New approach to clinical trials promises to make it faster and cheaper to do meaningful clinical studies, thus benefiting pharma firms and in vitro diagnostics manufacturers

There’s a new approach to clinical trials that helps shorten the time required to gain regulatory approval of new therapeutic drugs and in vitro diagnostic tests, while slashing the costs of a clinical trial by as much as 90%. This could end up being an important trend for clinical laboratories and pathology groups to perform medical laboratory testing.

Whatever it is—including clinical trials, everyone wants it faster, better, cheaper. That contemporary notion seems to apply to registry-based randomized clinical trials. This is one approach that can be used when both pharmaceutical and laboratory test companies seek efficient ways to demonstrate functional and clinical value of their products to the FDA, Medicare, and private payers.

Understanding a Registry-Based Randomized Clinical Trial

Several national healthcare experts are using the term “disruptive technology” when describing registry-based randomized clinical trials. It is electronic health records and improved informatics integration that now make it feasible to use clinical data registries, such as the National Cardiovascular Data Registry of American College of Cardiology, as part of a clinical trial.

One recent example is the international reaction to a registry-based trial presented at the European Society of Cardiology (ESC) last fall. Results of this trial challenged the current practice of blood-clot aspiration after heart attack.

But it is the unique way that the study was conducted that will be of interest to medical laboratory professionals, particularly those working for labs and private companies that regularly develop and introduce new diagnostic tests for clinical use.

National Registry Used as Platform for Patient Randomization

What was innovative about this registry-based randomized clinical trial protocol it that it used national registries as online platforms for randomization, case record forms and follow-up. This approach made the clinical trial economically and administratively feasible, said the ESC in a news release summarizing the results.

Researchers in the TASTE trial determined that aspiration of the blood clot or “thrombus” (that causes a heart attack) before re-opening a patient’s artery with a balloon catheter does not improve survival compared to performing balloon dilation and stenting alone. TASTE is an acronym for “thrombus aspiration during ST-segment elevation myocardial infarction” and describes the registry-based clinical trial conducted in Scandinavia.

Study’s Physician Leaders Comment on Value of Registry-based Trials

It was Dr. Stefan James, of Uppsala University, Sweden, who presented results from the TASTE Trial. He acknowledged that traditional randomized clinical trials are “still the gold standard.” He further stated that these traditional types of clinical trials are also expensive, time-consuming and often limited in scope.

In a traditional randomized clinical trial, two or more alternative treatments are assigned to volunteers by chance. The results of each treatment are compared at specific points during a trial, which may last for years, according to the National Institutes of Health.

Greater Use of Clinical Registries in Clinical Trials

James envisions opportunities to meld clinical research protocols by greater use of clinical registries. “National clinical registries have representative patient populations and could be used to complement randomized clinical trials in terms of assessing therapeutic options available and/or used in routine clinical care,” observed James in remarks summarized in a story published by the American College of Cardiology CardioSource.

The TASTE Trial involved 7,244 ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) and who were enrolled in the Swedish Coronary Angiography and Angioplasty Registry. Participants were assigned to manual thrombus aspiration followed by PCI or PCI only, reported a New England Journal of Medicine article by TASTE’s lead author, Ole Frobert, M.D., Ph.D. of the Department of Cardiology at Orebro University Hospital in Orebro, Sweden.

“This (registry-based randomized clinical trial) concept reduces costs to 1% or less of a conventional trial and enables the testing of treatments that have no revenue potential, since commercial interest is often the main incentive behind large-scale randomized clinical trials,” Frobert said in the ECC news release.

Experts Commend Cost Savings of Registry-based Trials

The TASTE Trial may encourage more registry-based trials, according to a recent article. published by Modern Healthcare.

A research protocol that utilizes a registry-based trial format is the “new paradigm going forward. “It’s cheap, you can enroll patients more easily, and you can get a better, broader picture of what is going on,” observed Ralph Brindis, M.D., (pictured above), Clinical Professor of Medicine at the University of California at San Francisco and a past president of the ACC. He was quoted in a story published by Modern Healthcare, which also reported that traditional clinical trials can cost $50 million or more, while the TASTE trial cost just $50 per patient, or well under $500,000. (Photo copyright by the University of California San Francisco.)

A research protocol that utilizes a registry-based trial format is the “new paradigm going forward. “It’s cheap, you can enroll patients more easily, and you can get a better, broader picture of what is going on,” observed Ralph Brindis, M.D., (pictured above), Clinical Professor of Medicine at the University of California at San Francisco and a past president of the ACC. He was quoted in a story published by Modern Healthcare, which also reported that traditional clinical trials can cost $50 million or more, while the TASTE trial cost just $50 per patient, or well under $500,000. (Photo copyright by the University of California San Francisco.)

 

Also, in an accompanying commentary published in the New England Journal of Medicine, Michael Lauer, M.D., Director of Cardiovascular Sciences at the National Heart, Lung and Institute, Bethesda, Maryland, and Ralph D’Agostino, Sr., Ph.D., Professor at Harvard Clinical Research Institute, Boston, shared views that “today we can no longer afford to undertake randomized effectiveness trials that cost tens or hundreds of millions of dollars. But today we also have registries and other powerful digital platforms.”

Registries currently require an added layer of data collection, according to Harlan M. Krumholz, M.D., Professor of Cardiology at Yale University School of Medicine and Director of Yale-New Haven (Conn.) Hospital’s Center for Outcomes Research and Evaluation. He was quoted in the Modern Healthcare article, saying that: “It (registry trials) works well, but I see it as an intermediary step. We’re moving toward exporting data directly from electronic health records without that additional burden.”

The TASTE study gained wide international exposure not only for its results, but for its protocol: the registry-based clinical trial. There appears to be growing support among healthcare and medical decision-makers for this type of research method. Such support bodes well for laboratory companies that are on the research road to prove quality and effectiveness of diagnostic and genetic tests.

—By Donna Marie Pocius

Related information:

Registry-based randomized clinical trials: Revolutionizing research

Registry-based clinical trial puts heart treatment to the test

Results of the TASTE trial challenge current practice of blood clot aspiration after heart attack

The Randomized Registry Trial

TASTE: Does thrombus aspiration before PCI reduce 30-day mortality in STEMI patients?

Thrombus Aspiration during St.-Segment Elevation Myocardial Infarction

Registry-based clinical trial puts heart treatment to the test

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