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What does it take to design and conduct a successful study in today’s research landscape?

Kaleab Abebe

At PCORI, we know part of the answer lies in listening to the voices of those in academic and scientific communities.

Through PCORI’s Advisory Panel on Clinical Trials (CTAP)—one of two advisory panels established as part of PCORI’s authorization—panelists bring firsthand experience to our research portfolio and award applications.

We spoke with former CTAP chair and biostatistician, Kaleab Abebe, PhD, MA, to learn about his path to becoming a panelist and his experience. He also shares his perspective on COVID-19’s impact on research and advice for applicants and nominators this season.

What led you to become a member of CTAP?

Kaleab Abebe: I’ve been involved in clinical trials since graduate school. When I joined the University of Pittsburgh School of Medicine’s faculty, I worked on a data coordinating center for a multicenter clinical trial.

From that experience, I gained a deep understanding of how critical data coordinating centers are to clinical trials and the importance of having biostatisticians serve in leadership roles within trials.

I was fortunate to be nominated to CTAP by someone well known and senior in the biostats community who knew about my experience and work in designing randomized trials. After my selection, I served for three years and was chair my final year. Now, I’m co-principal investigator on a PCORI-funded study on sickle cell disease.

It shows the importance of mentorship. Sometimes, you need that push from a senior mentor who recognizes your expertise and recommends you serve as an advisor, even early in your career.

I was fortunate to be nominated to CTAP by someone well known and senior in the biostats community who knew about my experience and work in designing randomized trials. It shows the importance of mentorship.

What were some of the most memorable discussions you had as a panelist?

We had interesting conversations about ways to identify factors predictive of clinical trial success and how to measure them. Some factors are complex, such as a study team’s readiness to provide infrastructure for data collection.

It was helpful to have a multidisciplinary group from all aspects of clinical trials on CTAP because we had collective insight as to whether a factor was not being measured properly. We helped PCORI determine how they could analyze their existing portfolio and ways to incorporate measures in assessing future proposals.

PCORI also asked for advice on whether some cluster-randomized trials had included enough clusters for a successful study.

PCORI Advisory Panel Applications and Nominations

PCORI is seeking applications and nominations for open seats on its advisory panels: health disparities and delivery research, patient engagement, clinical trials, rare disease, and clinical effectiveness and decision science. Membership on an advisory panel offers the opportunity to work with other healthcare stakeholders to provide crucial input on the direction of PCORI-funded healthcare research.

More information on PCORI’s advisory panels can be found here. Applications and nominations are due March 31, 2021. Click here to get started.

A cluster, for example, could be classes of students at a school. How tightly connected clusters are ultimately affects how many participants you need for a study.

It was gratifying to contribute my knowledge from designing these types of trials to help PCORI make decisions affecting their portfolio.

What challenges does COVID-19 present to the research enterprise and clinical trials? How can CTAP help?

One of the pandemic’s greatest challenges to research is having to determine how to conduct well-designed studies that answer certain questions in an environment where there is so much uncertainty.

We need to find ways to adapt and be flexible without compromising scientific integrity.

CTAP can be a helpful resource, as the panel creates a network of people connected via shared experiences. So, I have people to reach out to for ideas or solutions.

What advice would you give someone nominating others or nominated for a PCORI advisory panel?

Nominators should think broadly about who they consider experts. Panels should be diverse from the standpoint of race, ethnicity, expertise, and panelists’ career levels. This creates diversity of ideas and may provide early-career panelists a stepping-stone to future leadership positions in their careers.

There are not many instances where a large funding agency will hear and value your opinions. Serving as a panelist provides an opportunity for enriching discussions in small groups with a minimal time commitment of two yearly meetings.

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