Although oncology trials account for almost 31% of clinical trials globally, recruitment of patients can often be a problem with only 5% of cancer patients participating in clinical trials. With regulators including the FDA placing an increased importance on the voice of the patient in clinical trials, a shift from clinician reported outcomes to patient reported outcomes is emerging. CRF Health recently presented a webinar with Jack Whelan, a cancer patient and clinical trial advocate, who described the concerns of sponsors and what patients want from their clinical trials, including concerns related to patient recruitment, retention and motivation.
Many patients are unsure about how much information they will receive during their clinical trials, a concern that may deter them from participating. Jack highlighted that most patients sign up to clinical trials to help achieve their goal of long time survival and they believe that they will be closely monitored in a clinical trial setting. He also expressed how patients would like to be appreciated and rewarded for taking part even if it is just a simple ‘thank you’ from the trial site. Using eCOA for oncology trials can help improve patient motivation and retention while easing the concerns of both the sponsor and patients through status reports and tracking of treatment progress. Jack also talked about the possibility of gamification, an interesting concept that aims to engage patients in the progress of treatment or study via interactive feedback. Turning this concept into a practical, effective and regulatory compliant solution for clinical trials is a challenge that is heavily discussed at industry meetings today.
Lack of communication is also a big concern for patients. With the regulatory environment perceived to prevent open communication, patients believe that the way sponsors carry out their trials doesn’t facilitate open communication. Jack expressed that one of the key messages from oncology patients was that pharma companies needed to do more to educate patients and communicate with them to ensure that there is a better relationship between patients and sponsor. Jack talked about the importance of supporting open communication between the site and patients. He suggested that an eCOA platform can help achieve that. Allowing sites to have a better near real time view on a patient's well-being and pain management helps them support patients better and optimize pain management. As oncology patients may be very ill, being able to flexibly schedule visits and re-schedule if they are not able to come or stay until the end of the visit, is important. An eCOA solution that is in the hand of the patient can help the patient to contact the site for these changes instead of missing a visit. In addition, oncology patients frequently find treatment very complicated and yearn for more information about it. Sponsors may be able to reduce their frustration by providing information about the medication and treatment via the eCOA solution, an application that patients have at home with them every day.
Another concern for patients is a lack of awareness. The number of patients participating in cancer clinical trials is very low, as many patients are unaware they are taking place or how to register. Patients need to be educated on the process and how to find and sign up for trials on sites such as clinicaltrials.gov.
In order to address patients’ concerns about clinical trials, Jack believes that pharma companies must do more to educate and communicate with patients; to view them as a valuable partner and ensure they maintain a good relationship with them. Whilst we are aware that new best practices are required, we appreciate this will take a significant amount of work, and is not an easy solution. He also believes that sponsors can address the adherence and recruitment issues by improving patient engagement through specifically designed electronic solutions, which is something we are working towards here at CRF Health.
To learn more about the clinical trial patient perspective, register on our website and watch the on-demand webinar hosted by CRF Health’s Katie Garner and patient advocate Jack Whelan.