This article is the third part of a Cloudbyz article series about Recruitment & Retention in clinical trials. You can read the previous article in the series here.
Welcome to the third and final part of this Cloudbyz article series. The second part of this series highlighted some of the most common challenges in recruitment & retention for clinical trials. If you’d like to take a look at it, please follow the hyperlink above. The first article in the series gave a general overview of the conventional recruitment process, and we’ve included a schematic below which summarizes conventional recruitment. This article will go into a bit more detail for potential solutions to recruitment challenges, some of them touched upon when addressing challenges in the previous article. And shall then address these solutions from a future perspective.
In the previous article, some of the reasons for poorly designed clinical trials were explored, amongst the challenges which clinical trial recruitment faces. It is not currently possible to forestall all these reasons at the roots, but it is possible to forestall all poorly designed clinical trials before they launch. Going forward in the future, we can further assess any clinical trials before launching them under a new, unified standard. In fact, some would go as far as to assess and prioritize clinical trials based on their potential value and impact, but that’s another discussion altogether. Assessment is an appropriate solution for multiple challenges.
But who should make this new, standardized assessment? Should it be compulsory, enforced by regulatory authorities across jurisdictions, in cooperation with each other? Like an extra step in an already challenging process? Should it just be introduced as an industry norm for all major sponsors with no regulatory compulsion? There are no available answers to these questions yet, but they will emerge eventually. We can, however, answer another question. What new criteria should this new standard assess clinical trial protocols for before they’re launched?
There’s room for more, but there are at least three basic aspects to assess. The first aspect is the financial feasibility of a clinical study. Even in studies without recruitment incentives, more participants cost more money. Lack of funding for a launched clinical trial is still a possibility in the current system.
The second aspect should cover the eligibility criteria. Strict eligibility criteria, in general, may hinder the progress of recruitment, or even cause a failure to recruit sufficient clinical trial participants. While sometimes strict eligibility criteria are unavoidable, those that have no bearing on the study should be determined through this new pre-launching assessment standard and relaxed whenever possible if they hinder recruitment. Stringent eligibility criteria make recruitment difficult enough when they’re necessary for the study. Unnecessarily stringent eligibility criteria for the sake of conformation to norms and common practices, with no true justification, should be eliminated systematically before a study launches.
The third aspect should cover the sample size targeting. It is entirely feasible for only 9-12 out of every 100 being considered for a study to ultimately qualify for actually taking part in the trial portion of the study, and out of those 9-12 people, it is entirely feasible that only 7-11 people will complete the trial. This typically means that the greater the sample size targeting, the greater the number of clinical trial participants. The third aspect of the assessment should ensure sufficient targeting to recruit the number of participants needed. The third aspect is necessary to account for sponsors who may underestimate the targeting size number, which is a common enough occurrence. And of course, greater targeting requires greater reach.
This brings us to another solution to hope for in the future. The solution to budget misallocation. Budget misallocation causes significant hindrance to studies’ potential progress or success. Budget misallocation affects recruitment reach, recruitment site performance, and other recruitment aspects. Addressing budget misallocation thus enables greater reach. Contrary to the poorly designed trial challenge, budgetary misallocation actually can be addressed at the root.
At the root of the budget misallocation challenge is the process by which a budget is determined. Its very naming implies a somewhat challenging and adversarial tone. “Budget Negotiation.” Essentially, the sponsor is making justified concessions to the research sites, based on what the research sites can justify. But research sites fighting for every penny in their research budget might not dedicate enough resources to justify their budgetary needs for advertising reach nor their demographic reach strategies. And motivating research site teams is paramount for good recruitment.
In the future, many of these challenges can be resolved if the trial budgeting process takes a less adversarial tone. This might be achieved if the sponsor takes a more proactive role in studying the budget. In an ideal scenario, the sponsor offers the research site a well-researched budget that is accepted almost right away without any “negotiation”.
Designing retention material and addressing participant inconvenience is also a great way to address the challenges posited by ongoing consent processes. It would be helpful to effect a standardized “expansion of focus” in recruitment plans in the future to include more retention strategies in the recruitment plan. Things like planned material to continue communicating the importance of the clinical trial to the participants and more comfortable transportation to research sites for those commuting from long distances. Rather than planning recruitment material only around capturing the attention of potential participants before initial consent, recruitment plans should include room for retention material since participant consent is an ongoing process.
This article concludes Cloudbyz’s “recruitment in clinical trials” article series. You have read more details about some solutions touched upon in the previous article and considered possible standardized remedial actions in the future. If your organization is involved in recruiting clinical trial participants, these are a few factors to consider. Some solutions touched on in the previous article have not been mentioned in this article, to leave room for the most relevant details of other solutions and potential future practices. Ultimately, the future of addressing challenges in clinical trials can be summarized in one word. Standardization. New, widely followed standards, can help teams overcome a vast number of recruitment challenges.