Designing clinical development programs for radiopharmaceutical therapies

This article is part of Parexel's "Advancing radiopharmaceutical development" playbook series. This series offers insights across feasibility and site selection, patient-guided trail design, regulatory strategy, and supply chain and logistics management to support sponsors in this evolving market.  

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Patient-centric RPT trials: A Q&A with Parexel experts

Translating RPTs’ promise into benefits and better outcomes for patients hinges on the ability to educate and motivate them to participate in clinical trials. We asked two Parexel experts for insights on how sponsors can address patients’ fears about radiation and other unique patient needs in trial design and execution. Charlotte Moser serves as Parexel’s Chief Medical Officer, and Stacy Hurt is our Chief Patient Officer.

Question: What are patients’ top concerns about radiopharmaceuticals?

Stacy Hurt: Fear of radiation is probably the number one concern I hear from patients. It’s counterintuitive to use radiation to cure cancer. Most RPT trials involve two positron emission tomography (PET) scans, one at the diagnostic stage and another at a follow-up visit. These leave a small amount of radiation in your body. Patients also receive multiple computed tomography (CT) scans, which involve higher doses of radiation than other imaging tests (though the radiation does not stay in the body), and an infusion of a radioactive investigational product. As a cancer survivor who received a PET scan, I understand concerns about radiation. In my case, the higher accuracy of the PET scan, compared to a CT scan, enabled my physicians to re-stage my colon cancer from stage 2-3 to stage 4. Those stages are treated differently, so I began receiving chemotherapy immediately, instead of first undergoing surgery. It saved my life.

Question: How can sponsors reassure patients?

Stacy Hurt: A patient’s concern about radiation is serious and must be addressed with emotional sensitivity and transparency about potential risks and benefits. Patients ask questions like: Am I going to get leukemia one day from undergoing these scans? Will I glow with radioactivity after I am dosed in this trial? RPT trials present an unfamiliar scenario. Patients will technically be radioactive after dosing, because beta and alpha emitter particles have a local effect. Patients will need to isolate themselves from site staff and family members for some time. At Parexel, we provide patients with information in understandable language through videos, brochures, and trial websites. Sponsors and CROs must manage patients’ expectations because, after hearing the words “you have cancer” from a physician, patients don’t want any more surprises.

Question: How do RPTs change the patient care pathway?

Charlotte Moser: Oncologists often don’t consider RPT clinical trials a treatment option, potentially due to a lack of understanding of the logistics. Most assume they must transfer their patient to a nuclear medicine team, and these referrals are not always straightforward. In RPT trials, oncologists and nuclear physicians collaborate to treat patients. Personalized dosimetry (the measurement, calculation, and assessment of the ionizing radiation dose for each patient) complicates treatment planning, necessitating a change to the patient pathway. This is not without precedent. We now have an established tradition of including nuclear physicians in patient care for neuroendocrine tumors and prostate cancer. So we know it can be done, but it’s challenging. 

Question: What does participation look like for patients?

Charlotte Moser: During trials, patients often need to visit the site for the diagnostic dose, then return a few days later for the therapeutic dose(s). They then stay in isolated rooms waiting for the radio emissions to decrease to baseline levels. We are currently running a breast cancer trial. We have worked to ensure fluent collaboration between the oncology and nuclear medicine teams to secure a smooth referral route for patients from the oncologist to the nuclear medicine experts, and back again after the treatment period ends. We provided extensive information about the agent’s mechanism of action, expected safety profile, and anticipated level of efficacy (based on preclinical data) to investigators to promote engagement in the study. Sites tell us that the scarce availability of multidisciplinary teams is one of their primary pain points in conducting RPT trials. Integrating RPT education into oncology training and fostering interdisciplinary collaboration takes time and effort.

Question: Can trial materials and support improve patient recruitment?

Stacy Hurt: Sponsors need to simplify complex stories for patients. At Parexel, we map out the site visits and procedures for diagnostic, therapeutic, and theranostic RPT trials using practical, everyday language and graphics. Simplifying intricate scientific details without losing accuracy demands creativity and diverse communication tools. We encourage sponsors to provide comprehensive patient navigation programs to coordinate appointments, arrange transportation, address patients’ everyday concerns, and even extend support to their caregivers. These programs require resources and institutional commitment, but they mean a lot to patients and can boost recruitment and retention. 

Question: How important is transparency in RPT trials?

Stacy Hurt: Transparency is hands down the best approach for patients. For example, radiopharmaceutical extravasations can occur if an RPT diagnostic or therapeutic is erroneously injected into a patient’s tissue during a site visit, missing the intended vein. Extensive extravasation can compromise the quality of diagnostic images or therapy delivery, inadvertently harming patients. However, RPT extravasations do not have to be reported to the patient, which patient advocates argue creates a lack of transparency.¹  At Parexel, we have found that most patients understand that not all medical procedures go as planned, and, if they are presented with a full and fair disclosure of risks, they can make informed decisions. Early and consistent engagement with patient advocacy groups and transparent communications about clinical research are vital to recruitment and trust.

Question: How can providers impact patient recruitment and retention?

Charlotte Moser: Oncologists are often the primary care providers for patients considering clinical trials. Training on the principles of RPT therapy helps them communicate effectively and address patient questions accurately. Moreover, when patients see their oncologist collaborating well with the nuclear medicine physician, and both deliver a consistent message, they feel more confident about being in the trial. 

Question: What resources do they need to guide patients?

Charlotte Moser: Supplying physicians with patient-friendly educational resources enhances their ability to guide patients through decision-making. It’s essential to make the underlying science accessible through lay-friendly summaries that avoid technical jargon when explaining isotopes and targeting mechanisms. Interactive tools and videos can visually demonstrate how the radiopharmaceutical seeks out and attacks cancer cells. The focus should always be on the "why" – clearly explaining the rationale behind this therapeutic approach and its potential advantages in their specific situation, such as the "see it and treat it" precision of theranostics.

Well-established success stories, such as radioiodine therapy for hyperthyroidism, can reassure patients of the efficacy of RPTs in a non-cancerous setting. As more data emerges from oncology trials, showcasing positive outcomes builds hope and encourages participation. Emphasizing the "educated patient" concept invites individuals to actively discuss their treatment options and make informed choices based on a clear understanding of the potential benefits.

Resource

1. Transparency – a patient-centric view on radiopharmaceutical extravasations, Frontiers in Nuclear Medicine (February 27, 2023).

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