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Clinical trials have been a crucial part of medical research for decades. They are the centerpiece of evidence generation used by researchers, regulatory authorities, doctors, and patients to determine which treatments are effective across nearly all areas of medicine.
Since the 1950s, the fundamental design of clinical trials had largely remained the same. In the digital age, however, that changed. Patient care is now increasingly captured in electronic health records, and researchers are developing new and more advanced analytical tools. As a result, new kinds of clinical trials are possible.
One recent innovation is the Randomized, Embedded, Multifactorial, Adaptive Platform (REMAP) trial. UPMC is leading a global REMAP trial site to test treatment therapies for COVID-19.
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What Is a Clinical Trial?
In a traditional clinical trial, a random group of participants receives one potential treatment from a small list of options. Other participants in the same trial receive a different treatment from that list.
For example, in a clinical trial of an antiviral drug, some participants may receive one of the drugs being tested, while others receive a placebo (a so-called “sugar pill” that resembles the actual drug but has no treatment benefit).
Comparing the outcomes from patients who take the actual drugs with those who take the placebos allows researchers to determine whether the actual drugs are effective.
But these types of trials also have limitations:
- They usually only test one narrow question — whether one treatment is superior to another on average. They don’t consider that there are often multiple treatment options available, that many options can be given in combination, or that effects may vary across different types of patients.
- They typically assign half of all patients to either the “placebo” or the control group, and do so for the entire period of the trial. This means there is little or no ability to learn or adapt during the trial from either the information discovered in the trial or from any other evidence that emerges.
- With only a 50/50 chance of receiving the active drug, patients may feel there is little value in participating in a clinical trial other than as an altruistic act to help others.
What Is a REMAP Trial?
A REMAP trial attempts to work beyond the limitations of a traditional clinical trial. In a REMAP trial, participants can receive multiple treatments in combination with each other.
“When you’re testing several things simultaneously, the total number of combinations gets huge rapidly,” says Derek Angus, MD, MPH, chief health care innovation officer at UPMC, and professor and chair, Department of Critical Care Medicine at the University of Pittsburgh and UPMC.
The REMAP design allows for an evaluation of all these combinations simultaneously and in a manner where the vast majority of patients receive at least one form of active therapy. Few patients are in the “placebo” or control-only part of the trial.
REMAP trials also are adaptive. As the study continues, if a treatment combination appears to be more effective, more participants receive that combination in the future. If a treatment combination isn’t showing results, its use can be reduced or eliminated.
How Is the REMAP Trial Being Adapted for COVID-19?
The REMAP approach was originally developed in 2016. Called REMAP-Community Acquired Pneumonia (REMAP-CAP), it was designed to find the best treatments for severe pneumonia in both nonpandemic and pandemic settings.
As COVID-19 spread worldwide in early 2020 and became a global pandemic, REMAP-CAP was adapted to study treatments for COVID-19.
“We wanted a design that did not make clinicians or patients feel uncomfortable about participating,” says Dr. Angus, part of the international team that developed REMAP-CAP. “This is especially important for something like COVID-19. In a pandemic, medical practitioners feel it is imperative to try to do the best thing for the patient.”
The UPMC REMAP-COVID-19 project has been testing different combinations of treatments including:
- Antiviral agents.
- Targeted immune-modulating agents.
- Alternative anticoagulation strategies.
- Supportive care interventions (e.g., vitamin C).
The corticosteroid portion of the study, which already concluded, found that hydrocortisone was highly effective. As more treatment combinations become available, more will be added to the study. Across the entire UPMC system, more than 200 patients have been enrolled in the REMAP-COVID-19 trial.
“We could not have achieved what we have without the dedication and efforts of the whole system,” says Dr. Angus.
Because of international participation in the study, treatment options are being tested across the globe. All told, thousands of different treatment combinations are being tested.
How Can REMAP Help in the Fight Against COVID-19?
As the UPMC REMAP-COVID-19 trial tests different “recipes” of treatments, results are fed into computer software. Each different recipe and each different individual drug is tested statistically. The software can help determine if a particular drug or particular recipe is effective against COVID-19.
International participation is essential, says Dr. Angus. It allows for more participants and more potential treatments.
Ideally, the project should include “a spider web of sites across the globe that are ready to enroll any patient who is eligible so that you can learn from as many patients as possible,” says Dr. Angus.
The goal is to find the best treatments for COVID-19 — a disease responsible for tens of millions of infections and more than a million deaths worldwide — in the shortest amount of time.
“We want to get rid of this disease,” says Dr. Angus.
For more information on the REMAP-COVID-19 project, go to UPMC.com.
Derek Angus, MD, et al, Annals of the American Thoracic Society, The Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia (REMAP-CAP) Study: Rationale and Design. Link
National Institutes of Health, NIH Clinical Research Trials and You, The Basics. Link
REMAP-CAP, What Is an Adaptive Clinical Trial? Link
U.S. National Libraries of Medicine, Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP). Link
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