Optimizing Your Obesity Patient Recruitment Strategy

It’s time to take stock of your patient recruitment strategy, cutting out what’s not working and employing strategies and technologies designed to optimize your enrollment timelines.

The obesity trial landscape has never been more competitive — or more complex. With a surge in GLP-1 trials and a patient population that can appear broadly eligible but screen out at disproportionate rates, enrollment timelines are under pressure even for experienced sponsors. The question isn't whether to rethink recruitment strategy, it's where to start.

First, ask yourself the following questions (and answer honestly):

Are your study sites overwhelmed by suboptimal patient referrals? Are your obesity trials missing their recruitment goals? Do you rely on the same sites over and over again with less-than-satisfactory results? Are you discouraged by an abundance of screen fails? Do you find your trials in rescue mode more often than not?

If so, you need to take stock of your patient recruitment strategy, cutting out what’s not working and employing strategies and technologies designed to optimize your enrollment timelines.

Incorporate patient recruitment from the get-go

Don’t wait until you’re behind on recruitment; get ahead of the curve and make it part of your clinical planning process. In the protocol design stage, re-examine your inclusion/exclusion (I/E) criteria to determine whether they are overly restrictive.

To be truly patient-centric, sponsors should revisit their I/E criteria with patient access in mind. While such criteria make it easier to meet endpoints, they also can make it difficult for patients to qualify for participation.

Remember, your I/E criteria are not set in stone. Consider whether it would be possible to loosen the eligibility criteria without compromising safety and data integrity or introducing possible regulatory risks. And you don’t have to completely revamp your criteria; start with one element at a time and see if it moves the needle on recruitment.

Keep your sights on the sites

Site selection is an important part of the recruitment process. If you continue to contract with the same sites out of familiarity, it may backfire. The key: Be open to working with new sites.

With historical performance data, it’s easy to see the track record of sites and investigators. That way, you’re not proceeding blindly, but with the information you need to make informed decisions.

It’s quality that counts

It may be tempting to cast a wide net and see what “sticks” in terms of patient enrollment. With that approach, however, you run the risk of sending ineligible patients to your already-overburdened sites for prescreening. This is especially true for obesity trials, which tend to attract a greater pool of applicants that then must be further qualified.

Here’s where precision patient recruitment comes in. Precision recruitment is not limited to clinical trials with exceptionally restrictive I/E criteria such as rare diseases. This strategy can apply to any clinical trial, any therapy area, disease, or condition.

So what exactly is precision patient recruitment? It’s a strategy that uses real-world patient data — such as medical and Rx claims, diversity data, and EHR — to pinpoint the right patients for a given trial. This produces relevant, protocol-matched patients for follow-up.

Make healthcare practitioners (HCPs) your recruitment partners

Ideally, HCPs should help, not hinder, your patient recruitment outreach. However, they first need to be made aware of your trials. Only then can they determine whether patients they are treating meet the I/E criteria of a particular trial.

According to the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2025 Perceptions & Insights study, 51% of respondents prefer to learn about clinical trials from their doctor; however, only 17% actually do hear about trials from their doctor.

A Citeline survey of physicians underscores the challenges physicians face when searching for trials and referring patients. When asked about the quality of trial information, around 69% of respondents said information problems at least sometimes prevented them from making a trial referral they would have otherwise made. About half of respondents said their trial searches rarely result in referrals, and most of the remainder said they lead to a referral about half the time.

Making HCPs aware of a trial is only half the battle. Sponsors must provide clear, accurate, and complete information so that HCPs can refer patients with confidence.

Establish trust with patients

Patients are more likely to enroll in a clinical trial conducted by a sponsor in whom they trust. That’s why patient education must begin well before a trial is launched. By providing educational materials on clinical trials in general as well as information specific to a given disease, sponsors earn the trust of patients. When sponsors wait until they are actively recruiting for a trial to engage the patient population, it can come across as inauthentic.

How sponsors communicate with patients is equally as important (if not more so) as when they communicate. It’s important to use patient-friendly language so as not to unnecessarily frighten or confuse patients. For obesity trials in particular, be careful of your word choices so as not to inadvertently offend potential participants.

The lines of communication should continue throughout the patient journey: before, after, and during the clinical trial. To acknowledge the patient’s participation and contributions, sponsors should provide trial results. This is more than a moral obligation; in the US and EU, results are mandated by law.

Researchers are finding additional benefits of GLP-1 drugs, so positive word of mouth can work to a sponsor’s advantage. Beyond obesity, these drugs are being used to treat cardiovascular events, chronic kidney disease, obstructive sleep apnea, and metabolic liver disease (MASH).

Choose targeted direct-to-patient (DTP) outreach

Just as it’s unwise for sponsors to rely solely upon study sites they are familiar with, sticking with traditional DTP outreach is shortsighted and more often than not ineffective. Traditional methods such as online advertising cast a broad net, which results in overloading study sites with a flood of less-than-stellar referrals.

Savvy sponsors see their I/E criteria not as a limiting factor but as a way to home in on protocol-eligible patients. They should find a recruitment partner with the capability to not only find eligible patients but then to close the gap by conducting outreach to consented patients via a vetted third party.

Embrace technology (yes, we mean AI)

Sponsors should embrace — not fear —  technologies that incorporate AI in order to find the right patients for their trials. Of course, not all AI is created equal. It goes without saying (but we’ll say it anyway) that any AI used must have a human in the lead.

The goal of AI in patient recruitment, as with any AI initiative, is to make the process more efficient. AI can consolidate and analyze vast amounts of data to design better protocols, select the best sites and investigators, and find patients matched to a specific trial.

Don’t underestimate the power of data

We’ve previously mentioned site, investigator, and patient data. Let’s not forget the clinical trial data, too. There’s no reason to reinvent the wheel; by looking at similar trials, you can see what worked (and what didn’t).

Revisit both the caliber of your data sources and the platform on which they are hosted. If data are inaccurate, incomplete, or outdated, this will negatively impact your clinical planning and recruitment efforts. The ability to connect those datasets is also crucial for selecting the best sites and investigators, and for finding the right-fit patients.

It’s OK to outsource

Whether you’re a large pharma company or a small biotech, don’t discount enlisting the help of external experts to refine your recruitment strategy. If nothing else, this can provide an unbiased view of the situation and lead to recommendations not previously considered internally.

A recruitment partner should be seen as just that: a partner, not a mere vendor. The partner should become an extension of your own recruitment team. A good partner will not simply tell you what you want to hear; a good partner will offer tangible solutions to boost patient enrollment.

Be prepared to pivot

Just as you may have to ease your I/E criteria, you may need to alter your recruitment strategy. It’s never too late to course correct.

This is why it’s important to monitor your recruitment efforts along the way. And, once you’ve met your enrollment goals, conduct a retrospective so that you can take the learnings and apply them to future trials.

Learn how Citeline PatientMatch and its Patient Outreach component can zero in on the right patients for your trial.