Approved Training Institute of Food Safety and Standards Authority of India (FSSAI), Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh, Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC)
Trusted by organizations & training participants in over 30 countries. Training | Certification | Education | Research

US FDA draft guideline on clinical trial diversity augmentation


05th June 2019

Draft guidance has been released by the USFDA regarding the ways to enhance the participation of population diversity in clinical trials. Sponsors must consider the USFDA recommendations while designing and conducting clinical trials in order to eliminate avoidable exclusions and to get effective safety data.

The salient recommendations by the US FDA in the draft guidance includes

Inclusive enrollment practice and broadening of eligibility criteria must be followed by sponsors to include diverse participant population in clinical trials.
Recruitment events can be conducted more often during weekend hours and evening time, which can enhance the active participation of potential participants. Commercial and trusted locations such as beauty salons and houses of worship can be selected for conducting recruitment events in order to get diverse population.
Potential challenges can be shared by patients, which must be included in informed consent.
Financial reimbursement can be offered to the participants.
Study visits frequency can be reduced with the inclusion of various technologies such as secured electronic mail, telephone, mobile technology tools, etc. In this way, real-time data can be received by the investigators without the physical study visit of participants.
An adaptive design can be initiated with less population, if there is a safety concern and can be extended following the safety data.

Comments on this draft guidance can be accepted by the USFDA till 06 August 2019.


For further enquiries, write to or call us on:
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175

Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like