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Editorials: Point and Counterpoint |

Rebuttal From Dr Tillotson FREE TO VIEW

Glenn S. Tillotson, PhD, FCCP
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FINANCIAL/NONFINANCIAL DISCLOSURE: None declared.

CORRESPONDENCE TO: Glenn S. Tillotson, PhD, FCCP, GST Micro LLC, 227 Kayleen Ct, Durham NC 27713


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(5):1133-1135. doi:10.1016/j.chest.2016.01.027
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Dr Courtright raises some excellent and valid points regarding the debate, and clearly this is an important aspect of improving medical practice. In essence, there are two “camps” of clinical research, those of academia and industry, each with their own perspective and aims. The topic of underrepresented or minority populations in studies has been examined with respect to oncology, multiple sclerosis (MS), stroke, and other conditions. However, before we believe that we have totally failed these populations, it is important to consider the actual incidence of various minorities in the United States in 2014. Almost 80% of US citizens were white; 12.8%, “black”; 4.4%, Asian; and < 1% were American Indian/Alaskan. It is important to remember these data when discussing this sensitive topic. Three specific conditions have been reviewed with respect to minority balance: MS, stroke, and cancer.

The heterogeneity of MS across various ethnic minorities has been examined previously in which a PubMed review was conducted of almost 60,000 publications. Of these, 52,000 were in English but only 113 focused on African-American (black) populations and 23 focused on Hispanic populations. These represent < 1% of the literature on MS, but they do suggest that there is interest in these ethnic groups. For patients with MS, there are socioeconomic barriers and cultural influences that may adversely affect the ideal therapeutic approach. It is accepted that minority patients have difficulty accessing and using specialty care due to insurance issues, low income, lower educational levels, and language and literacy (both written and computer) issues. If a patient does not routinely see an appropriate physician, then the chances of even being considered for clinical trials or research programs are slim. A large study of 21,557 patients with MS found that African-American patients were more likely to have severe disability but also to be in the lower income and educational levels than white subjects. In addition to these socioeconomic barriers are equally important cultural influences (eg, religious beliefs, societal distrust). Indeed, the mere participation in clinical trials is regarded with major concern. Due to deeply held religious beliefs, there may be conflicts with using therapies such as antibiotics, vaccines, or blood transfusions. A mistrust of the medical community, and especially of researchers and sponsoring agencies, was highlighted, with many issues related to experiments and being “used as guinea pigs.”(p126)

From the stroke perspective, Boden-Albala et al conducted a survey of 93 researchers to identify the barriers to improved minority enrollment. Focus groups again highlighted mistrust of the research/medical enterprise, poor communication, and lack of understanding of clinical trials as recruitment barriers.

National Cancer Institute-sponsored clinical trials have consistently failed to achieve minority target recruitment. Six years ago, the Institute of Medicine made consensus recommendations intended to improve clinical trial recruitment and overall cancer trial design. As part of this process, a workshop was convened to tackle these issues; again, the problems of myths, religious beliefs, mistrust, and comprehension of what clinical trials were intended to do resonated as reasons why minorities tended to comprise approximately 20% of all cancer subjects enrolled into National Cancer Institute-funded trials in 2003 to 2013. Compared with the current US demographic characteristics, this finding does not seem too skewed.

From an overview of trials, Schmotzer identified patient barriers to participation as fear, mistrust, and the unknown burden of trial involvement, in addition to poor physician understanding of the study and enthusiasm. It was recommended that better communication, physician participation, development of a better patient-provider relationship while recognizing and promoting the perceived benefits and a feeling of altruism would yield better patient involvement. Although some of the author’s suggestions are sound, the applicability of such approaches to regulatory agencies has yet to be determined; they may be unacceptable due to rigid regulatory and statistical analysis restraints.

