Patient centricity was a key focus item at the recent Avoca Quality Consortium’s Fall Meeting, acknowledging that serving patients to the best of our ability is often easier said than done in today’s heavily regulated clinical development environment.
During the meeting I had the privilege to moderate a lunchtime breakout where discussion centered on novel approaches for communication of clinical trial status and results to patients. The participants highlighted the challenges of implementing patient-centric initiatives, with conversation centering on the contents of three recently published papers about patient group surveys and using patient webinars mid-study to communicate interim results (click the link to review the full paper summaries).
The group spoke about how a simple exercise, like communicating a brief statement on what was learned during the study and how the patients’ involvement contributed to the body of scientific evidence, was fraught with challenges. The obstacles to patient-centricity efforts that were identified included:
- Having the bandwidth to work on an effective solution.
- Using patient-friendly language.
- Requiring ethics approval.
- Securities and Exchange Commission concerns over information that is not already in the public domain.
- Communication of unblinding information to patients.
- Selecting the platform and mechanism for delivery of information.
- Choosing the appropriate timing of information release.
Clearly, there is bandwidth for success, as sponsors are already spending a lot of time monitoring advocacy group forums to ensure that they hear what patients are saying. The progressive discussion quickly moved towards addressing the key question of “how do we overcome these challenges?”
“As sponsors, patients can hold us liable”
It was suggested that, as patients are central to clinical development, we “need to move to using the term participants rather than subjects” and “thank patients for their involvement”. The importance of collaboration and the “theme of teams” in driving retention and compliance in studies was also recognized. Both the literature and the discussion group agreed that the benefits of reporting aggregate results to participants had far-reaching value to clinical research, and that sponsors have an obligation to communicate results directly to participants. During the session, it was stated that, “As sponsors, patients can hold us liable." When a patient discovers information in the public domain, about a study in which a patient participated, they will automatically wonder why the sponsor did not communicate this directly?
"We need to move to using the term participants rather than subjects”
A concern was raised that there may be Security and Exchange Commission concerns about the possibility of a patient releasing commercially sensitive study information. However, the conclusion here was that any information about a study that is already in the public domain should be immediately communicated to participants in patient-friendly language. This approach allows for better communication with the patient, particularly considering that media releases regarding study results can often be sensationalized or not provide the full picture. Patients should be able to subscribe to study alerts so that they are notified when clinical trial results become available and be given direction and information on contacting their physician, who can appropriately communicate the unblinded information to them if required.
Patients are at the heart of everything we do in clinical development. Therefore, it is important to highlight to patients when sponsors make great efforts to design their studies around the needs of the patients. Thanking patients and ensuring they are fully aware of the impact of their study involvement is vital to generating public awareness surrounding the importance of clinical research and increased participation into the future.