The number one reason that clinical trials fail is not rooted in staffing issues or strategic misfires; it is due to recruiting sub-standard participants. This is typically not a matter of effort or intent, but a question of knowledge and awareness. Simply put, while research teams are competent when it comes to methodology, compliance and protocol, they are not necessarily as well-versed in the art and science of recruitment.
To close this gap and put clinical trials in the best position to succeed, here are four best practices for selecting qualified test subjects according to clinical trials expert Greg Orzeck, the co-founder of full-service Clinical Research Organization (CRO) AI Research, Inc.
Explore and expand recruitment sources
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Clinical trials can study:
- New drugs or new combinations of drugs
- New ways of doing surgery
- New medical devices
- New ways to use existing treatments
- New ways to change behaviors to improve health
- New ways to improve the quality of life for people with acute or chronic illnesses.
The goal of clinical trials is to determine if these treatment, prevention, and behavior approaches are safe and effective. People take part in clinical trials for many reasons. Healthy volunteers say they take part to help others and to contribute to moving science forward. People with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have added (or extra) care and attention from the clinical trial staff. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future
Develop targeted outreach strategies
Targeted outreach strategies start by focusing on sources — not tactics. By doing a deep dive into where potential test subjects congregate (which is a by-product benefit of implementing best practice #1 described above), research teams get a clearer picture of how they can generate visibility and drive engagement.
According to Greg Orzeck, it is tempting for research teams to rely on a familiar outreach toolkit with proven tactics, such as online advertising, flyers, radio spots, and so on. However, by taking a closer look at recruitment sources, they can discover new and often better ways to connect. For example, by asking some simple questions it may come to light that a community center has an information fair for senior citizens planned in the weeks ahead, which would be an ideal venue to recruit this cohort.
In this patient-centric world, a major component of recruitment is trying to understand the type of patient who would participate in a study, and that means understanding their attitudes, opinions, and concerns. Learning from those who live with the condition on a daily basis provides key insight to defining the target audience. Effective social listening can provide an overview on what is being said about specific health indications, where they are being discussed, and how people feel about particular conditions, medications, symptoms, and even clinical trials.
Build strong relationships
Clinical trial recruitment is hard — really hard. You need to get the word out to as many potential participants as possible, but simply sending a message to the masses can result in a lot of wasted time, effort, and money (and no one wants that!). Identifying a target audience well before recruitment even begins will help you avoid the pitfalls of sweeping, unfocused messages. And having a thorough understanding of your target audience will help create a stronger plan to market, advertise, and ultimately enroll a study.
Whom are you talking to?
The journey to identifying your target audience begins with the demographics of the group most likely to participate. Gender, age, and the condition involved are initial parameters you can use to start generating a profile. Much of this information is driven by the inclusion criteria of a trial. On the flip side, knowing who can’t participate in the trial is just as important, so make sure you’re aware of the exclusion criteria as well.
Create standardized and optimized recruitment processes
Many research teams have standardized recruitment processes, but they are not necessarily optimized — typically because the workflow was established years ago, and the prevailing sentiment is “if it ain’t broke, don’t fix it.” However, the fact is that it is indeed broken; or at least, it is not firing on all cylinders and in urgent need of anything from a tune up to an overhaul.
Greg Orzeck claims that research teams should monitor recruitment-related analytics to make adjustments, and regularly compare their processes with emerging industry best practices. And when expectations are not met — which is a nicer way to say that when mistakes happen and failures occur — research teams should see this as an opportunity to learn and develop. Sometimes, the most potent insights that drive long-term recruitment capacity and efficient arise when things do not go as desired.