Dr. Leen Kawas, co-managing partner of Propel Bio Partners, highlights ways in which clinical trial innovation is integral to allowing for more effective outcomes.
We have talked a lot about the importance of conducting new research to improve the quality of medicine. We even have an article on tips for creating a great clinical trial.
One analysis found that there are over 491,000 clinical studies conducted across the world every year. However, some of them have some significant limitation.
In the complex drug development arena, clinical trials enable promising therapies to receive real-world testing and evaluation. Managed by a principal investigator (or PI) and their team, each trial follows a carefully designed protocol that ideally ensures patient safety while achieving the trial’s specific goals.
The clinical trial design and management team seeks to structure a trial that meets specific goals while effectively utilizing available resources. Ideally, the team will recruit (and retain) enough qualified patients to enable the trial to proceed to conclusion. Finally, patients and (if applicable) caregivers will receive the support they need throughout the clinical trial’s duration.
Leen Kawas, Ph. D. offered insights on these and other topics during the May 22, 2024 edition of “Trials with Maya Z.” TrialHub, a clinical trial-focused data intelligence platform, sponsored the podcast. Every episode features a recognized expert who discusses clinical trial challenges and joins the host in devising creative solutions.
Dr. Leen Kawas’ Clinical Trial Experiences
Dr. Leen Kawas is well acquainted with clinical trial logistics. A licensed pharmacist who holds a Ph. D. in Molecular Biology, Dr. Kawas serves as Propel Bio Partners’ Managing General Partner. This Los Angeles-based venture capital firm works with start-up and early-stage companies in the biotechnology and healthcare industries. Prior to her current role, Dr. Kawas co-founded drug development firm Athira. During her Athira tenure, Dr. Kawas managed the firm’s Initial Public Offering (or IPO) in September 2020.
Dr. Leen Kawas also successfully guided several drug candidates through the development cycle. “And I had an amazing experience both building the company financially, but at the same time, building a platform of drugs and a clinical pipeline…Since then, I became super passionate about clinical development and the importance of understanding clinical operation and how it impacts the data and the outcome of clinical trials,” Dr. Kawas remarked.
People that are interested in learning more about different clinical trials can use a clinical trial finder, like the ones we talked about in this article.
Dr. Leen Kawas Discusses Patient-Related Trials Concerns
Dr. Leen Kawas’ extensive clinical trials experiences led her to advocate for earlier-phase patient inclusion and more patient support. She received considerable resistance from industry colleagues at the time.
During the podcast, Dr. Kawas discussed several issues that had emerged while coordinating Alzheimer’s therapies clinical trials approximately a decade ago. She raises the same concerns when speaking with potential Propel Bio Partners’ clients today.
Importance of diversity in clinical trials
Dr. Leen Kawas expressed her concern about the lack of diversity on clinical trials’ management teams. She related the experience of an older black female Alzheimer’s patient. When researching clinical trials’ management sites, the woman didn’t find anyone from her demographic on the management team.
“Like, that was a learning experience from a corporate point of view, right?…Diversity is critical at every stage of the company, not just the clinical trial managers…When someone participates in the clinical trial, it’s a trust relationship,” Dr. Leen Kawas emphasized.
Management of data quality in clinical trials
Specifically, Dr. Leen Kawas emphasized that a quality patient trial experience would help ensure data integrity. She also expressed concern about the large Alzheimer’s clinical trial dropout rate, which negatively impacts data quality.
“I want to see the schedule minute by minute because patient experience is very important when we think about the clinical trial quality and the integrity of data, right? The other challenge that I’ve seen in clinical trials for Alzheimer’s is the huge dropout rate. Right, when we have large dropout rates, it impacts again quality of data,” Dr. Leen Kawas remarked.
Support of patients and caregiver in a trial
Dr. Leen Kawas also recalled feedback from Alzheimer’s caregivers. One woman noted that her husband, a trial participant, became anxious during long trial days without food. On a related note, trial-related EEG tests were impacted by food (or the lack thereof).
During clinical trial days, Alzheimer’s caregivers were compelled to spend long hours in waiting rooms. Patients with often-disruptive neurological conditions often caused added stress.
Dr. Leen Kawas’ Creative Solutions
To resolve these issues, Dr. Leen Kawas arranged for meals for trial participants and their caregivers. The caregivers were also given WiFi-enabled tablets to improve their waiting experience. Disruptive patients were moved to other rooms.
“So those are the things that are just related to the clinical trial experience, which a lot of people don’t think impacts data. It does impact data because if the patients feel that they’re seen, they’re going to commit to the clinical trial,” Dr. Kawas said.
She also noted that after implementing these patient-centric measures, the trial dropout rate was “half of what you would expect from industry standards…And it’s all from these small things,” Dr. Kawas concluded.
A “Beginner’s Mindset” and New Technology are Key
With these successes in mind, Dr. Leen Kawas recommended that clinical trial designers adopt a “beginner’s mindset” during problem-solving exercises. “We need a more ‘beginner’s mindset.’ And when I say ‘beginner’s mindset,’ [this would mean] experienced people who approach problems with a different mindset [than the one that] brought us to these problems.
“The second part is technological. You know, these things take commitment, time, and sometimes resources. You can do it efficiently if you’re nimble, but having technological solutions can help us capture this information,” Dr. Kawas said.
The Patients Should Remain the Primary Focus
Looking forward, Dr. Leen Kawas emphasized the importance of quality clinical trial data. Concurrently, she stressed that the patients’ contributions are key to successful clinical trials. “And we should not forget that the patient’s input is part of the clinical operation. Patient voice is part of clinical operation. They are the centerpiece of clinical operations.
“And I think starting with that mindset. Having the biggest focus on the patients…And bringing them at the forefront in everything that we do, starting from investment, ultimately to product in the market and commercialization, I think will impact our industry significantly and will lead to more successful drugs commercially that truly address patients’ needs,” Dr. Leen Kawas said.
Clinical Trials Logistics when considering an investment
As Dr. Leen Kawas evaluates potential biotech investment candidates, she said each company’s CEO should be keenly aware of their clinical trials’ logistics. Dr. Kawas’ business background and clinical trial design expertise enable her to capably evaluate each candidate.
“It’s looking at the team, the management team. We talk with the VP of operations, clinical operation, and clinical research. If the clinical scientists are not working hand in hand with the clinical operation team, there is also a challenge there.
“A big part of our differentiated strategy is being able to quantify clinical development and clinical research risk,” Dr. Kawas remarked. Candidates that are approved for investment can expect to receive Dr. Kawas’ valued business and technical support.
