Background – Ethnic Data in US Clinical Trials
“FDA regulations require sponsors to present in certain marketing applications an analysis of data according to demographic subgroups (age, gender, race) […].
In 1997, the Office of Management and Budget (OMB) issued its revised recommendations for the collection and use of race and 56 ethnicity data by Federal agencies (Policy Directive 15). FDA now recommends the use of the standardized OMB race and ethnicity categories for data collection in clinical trials for two reasons.
– First, the use of the recommended OMB categories will help ensure consistency in demographic subset analyses across studies used to support certain marketing applications to FDA and across data collected by other government agencies […].
– Second, these categories may be useful in evaluating potential differences in the safety and efficacy of pharmaceutical products among population subgroups.”[1]
What Does the French Law Say?
“France’s Data Protection Act No. 78-17 created the French Data Protection Authority (Commission Nationale Informatique et Libertés [CNIL]).
Article 8 of this legislation states: ‘The collection and processing of personal data that reveals, directly or indirectly, the racial and ethnic origins, the political, philosophical, religious opinions or trade union affiliation of persons, or which concerns their health or sexual life, is prohibited’.”[2]
This means that the majority of ethnic differences may not be usable for pharmaceutical needs. Not having access to the information can put a company into a difficult situation, as this information is helpful, but all is not lost.
10 Exceptions
There are 10 exceptions to the French Data Protection Act. These exceptions pertain to the aim of the treatment, the conditions in which the data is collected, and the nature of the organization delivering the treatment.
The exceptions are as follows:
- Processing of sensitive data belonging to a person, who previously gave their express consent to this processing (unless legal texts provide that the prohibition cannot be lifted) can be used.
- Processing of data made publicly available by the data subject is not prohibited.
- The files from associations and organizations of a religious, philosophical, political or trade-union character can be shared (only sensitive data pertaining to the aims of the association may be collected and only on members who are in regular contact with the organization).
- Processing necessary for the establishment, exercise, or defense of legal claims is usable.
- Processing required for the purpose of preventive medicine can be performed.
- Processing required for establishing a medical diagnosis is acceptable.
- Processing required for the provision of care, treatment, and management of a medical condition can be done.
- Usable personal data must be processed in a location and by people that are already under obligations of professional secrecy in accordance with federal law.
- Processing necessary to the safety of human life is permitted.
- Processing of health-related data for medical research needs is acceptable.[3]
Why does ethnic origin matter in clinical trials?
You may ask yourself why data on ethnicity is necessary.
It’s because some diseases affect more commonly people from specific ethnic origins.
For example, “In the Netherlands, chronic diseases, such as diabetes mellitus and cardiovascular disease, are more common and have a poorer prognosis in patients of Surinamese, Turkish and Moroccan origin. Surinamese develop cardiovascular diseases more often and at an earlier age; it is recommended that their cardiovascular risk profile be checked at an earlier stage. […] Ethnic differences in the efficacy and toxicity of drugs are mainly caused by genetically determined variations in the activity of drug metabolizing enzymes.”[4]
What about you? As a Clinical Research Associate or a researcher, have you ever been in a situation where you couldn’t collect data on ethnicity because the law prohibited it? Were you able to find the information you needed, and if so, what steps did you utilize to ensure it was appropriately gathered and processed?
Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!
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[1]https://www.pharmamedtechbi.com/~/media/Images/Publications/Archive/The%20Gray%20Sheet/29/050/01290500018/031215_race_and_ethnicity_guidance.pdf
[2]https://www.advamed.org/sites/default/files/resource/9_19_2016_advamed_comments_on_dkt_no_fda-2016-d-0734_evaluation_and_reporting_of_age_race_and_ethnicity.pdf
[3]Translation of https://www.ladocumentationfrancaise.fr/var/storage/rapports-publics/074000339.pdf
[4]https://www.researchgate.net/publication/236224174_Chronic_diseases_in_ethnic_minorities_Tools_for_patient-centered_care_in_diabetes_hypertension_and_COPD
Post reviewed by Johanna Galyen from Glowing Still
