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Applied Clinical Trials
There is a misalignment of experiences, expectations, and beliefs among subjects, investigators, sponsors, and service providers.
You can't fix something without a fundamental understanding of the root cause and how all the moving parts work together. And the recruitment of subjects and investigators has many moving parts: sponsors, CROs, investigators, study coordinators, subjects. That's why we conducted a 360-degree assessment of the industry by interviewing 362 pharma and CRO representatives, investigators, and subjects to capture their experiences, assess their motivations, and determine how they—if in charge—would improve recruitment.
Here's the good news. Clinical trials suffer from a lack of awareness. That's right. That's great news. The problem isn't that trial participants disagree with clinical testing—91% rate it as "very" or "extremely" important. And it isn't that they are uninterested in participating—80% are at least "somewhat interested" in participating in a clinical trial. When we asked clinical trial-naïve respondents why they had not participated in a clinical trial, more than two-thirds said they had not been made aware of any trials (Figure 1). We're not naïve enough to think that 80% of the population will flock to clinical trials if they hear a radio commercial, but the data suggest that targeted efforts to raise clinical trial awareness will help close the quickly expanding gap. So what else can be done? That depends on whom you ask. Our research found that, in many cases, drug development professionals (at sponsor companies and CROs) were not on the same page as investigators and trial participants.
Figure 1. These results from clinical trial-naÃ¯ve respondents suggest that efforts to raise clinical trial awareness would go a long way to increase recruitment.
We know the population has some level of interest in clinical trial participation, but how does the industry convert interest into action? When we asked clinical trial participants what motivated them to participate in a trial, the top response was "to help find a cure." The least common response was monetary compensation. Later we asked trial participants how they would motivate participation if they were responsible for doing so. Interestingly, they would offer increased levels of compensation: a slight disconnect from their previous responses.
In large measure, investigators express opinions similar to those of former and potential trial subjects. Investigators indicated they would invest more in recruitment advertising (awareness) and provide increased compensation to participants.
What did sponsors and service providers believe are the primary contributors to successful subject recruitment? The top responses were the inclusion/exclusion criteria and the study's protocol. Only 5% chose the recruitment advertising budget and none said participant compensation.
To be honest, we don't know whether higher subject compensation would increase recruitment rates, but the disparity in perspectives is striking and is worthy of further consideration and testing. We're sure some people are cringing at the thought of increasing subject compensation. And that might not be the answer. But trial participants are looking for more value and value can come in many forms. Understanding subject motivations (what they value) on a study-by-study basis is a step in the right direction.
Although we found many points where the stakeholders were not on the same page, the importance and state of feasibility assessments in clinical trials was not one of them.
Everyone wants better feasibility projections. Stakeholder views converge in their dissatisfaction with the feasibility process and its accuracy. When sponsors and service providers were asked, "Which one of the following is the biggest issue when dealing with investigators?" the overwhelming response was "inaccurate feasibility estimates" (Figure 2). However, less than one-third of sponsors believe their own feasibility analysis is on par with or better than that of their peers. Couple this with the fact that 70% of industry representatives said feasibility is the single hardest part of subject recruitment, and feasibility begins to emerge as a highly important, perhaps underserved, function. Extrapolating from several survey data points, we find an overly simple feasibility questionnaire sent to an investigator who receives inadequate study information. In this scenario, it's no wonder recruitment professionals miss, meet, and exceed recruitment targets at seemingly random rates.
Figure 2. Where PIs and Sponsors & Service Providers see areas for recruitment process improvement.
A great many ideas are circulating throughout the industry on how best to improve study feasibility. We would make one recommendation: Start any new initiatives about study and recruitment feasibility by having conversations with principal investigators. Spend a day in the life of investigators, go to their offices, and use their systems to answer fax or email feasibility requests in the time allotted. Start the dialogue.
This piece focused largely on the differences in perspectives between industry and investigators and industry and trial participants. Another article could discuss differences between sponsors and service providers in the drug development community. Given a choice of what to invest in, service providers tend to focus on subject motivations whereas sponsors lean toward increasing the investigator payment. Again, we do not know which view could produce improved recruitment results, but the different perspectives add another dimension to the moving parts at work in the recruitment process (Figure 3).
Figure 3. Results to the question, "How would you improve the recruitment process?"
We believe that the industry is missing an opportunity for material improvements to its recruitment challenges by focusing too exclusively on internal improvement efforts. Market research professionals strongly believe in the notion that collecting first-hand feedback, suggestions, motivations, and barriers from decision-makers and influencers is time and money well spent. The drug development industry needs to adapt a market research technique known as voice of the customer (VOC). They can call their adaptations voice of the subject (VOS) and voice of the investigator (VOI). Our hypothesis is that the process of recruiting and retaining clinical trial subjects could be improved if more sponsors, CROs, academic research organizations, and subject recruitment agencies used these 360-degree techniques to more thoroughly understand the views and expectations of all interested parties.
Would developing processes and techniques to capture the voices of subjects and investigators take more time, resources, planning, and money? Yes it would. Would it cost more than a day's sales? Unlikely.
Kevin Olson is president of Industry Standard Research (ISR Reports), Cary, NC, email: KevinO@ISRreports.com.