The era of one-size-fits-all cancer treatment is no longer. A new age of personalized medicine, where radioactive drugs seek and destroy cancer cells with pinpoint accuracy, brings much-needed hope for those impacted by cancer.
Targeted radionuclide therapy (TRT), in which radioactive drugs seek a molecular target on the cancer cell, can potentially extend life and improve the quality of life for cancer patients.
As the field expands from the treating of specific cancers, such as thyroid cancer and bone metastases from prostate cancer using beta (β)-particle emitters, into a broader range of cancers by harnessing the power of alpha (α)-particle emitters, the challenge of operationalizing the protocol begins.
The key to operationalizing TRT trials is site selection and subsequent support. Understanding the site's requirements and patients, reducing their burden and ensuring they have knowledge and support makes the difference between an engaged stakeholder and one who checks out of the process.
Excellence in site selection a critical differentiator for TRT trials
Successful TRT trials start with choosing sites with recognized experience, knowledge and infrastructure.
Having a TRT-specific feasibility questionnaire and following up with a call to include all departments (principal investigator (PI), study coordinator (SC), nuclear medicine, radiopharmacy responsible person (RRP) and imaging) is the most efficient way of understanding the sites' capabilities and their ability to navigate the complex logistical demands.
The inclusion of both infusion and non-infusion sites in feasibility ensures that all possible patients from all potential locations are considered at this stage, paving the way for cross-border recruitment potentially using home nursing.
The competitive difference of having access to a site network that includes TRT sites of excellence, like Worldwide's global Site Alliance Collaboration, cannot be understated: "Having experience working with TRT trial sites is a real advantage when setting up these trials. Working with the study coordinators and providing them with forecasting, planning, and tracking tools, and generally going the extra mile to assist them, is something we take pride in," explained Sue Batchelor, Executive Director of Oncology Project Management at Worldwide Clinical Trials.
"Our approach also means that we can support those sites that may not have as much TRT experience but have the potential to be included and benefit from the study team's support. We believe that we directly impact patient outcomes by increasing accessibility," Batchelor added.
Local radiolabeling of TRTs brings additional logistical complexities. For example, radiolabeling can take up to half a day, and due to the short shelf life, it may need to be completed on the day of production. Coordinating these logistics with the patient, specialized nurses (trained explicitly for working with patients treated with radioactivity and handling radioactive samples), infusion suites, PIs, imaging and nuclear physicists can present serious hurdles.
This is where the extension of a forecasting tool is vital, especially when the treatment is cyclic, and visit windows need to be used for production to meet demand.
Patient-centric care a top priority
Patients participating in radiopharmaceutical trials experience unique burdens and experience long days at the site. Supporting the site and patients go hand in hand to provide a good patient experience, optimum results and a successful trial.
Early review of the protocol by the site and CRO's operations team can help visualize the patient journey. Reduced, combined and flexible visits are ideal when possible. Adding home nurses is an option, but the less demanding the visit schedule for patients, the more likely they are to enroll and stay enrolled.
Educating patients, caregivers and families is also vital for trial success. Providing clear information and site-provided details on a platform (e.g., an educational video) can reduce treatment-related anxiety in patients and make participation easier.
Supporting patients during treatment is a proven strategy for retention. Practical examples include investing time in well-thought-out visit schedules, being flexible with visit dates, reimbursing for overnight stays near the hospital, and including companion reimbursement on treatment days.
As radiopharmaceuticals continue to revolutionize cancer treatment and diagnostics, Worldwide Clinical Trials stands ready to partner with sponsors in navigating the complexities of this exciting field. Through effective collaboration, partnerships can accelerate the development of lifesaving therapies and improve patient outcomes.
Partner with Worldwide and benefit from their unmatched experience and commitment to excellence. Contact them to learn more about their prequalified site network or to discuss how they can support your trial.
