RealTalk MS: Special Episode – Dr. Aaron Boster Explains MS Clinical Trials

Podcast: RealTalk MS
Host: Jon Strum
Guest: Dr. Aaron Boster (Founder, Boster Center for Multiple Sclerosis, Columbus, OH)
Release Date: September 17, 2025

Episode Overview

This special episode of RealTalk MS, hosted by Jon Strum, features Dr. Aaron Boster, a leading MS clinician and clinical trial principal investigator. The conversation provides a comprehensive breakdown of the MS clinical trial process—covering the principal investigator’s role, trial phases, patient eligibility, risk and benefit assessment, ethical considerations, and the crucial importance of patient diversity. The discussion aims to demystify clinical research for people living with MS, their loved ones, and caregivers, helping listeners make informed decisions about trial participation and understand the future of MS treatment.

Key Discussion Points & Insights

The Role of the Principal Investigator (PI)

[01:20 – 04:30]

• PI’s Responsibilities: Dr. Boster explains he runs the trial at his site, overseeing patient identification, consent, education, care, and data integrity:
  • “I'm sort of like the shepherd to make sure that the trial is executed properly, with integrity, and that the patient's well being is always first and foremost in all decisions.”—Dr. Aaron Boster [04:18]
• Collaboration with Pharma: Drug manufacturers partner with clinicians like Boster to test drugs in human subjects and pool global data.

Motivation for MS Research

[04:30 – 06:06]

• Dr. Boster’s uncle had MS, inspiring his career focus. A pivotal conversation during his medical school application clarified the difference between private practice and research, steering him toward a career developing new therapies:
  • “If you go into research, then you can help develop new therapies to help more people.”—Dr. Boster [04:57]

Challenges and Rewards of Being a PI

[06:06 – 07:57]

• Rewards: Bringing new treatment options to people in his community and enabling patients to “stick it to the disease” by contributing to future therapies.
  • “There's arguably no better way to stick it to the disease than to volunteer your body to help find a new therapy which you might not even benefit from.”—Dr. Boster [06:43]
• Challenges: The work is extremely tedious, involving rigorous scheduling and documentation.
  • “The day to day operations of a trial is extremely tedious and requires a tremendous amount of very close attention to detail.”—Dr. Boster [07:12]

Phases of Clinical Trials Explained

[07:57 – 12:13]

• Phase I: Focused on safety and dosing, performed with healthy volunteers.
• Phase II: Proof-of-concept in people with MS, mostly to show safety and early efficacy via biomarkers (often MRI).
• Phase III: Large-scale testing for genuine clinical efficacy and regulatory approval (current stage for Fraxalumab).
  • “When a phase two is successful, then you move on to the phase three trial...to prove unequivocally that it works for people impacted by MS.”—Dr. Boster [11:27]

Diversity in MS Clinical Trials

[12:13 – 14:28]

• Importance of Representation: Trials must reflect MS’s real-world demographics to be generalizable.
  • Earlier trials lacked diversity: “...trials conducted in the 90s...didn't enroll anyone that wasn't white.” [12:48]
• Systemic Barriers and History:
  • Cites the Tuskegee Syphilis Study as a cautionary example and the genesis of Institutional Review Boards (IRBs) to ensure participant safety [14:28].
  • Notes historic distrust among African Americans and the shift needed: “For example, African Americans aren't invited into trials as frequent, was largely because doctors didn't have the guts to ask.” [15:50]

Clinical Trial Eligibility

[16:20 – 20:41]

• Stringent Criteria: Enrollment aims to control variables for clear results, often excluding those with comorbidities or more severe disability.
  • “Inclusion and exclusion criteria for a given patient is actually pretty, pretty significant.”—Dr. Boster [17:31]
• Emotional Difficulty: Dr. Boster finds it painful to exclude eager, motivated patients due to statistical reasoning:
  • “They don't allow people to enroll that are, for example, in a wheelchair... It has to do with math.”—Dr. Boster [18:19]

Risks and Benefits of Trial Participation

[20:41 – 25:54]

• Benefits:
  • Contribution to scientific and patient progress—described as “heroic.”
  • Access to care without insurance constraints, stipends for time and travel, open-label access to study drug post-trial.
  • “Sometimes patients struggle in the United States because of difficulty with access to care, right? ...it is lovely that it doesn't cost the patient or the family anything.”—Dr. Boster [21:59]
• Risks:
  • Potential that investigational therapy is ineffective or has unknown side effects (e.g., unexpected brain bleeds, liver issues).
  • Participants and investigators are “blinded” to the treatment received and can’t monitor MRI results in real-time.
  • “By almost by definition, we don't know all the things that could happen with the therapy.”—Dr. Boster [24:14]

Placebo Use and Ethics

[25:54 – 29:15]

• When Placebos Are Used:
  • Not used in relapsing MS trials with established treatments (ethical requirement to compare against a standard).
  • Used in non-relapsing secondary progressive MS where no proven therapy exists.
  • “It’s ethically, completely not okay to put someone into a three year clinical trial on a placebo drug because we know that there are drugs that work.”—Dr. Boster [27:38]
• PI Discretion: Dr. Boster refuses to participate in placebo-controlled trials for relapsing MS.

What’s Exciting in MS Research

[29:15 – 32:08]

• New Biomarkers: Emerging blood tests to detect MS activity.
• Therapeutic Frontiers:
  • Remyelinating and neuroprotective therapies.
  • Improvements in stem cell transplantation safety.
  • CAR T cell therapy: “Super amazing precision medicine”—customizes therapy to an individual’s MS profile.
• The Role of Patients: Without clinical trial volunteers, progress halts:
  • “If nobody volunteered to be in a trial, we'd have no therapy. Zero.”—Dr. Boster [31:33]

Memorable Quotes

• On Diversity:
  “It's super, super, super important that the people that we enroll into a clinical trial represent the people that have the condition.” — Dr. Boster [12:34]

• On Patient Impact:
  “It's heroic to participate in a trial. You're helping a population of people, many not even born yet, in a way that only you can help.” — Dr. Boster [21:22]

• On Ethical Trial Design:
  “I refused to enroll my patients into a phase three trial where they were getting a placebo... because we have all these drugs available.” — Dr. Boster [28:32]

Notable Segments & Timestamps

• PI Responsibilities Explained: [01:46–04:30]
• Phases of Clinical Trials, with Fraxalumab Example: [07:57–12:13]
• Diversity—Past Failures & Modern Solutions: [12:13–14:28]
• Eligibility and Its Real-World Impact: [16:20–20:41]
• Risks & Benefits In-Depth: [20:41–25:54]
• Placebo Use and Ethics: [25:54–29:15]
• Most Exciting Developments in MS Research: [29:29–32:08]

Conclusion

Dr. Aaron Boster’s conversation with Jon Strum provides listeners new to clinical trials—and those considering participation—a candid, thorough, and compassionate overview of the MS research process. Dr. Boster emphasizes both the rigorous safeguards protecting participants and the profound impact patient volunteers have on the future of MS therapy. The episode leaves listeners with hope: The MS research pipeline is robust, and meaningful progress relies on the courage of trial participants.

“If you're impacted by this disease and you don't qualify for a trial, that doesn't mean all is lost. It means that we need to keep you healthy through the currently available therapies so that when those exciting breakthroughs occur, you can benefit from what we come up with.”
— Dr. Aaron Boster [31:48]