Crisis in Clinical Trial Recruitment: More Short-Term Thinking is NOT the Solution

There’s a crisis in clinical trial recruitment and it’s negatively affecting patients. Most studies do not achieve the trial recruitment targets within the planned timeline. Missed milestones push back the time to analyze and report on the data. Delayed data reporting creates delays in getting new therapies approved. The delays also increase the cost of the clinical trials and this results in higher drug prices.

The solutions currently used in the clinical trial industry to address low recruitment are largely short-term solutions focused on one study at a time. This creates a great deal of waste and is not fixing the problem. Tremendous amounts of money wasted. Effort wasted. Expertise wasted. Ideas wasted. Time wasted.

Sponsors attempt to address the recruitment issue by hiring large central recruitment vendors at a significant expense for that study. They work with their CROs to add more sites to the study. There may even be success for that one study, but the issues resurface rapidly in the next study and the study after that. Over time, the same strategies become less and less effective.

The “This one study is the most important study in the world” approach is hindering efforts for operational improvement in clinical trials.

A short-term study-by-study approach by sponsors and CROs then gets forced onto clinical trial sites. Not only are clinical trial sites unrealistically expected to focus on just that one study, but in many cases are prevented or prohibited from doing things that will benefit all trials.

Sites are tightly constrained when it comes to strategies used for recruitment. Many of those protections are very important. We need to ensure that recruitment activities are ethical and appropriate for clinical research. However, there are strategies that sites are not able to utilize because they can’t afford them or, heaven forbid, they may also benefit another study.

For example, there are tools to increase physician referrals for studies. However, to use them for just one study is simply another burden to the site. Far better if the site was able to use the tool for all their clinical studies. Unfortunately, a sponsor won’t reimburse a site for a tool that is used for multiple studies. The site can’t afford to pay for the tool themselves. A potentially promising recruitment tool goes unused.

This falls into the category of recruitment tools that sites must fund themselves but can’t afford to because of the way budgeting is structured for clinical trials. Additional items in this category are things like advertising and programs to raise awareness about clinical trials in the local community, engagement with patients and patient groups, and education about clinical trials and diseases beyond a specific study.

There are other strategies that should be normal that aren’t because of short-term thinking. Think of the benefits of sponsor engagement with sites through the lifecycle of a drug in development. Instead of using the broken “feasibility” process and randomly picking sites out of a hat, Sponsors and CROs should get to know sites, their capabilities, goals, and potential and engage them for a development program. Plan to engage them across multiple studies. This means sharing more information with them and engaging them in the study planning process. That’s something most sponsors don’t even think about outside a small group of “KOLs”.

What if recruitment was planned across multiple studies in a phase II-IV program instead of one study at a time? What would that look like and what might the benefits be?

What if a candidate was interested in a study but didn’t qualify? There might be a study ongoing or down the road for the same indication where they might qualify. Sites, sponsors, and recruitment vendors should plan for this. Sites and recruitment vendors should ask permission to contact them in the future if a study comes up that might be of interest. This should be standard throughout the industry. The industry spends so much money on advertising for recruitment and loses most people who are interested in clinical trials just because they didn’t qualify for that one specific study. If the clinical trial industry really wants to help patients, it must engage people with interest in clinical trials and assist them to find a trial that might be appropriate for them.

All recruitment strategies require funding. Some study specific recruitment strategies are funded by sponsors but most of the work and time is not compensated (so much for Fair Market Value budgeting). None of the long-term strategies for recruitment in clinical trials are currently funded by sponsors, but they should be if we want to improve the system.

Let’s budget for recruitment as if it was actually important to a clinical trial.

1. Pay sites for time they spend recruiting and not how it is currently reimbursed in the budget. Current process is to pay a token amount per hour or per chart reviewed that is nowhere close to reflecting the actual site cost of pre-screening or recruitment activities. Reimburse a token amount for recruitment work and expect to get token recruiting efforts.
2. Sites know their communities best – let’s support that knowledge financially and put it in action with grants to support community-based initiatives. Initiatives that will raise awareness of clinical trials and the indications researched.
3. Why not fund a paid recruitment strategy session with the site facilitated by a professional to generate ideas and provide an unrestricted line item in the budget for the strategy meeting along with funding for the ideas that result?
4. Meet with key sites to find out how they identify potential candidates and where they come from. Pay them for those meetings. Fund initiatives that will build on what is already being done. If IRB approval is needed, fund that too – even if it is not study specific.
5. In its draft guidance, the FDA highlighted the potential expanded role for local Health Care Providers (HCPs) in clinical trials. When the final guidance comes out, it will be important to review and fund sites’ ideas for involving HCPs. However, we don’t need to wait for the FDA’s final guidance to better engage the HCPs now who refer candidates for clinical trials.

Yes, some of these concepts are complex, may require special contracts and special consultation to move forward and will absolutely need funding. There may be some legal departments at pharmaceutical companies that get anxious about some ideas for a long-term approach to recruitment because they’re concerned about payments to physicians. These are important conversations that need to be undertaken so progress can be made.

Otherwise, the clinical trials industry will continue to approach recruitment the same way it’s currently doing it and it will continually fail.

Patients deserve to learn about clinical trials. The clinical trials industry owes it to them to have difficult discussions internally and come up with new ideas on how to communicate with them.

Instead of approaching recruitment just one study at a time, let’s start the conversation on how to recruit across a whole program of drug development and across all the studies at a site. Let’s convert the short-term approach to an executable long-term plan.