This article is the first part of a Cloudbyz series of articles about Recruitment & Retention in clinical trials.
There are many challenges to recruitment in the field of clinical trials. There are also a number of solutions; some of them new and burgeoning, while others are tried and tested. But before delving into details as deep as the challenges of recruitment & retention in clinical trials, potential resolutions, and the future of recruitment, it is important to see the current recruitment process itself more clearly.
As an overview, this is an introductory article. If you are already deeply familiar with the current process, you might want to wait for the next article in the series, which will address some common recruitment challenges more closely. Recruiting and retaining participants for clinical trials is in and of itself a generally challenging process. The recruitment process begins long before participants are actually recruited to a clinical trial.
The first step in the recruitment process is to draw up a recruitment plan. This is generally done by highly qualified individuals with extensive experience. They are often assisted by professionals in the field who may be more junior in terms of experience but also very highly trained. The recruitment plan is heavily affected by the general budget allocation for the clinical trial. Based on the finalized recruitment plan, the recruitment materials are prepared. These materials could include incentive packages, literature explaining the importance of the study for hospitals, physicians, and medical professionals to make available to potential participants who fulfill preliminary trial criteria. It could also include finalized drafts of recruitment advertisements intended for traditional and social media.
The recruitment plan along with the recruitment materials based on the plan are then presented to the relevant Institutional Review Board (IRB), which must then review the submissions and approve or reject them. Once the submissions for recruitment have been approved, only then can recruitment begin. Of course, there are specific rules to recruitment, such as the level of solicitation permitted during initial advertising, how much an organization can reveal about potential incentive packages before a potential participant accepts recruitment, amongst other rules.
There are generally two types of participants to recruit. Subjects, who are usually healthy individuals that fulfill a required set of criteria, and Patients, who fulfill another set of criteria. The most prominent criterion for a Patient is often the health concern from which they suffer since clinical trials’ most conventional purpose is to find new treatments.
Subjects are recruited in a variety of ways. One way is email campaigns. People who consented to be on certain mailing lists may be sent general emails notifying them of a study and informing them of the preliminary criteria to be accepted into a study. Should they choose to respond, it is then permissible to contact them in a more specific capacity. Subjects may also be reached via social media advertising campaigns, SEO positioning, and more.
Patients on the other hand are typically recruited through healthcare organizations. Doctors and healthcare institutions who are aware of a clinical trial through a relationship with the sponsors or the research team may inform the Patient about the trial and provide access to some of the study materials (such as the study brochure). If a Patient chooses to get in touch using the information provided, the research team may at this point become more involved in directly recruiting them. Some of these Patients may be internally flagged on institutional databases with the help of sorting software so that their institutionally associated healthcare providers will remember to investigate their potential candidacy.
However, the patients’ healthcare providers are strictly required to not pass on any flagged patient information to the sponsors. Or any patient information whatsoever. At least not without the patients’ consent, but sometimes even with it. The most common occurrence is for patients to initiate contact with research sites or research teams, after being informed of a clinical trial by their relevant healthcare providers, usually physicians.
In either case, those who fulfill the preliminary study requirements are then registered with the appropriate research site. The applicable IRB may choose to monitor any and all parts of the recruitment process, as well as the general study. The IRB may monitor the whole site. The registered candidates then undergo some general screening, which includes various types of medical checks. This is part of the qualification process called pre-qualification. It doesn’t mean that this is a process done before participants are qualified. The word “pre” here refers to the participants becoming qualified before they proceed with the trial portion of the study. Having become prequalified, the participants may now take part in the trial.
As you can see, this process is challenging in and of itself. However, additional, specific recruitment challenges tend to arise at various points of this process, whereas retention challenges might also arise after the initial recruitment phase. The next article will examine some of the most common of these challenges in the present day.