Clinical Trial Considerations for Ethnically Diverse, Underrepresented MS Patients

EP: 1.Multiple Sclerosis and Pregnancy Misconceptions

EP: 2.Considerations and Resources for Pregnant Patients With MS

EP: 3.Treatment Selection in MS and Pregnancy

EP: 4.S1P Receptor Modulator Therapy Reversibility Considerations

EP: 5.Postpartum Relapse in Patients With MS

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EP: 6.Clinical Trial Considerations for Ethnically Diverse, Underrepresented MS Patients

EP: 7.Fostering Patient-Centered Care in Ethnically Diverse, Underrepresented MS Patients

EP: 8.Building Trust in Ethnically Diverse and Underrepresented MS Patients

EP: 9.Patient Education in Ethnically Diverse and Underrepresented MS Patients

EP: 10.Surgical Considerations for Patients With MS

EP: 11.Considerations for Infection Risk in Patients With MS

EP: 12.Immunogenicity and Disease-Modifying Therapies

EP: 13.Family Planning and Vaccination Considerations for Patients With MS

EP: 14.The Benefits of Collaborative Care for Patients With MS

EP: 15.Tools and Resources for the Management of MS

Jeffrey Dunn, MD: As there is increasing understanding that multiple sclerosis [MS] is more prevalent than we used to think years ago, with recent estimates of perhaps a million men and women living with MS in the Unites States alone today. It’s also become apparent that [MS] is not just a disease of 30-year-old White women with blonde hair and blue eyes, which had been a stereotype in the past. In fact, we’ve come to know that MS affects people of all races, and that it’s an issue for those of multiple different genetic backgrounds. The question of treating and addressing MS in ethnically diverse populations is an especially important challenge. I think you and I would both agree it’s been unaddressed in the past. Let me first ask your general impression of that whole topic, about the underrepresentation we’ve had of ethnic minorities in clinical trials. Is that true, and do you think it affects us in our daily decision-making?

Regina Berkovich, MD, PhD: That definitely is the case, and you would think that now the more we learn about ethnic minorities in MS, the more representation should be given to these cohorts. Unfortunately, because a lot of clinical trials were done in Eastern Europe, where the population is more inhomogeneous, I would say, we under enrolled the patients of different racial and ethnic backgrounds. Therefore, it makes it even more important to look at some of the studies of our colleagues, such as Dr Lilyana Amezcua, MD, from University of Southern California, Dr Angela Chien, MD, Evergreen Health Medical Center or Annette Okai, MD, North Texas Institute of Neurology & Headache.Those are important observational studies we must pay close attention to.

Jeffrey Dunn, MD: To your first point, there are studies and clinical trials in which 97% of the study cohort was of Caucasian or European background, and maybe that’s not relevant. Maybe we’re so close across races genetically that you could expect the same results from someone of a different genetic background, but the truth is we don’t know. We’re not going to know empirically until we’re successfully able to engage ethnic minorities in clinical trials and see their results on different medications, too, and then can advise them with a greater degree of reliability. Let’s take a scenario in which—and I know you’ve done multiple clinical trials. You’re a clinical trialist with a rich experience. Let’s say an African American woman presents to your practice. She has definite MS. You think she might be an excellent candidate for a clinical trial, and the clinical trial seems to not offer any placebo that she would be treated. Is there an approach you would take? Do you think there are certain things you would want to emphasize as you approach this patient to try to reassure her that her experience would be favorable as much as can be predicted in clinical trial participation?

Regina Berkovich, MD, PhD: Let’s say we have a controlled clinical trial, double blinded, controlled with active comparator, currently existing medication on the market, and the study medication. Usually, we talk about the design where no one knows what patient gets, so we talk about patient getting 2 medications—1 of which is placebo and the other 1 is the real drug, whichever that is. It’s important to explain to patients, who may otherwise have not necessarily known how that works, that in every clinical trial, a very important criterion we always look into before we agree to do any clinical trial is the escape criterion. Every patient in clinical trials is going to be closely monitored, clinically and paraclinically, in terms of the lab results and magnetic resonance imaging. If we see a patient who has evidence of active disease, that patient can effectively be discontinued from the clinical trial and probably should be, because then this patient needs to be treated according to what the disease indicates.

It’s important for all potential subjects of clinical trials to understand that no matter how much we’re interested in enrolling and providing the diverse population for the clinical trials, we still have the patient’s best interest as a top priority. The patient and the experience of the patient will always be reviewed, not only by the principal investigator of this particular site but also by an independent committee.

When the clinical trial comes as a potential avenue, then nothing changes, it is still going to only be a case and only going to continue if I see, as a treating physician, that you are doing well. If you’re not doing well, I don’t want you to stay on it because it’s not about experiment. It’s about you contributing to this study only if it’s not at the expense of your safety and health.

Transcript Edited for Clarity