(UroToday.com) The 2025 GU Oncology Early Career Thought Leaders Conference featured a clinical trials and research session and a presentation by Dr. Elizabeth Plimack discussing how to get involved in clinical trials. Dr. Plimack started her presentation by highlighting the shared values for clinical trials at her institution, Fox Chase Cancer Center:
- Clinical investigation is core to the mission and considered an institutional strength, and clinical trials are critical for providing the best patient care
- Each clinical trial should serve the patients who enroll and advance our scientific knowledge
- Bench-to-bedside discovery is a key objective of the comprehensive cancer center: engagement and collaboration of translational scientists with disease site teams is critical.
- Clinical faculty within the disease site teams are best positioned to decide which trials to submit.
- OCR resources are finite, and every trial submitted uses this valuable resource. Therefore, trials submitted to the OCR should be carefully selected to be of the highest quality and value.
- Prompt transit through the OCR from submission to activation is important
- Trials that are submitted and activated but accrue 0 patients and then close are a detriment to a trials program, a core grant, and the institution and do not advance patient care, scientific knowledge, or investigator careers
- Trials that accrue well are of high value to patients, the trials program, faculty professional advancement, the core grant, and the institution
- Expanding access to clinical trials across a catchment area, community, and health system is critical
Dr. Plimack emphasized that trials should serve patients and their communities and advance the field scientifically. To meet these goals, (i) each trial must accrue towards a meaningful result, (ii) clinical faculty disease sites must steward their trial portfolios with active engagement and expertise, and (iii) resources must be deployed equitably and efficiently to maximize impact. There are several pearls for success as a clinical investigator. Dr. Plimack notes that these include:
- Developing a team culture around portfolio building:
- Advocating for the spread of principal investigator roles across the faculty
- Developing a group culture where there are no competing trials and every clinician has consensus buy in
- Vet trials carefully yourself and within your group:
- Decline promptly, or
- Commit and follow through
- Beware of the niche biomarker trial
- Choose studies you would recommend for yourself or your family member if you were in the patient’s shoes (clinical equipoise)
- Write your own investigator-initiated trials to answer questions you care about
Dr. Plimack notes that clinical research is a team sport, including the external team (the sponsor/CRO), and the internal team (site). The sponsor of the external team is the company running (and paying for) the study, the CRO is a company contracted to monitor the study, and vendors are contracted to review scans, EKGs, etc. The internal team is the principal investigator, co-investigators, clinical research nurse/coordinator, clinical research data manager, clinical team (clinic nurses, PAs, residents, fellows), investigational pharmacist, regulator lead, and finance lead.
Dr. Plimack reviewed several ways to shine as the principal investigator of a clinical trial. These include being engaged, running a tight ship, and telling the truth. Being engaged means communicating well and showing up to key meetings, such as investigator meetings and dose level calls. Running a tight ship means that you have your finger on the pulse of your trial at every stage: the pipeline activation/accrual follow-up. Additionally, we should meet with the site team regularly and be the ones to answer questions about the protocol. Ultimately, co-principal investigators and the CRN/CRCs should go to you before the sponsor. Telling the truth entails (i) disclosing errors promptly and learning from them, (ii) improving your process to prevent future mistakes, and (iii) disclosing relationships accurately on all required forms. In addition to knowing the protocol and understanding the science, the patient comes first, and we should push back if something does not seem right. However, do not bend the rules; live by them.
Dr. Plimack also highlighted several pitfalls to avoid as a principal investigator. We need to know when to quit, which may be secondary to unexpected low accrual, unexpected protocol snags, loss of equipoise for any reason, and/or staffing shortages that limit safe patient care. In her opinion, we should also avoid joining a trial as an additional site once it’s been open for years, as this is likely a sign that the study is struggling. Although politics can be fierce, we must stick to our values.
When getting trials started at your site, it is important to accrue, accrue, accrue. Additionally, it is important to keep the following points in mind when getting trials started:
- Demonstrate accurate and prompt data entry – this is part of your site’s report card
- Participate in your institution's clinical trial infrastructure – this includes attending scientific review committees, IRB meetings, and activation meetings.
- Advocate to solve structural problems in your institutions' support of clinical trials.
- Engage with your Cooperative Group
- Invest in relationships with your Medical Science Liaisons - they know the trials coming down the pike.
- Collaborate with preclinical colleagues and ensure that the trial question is clinically relevant – it is important to write trials that answer both clinical and scientific questions.
- Browse the Trials in Progress posters at ASCO - sometimes they are still looking for sites.
- Show up to meetings and become known as a disease expert.
With regard to phase III trials, there are several benefits and potential drawbacks to being the phase III site principal investigator. The benefits include (i) the straightforward trial design, (ii) there is likely compelling early data, (iii) it brings access to good drugs early for your patients, (iv) the control arm is (and should be) an accepted standard of care, (v) high accrual can earn authorship on the first and multiple subsequent presentations/papers (ie. subgroup analyses), and (vi) someone else does all the work writing the protocol and the papers. However, drawbacks may include (i) phase III trials are competitive with regards to being selected as a site, (ii) it can be hard to accrue enough patients to garner authorship, which is even harder if you have competing trials, (iii) for registration trials, your data will be scrutinized, (iv) there are lots of moving parts and players – the sponsor, CRO, study team on the sponsor site, monitoring, regulation, etc.
Dr. Plimack concluded her presentation discussing how to get involved in clinical trials by highlighting several points regarding authorship politics:
- For cooperative group studies, there are strict rules – know them. Authorship is pre-determined except for a few slots.
- For industry studies, authorship is a blood sport – don’t be subsumed. The first and last author are pre-determined based on negotiation.s
- Know where you rank by enrollment in order to manage your expectations. NCTN has this online, and for pharma trials, your monitor can usually tell you
- Steering committees often ensure authorship regardless of accrual
- If you are not on the steering committee but are a top 5-10 enrolling site, indicate to the medical monitor your expectation for authorship ahead of time
- Investigator-initiated studies, either yours or those of your collaborators or colleagues, are your surest bet for authorship
Presented by: Elizabeth R. Plimack, MD, MS, Fox Chase Cancer Center, Philadelphia, PA
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 GU Oncology Early Career Thought Leaders Conference, Philadelphia, PA, Thurs, Mar 6 – Sat, Mar 8, 2025.
