Making Patients the Center of Your Clinical Trial
At the heart of every clinical trial lies the patient. Yet patient-centricity is probably the most underrated concept in clinical trial planning and execution. However, more recent trends in clinical trials have been to move away from a safety-only focus, to a more patient-inclusive, or patient-centered perspective.
Every clinical investigator wants to run their trial successfully, and as any researcher understands, this relies on sufficient patient enrollment, in the most time-efficient manner. Incorporating the patient’s voice into the trial design can improve patient recruitment, retention and outcomes, promote patient engagement and awareness, thus saving trial resources. Here are some examples of how Patient-centricity is enhancing and accelerating clinical research.
Patient Engagement: Put the Patient First and Everything Else Will Fall into Place
You can’t have a trial without patients—it’s as simple as that. Understanding the clinical study from this viewpoint, moves investigators from the mindset of templated protocols into the unique, complex lives of their study participants. Taking into account considerations like, when is the best time to screen and consent patients and what questions to ask, could significantly increase enrollment and patient engagement. Establishing how many office visits per week/month would be convenient, and what their transportation needs are upfront, can reduce non-adherence issues and protocol deviations, increasing overall retention. Further engaging with the patient early in the study and throughout, can help address language and cultural barriers which may inadvertently get overlooked. Patient engagement promotes compliance and eases patients’ fears by making them feel more like partners rather than guinea pigs.
Promoting clinical trials without risking coercion is something to be considered carefully. However, many patients aren’t aware of the clinical trials that may be available to them. How can patients partake in the advancement of the prevention, treatment and diagnosis of many diseases, if they aren’t aware of the numerous studies which exist? Again, engaging with the patient and informing them about trials to consider may be all that it takes. Physicians can increase clinical trial awareness by discussing available study options with patients who may qualify. At the very least, starting the conversation can give patients a different perspective on participating in a study whereas they otherwise may not have known existed.
Recruitment + Retention = Outcomes
Recruitment and retention are two of the most important factors contributing to a trial’s success. Nearly half of all clinical studies are delayed due to low enrollment rates, and 85% fail to retain the required amount of study participants. Such setbacks cost the industry nearly $40 billion each year. Understanding the patient experience and how to make it better can eliminate many of these setbacks and improve patient recruitment and retention. Participating in a trial may cause patients to miss time from work, interrupt their current drug therapies, and let’s not forget the disease burden. Therefore, it may be beneficial to discuss compensation, travel arrangements and personal accommodations like weekend and home visits, or the use of technology to monitor patients remotely. The goal should be to create as little burden on the patient as possible, to improve any avoidable withdrawals.
Giving the Patient a Voice
There are many stakeholders to consider when designing and executing clinical trials. The most valuable asset is the patient. Who could possibly know more about their illness than the person living with the disease? It doesn’t take a specialist to understand what you are feeling and experiencing as an individual. Listen to the patient and work around their needs.
As eager as clinical researchers are to develop novel treatments to bring to market, patients are equally excited about how this will affect them, and possibly improve their lives. Much controversy surrounding clinical trials has been brought up from the past, and many patients are concerned about their participation. Engaging with the patient and listening to their concerns, builds trust in the relationship between them and investigators. Becoming a partner in their health can reshape clinical trials and revolutionize the healthcare industry.
Moving from a numbers-driven clinical trial to a patient-centered trial can take time, training, and expertise. Contact Novelle to learn how we can help you put your patients front and center and run your best trial yet.
LaTeeya is a graduate student of George Washington University, pursuing a Master's Degree in Regulatory Affairs, as well as an active duty Air Force spouse, and mother to her 10-year-old son.