Biopharmaceutical companies developing cancer treatments need to restart the clinical trials shut down or delayed during the early stages of the coronavirus pandemic. Some are holding back, however, due to a lack of confidence that sufficient eligible patients can be recruited and enrolled in the trials. Recruiting patients into a clinical trial was challenging before COVID-19 hit, and it has only become exponentially more difficult. Sponsors also know many patients have been putting off mammograms, colonoscopies, and other screening and diagnostic tests that bring them to the oncologists who recommend patients for trials.
Cancer patients who are still regularly visiting cancer centers, meanwhile, are highly sought after among pharmaceutical companies now competing intensely to find patients for the trials that have managed to keep going. That competition has made it even harder to match patients for trials.
The traditional process for recruiting and enrolling eligible patients in clinical trials was, and in many cases still is, painstaking and unsatisfactory. Numerous stakeholders play a role in determining who can join trials – pharmaceutical companies, contract research organizations, hospitals, doctors, and even the individual patient and their family. Cancer center research staff must often interface and coordinate among these stakeholders. But center staff often work with antiquated tools. Many comb through a combination of paper records, pdf’s and electronic documents and records to manually match patients to trials with increasingly complex inclusion/exclusion criteria.
Sadly, this traditional process of patient matching and enrollment results in less than five percent of oncology patients receiving the opportunity to participate in a trial. What’s more, approximately10 percent of clinical trials shut down, often due to lack of enrollment. Those numbers have surely fallen even further during the pandemic. More than 1,200 clinical trials worldwide have ended because of the coronavirus pandemic, according to TranspariMED, a nonprofit research advocacy group.
That’s unacceptable. The mammoth effort of expertise, time, and money required for those low results, moreover, suggests there must be a better way. The patients are out there, waiting to be found if we only had a better way to find them.
Fortunately, doctors and cancer centers can give pharmaceutical companies the key to recruiting and enrolling patients in clinical trials – the data that they and their research assistants and staff already generate in their daily workflows through physician notes, procedure histories, lab and diagnostic reports, and other information in Electronic Medical Records (EMRs) and elsewhere. The challenge, however, is that the data is overwhelming and inconsistently captured, making it extremely difficult to efficiently harvest and analyze.
When a trial sponsor approaches a cancer center in search of patients for clinical trials, treating physicians, research directors, and/or primary investigators must sift through multitudes of cancer biomarkers, patient traits involving their treatment and its timing, genes, and other factors. As many as 20,000 permutations determine if a patient is eligible for a trial. The clinical research staff might have some of that information handy, or they may not.
Meanwhile, overworked doctors, nurses, and staff in a cancer center can only divert some of their time from directly treating people to coordinating with research directors and sponsors on trials. It’s no surprise that doctors who might see 25 or more patients a day – some in trials – might lose track of potentially feasible candidates for the thousands of trials underway at any time.
The good news is that we have technologies that can sift through these massive data sets – natural language processing, heuristic parsers, artificial intelligence, and data management – and cut down on the excessive time and resources that sponsors and clinicians now devote to marching patients to trials. Currently, much of that data is unstructured, or saved in different formats, platforms, and locations (e.g., paper, EMRs, faxes, scans, and images.) Converting that data into a unified structure that puts all the information together in one searchable package can revolutionize how the industry can match patients with trials.
This technology doesn’t cut out anyone in the current patient-matching process. Pharmaceutical companies and others still need to refine their inclusion and exclusion criteria and secure FDA approval for their study protocols. Sponsors and contract research organizations have to identify sites to coordinate recruitment and enrollment. Doctors must determine if a patient is suited for a trial. Clinical research staff manage the whole process and facilitate the transfer of information.
Rather than searching through haystacks for needles, though, research directors can use this new technology to simply input trial sponsors’ requirements into a database that will immediately enable the identification of potential patients for trials. The painstaking, inefficient process gives way to instantaneous and more complete results that doctors and trial sponsors can then review.
The benefits of the collaboration between the technology and hardworking people, now liberated from work that machines do best, are threefold. Pharmaceutical companies stand a better chance of enrolling the patients they need for successful trials, especially when the technology is deployed across a consortium of healthcare systems, drawing on vast resources and populations. Patients gain access to more treatment options that might help their recovery. Lastly, hospitals and cancer centers save time as well as the financial and reputational costs incurred from canceling or shutting down trials.
Patient trials are the future of medicine. That future is under threat. Cancer centers and pharmaceutical executives now have the tools to make sure it comes.
About Marie E. Lamont
Marie E. Lamont is President and COO of Inteliquet, a patient matching software company for clinical trials. Before Inteliquet, Lamont was President of the patient services business unit of Dohmen Life Science Services, and previous to this global head of business strategy and commercial operations for rare diseases at Genzyme.
