Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials.
Today, all CROs have their own methods for identifying optimal investigator sites and recruiting patients. But how many sponsors, CROs, or patient recruitment firms are pausing and asking the patient, “What would make you more likely to join a clinical trial?” People are talking to patients, but how many have asked that simple question? And how many drug developers are considering these insights when developing their clinical trial protocol? I believe the industry MUST start with the patient and listen to their specific needs. This will lead to better clinical research recruitment, drive up participation and save time and money.
The power of a simple question
At Covance, we take the patient voice very seriously. Leveraging the millions of patient touchpoints generated by LabCorp, our parent company, or with proactive outreach to some of the most critical disease areas drug developers are working in, we have generated a proprietary database of over 65,000 voice of patient surveys, giving us detailed insight related to their drivers for clinical trial participation.
Our portal continues to gain momentum, with about 3,000 new entries monthly, representing insights from over 30 countries and 20+ indications.
Applying the voice of the patient in protocol design
Applying patient intelligence is especially helpful to avoid major recruitment delays that threaten the success of a trial. For example, my Patient Intelligence team was recently approached by a sponsor who had designed a protocol requiring overnight stays but the target patient population wasn’t remotely interested in joining once they learned of this requirement.
After logging this indication into our Portal, I found that of the 10,000 patients who we talked to with this disease, only a small percentage said they would agree to participate in a trial if they knew it had an overnight stay. Getting this simple data point to the client – as early as possible – saves time and money. Understanding patients’ needs and preferences, before a protocol is designed, will have significant downstream impact.
Improving upon the reactive approach to protocol design
In another Covance-supported program, we were helping a new client get ready to start a Phase I clinical trial. Their senior leadership told us that their historical patient recruitment rate was less than 1%.
Beyond changing the sponsors’ approach to recruiting patients, the Covance team walked the sponsor through our patient database and performed an in-depth evaluation. We conducted outreach across 13 countries to survey 500 patients who had this disease state and looked into the specific protocol design elements this sponsor was considering.
With this more focused look, we could discern not only what would drive patients to participate, but also determine the right length of a stay, number of visits throughout the trial, distance they are willing to travel, financial expectations and more.
This indication requires a significant amount of monitoring time. Our database clearly showed that if patients with this disease were required to stay two to three hours at the clinical site, they would never join the study.
Was this barrier a non-starter for the client? No. Because our team followed-up to better understand what might make these potential participants more likely to accept lengthy monitoring appointments. With further research, we found that potential participants were three times as likely to enroll if they knew they could access the internet, watch movies or even get some work done online while being monitored.
This insight from patients was a true “aha!” moment for the client, and evidence that slight changes in how they present the recruitment specifications could make a substantial impact to the overall trial success.
Incorporating the patient voice
In my 20+ years collecting patient insights, I’ve heard sponsors push back and say that “patients don’t know what they want or need until the decision is put in front of them,” and “patients are not scientists and not doctors,” but we’ve demonstrated measurable success by incorporating the voice of the patient into trials – from the very start.
A new paradigm for the voice of the patient is here. We hope the industry adopts this approach and that one day all clinical trials incorporate some form of patient voice into their protocol design. Whether it is surveying patients across multiple countries or creating alignment at the earliest stages with the patient advocacy organizations, patient-centric perspectives can make a difference in clinical trial recruitment and, ultimately, for patients in need of a life-changing treatment.
Learn more about how Covance embeds patient insights into protocol design and study conduct: Incorporating the Patient Voice to Improve Ulcerative Colitis Recruitment