How my prostate cancer journey informs my advice to trial sponsors
Shaun Martin has spent decades evaluating and refining the strategy for sponsors’ clinical trials. He has worked with clients of all sizes in all indications. He analyzes the broader therapeutic landscape, patient populations, biomarker strategies, and the feasibility of studies from Phases 1 to 3. As a Stage 3 prostate cancer survivor, Shaun combines his personal experience with decades of professional expertise. In this article, he shares his cancer journey through diagnosis, treatment, and recovery, and describes Parexel’s approaches to easing the journey for others.
An unexpected diagnosis reveals a flawed system
My journey with prostate cancer began unexpectedly. Despite leading a healthy, active lifestyle—running 10K daily into my mid-50s—a proactive prostate-specific antigen (PSA) test, recommended by my new doctor, revealed a dangerously high level. I was suddenly diagnosed with Stage 2 prostate cancer, which, after surgery, was found to be a more aggressive Stage 3. This experience taught me that cancer doesn't discriminate based on fitness; early screening is crucial. My treatment journey highlighted the fragmented nature of prostate cancer care in the United States, including:
Segmented specialists: I couldn't get a coordinated treatment plan. My urologist, a skilled surgeon, was excellent at prostate cancer surgery but lacked expertise in radiation oncology. The radiation specialist was knowledgeable in her field but couldn't advise on surgery. I had to evaluate complex risk-benefit scenarios on my own, which proved to be very challenging, despite my professional background.
Lack of options to participate in clinical research: After decades of working in clinical research, I was shocked that my doctors didn't suggest any clinical trial options for my treatment. When I asked, they sent me to distant academic centers, admitting they didn't have current trial info.
The information barrier: I began searching for relevant clinical trials. Public resources, such as ClinicalTrials.gov, are difficult to navigate because of inconsistent data categorization. I relied on commercial databases, like CiteLine, which contain crucial information that is inaccessible to most patients. Ultimately, within the limited time between diagnosis and surgery, I did not find a trial.
The age factor: In my urologist's waiting room, I was often the youngest patient by 15 to 20 years because prostate cancer mainly affects older men. They face unique challenges: complex medical decisions, nuanced information, and travel for specialized care or clinical trials. They often need considerable logistical and emotional support from caregivers.
Emotional toll on family and caregivers: A cancer diagnosis doesn't just affect the patient; it causes ripple effects throughout their entire support network. Although I approached my diagnosis objectively, my wife and daughter experienced a complete breakdown. To them, the word cancer meant death; they fought with fear and uncertainty. This taught me that healthcare professionals must never forget the deep emotional toll of illness on caregivers and family members, who often lack the clinical understanding to process the news. Unfortunately, fear and urgency can lead patients to choose surgery when other options might offer equal or better results.
Leveraging patient insights to improve prostate cancer trials
Prostate cancer care remains mainly surgical and lacks coordination between disciplines, unlike breast or lung cancer, where multidisciplinary approaches are standard. At Parexel, we gather insights from patients like me to develop strategies for recruiting and retaining participants in clinical research. Sponsors can leverage clinical trials to improve the patient experience in prostate cancer, while speeding up development and bringing new therapies to market. Well-designed clinical studies can:
Increase access to advanced diagnostics
Molecular profiling of tumors—standard for breast and lung cancer—is increasingly being used for prostate cancer. For example, precision medicine treatments such as PARP inhibitors require evidence of a BRCA1, BRCA2, or other DNA repair mutation. However, advanced diagnostic tests, such as next-generation sequencing (NGS) panels, can be expensive or unavailable.
One of the most immediate ways clinical trials can improve the patient journey is by providing patients with access to diagnostics and treatments they might not otherwise receive. This is a powerful motivator, especially in healthcare systems where access to specialized care or certain drugs is limited. This increases healthcare equity.
Sponsors can ensure their trials include essential molecular testing for patient eligibility at no cost. At Parexel, we recommend that sponsors focus on biomarker validation and educate patients about the importance of testing. These approaches can lead to faster development and greater patient access.
Empower sites and patients by communicating in plain language
At Parexel, we actively invest in educating and communicating with investigative site staff. By providing them with comprehensive training on a trial's science, value, and patient-centric features, we equip them to be strong advocates. They become key influencers, capable of effectively presenting clinical trial options to patients and closing the information gap that I experienced.
An informed patient is empowered. We develop and provide tailored, accessible communication tools. These include dialogue aids for physicians, plus videos and printed materials to help patients understand complex treatment paths and scientific concepts in plain language. We ensure trial collateral is sensitive to diverse demographics, cultures, and individual values. Investing in recruitment and educational materials for subjects and sites is central to trial success. Cutting communication budgets early almost inevitably leads to lagging enrollment and debilitating delays, ultimately costing sponsors more in the long run.
