Building Connections for Clinical Trials: How Patients Can Improve Trial Enrollment & Engagement – Part 3

Part 3 of 3: Engaging patients before, during and after the clinical process

This blog is part 3 of a series on the impact and benefits of patient involvement with the clinical trial process –  patient willingness to participate in trials, what they can contribute beyond their role as study participant and how to most effectively find and communicate, and engage with them.

In this third and final blog in the series, we’ll look at why bringing in patients early and often is the key to being able to make changes that improve a clinical trial before it starts, as it is ongoing and even after completion. We’ll also explore specific tactics to enable the most impactful engagement with patients around clinical trials.

In the first two blogs in this series, we’ve discussed why and how patient engagement for clinical trials is important. Read Blog #1 here https://reverba.com/building-connections-for-clinical-trials-how-patients-can-improve-trial-enrollment-engagement/and Blog #2 here https://reverba.com/building-connections-for-clinical-trials-how-patients-can-improve-trial-enrollment-engagement-2/.

Now we will look at how to specifically use patient engagement programs to improve protocol design and the clinical trial experience.

Before The Clinical Trial

It’s important to get patients involved early in the clinical trial protocol development process to ensure the trial doesn’t have roadblocks built in that will impact recruitment and retention.  Early engagement also enables you to request patient feedback during the development of all recruitment materials and channels planned with ample time to make any needed revisions.  Some examples of ways to involve patients include:

• Patient interactions with teams – Informal, internal lunch meetings that bring together patients and employees can provide eye-opening discussions and insights to both groups. Employees can learn about living with the diseases they are working to treat, giving them an empathetic point of view that they can apply long after the meeting is over. Patients can lend their voices through follow-up voicemails and emails, providing further motivation to employees.
• Patient advisory board – These one-time meetings bring together 10 to 12 patients and caregivers to share their patient journeys and perspectives on a range of topics, from recruitment materials, to wording of trial onboarding materials, to the clinical trial protocol itself. If all goes well, consider expanding to a patient advisory council, so the same group of patients can provide longer-term ongoing feedback, both in person and virtually, as you develop your clinical trial program.
• Co-creation workshop – A workshop that brings together key stakeholders including patients, clinical investigators, clinical coordinators, and the internal clinical development staff to discuss issues, collaborate, and brainstorm solutions. In this session, you can map out the site experience and the patient experience to identify potential problems. You can also work with patients to create tools that help patients understand the trial, why they should enroll, and what is required of them to participate.
• Patient advisor on study team – Embed a patient opinion leader into the study team. This is a patient who is educated about their disease and treatment and has personal experience with clinical trials. The patient advisor can engage in protocol review but also provide a more intimate patient perspective throughout the development process – allowing for ongoing pressure testing and validating assumptions.
• Patient council – This carefully selected and trained group of patients and caregivers can be consulted periodically or on an ongoing basis through in-person meetings, video conferencing, and written feedback on key clinical trial topics. Training allows patients and caregivers to better understand the complexities of clinical development to make the most of their feedback.

During And After the Clinical Trial

As the trial protocol is being developed, you can also plan for ways to continue to engage patients during the clinical trial and beyond.

•  In-trial insights platform – Conduct surveys or interviews with patients currently enrolled in clinical trials with standardized controls for consent, release, and data integrity. The results enable sponsors to obtain patient perspectives on services provided by any contracted vendors along with trial site communication and scheduling practices, pretrial and ongoing education, and whether trial experiences align with expectations.

• Clinical trial results sharing – Plan for how you will provide results from clinical trials to participants in a timely manner and in patient-friendly language that is easy to understand.

Maintaining the relationships you have built with patients throughout the clinical trial process opens the door to additional engagement programs with them. Another finding of interest from our survey: 93% of patients reporting a positive clinical trial experience are “very” or “extremely” interested in future engagement opportunities with the sponsor of the trial. Ideas:

• Clinical trial alumni platform – Communicate with patients from the time of study completion through product approval and beyond with this turnkey solution patients who opt in. This kind of program provides the opportunity to obtain feedback and provide disease education and trial milestone updates, patient advocacy group information, and company news to the engaged clinical trial participant population.
• Patient speaker programs – With training on compliance and privacy guidelines, clinical trial alumni who want to share their personal stories can speak at internal and external events. The information they share would be limited to their experiences from participating in a clinical trial, excluding discussion of trial results.
• Patient-to-patient mentor programs – Trained clinical trial alumni can serve as mentors, assisting other patients through private one-on-one communication by email or phone. Mentors would not have to have participated in a clinical trial for the disease state, or even for a trial conducted by your company. They just need to have previously participated in at least one clinical trial and be willing to share their experience with others.

Conclusion

Our survey results show that including patients in a significant and meaningful way before and during the clinical trial process can improve recruitment, keep costs down by eliminating expensive and time-consuming changes, and boost retention by improving the trial experience for patients.  Creative and compliant engagement programs built around the patient experience can make these benefits attainable.

While it’s true that these approaches require a commitment of time and resources, as well as strict attention to privacy and security, the potential payoff is significant. Creative and compliant programs built around the patient experience have the potential to dramatically change your clinical trials — and actually improve the outcomes of the studies themselves. Once you have opened the channels of communication and interaction with a group of patients, you can expand your programs in many beneficial directions.