This article is the second part of a Cloudbyz article series about Recruitment & Retention in clinical trials. You can read the previous article in the series here.
In the previous article, we outlined how a typical clinical trial recruitment process may flow. If you haven’t had a chance to peruse the previous article, you can follow the hyperlink above to take a look at it. If you’ve read the previous article but would like a refresher, we’ve included a schematic from the previous article below that summarises much of its key information. Having covered what a conventional clinical trial recruitment process may look like, this article will illustrate some of the most common challenges which arise during various stages of the recruitment process in the present day.
1. Poorly Designed Clinical Trials
In the “Overview” article, you may have read that recruitment plans are usually drawn up by highly trained professionals. Clinical trials are also usually planned by very experienced, very well trained professionals. However, poorly designed clinical trials are still a real and present problem for a multitude of reasons. Budgetary constraints, regulatory hurdles, and internal sponsor organization politics might all contribute to a poorly designed clinical trial. In some cases, the trial designers’ qualifications are stellar but they may lack enough experience to independently design clinical trials.
2. Strict Eligibility Criteria
Sometimes the requirements for a clinical trial are highly restrictive. For example, patients or subjects considered for recruitment may have a very narrowly divergent age range, or very narrowly divergent defining physical characteristics such as height or weight. There are also lifestyle requirements that may be rare in specific populations. For example, if 95% of adults under 30 drink alcohol in a particular region, and a clinical trial requires adults under 30 who do not drink alcohol from that very same region. Another example could be the requirement of extremely rare prerequisites such as a rare subtype of an already rarely diagnosed disorder. Challenges like these require a greater range of reach.
3. Regional Challenges
Speaking of a greater range of reach, the distribution of research sites in primarily urban population centers is another problem, as well as the lack of sufficient research sites altogether in countries where eligible participant demographics may reside. The rising answer to this particular challenge has been deploying Decentralized Clinical Trials whenever possible, however, Decentralized Clinical Trials don’t apply to each and every study. Some studies still require the extensive amounts of time that research staff and trial participants spend at their research sites.
4. Ongoing Consent Processes
When you read phrases like “consent” and “informed consent” in fields related to clinical research, you might find yourself thinking about the forms you find yourself signing before medical procedures in order to reduce liability. And you’re not totally wrong, these forms exist in clinical research as well. But consent in clinical research is an ongoing process, as well it should be. However, this ethical necessity presents a retention challenge rather than an initial recruitment challenge. Many clinical trial participants sometimes withdraw their consent before sufficient data has been gathered from a clinical trial. You might have heard the solution to this issue is to communicate more clearly with participants and take the time to explain the importance of their particular clinical trial. While there is definitely merit in that, it can also be safely said that spending some time, money, and effort minimizing inconveniences for clinical trials would work wonders in retaining clinical trial participants.
5. Distrust of Sponsors
Anyone would naturally be suspicious to a minor degree if someone offers them a place in a clinical study. It’s not the most common experience in the world. This suspicion amplifies many times when the sponsor for a clinical study is a large pharmaceutical corporation, with a history of litigation against it. Ultimately, this distrust is largely rooted in unawareness of the strict rules and regulations which attend clinical trials, which means the answer lies in directing resources towards educating the general public about how clinical trials work. This doesn’t quite alleviate distrust, but may indicate to many people that distrusting a study’s sponsor does not mean they need to distrust the study itself.
6. Budget Misallocation
Misallocating the budget for recruitment and retention is quite common in clinical trials. One of the reasons it is quite common is because sponsors tend to aim for the required number of recruits, rather than the required number of people to reach or the required number of people to screen. Which means the teams in charge of budgeting don’t sufficiently account for the difference between contacted potential recruits and fully eligible and willing recruits. You may need to screen 2000 to eventually recruit 200 people. And to screen 2000, you need to target a promotional demographic of 20,000 people. Then of course, in order to target this demographic, you may need a reach of 200,000 people.
A compounding factor is the research sites acting as recruitment sites. The budget allocation sometimes only allows for a unified recruitment strategy across all research sites, whilst the different positioning of all these research sites might call for greater diversification by using multiple recruitment strategies, with a particular focus on a different strategy for each research site. When this happens, some research sites perform more poorly than others, recruiting only a small portion of the number of recruits they need in the beginning. When this happens, they are also paid a much smaller portion of the recruiting budget, which essentially demotivates the site from continuing to devote resources towards recruitment. As a result, the next month, recruitment numbers are even less.
These are some of the most common challenges in Recruitment & Retention for clinical trials in the present day. If you currently face any of these recruitment challenges professionally or personally, stay tuned for the third part of this series. We touched a little upon potential solutions here, but the next article in this series will discuss them in a little more detail and will focus primarily on the future of recruitment in clinical trials.