A Comprehensive Guide to Clinical Trial Patient Recruitment
Arguably, one of the most important elements to clinical research is patient recruitment. For a new medicine to come to market, it must withstand rigorous testing with a substantial population of participants. How can researchers ensure they are recruiting enough participants and recruiting the right ones? Read on to learn more about the basics of patient recruitment for clinical trials.
Defining Clinical Trial Patient Recruitment
As a drug moves through the phases in clinical research, it’s up to the research team to find a set number of people – otherwise known as participants – to take part in the trial. The number of participants needed depends on the trial and the phase of study, but nonetheless, for researchers to understand more about the drug they are testing, they need participants so they can gather the correct amount of data.
Researchers are looking at many things as they are gathering data. They want to know how participants react to the drug and how it may differ from those receiving the placebo. They’re looking for any sort of side effects, called adverse events (AE) or serious adverse events (SAEs). These unexpected occurrences happening to a participant during a study help determine the safety and effectiveness of the drug.
It’s also important for researchers to consider diversity in their patient recruitment efforts. Different drugs affect people in different ways, so consider factors such as gender, age and race as you are recruiting. Not only does this give those who are underrepresented in trials a chance to become involved, it helps research teams understand the full extent of a drug’s effectiveness.
Challenges in Patient Recruitment
There are a lot of challenges when it comes to recruiting the right participants for a study. While some challenges can be mitigated by explaining the study more thoroughly, other challenges require a little more effort, ranging from building trust to ensuring deadlines are met in a timely manner.
Inclusion and Exclusion Criteria
When studies are designed, researchers must establish a set of qualifications they are looking for in potential participants – and specify what would disqualify someone from participating. These are known as inclusion and exclusion criteria.
A frequent pain point in inclusion and exclusion criteria is they are often too complicated. In the quest of finding the perfect participants for a study, these criteria can end up being overly restrictive. On average, trials contain 31 criteria for participants to meet before they are considered for inclusion.
Simplifying the inclusion and exclusion criteria not only widens the pool of participants, but it helps get trials off the ground and into motion more quickly – which also helps reduce costs by more than 20 percent. Bottom line: criteria should be designed to keep participants safe and help researchers answer study questions while not being overly complicated or restrictive.
Limited Awareness and Understanding
Oftentimes, when talking to the general public about clinical trials, there are several preconceived biases, including:
- Mistrust in the clinical research industry
- Misunderstanding of what clinical trials actually do
- Fear of the unknown
The best way to overcome this challenge is to listen to people’s hesitations and fears. Then, educate them on what happens during a clinical trial so they can know what to expect if they were to participate.
Trial Deadline Pressure
In clinical research, time is of the essence. With the ultimate goal of bringing a drug to market, it’s easy to see how it’s important to keep things moving as a drug moves through each phase. With that, there is enormous pressure to keep up on timelines. Not only are deadlines down the road affected, but costs are impacted as well. The longer a trial takes, the more money will be used as a resource.
Key Strategies for Effective Patient Recruitment
While finding participants to recruit for your clinical trial may seem daunting, there are effective strategies your team can implement to find qualified participants.
First and foremost, recruit in the community where the clinical trial will take place. Work with physicians to identify patients who could be eligible for the study. Plug into patient advocacy groups, which enables you to tap into a bigger network of potentially eligible participants.
Another way to find potential participants is through patient recruitment platforms or social media groups. This is especially helpful for studies that aren’t location-bound or need a wide net of participants.
As always, when recruiting for a study, you must build trust with those you are talking to. Educating people on the trial process itself, as well as the benefits, can go a long way when it comes to easing hesitancy. Equally important is explaining trial risks, listening to participant concerns and addressing any questions they may have. The more a participant understands about the trial and their involvement, the more likely they are to be a part of a study and stay with it.
The Role of Technology in Patient Recruitment
Additionally, using other clinical trial technologies such as remote monitoring, eConsent and telemedicine will make trials more accessible and less burdensome. While they may not be used during the recruitment process, they are definitely things to talk about with potential participants.
With the rise of technology in recent years, there are plenty of ways to use it to your advantage. For example, it’s becoming more commonplace to utilize online platforms specifically designed to match participants with available clinical trials. Not only does this help you meet your recruiting goals, but it shows participants that they have other options of treatment available to them.
Adopting a Patient-centric Approach With an IRB
At Sabai, our mission is to protect the rights, safety and welfare of human research participants who participate in clinical trials. It is of utmost importance to us to take a patient-first approach while we are reviewing recruitment methods and materials. As a central institutional review board, we know what an IRB must review and approve, we understand ethical considerations when it comes to reviewing research, and we work to make sure researchers are avoiding undue influence.
If your team needs guidance on developing ethically sound, effective patient recruitment strategies, Sabai can help. Connect with us to learn how our IRB services can support your study from the ground up.
