In recent years, patient centricity has become a buzzword in the pharma and biotech community when speaking on the subject of oncology study design. Despite the industry’s recognition that a patient centric approach to cancer research is an important part of a company’s business model, it seems that comparatively few have worked with Patient Advocacy Groups.
Patient Advocacy Groups were established in the 1950s when cancer research was in its earliest stages. These groups were initially formed to act as a mediator between researcher and patient. They ensured that the patients’ best interests were kept in mind during the trial and also contributed to the complex legal and ethical discussions surrounding the study of investigational oncology candidates on a human population.
Today, patient advocacy groups remain important influences on the progress of cancer research — from product development to patient care. Moreover, trial sponsors can benefit from these organisations by involving them at an early stage in their product’s life cycle. Overall, a PAG’s involvement in an oncology study can increase its chances of success by:
1. Increasing patient recruitment
2. Improving communication between trial sponsors and regulatory bodies
3. Ensuring patient retention for the duration of the study
In the competitive environment of cancer research, engaging and recruiting the target population is becoming increasingly difficult for oncology companies. Trial sponsors struggle to find innovative methods to achieve minimum patient enrolment. Some companies still hail good relationships with key sites and physicians as the solution to this challenge while others have begun experimenting with social media as a way of engaging potential patients. However, as a recent Tufts survey shows, the uptake of this strategy has been slow due to a number of concerns, such as a lack of FDA guidance on the subject or the danger of patient communication during ongoing trials.
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While patient communication can ruin an oncology study, it can also save it. Survivor testimony is a powerful tool for trial recruitment and Advocacy Groups can enable these testimonies to reach a vast network of patients and thus increase recruitment for oncology studies. They can also be integral in ensuring patient retention throughout a trial. For instance, the Research Advocacy Network, which aims to develop a network of cancer researchers and advocates, claims on its website that clinical timelines can be made more efficient by taking note of patient experience during the research process. Few pharma and biotech companies working in oncology would disagree with the assessment that it is important to put the patient first if you want to enhance recruitment and retain numbers throughout your oncology study but translating patient experience into protocol is not a straightforward process. Therefore, to enjoy the full benefits of a patient-centric approach, trial sponsors should seek to bring Patient Advocacy Groups on board at the earliest stages of protocol development.
Collaboration with Patient Advocacy Groups can also benefit sponsor companies who are at the IRB approval stage. While examining the ethical parameters of oncology studies, IRB groups can tend to focus on the toxicity of the oncology drug candidate and its potentially harmful effects to study participants. However, PAGs view investigational oncology treatments as central to patient care and so can encourage IRBs to weigh up the risk of the investigational candidate’s toxicity against the more fatal effects of the cancer itself.
A well-organised PAG can also successfully petition the FDA and see positive results in terms of advancing clinical timelines for drugs for unmet medical needs. Sponsor companies often lament the communication difficulties with the FDA, such as long gaps between meetings, which delay drug development. The personal experience of Stephen Smith, a rare disease patient advocate, shows how PAGs can successfully intervene when problems arise between sponsors and regulatory bodies and ultimately increase operational efficiency by opening up channels of communication.
A patient-centric study design can also increase patient retention rates throughout an oncology trial. Indeed, PAGs are sometimes sought out in an attempt to rescue a study but there is no definitive formula for patient-centricity in oncology study design. It may mean deciding how many biomarkers need to be taken and negotiating how to spread out patient visits over a period of time; this has minimal impact on study timelines compared to patient drop-out. Putting together patient-friendly educational materials is another important consideration for those who aim to integrate patient-centricity into their oncology study. For instance, information about the potential physical and psychological side-effects of the investigational drug can ensure the patient is prepared for the duration of the trial. Visit and compliance reminders can be issued by text message or email to ensure that complex instructions are followed properly and in-home or alternate site clinical trials are still a relatively niche market of which more oncology companies could take advantage.
To learn more about working with patient advocacy groups for oncology study success, join us at the 3rd Annual Clinical Operations in Oncology Trials Conference where Deborah Collyar, President of PAIR (Patient Advocates in Research) will be speaking on the subject.