Attract and retain patients with flexible, decentralized approaches
Flexibility benefits sites and patients. During the pandemic, clinical trials were decentralized by necessity. Flexible, at-home study visits and sample collections proved not only possible but also more efficient in some cases. Blood can be drawn at a local drive-through instead of a central site. Quarterly check-ins with the principal investigator (PI) can be via phone or online, with a brief review by a research nurse of quality-of-life (QOL) surveys and health diaries. Sponsors can create hybrid trials that combine remote technology, home-based or local nursing, and traditional visits.
Virtual data collection saves patients from traveling to and from sites, which can lead to missed workdays and extra costs like childcare. However, patients don’t always prefer it. For example, we recently asked patients about their experiences with telehealth visits in a prostate cancer trial we conducted. One patient told us he received difficult news about his disease progression and a change in prognosis. He felt uncomfortable hearing this information in an online appointment. If a meeting is going to involve distressing or sensitive information, nothing replaces talking with a PI in person. Notably, the same prostate cancer patient preferred completing QOL questionnaires privately online. That’s because QOL questionnaires often include sensitive questions about sexual dysfunction, bowel movements, and depression or anxiety, among other topics. He felt uncomfortable discussing those subjects in face-to-face meetings or interactive telehealth sessions with site staff.
Drive multidisciplinary collaboration that advances the field
At Parexel, we are actively working to break down the barriers in prostate cancer care. For example, we recently conducted two pivotal multinational Phase III trials of a targeted radioisotope-labeled imaging agent to detect, stage, and localize initial and recurrent prostate cancer.1 Prostate cancer trials require collaboration between urologists and oncologists (who identify patients), and nuclear medicine specialists and radiologists (who perform PET scans). Since these specialties don't always align, our experienced medical monitor engaged urologist PIs from group practices in the U.S., which are key referral sources. Our PI selection guidelines targeted sites with a history of effective urology-radiology collaboration. Urology-affiliated sites emerged as top recruiters, averaging 14 patients per site, significantly higher than others. The strong rapport between urologists and patients helped recruit and retain participants. This collaboration also streamlined data entry, enabling one trial to achieve its last patient first visit (LPFV) milestone 45 days ahead of schedule. Overall enrollment in both trials significantly exceeded industry benchmarks.
Addressing systemic challenges of the cancer journey
My personal battle with prostate cancer has deepened my dedication to improving the clinical trials. The obstacles I faced, such as fragmented care, the information gap, and the emotional impact on my family, are common experiences for many patients. At Parexel, we aim to be a key partner for progress. We don't just run trials; we address the systemic challenges of living with cancer. Recent data show that our patient-centered strategies are effective; we enrolled patients in prostate cancer trials 11 months faster than the industry standard.
We believe that combining scientific advancements with empathetic understanding of patient experiences can ease the journey for others, leading to more efficient drug development and better outcomes in prostate cancer and beyond.
How Parexel improves the patient journey in oncology trials
Train site staff
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Write a briefing document for site staff and clinical research associates that explains the rationale for a trial’s design, including how it reduces patient burden and improves access to care.
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Highlight the role of study coordinators and nurses as evangelists for the study.
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Train the entire investigative team, not just the physician, in the nuances of the study. For remote technologies, include up-front training at investigator meetings and ongoing technical support.
Develop compelling forms & trial brochures
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Create visually engaging trial materials in a variety of formats for different learning styles.
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Produce videos and animated, interactive guides to improve the informed consent process.
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Use plain language: concepts should be accessible and words easy to understand.
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Ensure all text (and context) is at the right literacy level for patients to comprehend.
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Translate materials into different languages based on local demographics.
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Address the needs and concerns of diverse races, cultures, and age groups in your materials.
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Create a suite of study introduction tools and a format for regular ‘study progress’ bulletins.
Support patients
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Provide access to a real person by phone who helps patients solve technology glitches with wearables, sensors, or telemedicine tools, reschedule appointments, hire a taxi, find mental health counseling, and other trial-related tasks. At Parexel we provide these services under our Patient Navigator Service.
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Remind patients in advance of appointments.
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Provide sites with information about relevant patient advocacy groups for interested patients.
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Send a thank-you note to every patient who takes part in a trial.
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Deliver a clear, readable summary of results to every patient once the trial completes.
Disclaimer: Parexel provides the information contained in this document for educational purposes only. The information does not constitute legal or regulatory advice. Readers should not act upon this information without seeking advice from professional advisers.
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