While patients have always been at the center of clinical trials, clinical trials have not been patient-centric. Historically, pharmaceutical companies have relied on experts to design and run clinical trials instead of involving patients in the design of the trial or educating them about the trial.
I met T.J. Sharpe, a patient advocate who is currently participating in a clinical trial, at the Disruptive Innovations to Advance Clinical Trials conference earlier this month.
When T.J.had been diagnosed four years ago with stage IV melanoma, he knew his situation was severe and that his chances of survival were low. Fortunately for him, he had worked in the pharmaceutical industry earlier in his career and knew that clinical trials could be an option. Finding the right trial wasn’t easy as he met with four different doctors until he was presented with an opportunity to participate in a trial. He signed up for the trial but it did not work out because his condition worsened. With the help of a melanoma advocacy group, he registered for another trial in April 2013. Fortunately, his melanoma is currently in remission and he will remain on the treatment for a few more months.
For patients like T.J., finding the right clinical trial is literally a matter of life and death, but as T.J. learned, it is anything but easy. Pharmaceutical companies who run clinical trials, find it equally difficult to find and retain patients for trials. Can these dynamics be improved by making clinical trials more patient-centric? Many think so and the shift to patient-centricity is underway, led by none other than the FDA, which announced its first-ever Patient Engagement Advisory Committee (PEAC) for medical devices in September 2015.
Pharmaceutical companies are taking the U.S. Food and Drug Administration’s lead and many of them have appointed executives to the roles of “Chief Patient Officer” or “Chief Patient Affairs Officer”. These companies are in the process of orienting their organizations and specifically clinical trials to the concept of “Patient Centricity”.
A survey of 2,346 pharma executives in 84 countries conducted by Eye for Pharma in March 2015 indicated that pharma executives strongly believe in the importance of patient centricity. Eighty-six percent of respondents put the importance of patient centricity at >= 8 out of 10). They also believe patient centricity is good for business — 93 percent said that a patient-focused strategy improves business outcomes. About 92 percent said a long-term focus is required to implement patient-centric missions, but many of them acknowledged that more can be done.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
So why is there a large gap between the importance of patient-centricity and the efforts to achieve it? It is partly because pharmaceutical companies are still learning what patient-centricity means and what specifically needs to be done to achieve that goal. While specifics will vary depending on the treatment and trial, here are three practical ways to improve patient-centricity in clinical trials.
Educate
There are approximately 65,000 clinical studies listed on clinicaltrials.gov. The registry run by the U.S. National Institute of Health includes registrations for more than 200,000 clinical trials from roughly 170 countries in various stages of patient enrollment. By one estimate, it would require 58 million volunteers to meet the need for those open studies. Finding patients for these trials is a daunting task and the associated cost is staggering. A study sponsored by the U.S. Department of Health and Human Services estimates the patient recruitment and retentions costs to be 3 percent of trial budgets (or approximately $2.28 billion per year).
Educating the patient population about your trials and clinical trials overall help with patient recruitment.
“There is no lack of information available on clinical trials but it is not presented in the best possible way to help patients make the right choices.” said T.J.
Research by organizations such as PatientLikeMe and CISCRP suggest that the top two pieces of information leading to a decision to participate in a clinical trial are “potential risks and benefits” and “research purpose”; information that is readily available and can be shared.
T.J. also thinks that informed consent forms could be simplified. He believes that patients in a dire situation like he once found himself, would appreciate being presented with a version that “boils participation down to key points instead of a long-form legalese version”.
Assist
Too often sponsors leave patient logistics such as assistance with travel to sites and patient payments to sites which as often ill-equipped to deal with these.
A report by National Research Council suggests that “need for transportation” is one of the major reasons for study dropout which can be 30 percent or higher in Phase III trials. Interestingly, rideshare application leaders, Uber and Lyft, have jumped into the fray and now are offering their services to sponsors of clinical trials. Obvious benefits include lower administrative burden and better travel options for patients.
For many, just the sheer task of managing the logistics and schedules can be a daunting task. “For patients who are in clinical trial, receiving information electronically about visit schedules, medications and tests can be very helpful as it is difficult to track all the activities,” said T.J.
Inform and Engage
US Department of Health and Human Services (HHS) recently issued a ruling, mandating registry of clinical trials and submission of summary results information to ClinicalTrials.gov, designed to improve transparency in clinical trials. While that is helpful, patients still have to go seek out that information on sites like ClinicalTrials.gov or scour industry publications and conference materials. Providing that information directly to patients can significantly improve patient’s experience in the clinical trial.
Photo: Bigstock
