Project Site Selection: Site selection in oncology clinical trials: Considerations for selecting sites in limited geographic regions or areas of political unrest, limiting inspection capabilities.

Department of Health and Human Services Food and Drug Administration
Posted on:

Type

Research/project funding

Reference Number

FOR-FD-23-008

The recent marked increase in the volume of marketing applications submitted to FDA for oncology indications that are primarily supported by pivotal trials in only one country or in countries limited to one or two geo-political regions now makes it imperative for the FDA OCE and oncology stakeholders to discuss the ethics and considerations around clinical trial site selection in such trials and across oncology drug development programs in general. It is equally important to discuss and review mechanisms and strategies that may fall within FDA’s regulatory authority for addressing this trend of selection of clinical trial sites that are completely ex-U.S. and limited in geographic scope. These discussions and their conclusions may help assure that clinical development programs and trials in oncology supporting marketing applications submitted to FDA generate robust data which are applicable to the U.S. population and medical practice, and are generally devoid of concerns around their ethical conduct and/or data integrity issues. These discussions will be carried out over a series of workshops which will have the following as its specific objectives:1. Discussion of the ethics and geo-political factors that guide clinical trial site selection. 2. Discussion of the impact of clinical trial site selection on ethnic and racial equality, and the importance of a priori discussion and justification of site selection. 3. Discussion of issues relating to access to the clinical trial system, with site selection as a factor in instilling confidence in the public with regards to awareness of location of sites, among other factors.
Categories: Consumer Protection, Science and Technology and other Research and Development.

More Information

Posted on:

Type

Research/project funding

Reference Number

FOR-FD-23-008

United States