If a baseball player finished a season with a .100 batting average, they would likely get cut from the team. And if a teacher saw only 10% of their students graduating, they’re probably out of a job.
But that’s the reality for clinical researchers as only 1 in 10 drug development projects make it all the way from Phase I to approval. Why is that number so low, and are there any patient recruitment solutions for the pharmaceutical industry as a whole?
Patient recruitment is an almost universal challenge in the healthcare industry, but it’s also where any improvement could have the most significant impact. 80% of trials are delayed or closed because they can’t find the right patients. 90% of trials double their original timeline in order to meet enrollment goals. And over 10% of trial sites fail to enroll a single participant.
The success of medical research depends on recruitment that quickly identifies the right patients and effectively moves those patients through the enrollment process.
Let’s explore patient recruitment challenges, unpack the most common reasons that clinical trials fail, and explain the best recruitment strategies for clinical research success.
Differences between patient recruitment and clinical enrollment
Patient recruitment is a multi-step process of identifying, engaging, and enrolling patients in a clinical trial. Once a patient has submitted their informed consent, they are considered “recruited” and efforts are made to retain the patient through the end of the study. Below are the typical steps in the patient recruitment process:
- Identifying Candidates: Recruitment companies begin to identify and engage target patients who meet a specific set of criteria, including age, gender, pre-existing conditions, medical history, and more.
- Pre-Screening: Participants are now moved into a pre-screening process that can include physicals, medical exams, lab tests, and psychological evaluations to further determine eligibility.
- Site Visit Scheduled: Before participating in a study, patients must be fully informed about the study’s purpose, procedures, potential risks, and benefits. This ensures that enrollment is both voluntary and ethical. It’s also where patients submit their informed consent, which is essential to the recruitment process and allows healthcare professionals to access their private medical information for further use in the study.
Clinical enrollment is the entire patient journey, which includes patient recruitment, but follows through after informed consent has been given. Patient enrollment in clinical trials is the overarching term that includes patients going through recruitment and then getting screened and randomized.
- Patient Recruitment: Once candidates are identified, they’ll go through additional pre-screening processes for further qualification. After that, they’ll be invited to an initial site visit and asked to submit their informed consent. This is where patient recruitment ends and clinical enrollment continues.
- Clinical Enrollment: Because they’ve signed their informed consent, patients are officially enrolled as trial participants once they finish screening and meet all eligibility criteria.
- Randomization Begins: Participants are randomly selected into control and treatment groups, and the clinical trial is started. Until the end of the study, patients are engaged and active through the entire study period with communication that is clear and consistent. This allows clinical researchers to regularly collect data, monitor progress, and address any patient concerns.
Challenges currently facing the patient recruitment industry
Over 80% of clinical trial attempts fail to hit target enrollment numbers on deadline, and research from the Tufts Center for the Study of Drug Development found that nearly one in ten trial sites fail to enroll a single patient. Patient-centric recruitment is as important as ever. If we’re not building the recruitment process with the patient’s capabilities and sensibilities in mind, we’ll continue to see stalled enrollments and delayed studies.
As it pertains to a patient’s capabilities, recruitment efforts see an advantage when clinical researchers embrace decentralized trials (DCT). This makes it easier for participants to enroll by eliminating unnecessary travel to physical sites. In a decentralized clinical trial, clinical activities can be conducted in a participant’s home, a nearby healthcare facility, or a neighborhood hospital.
When it comes to a patient’s sensibilities, not only do they want consistent communication and immediate follow-up. They expect it. For example, if you were to order something online and you hadn’t received any sort of automated response—a text message, an email, or a phone call—you would think something was wrong.
The same goes for patients wanting to enroll in a trial.
The most common reasons clinical trials fail
As we said before, only 1 in 10 drug development projects pass clinical trial testing and make it to regulatory approval. In 2016, an analysis of 218 reported failures between Phase II and submission was conducted and a total 174 had stated the reason for the failure. Researchers found that…
- 40%-50% of failures were due to a lack of clinical efficacy (the drug could not produce the intended effect in participants)
- 30% were due to side effects that could not be managed
- 10%-15% were due to poor pharmacokinetic properties (how well a drug moves through the body)
- 10% of failures were attributed to lack of commercial interest and poor strategic planning
Knowing why clinical trials fail is important because each of these reasons is related to patient recruitment to some degree. A more comprehensive screening process might have omitted patients who would have experienced adverse side effects, or asked questions that identified participants whose medical histories contributed to poor pharmacokinetic results. That, in turn, would have improved strategic planning and led to greater trial efficacy—meaning fewer delays and more approvals.
Ways we can improve patient recruitment going forward
There’s no silver bullet when it comes to improving your recruitment efforts. Think of it like a barstool—with thoughtful strategy, data-driven targeting, consistent communication all working together.
- Know Your Audience: Imagine going to an archery range and finding that the bullseye isn’t marked and you don’t know how far away the target is. That’s what recruitment without audience research is like. Who are they? Where do they live? What are their challenges? How do they use the internet? The answers to those questions will help you flesh out your ideal patient population and guide your recruitment efforts.
- Utilize Digital Tools: Nearly 92% of Americans use the internet. Your patients are online. It’s likely the one common thread between any patient population. If you’re not optimizing every step in your recruitment process for digital use, you’re creating unnecessary obstacles and putting your enrollment efforts at a disadvantage.
- Embrace Remote Screening: Advocate for any part of the screening process to be completed at a patient’s home. It’s only going to lower the barrier of entry for enrollment, increase the pool of qualified participants, and lead to higher levels of engagement and retention.
- Communicate Clearly & Consistently: Every step of the journey should prepare a patient for what’s coming next. Communication should be on the patients’ terms, and that typically means texting, emailing, and then calling—in that order. Adopting an omni-channel messaging approach ensures that patients are reachable no matter their preferred communication style.
1nHealth: Bridging the gap in patient recruitment
1nHealth is uniquely positioned to help researchers overcome these challenges, recruit the right patients for your study, and help fill clinical trials faster than you ever thought possible while being great humans to clients, to each other, and to patients around the world. Ready to learn more about how we can help you fill your next clinical trial? Click here for a free consultation today!
