3 Protocol Design Strategies To Enhance Patient Recruitment
By Julia Ogier and Sam Soloway, Halloran Consulting Group
How many of the clinical trials that your company has conducted have met the initial recruitment timelines? How often have you seen recruitment issues increase costs or cause delays in your company’s operational objectives? Nearly 80 percent of clinical trials experience delays or even early termination due to recruitment issues.1 These delays not only negatively affect the sponsor company but also keep patients from getting potentially life-saving treatments in a timely manner (if at all).
Success in running clinical trials in the current, competitive clinical development environment has become increasingly dependent on proactively using effective measures for enhancing patient recruitment. That said, getting patients to enroll in clinical trials comes down to two things: making the trial more patient-centric, and being transparent about the trial and its objectives.
Patients are more likely to enroll in trials that involve less hassle, which most often comes down to allowing them to stay in their environment and their routine. They are also more likely to enroll in trials when they know exactly what they are getting into. People are more apt to participate in activities that have goals that match their personal wants and needs.
Patient centricity and transparency sound easy enough to implement, but there are many opinions about the best tactics to use. Many suggestions require large, institutional shifts to take effect. While these may ultimately prove useful, the focus of this article is on tangible, workable strategies that companies of all sizes can implement in the short term to realize their clinical development objectives and deliver therapies to patients in a timely manner.
Protocol Design Tactics To Improve Recruitment
Let’s start from the beginning with planning for the trial. We don’t always connect the dots on how complex protocols can doom both patient and site recruitment efforts from the start. Companies that engage early in effective clinical study planning generally have a better understanding of the recruitment challenges they face and how to proactively address them. The tactics below are ones that can be used by most companies regardless of size — they are relatively simple in execution and, when done correctly, are cost-effective as well.
Simplifying a trial at its start can save the sponsor company time and money throughout its execution and can also make the entire process easier on patients. Crowdsourcing is one method that can be used to ensure that the simplification is done in a way that positively affects the patient experience. By soliciting feedback from potential trial participants, you may learn that an additional study visit would prevent some people from enrolling or that an assessment you are considering including in the trial would deter some patients. You then have the opportunity to consider whether this visit or procedure is critical to the study’s objectives.
By talking to patients or other researchers who have performed similar studies, you may find that the benefit of narrow eligibility criteria designed to reduce variability may not be worth the limitations it places on the study. Instead, criteria that may not be critical to the outcome of the study keep people from being able to enroll. If you eliminate overly narrow eligibility criteria, more patients will be able to participate in your study. The examples are endless, but the story is the same: Simplicity leads to efficiency, both for sponsor companies and for patients.
The idea here is to have a clear focus that is aligned with the goals and objectives of the patient population. Let’s take endpoints, for example. Does that second endpoint really matter? Are you measuring something that patients care about? By creating endpoints that are measurable to a patient in their daily lives (such as grip strength for a patient struggling with a muscle function disorder), the trial has an end goal that patients are invested in and want to see through.
But what about the FDA — won’t they push back and require that you include that endpoint? The FDA cares about what the patient population cares about. If you have evidence (back to crowdsourcing) that patients and providers care about X and not Y, you can likely convince the FDA of it. When you focus more energy on your patient population, you can start your study on the right foot.
If a patient’s access to a trial is challenging, they are less likely to enroll or complete the study. Creating accessibility starts with engaging in thoughtful site selection. Some groups are gathering important data about patient populations that can be used to focus site selection around pockets of patients. (Transparency Life Sciences is one of the companies at the forefront of this research.)
It’s also important to focus on feasibility, because how sites execute the trial contributes greatly to the patient experience and your bottom line. Choosing sites that have the capability to implement technology in your trial — or even reducing your number of sites by engaging technology such as home-based site visits or remote monitoring — reduces the burden on patients and increases the likelihood that they will complete the study. They will endure less travel and fewer disruptions to their daily routines.
Rethinking Old Approaches To Patient Recruitment
Companies need to challenge the traditional model of patient recruitment, which involved asking patients to participate in something designed by the sponsor that did not integrate easily with their daily lives. It is not a matter of adding a layer of innovation to existing processes and expecting costs to decrease and recruitment to increase. Rather, it is a matter of strategically replacing traditional methods of study conduct with technologically savvy alternatives and waiting to realize the results over time. We have to think differently. We have to recognize that the way we have been doing it isn’t the only way
About The Authors:
Julia Ogier joined Halloran Consulting Group in 2016. She has experience in clinical project management, particularly focusing on study start-up in early-stage trials, as well as project management and submission of a variety of regulatory filings. As an associate consultant at Halloran, Julia provides support to medical device, biotech and pharmaceutical clients through the strategic management and execution of a variety of clinical, regulatory, and quality projects. She earned a bachelor’s degree in economics from Occidental College, where she graduated cum laude and was awarded honors for her thesis on drug pricing.
Samantha Soloway joined Halloran Consulting Group in 2014, bringing intense project management, submission and regulatory operations experience. Samantha focuses on developing and managing project plans for complex clinical and development programs and for global regulatory agency submissions for products at multiple phases. She earned a bachelor’s degree in evolutionary genetics, bioethics, and human rights from Binghamton University.