Clinical Research: Phase 1 - Phase 4

Build A Better Oncology Patient Experience: Supporting Participants Throughout A Study

Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy recruitment and not on patient engagement efforts, undermining retention rates and potentially negatively impacting the patient experience, thereby reducing the possibility of each patient’s participation in future clinical trials.

If a study must replace patients, it adds expense for the sponsor as well as timeline delays. Many modern clinical trials, particularly in oncology, also include a long-term follow-up element. Oncology trial endpoints are sometimes required to track patients for years to record side effects or the impact of future treatments, in addition to overall long-term survival rates. A patient who isn’t adequately engaged will not complete follow-up long term — if they even stay throughout the treatment portion of the study. Consequently, the sponsor’s submission goals could suffer because they don’t have adequate data, necessitating the enrollment of more patients or an additional trial. Therefore, implementing plans for patient retention for the duration of the study — and beyond — is vital, and considerations must be made during protocol planning to maintain acceptable retention rates.

Understanding Patient Needs

From a structural standpoint, timelines at the outset of a clinical trial — when it is vital to implement patient support strategies into the protocol — usually are driven by being first-to-clinic or by board expectations. Patient engagement efforts are often relegated to the back burner, even if sponsors recognize their importance. Thus, study endpoints are conceived without the context of patient needs and the patient journey.

A sponsor that wants to retain patients and build a reputation that cultivates improved recruitment must set patients up to succeed in each study. This process starts with educating patients at the front end of the study during initial enrollment. Patients need to fully understand expectations: the extent of their participation responsibility, how the study will look day-to-day, and what will occur during each clinic visit. The time commitment demanded by many studies, especially early-phase clinical trials, is among the most significant burdens patients face. Many patients want to participate in clinical trials but struggle to do so, knowing that they would only be in the clinic once a week if they received standard-of-care treatment versus participating in a more time-intensive clinical trial.

Patients may also feel the burden of commuting to a university medical center for a several-hour stay, paying for parking, and submitting to multiple blood draws. They may feel researchers do not hear their needs or that they have limited options for communication and participation. Patients are often left in the dark regarding the medication they received or the results after the study. That informational void constitutes a frustrating, dissatisfying finish for all the time and effort the patient has invested.

Sponsors can support patients early in the study process by working to truly understand where patients are in their disease journey. This includes knowing their target patients’ pain points and attempting to minimize them by developing flexible protocol schedules that allow for inclusion of a diverse patient group, structured in a way that minimizes patient burden when possible and streamlines the process of long-term follow up. 

Strategies for Empowering Patients

While timelines can be constricting at study outset, we encourage our clients to start the patient engagement process during study implementation. This initiative, informed by interactions with the CRO and advocacy groups who understand the relevant patient populations, allows you to build education and support into the study protocol: checkpoints, surveys, the use of community centers to reduce the patient burden, data sharing, feedback loops, etc.

For example, if a study has a two-year follow-up period, how will the protocol plan to meet those endpoints? Have any vendors been considered for patient reimbursement or off-site research nurses to minimize patient burden? What additional support might patients need to ensure researchers accrue all the necessary data to meet those endpoints?

Ultimately, the best way to determine patient needs during a study is to engage the patients themselves, which can be accomplished in several ways, from patient surveys and focus groups to roundtable discussions and online forums. The key element in each of these initiatives is providing patients a seat at the table.

Establish effective communication and data-sharing

Patients who give their time and insights want to know researchers are listening to them and want to understand what is being done with their data. This requires thorough, two-way communication that moves patients from passive to active participants in their care. Accordingly, a vital aspect of patient education and support is documentation detailing study processes or what will occur at certain study checkpoints, as well as other educational materials patients can easily reference. Providing patients access to trial data for their health records also supports their ability to choose and participate in future trials.

Historically, patient data has been shared at the end of the study, rather than at regular touch points throughout, to avoid concerns of unblinding. However, sponsors now are beginning to realize that some patient data captured through study visits, wearables, and lab tests can safely be shared during the study to create a more engaging study experience for patients. Typically, though, logistical hurdles have been the more prominent obstacle to patients accessing their data; that information traditionally has not been as centralized and digitized as it is today.

It is also important to impress upon patients the significance of their participation, explaining the benefits for them, as well as how the study advances the science and treatments surrounding the disease to serve other patients in the future.

Build and leverage existing patient communities

In addition to time constraints during trial initiation, sponsors are unlikely to have dedicated patient engagement personnel on staff because they run trials infrequently, so the responsibility falls to their CRO partner. Accordingly, the CRO must establish a community that provides access to patient information — and attentive, effective mechanisms for patient feedback — in real-time. There are also many social media platforms and sites where oncology patients and caregivers discuss disease impact, patient burden, unmet needs, treatment options, and regimens. Tapping into these discussions gives us unbiased views from both patients and caregivers.

