How to Avoid a Rescue Trial in the First Place

Too often patient recruitment doesn’t come into play until after the study protocol has been developed. For a clinical trial to be truly patient centric, however, the study must be designed with the patient in mind from the start.

Welcome to the April 2026 edition of Citeline’s Patient Recruitment Pulse. In this monthly blog, we discuss the trends shaping today’s patient recruitment landscape. This month, we’re taking a closer look at some of the key findings of our white paper, Earning Their Trust: Challenges and Best Practices in Rare Disease Patient Recruitment.

How to Avoid a Rescue Trial in the First Place

The phrase “rescue study” implies that a clinical trial is in peril. While the study in question may actually be in jeopardy, it’s likely the case that the study is simply behind schedule — usually because of failure to meet enrollment goals — and the sponsor seeks external support to get it back on track. In fact, there are kinder, gentler terms used to describe these studies, like “study augmentation,” “trial recovery,” “study remediation,” and “study transition.” These studies may not call for resuscitation, just a bit of Rx.

Besides the aforementioned recruitment challenges, what can cause a clinical trial to require rescue? Poor clinical planning, overly complex protocols, missed deadlines, budget overrides, insufficient resources, and noncompliance with regulatory requirements top the list.

Whatever you call it or whatever caused the need for it, the bottom line is the same: This study needs help, and it’s time to call in the clinical cavalry. Trial rescues are typically conducted by a clinical research organization (CRO) specializing in such interventions.

The more pertinent question is this: Wouldn’t it make more sense to avoid a rescue trial in the first place? No one wants to send out an S.O.S. (save our study) signal. Following are a few suggestions on how to nip these nagging study saboteurs — all related to patient recruitment woes — in the bud.

Poor clinical planning/overly complex protocols

Too often patient recruitment doesn’t come into play until after the study protocol has been developed. For a clinical trial to be truly patient centric, however, the study must be designed with the patient in mind. In doing so, the sponsor will recruit the right-fit patients from the get-go, saving precious time and money — and promoting retention, too.

There’s no need to reinvent the wheel. Sponsors should conduct due diligence and see what worked — and what didn’t — in study designs of similar trials. This is where real-world data (RWD) comes in. By looking at historical trial data, sponsors can replicate successes and avoid elements that led to less-than-desired outcomes.

One area that demands attention is the protocol itself. Overly restrictive inclusion/exclusion (I/E) criteria can lead to repeated screen failures, making patient recruitment a nightmare. In these cases, tweaking the I/E criteria is a good place to start, where possible. Of course, in rare disease trials this may be unavoidable. And it is compounded by the fact that rare disease patient pools are inherently smaller to begin with.

When it comes to patient recruitment, traditional models won’t cut it. Sponsors need to employ methods and tools that allow for precision recruitment to pinpoint these hard-to-find patients.

Lack of resources

Strapped study teams and overburdened study sites can create communication gaps that lead to costly trial delays. According to the 2025 Perceptions & Insights Study from the Center for Information and Study on Clinical Research Participation (CISCRP), the biggest obstacle (other than not qualifying for the study) to trial participation is that patients were never contacted by the study staff or had to wait too long to hear back.

A digital platform that fosters patient engagement before, during, and after a clinical trial can not only boost enrollment but promote retention. Sponsors that educate potential participants about clinical trials in general, as well as their own studies, build trust in their brand — a key consideration for patients when choosing a clinical trial. To accelerate the recruitment, sponsors should invest in a dedicated trial portfolio website with built-in questionnaires that enable patients to do an initial self-screen for eligibility.

Communication gaps contribute to missed deadlines which, in turn, lead to budget creep. Considering the fact that clinical trials are the element of the drug development process with the highest price tag, it behooves sponsors to keep a lid on study costs.

Delays push those costs even higher. According to the Tufts Center for the Study of Drug Development (Tufts CSDD), each day a trial is delayed represents an $800,000 loss in unrealized or lost prescription drug sales and $40,000 in direct daily clinical trial costs. For sponsors, the adage “time is money” certainly rings true.

Regulatory noncompliance

Sponsors must know what information must be disclosed, where it should be disclosed and, most importantly, when it should be disclosed. “Ignorance of the law is no excuse” applies to clinical trial regulations.

Failure to comply with global regulations can result in a trial being suspended or even halted, putting all that time and effort spent recruiting patients in jeopardy. In some instances, a noncompliant sponsor can be levied civil money penalties. Nondisclosure directly impacts attempts to stay in budget.

If you make patient recruitment part of the clinical planning process, you just might be seen as the hero who saved the day (or the study). So put on your cape and keep your recruitment from going off the rails.

Visit Citeline.com to see how Citeline’s solutions and services help sponsors optimize clinical trials, from study design to recruitment to disclosure.