We Need a Better Clinical Trial Recruitment Process

July 24, 2019

Clinical trials hold great promise for advancing healthcare-but only if the right patients are found.

A better process for recruiting patients to the right clinical trials is deceptively simple: produce a single source for massive quantities of comprehensive, quality data and sophisticated trial algorithms. The hard part is that it can only be achieved by long, hard, detailed work that doesn’t skip a single step.

It begins with deeply understanding the patient population, it requires identifying the patients of tomorrow and it means finding the right sites where the patient populations can be found for the specific clinical trials that will produce the discoveries we need to take giant leaps forward in the quality of care.

Recruitment

Here’s how it works. The right data and tools can help researchers improve the scale and precision of clinical trial recruitment.

While the number of available clinical trials is increasing, the reality is that about 50% of trials do not meet recruitment goals. Proper adoption of a clinical workflow based on new digital tools with the right data can ameliorate this challenge, but simply being data-driven is not enough. The core value of putting patients over process must rule the day so that the industry migrates efforts toward drug development tailored to patient population.

The goal is to use real-world data (RWD) to improve clinical trial design, as well as to find consistent and predictable methods to accelerate clinical trial recruitment. This means that sponsors and their clinical research organizations (CROs) must use digital tools to decipher which patients should be enrolled and where clinical trials should be opened. 

Related article: New Study Could Speed Up Drug Trials

We need to focus on helping to find eligible patients faster, today. We need to provide early insights to broaden or enrich a trial’s patient population with the use of specific EHR data fields like diagnosis codes, histologies, treatment pathways to trial, laboratory tests around the time of trial availability, and comorbidities at and before trial availability.

All of this information is currently spread out among many different clinical settings and systems – hospital EMRs, practice management systems, lab information systems, biobanks, and registries. Centralizing this information into one repository is one way to get one source of truth, where researchers can draw evidence-based insight to help design better inclusion and exclusion criteria.

Patient recruiting can be improved through the use of digital technology and automation to identify and match eligible patients. Automation and technology can help clinical site personnel discover much more information about the uniqueness of the patient population in terms of geographic location, as well as the patient’s age, gender, type and stage of a disease, treatment history, and other medical conditions that affect the patient’s ability to participate in a clinical trial.

The right technology can help provide insight and harness knowledge to dramatically improve this process for everyone, from sponsors to patients. It is essential that the recruitment process be a collaborative partnership between healthcare providers, sponsors, CROs, and patient advocacy groups-all working from a central clinical trial enablement platform to bring lasting solutions to cancer and other critical illnesses that can improve the standard of care for patients everywhere. It must be a shared mission to ensure that every patient has access to the best treatment option, which can be a clinical trial. Technology at scale and invested with comprehensive detail can help enable such a mission.

Identifying tomorrow’s patients

Participating in trials as a clinical research site can be difficult. Screening for eligible trial patients can be a tedious and error-prone process for sites, akin to finding specific snowflakes in a storm. The most time-consuming element is knowing which patients to review for matching to the eligibility requirements of the clinical trial, which is often a manual process that can take a significant amount of work and time. And more complex eligibility criteria make it even more difficult to find patients who qualify and want to participate. The search process requires an automated method to sift through thousands of patients who may not be right for the trial, so researchers can concentrate on the ones who are.

Identifying patients who could be eligible for a trial tomorrow can accelerate research. A powerful single source of truth can reach out and help watch patients who could be eligible once the current treatment is no longer working, so that they would move to be eligible-for example, if they meet all criteria for a trial. Perhaps the latest treatment hasn’t failed yet.

Once we learn that it has failed, then that patient automatically becomes eligible and the site is made aware of it so that the physician has a comfortable workflow to move the patient to a trial. The research staff can discuss the trial as the next treatment option with that patient at their next appointment.

The research and data to propel new therapies is there. We just need a single source of truth with the detail and capacity that can guide us into new frontiers in care.

Carla Balch is CEO of Inteliquet, a maker of software for matching cancer patients to clinical trials. Previously, Carla was President and CEO of Altos Solutions, now Flatiron Health.