Finally, a large number of current clinical trials are industry sponsored, most of which are designed and implemented in accordance with governmental agency guidance. Ironically, industry research is regarded as being “substantially superior to academic research in preparing, organizing and monitoring studies.”(p906) Obviously, a large part of this position is based on the primary objectives and conduct of the research. However, industry-sponsored studies are designed, sometimes in collaboration with academics, to recruit the requisite number of eligible subjects as soon as possible, often with little attention to race or sex, unless prespecified in agreement with regulators. Frequently, there is neither the time nor the resources to comply with the various previous suggestions for improving minority enrollment.

Unless a researcher specifically undertakes studies in regions in which such minorities are in fact the majority (eg, Africa, Asia, Latin America), then redressing these imbalances will continue in trials conducted in the “western world.”

References

Courtright K. . Point: Do randomized controlled clinical trials ignore needed patient populations? Yes. Chest. 2016;149:1128-1130 [PubMed]journal
 
Index Mundi. United States demographics profile 2014.http://www.indexmundi.com/united_states/demographics_profile.html. Accessed January 6, 2016.
 
Khan O. .Williams M.J. .Amezuca L. .et al Multiple sclerosis in US minority populations. Neurol Clin Pract. 2015;5:132-142 [PubMed]journal. [CrossRef] [PubMed]
 
Durant R.W. .Legedza A.T. .Marcantonio E.R. .et al Different types of distrust in clinical research among whites and African Americans. J Nat Med Assoc. 2011;103:123-130 [PubMed]journal
 
Boden-Albala B. .Carman H. .Southwick L. .et al Examining barriers and practices to recruitment and retention in stroke clinical trials. Stroke. 2015;46:2232-2237 [PubMed]journal. [CrossRef] [PubMed]
 
Nass S.J. .Balogh E. .Mendelsohn J. . A national cancer clinical trials network: recommendations from the Institute of Medicine. Am J Ther. 2011;18:382-391 [PubMed]journal. [CrossRef] [PubMed]
 
Schmotzer G.L. . Barriers and facilitators to participation of minorities in clinical trials. Ethn Dis. 2012;22:226-230 [PubMed]journal. [PubMed]
 
Laterre P.F. .Francois B. . Strengths and limitations of industry vs. academic randomized controlled trials. Clin Microbiol Infect. 2015;21:906-909 [PubMed]journal. [CrossRef] [PubMed]
 

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References

Courtright K. . Point: Do randomized controlled clinical trials ignore needed patient populations? Yes. Chest. 2016;149:1128-1130 [PubMed]journal
 
Index Mundi. United States demographics profile 2014.http://www.indexmundi.com/united_states/demographics_profile.html. Accessed January 6, 2016.
 
Khan O. .Williams M.J. .Amezuca L. .et al Multiple sclerosis in US minority populations. Neurol Clin Pract. 2015;5:132-142 [PubMed]journal. [CrossRef] [PubMed]
 
Durant R.W. .Legedza A.T. .Marcantonio E.R. .et al Different types of distrust in clinical research among whites and African Americans. J Nat Med Assoc. 2011;103:123-130 [PubMed]journal
 
Boden-Albala B. .Carman H. .Southwick L. .et al Examining barriers and practices to recruitment and retention in stroke clinical trials. Stroke. 2015;46:2232-2237 [PubMed]journal. [CrossRef] [PubMed]
 
Nass S.J. .Balogh E. .Mendelsohn J. . A national cancer clinical trials network: recommendations from the Institute of Medicine. Am J Ther. 2011;18:382-391 [PubMed]journal. [CrossRef] [PubMed]
 
Schmotzer G.L. . Barriers and facilitators to participation of minorities in clinical trials. Ethn Dis. 2012;22:226-230 [PubMed]journal. [PubMed]
 
Laterre P.F. .Francois B. . Strengths and limitations of industry vs. academic randomized controlled trials. Clin Microbiol Infect. 2015;21:906-909 [PubMed]journal. [CrossRef] [PubMed]
 
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