Like many areas of healthcare, clinical trials have quickly progressed from being all-but-inaccessible, informationally, to a state where patients are inundated with so much information they may have difficulty processing what is accurate or understanding it within appropriate context (i.e., relevant to their disease state). Patient engagement specialists and specialized CROs can be the bridge to help patients navigate through available clinical trial information, obtain feedback on patient needs, share that information back to sponsors, and ensure timely responses to patients so they can see the value added by their participation in clinical research.

Partnering with advocacy groups is also effective for gaining patient insights, including how potential trial participants prefer to be contacted (e.g., phone, text, and/or mail). For patients comfortable using a bring-your-own-device approach, sponsors can utilize a patient-reported outcomes (PRO) tool accessible through a participant’s smartphone or tablet. This enables patients to upload trial information (e.g., how they are feeling), ask questions, or receive daily reminders. Researchers can use that data and bring the effort full circle by showing patients over time how their data was collated or how it was used.

That said, not all patients may have access to, or feel comfortable using, a smartphone. In lieu of a device-enabled PRO tool, they may prefer email surveys or providing information to a surveyor over the phone. Patients need options serving the ways they want to interact, just as we give them options for other aspects of the study (e.g., teleconference call or face-to-face visit).

Regulatory Trends Toward Increased Patient Engagement

From a regulatory standpoint, patient engagement currently is aided by a sparse collection of nonbinding guidelines. However, the U.S. Food and Drug Administration (FDA) is wading more deeply into the patient engagement waters recently, as evidenced by its formation of the Patient Engagement Collaborative (PEC), “a group of patient organizations and individual representatives who discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions at the FDA.”

The FDA also published a Draft Guidance in June 2021 titled Core Patient-Reported Outcomes in Cancer Clinical Trials.  The document’s introduction notes that “systematic assessment of a core set of PROs using fit-for-purpose PRO measures can facilitate high-quality data on patient-reported symptoms and functional impacts.” While such guidances are nonbinding, they could lay the groundwork for future regulations dictating how sponsors communicate certain checkpoints with patients, engage certain patient advocacy groups, or enable patient access to data-sharing tools.

Final Thoughts

When patients understand the clinical trial process, have access to their data, and feel as though they have a voice, they are engaged. Engaged patients stick with the study for the long haul, even during periods of long-term follow-up, which is essential for client endpoint data. At Premier Research, we’ve had this focus for years and understand how to implement strategies for patient education and support upfront.

Premier Research uses these insights to construct the patient disease journey, which creates the foundation of our overall patient recruitment strategy and helps us to map which information will be most useful to patients at certain checkpoints during a study. Our goal is not only to support the patient at the beginning of the study but to anticipate their needs/questions/feelings throughout. To this end, we have established embedded Patient Liaison Advocate teams in over 15 countries. These teams possess a deep knowledge of country-specific regulations, healthcare systems, treatment landscape, and standard-of-care mapping. They also can engage patients and advocates in their native language with culturally appropriate questions, as well as point them to region- or language-specific resources.

While many CROs offer similar resources in the United States, our ability to do so internationally, serving each country included in a given study, is a significant differentiator. Using the same questions abroad that are asked of patients and advocacy groups in the U.S. may yield answers, but the feedback will not be nearly as precise or relevant because it has not been properly contextualized.

To learn more about how Premier Research supports sponsors in engaging and educating patients throughout the clinical trial, contact the authors or visit us at

About The Authors

Ashley Herrick, Ph.D., is Executive Director of Oncology Program Strategy at Premier Research, where she provides strategic planning, coordination, knowledge, and expertise for oncology projects. She has more than 13 years of experience in oncology clinical trial oversight and drug development. Dr. Herrick holds a doctorate degree in molecular and cellular biology with a focus on hematologic malignancies from Baylor College of Medicine. She is CCRP-certified and is a member of the American Association for Cancer Research and the American Society of Clinical Oncology. She’s also an active volunteer with the Leukemia and Lymphoma Society.

Nicole Carswell is Executive Director of Patient Engagement & Recruitment at Premier Research, where she leverages worldwide emerging technologies to educate and recruit potential patients. Nicole has over 25 years of clinical experience, including trial optimization, patient recruitment and engagement, and project leadership.  She is a recognized leader who believes in empowering teams to maximize organizational success.

Originally published at Clinical Leader.