Patient recruitment is widely acknowledged as the most persistent and challenging problem confronting clinical research. Yet, despite the best efforts of so many talented professionals, the process shows no sign of improvement.

None of the traditional remedies have moved the needle. Throwing money at the problem in terms of large-scale legacy and social media buys can generate more leads in some cases, but there are no guarantees for randomizations. Automation technologies and AI are helpful, but they are far from the panacea they’re often depicted as.

What ails clinical trial recruitment is best characterized as a structural problem resulting from misaligned incentives between research sites and lead generation and management companies.

Here are the three steps necessary to fix the problem and improve the recruitment process for sponsors, sites, recruiters, and patients.

1. Understand the root cause.

The primary disconnect between the incentive models for sites and recruiters is that sponsors, or sites, typically pay lead generation companies for leads — but what sponsors and sites actually need are randomizations.

In a typical scenario, a sponsor or CRO budgets an amount for lead generation — say $500,000. Then, a recruitment or lead generation company is hired to run the campaign, either for a flat fee or based on the delivery of leads. Regardless of how many (or how few) screens and randomizations the campaign generates, the recruitment company still gets their fee.

This is the first disconnect: The level of compensation is not dependent on the results of the campaign.

That structure incentivizes lead generation companies to focus on the number of leads they generate. Superficially, this may seem like a good outcome for the site. However, it just kicks the problem down the road, as far too many of the leads are low quality. This situation creates hundreds (or thousands) of unproductive man-hours of work at sites — which typically are not experts at lead management.

This is a terrible outcome for research sites, sponsors, and patients — every party involved except for the recruiting company.

C6 | Site Solutions offers a much better approach, one that incentivizes us to deliver candidates who have a higher probability of qualifying for the particular trial.

2. Prioritize high-potential candidates.

The most productive approach for increasing the number of randomizations is to focus on patients who have the best chance of participating in the specific trial. This sounds like a simple thing to do, but it is actually not easy. There is a persistent assumption that more leads correlates to more randomizations. In my experience, this is not the case.

The reality is that more leads only guarantees more work and higher costs.

Our approach, described below, helps ensure that we focus on delivering leads with a higher propensity to screen and result in randomizations.

3. Build the right strategic partnership to connect with high-probability candidates.

With the traditional patient recruitment model, research sites take on the monumental task of lead management — identifying the few participants who will enroll, from the hundreds who are interested. And while sponsors often provide funding for a marketing campaign (i.e., leads), sites need to take on call center and inside sales functions to successfully turn those leads into candidates.

When it comes to recruitment, research sites are understaffed, undertrained, and lack many of the tools/technology needed, yet the normal model is to “keep feeding them more leads.”

The problem is rooted in a misaligned incentive structure.

C6 offers a different approach, based on a shared risk partnership, and we’re seeking sponsors and sites that are open to innovative methodologies that produce randomizations.

Here’s how our approach works:

1. Sites agree that trial prospects are contacted and managed with our proven patient recruitment methodology. Typically, C6 will perform this work, and when sites align with our lead management process, we can take on more of the risk in delivering high-potential leads.
2. Sites agree to use our cutting-edge SaaS technology. Our purpose-built ENGAGE recruitment platform ensures lead management best practices, provides transparency and efficiency, and automates patient communications.
3. Sponsors/Sites only pay C6 when patients reach the agreed-upon milestone in the recruitment funnel (typically in-person screening and randomization).

Using our methodology, sponsors and sites only pay for the results that matter — enrollment — and their recruiters aren’t bogged down sifting through hundreds of low-probability leads with no guarantee of enrollments.

Improved Recruitment Outcomes Require Improved Processes

C6 is pitching a radical idea to sponsors, clinical research sites, and site networks. And we realize that it’s a big ask to request that clients change their processes and technologies to work with us. However, we’ve been pleasantly surprised with the inroads we’re making into the market.

It can be challenging and expensive to retrain employees and adopt new processes, and that’s why many of our clients are outsourcing patient recruitment to us. As you weigh the cost of retraining employees and/or outsourcing patient recruitment, also consider how much it will cost to maintain the status quo with the lackluster results you’re currently getting from patient recruitment.

C6 is a recruitment-as-a-service company that provides site-branded, patient-centered campaigns that engage and inform prospective patients. Contact us if you would like to learn more about our approach to patient recruitment.