Department of Health and Human Services
Food and Drug Administration
Docket No. FDA-2009-N-0674
5630 Fishers Lane, Room 1061
Rockville, MD 20852

To Whom It May Concern:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on FDA-2009-N-0674, Food and Drug Administration; Participation of Certain Population Subsets in Clinical Drug Trials; Request for Comment, published in the Federal Register, Volume 74, Number 8 on January 13, 2009. The ASM’s Committee on Microbiological Issues Impacting Minorities (CMIIM) has reviewed the notice and wishes to submit the following comments on Section II.A. Communication and Knowledge Barriers.

Many of ASM’s members are involved in the development of therapeutic agents, including basic and clinical research in microbial pathogenesis and identification of novel antimicrobials as well as the design of clinical drug trials. The ASM holds the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) (http://www.icaac.org/) a forum for the introduction of new antimicrobial agents. This past year marked the 48th ICAAC which was attended by over 10,000 researchers, physicians and other health care providers. The ASM has a significant interest in ensuring that all members of society are represented in clinical drug trials.

The ASM believes that the underrepresentation of minorities in clinical drug trials is detrimental to ensuring the generalization of trial results and subsequent treatments. Given racial disparities in prevalence and outcomes in diseases such as HIV/AIDS, syphilis, tuberculosis and others, inclusion of underrepresented minorities in clinical trials is imperative.

The ASM will focus its comments on Section II.A. concerning the effects of limited access to technology and medical care in clinical trial participation and best practices to address these barriers.

Conditions affecting a population’s participation in clinical trials can be multifactorial and complex. These factors include a community’s trust in the researchers involved in the trial and trust that they are fully aware of any detrimental side effects that may occur as a result of participation. Other factors may include whether they are informed of research opportunities and whether personal circumstances allow for participation.

Whether a group is informed of a clinical trial is a logical prelude to participation. A recent study (Wendler et. al, 2006) looking at participation data from previously published studies, demonstrated little difference in the willingness to participate among African Americans, non-Hispanic whites and whites. It did, however, find a difference in the invitation of individuals to participate. Almost half of the studies observed offered enrollment to disproportionally few individuals from minority groups although minorities made up a significant percentage of incidences of the diseases being studied. This is, in part, due to an individual’s bias regarding the perceived attitudes of a population towards involvement in clinical trials. Issues of a group’s perceived non-compliance must be addressed.

Enhanced targeted strategies to inform communities of clinical trials should also be implemented. These should include advertisement in local radio or television media that serve minority populations. Clinicians who are active within an underrepresented population should also be alerted to the existence of upcoming clinical trials, as they can serve conduits between study personnel and the community.

Other recent studies (El-Korazaty et. al. 2007; Worthington, et. al. 2008) point out the importance of clinical contact in recruiting and retaining individuals from minority populations. Some demonstrate a lack of trust by minorities as a determining factor which negatively affects the representation of minorities in clinical trials. This may be due in large part to revelations of the Tuskegee Syphilis Study and other related studies. Increased and regular contact between the study participant and the clinical staff and the inclusion of minority staff (e.g., P.I.s, study and recruitment coordinators, receptionists, etc.) can be used to increase the subject’s comfort levels and help address any misconceptions about the study that may affect retention of participants. To this end, participant contact information must be updated on a regular basis followed by regular and frequent contact by the study personnel.

Sensitivity to personal circumstances must also be addressed. Issues with child care and transportation should be considered by the individual study. Study sites should be selected which are easily accessible to minority populations. Furthermore, priority should be given to schedule study activities during a routinely scheduled medical care visit. This would decrease the personal burden on individual patients. Finally, when designing a study, monetary incentives to offset childcare and transportation costs should also be considered, but excessive monetary payments that might provide unfair inducement of vulnerable populations should not be allowed.

The ASM supports the FDA initiative to improve the recruitment of underrepresented populations in clinical drug trials. We welcome the attention and care being applied to the development of effective strategies to achieve that goal. Thank you for the opportunity to comment.

Sincerely,

Ruth L. Berkelman, M.D. Chair, Public and Scientific Affairs Board
Marian Johnson-Thompson, Ph.D. Chair, Committee on Microbiological Issues Impacting Minorities

References:

El-Khorazaty, M. N., A. A. Johnson, M. Kiely, A.A. El-Mohendes, S. Subramanian, H. A. Laryea, K. B. Murray, J. S. Thornmerry, J. G. Joseph (2007) BMC Public Health 7, 233

Wendler,D., R. Kington ,J. Madans, G. Van Wye, H. Christ-Schmidt, L. A. Pratt, Q. W. Brawley, C. P. Gross, E. Emanuel (2006) PLoS Medicine 3, 201-210

Worthington, C. A., MJ. Gill (2008) AIDS PATIENT CARE and STDs 22, 619-625

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