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Clinical Trials
Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED’s Health Science Advisory Council, interview Dr. Chukwuemeka Oko, MD, MBA, on clinical trials. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:13] Holly introduces today’s topic — clinical trials — and today’s guest, Dr. Chukwuemeka Oko, a Clinical Research and Medical Affairs Professional supporting Duke University Hospital’s Department of Gastroenterology and Transplant Hepatology.   [1:33] Dr. Oko explains that he is sharing general, educational information from his perspective and experience, not speaking on behalf of Duke University, nor any industry sponsor, nor any company he has worked for.   [1:50] Dr. Oko’s goal today is to help the listeners feel clearer, more confident, and more in control when they are thinking about clinical research.   [2:29] Dr. Oko’s work sits mainly at the intersection of clinical research and medical affairs. He helps translate evolving science into practical, patient-centered decisions.   [2:40] From an academic standpoint, he supports clinical trials and evidence generation from feasibility through education.   [2:49] Dr. Oko also engages investigators and thought leaders from industry sponsors in scientific exchanges that lead to insights, study design, and real-world care pathways.   [3:03] Dr. Oko had two reasons to study eosinophilic esophagitis and eosinophilic disease. The first is the patient journey and biology.   [3:11] On the patient side, many people spend a long time seeking answers. Sometimes they feel dismissed before they get a clear diagnosis and a plan that fits their life.   [3:24] On the biology side, eosinophilic disease teaches us a lot about how our immune signals can drive information differently across tissues like the esophagus and airways.   [3:40] Dr. Oko supported an EoE study experience with an industry sponsor in the past. The best research doesn’t just test; it helps patients and clinicians make clearer decisions.   [4:12] Dr. Oko explains that a clinical trial is a carefully designed, carefully crafted study in people that answers specific medical questions, most often about safety, effectiveness, or dosing of the study drug or how a treatment should be used.   [4:32] A key structure of a study is a written protocol where safety monitoring is in place, and the defined outcome or results are very reliable. The FDA always oversees clinical trials in the U.S.    [4:44] Dr. Oko often describes a trial as a highly-monitored learning system. It’s how medicine moves from “We think this might help” to “We know what helps, for whom, and also at what risk.”   [5:09] Dr. Oko says clinical trials usually study what improves patient outcomes, for whom, and at what risk, using methods that we can trust. Trials may evaluate new medicines, devices, dosage strategies, or even procedures.   [5:31] Clinical trials can also study non-drug approaches such as diet interventions, symptom tracking, monitoring tools, and education strategies.   [5:44] Many trials have also included biomarkers, or signals in the blood or tissue, helping to support an EoE diagnosis so that the patients can get treated in an early and effective manner.   [6:36] Dr. Oko says patients sometimes ask him if they are guinea pigs. In reality, trials are heavily regulated and closely monitored, with strict safety reporting requirements. Participants are not guinea pigs.   [7:06] Dr. Oko also hears patients ask if they are “stuck” once they join the clinical trial. No, a trial is a completely voluntary participation, and they can withdraw at any time.   [7:25] Other patients ask if trials are only for people who are out of options. Many trials are designed for earlier stages, especially when the goal is to prevent complications or reduce steroid exposure.   [7:46] The last question Dr. Oko hears a lot is “Will I be in the placebo group?” He says it’s an understandable fear. They are asking if they will go untreated in the placebo group.   [8:29] In many trials, a placebo is not the same as “no care”. Often, the participants continue the standard-of-care treatment, and the study drug or placebo is added to the standard-of-care treatment.   [8:45] Trials typically involve symptom monitoring and a plan for what happens if the symptoms worsen. There are exit criteria.   [9:01] From the pharmaceutical side, it’s the end of treatment once you decide to voluntarily exit the study.   [9:10] Dr. Oko’s advice is, if you participate, ask the study team physicians to explain in plain language what you’ll receive, what you can continue, and what happens if you flare up. Clear answers are always a part of ethical research.   [10:33] Holly asks what it means to participate in a Phase 1, Phase 2, or Phase 3 trial. Dr. Oko says a Phase 1 trial is focused mostly on the safety and the dosing regimen. It’s usually a small group of five to 100 or so.   [10:52] A Phase 2 trial always looks for the drug’s effectiveness and continues monitoring safety. It’s usually a group of 100 to 300 subjects. They look for meaningful signals of the outcomes derived from the trial.   [11:10] A Phase 3 trial is usually large. It’s multi-centered. It’s called a complementary study. It involves thousands of patients. It can even be across nations and states.   [11:26] This is where they compare new interventions against a placebo or against a standard of treatment to provide clinical benefits and support for regulatory approval.    [12:03] Participating in any phase of a trial includes fitting the eligibility criteria of inclusion for that particular phase. If you are a good match, you can be in either a Phase 1, Phase 2, or Phase 3 trial.   [12:52] Holly says she knows that a lot of people with EoE or EGIDs are very curious about trials and how to participate in them.   [13:00] Ryan says we have a very active patient community, and everyone’s looking for ways to get involved in research and new diagnostics or medications to improve their own outcomes and help everyone else.   [13:35] Dr. Oko says the benefits of participating in a clinical trial include access to potentially disease-modifying therapies years before they reach the market.   [13:47] Another benefit is extraordinarily close medical monitoring. When you’re in a clinical trial, you have more frequent visits and more frequent labs than usual.   [14:01] Endoscopies are out of the normal standard of care, but will be more frequent than normal to analyze the efficacy of the study drug.   [14:11] Dr. Oko says one of the risks is the unknown side effects the study drug comes with, because we are still understanding the biology.   [14:21] The time commitment for visits can be more than typical for a patient, especially if there is a long travel time involved. Patients may arrive at 7:00 or 8:00 a.m. They may need to find a place to live nearby, depending on the pace of the trial.   [14:57] Holly lives in Maine, and a lot of the trials are in Boston. It’s a lot of travel. For people with any kind of chronic illness, all we think about is money. Holly asks if people pay to be part of a clinical trial.   [15:25] Dr. Oko states that the patients do not have to pay anything to be part of a clinical trial. Patients do get compensated by the trial sponsor for travel, accommodation, parking, and a meal for the days they are onsite.   [16:33] Dr. Oko says that patients tend to bring up insurance. It is a misconception that the study will pay for their standard-of-care medication during the study. Patients need to ask the study team what insurance will pay for and what the study will pay for.   [16:59] Dr. Oko says the insurance usually covers the regular standard-of-treatment, but any other additional treatment, procedures, and visits are all covered by the study sponsor.    [17:29] The study sponsor may ask for an endoscopy to be done six months before the study to determine eligibility for the study. If it is done within a year, the study sponsor will determine if you are qualified. That is part of the eligibility criteria in some cases.   [18:26] Dr. Oko tells patients to always ask questions, like what the schedule of events is in the clinical trial.   [18:35] The schedule of events tells you how many visits are required for you to be part of this study. They will list the activities to be done. They will list the labs you will need at what week. They will list when you need endoscopies, at week one and later.   [19:05] If you exit from the study, if you don’t want to participate anymore, you are still required to come on site just to make sure that you are in good shape. Those are called formal visits.   [10:29] Dr. Oko explains that formal visits are necessary for the patient’s safety and to make sure that the data points collected in the study will be effective.   [20:01] Patients enrolling in a clinical trial can also ask about the known risks of the symptom monitoring plan. They can ask what is covered and what is not covered by insurance, and what will be considered out of pocket.   [20:20] If patients are in the placebo group, what will happen if symptoms worsen? In the protocol, there is always a rescue plan. If a symptom flares up, the Principal Investigator carries out the rescue plan.   [20:58] The study team is available on a 24/7 hotline. The questions you ask are very important. No question is too small to ask. Every question and every symptom you report is important. You can withdraw at any time, and there is always a follow-up.   [22:19] Dr. Oko says the trial data that has already been collected from part of our eosinophilic studies has led to various FDA approvals of the biologics. We are working  to try to transform EoE from a steroid-dependent or diet-only disease into a position of long-term control.   [22:37] Trial findings have shaped care, expanding evidence-based options, clarifying which patients benefit the most, and improving how we measure our outcomes, the symptoms, and quality of life, as measured by patients’ quality-of-life surveys.   [23:06] Quality-of-life surveys are very important for the study team. They help to measure safety, too. The evidence generated from this data leads to insights and improves study design, protocol design, and ultimately, improves patient care.   [23:40] Ryan says the community is interested in clinical trials because they benefit patients, researchers, and clinicians. We’re thankful for the clinicians and researchers putting in all the work to make these clinical trials happen.   [24:01] Ryan adds, we’re also thankful for the patients who are interested in these trials. For patients who are looking to participate, how can they find clinical trials to participate in and join?   [24:15] Dr. Oko says people can find the website ClinicalTrials.gov. It’s an important tool in looking for various clinical research. Scientists are recruiting at a given time. You can use the Advanced Search option to narrow the search by state and criteria.   [24:54] You can always discuss clinical trials with your primary care physicians. You can look for major academic medical centers. Most of them always have clinical research studies going on.   [25:07] Dr. Oko says APFED.org is a very good tool. It always maintains up-to-date trial listings and patient-friendly summaries where patients can read about the studies.   [25:30] Ryan says he’s very appreciative of the mention of APFED. There is a link on APFED.org so people can find studies. There are clinical trials listed that people can research more and join.   [25:46] Holly asks Dr. Oko to share advice for listeners who are considering participating in a clinical trial. He shares, “I want each one of you to approach the decision with the same care you would with any major medical choice. Review the Informed Consent Form (ICF).”   [26:23] “The word informed means you should be informed. It’s your right to get informed with every line, every detail. The Consent Form can be 30 pages long, but please just know that you are not in a rush to answer.”   [26:43] “You can take the Consent Form and discuss it with your friends, your family, your primary care physician, your gastroenterologist, and your allergist and get more information.”   [27:00] “When you join an interventional trial, or a registry, your contribution accelerates the science and benefits the entire eosinophilic community.”   [27:12] “From my years of reviewing medical charts and supporting new recruitments, I feel patients feel most satisfied when they are fully informed and genuinely partnered with the study team. That’s how I partner with the patients. I am always there to help.”    [27:40] Ryan says that is great advice for patients, and hopefully, some of our listeners to this episode will go out there and look for clinical trials to participate in or ask their physicians, next time they’re getting care.   [27:52] For patients who would like to know more about eosinophilic disorders, we encourage you to visit APFED.org and check out the links in the show notes below, specifically to research opportunities listed on APFED.org. [28:08] If you’ve been personally impacted by eosinophilic disorders and are interested in sharing your experiences, we encourage you to please check out APFED.org/shareyourstory.   [28:17] Ryan thanks Dr.Oko for joining us today. This was really helpful and insightful, and hopefully, we’ll have many new patients interested in joining clinical trials. Dr. Oko thanks Ryan and Holly for having him on and thanks every listener who has joined us.   [28:33] Dr. Oko says it has been a genuine pleasure and privilege for him. He has spent years seeing patients, reviewing their charts, and hearing their stories. We see you, we hear you. Science is advancing rapidly and shaping outcomes. You are not alone.   [30:17] Holly thanks Dr. Oko for his research and clinical trials, and thanks APFED’s Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast Apfed.org apfed.org/specialist apfed.org/connections apfed.org/research/clinical-trials Duke University Hospital’s Department of Gastroenterology Education Partners: This episode of APFED’s podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   “Many people spend a long time seeking answers. Sometimes they feel dismissed before they get a clear diagnosis and a plan that fits their life.” — Chukwuemeka Oko, MD, MBA   “On the biology side, eosinophilic disease teaches us a lot about how our immune signals can drive information differently across tissues like the esophagus and airways.” — Chukwuemeka Oko, MD, MBA   “In many trials, a placebo is not the same as no care. Often, the participants continue the standard-of-care treatment, and the study drug or placebo is added to the standard-of-care treatment.” — Chukwuemeka Oko, MD, MBA   “I tell patients to always ask questions, like what the schedule of events is in the clinical trial.” — Chukwuemeka Oko, MD, MBA   “[If a patient exits the study], formal visits are necessary for the patient’s safety and to make sure that the data points collected in the study will be effective.” — Chukwuemeka Oko, MD, MBA   “From my years of reviewing medical charts and supporting new recruitments, I feel patients feel most satisfied when they are fully informed and genuinely partnered with the study team.” — Chukwuemeka Oko, MD, MBA   Guest Bio: Chukwuemeka Oko, MD, MBA
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