Over the past several months, hundreds of clinical trials examining treatments for COVID-19 have been initiated throughout the world, but thousands of other trials testing new medications for heart disease, cancer and other conditions have slowed. In some cases, they’ve completely halted. Due to the pandemic, researchers couldn’t safely bring patients to health care facilities for study visits, laboratory studies or other procedures. And in many hard-hit areas, health care systems were overwhelmed, patients were difficult to contact and physicians could only focus their attention on the immediate threat of COVID-19.
While finding scientifically-sound treatments for COVID-19 remains critical, particularly as cases are increasing in much of the country, we must recognize that other conditions, such as heart disease and cancer, have not gone away. In fact, we may be dealing with a secondary health crisis because many patients have avoided seeking timely care at hospitals during the pandemic, spurred by fear of contracting the novel coronavirus. This is leading to patients missing screening procedures and presenting later in the course of serious conditions such as heart attack or stroke, and with much worse outcomes.
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Now, as businesses, restaurants and health care facilities cautiously reopen, so too do clinical trials. As with other sectors, research won’t be the same, and we enter a “new normal” for the patient visits and study procedures needed to restart clinical trials.
Even prior to COVID-19, patient safety has always been a key focus of research studies. And now, in the midst of a global pandemic, we must further prioritize reducing the spreads of infection. Each research project is nuanced and comes with its own unique challenges, so researchers must work diligently to maintain the scientific integrity of the trials while keeping patients safe. The inability to see patients face-to-face during the height of the pandemic has created enormous challenges for the conduct of clinical trials, which has required major adaptation to how these studies are managed.
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Study leaders are carefully examining protocols and making adjustments to ensure the safety of participants. These modifications include measures like virtual or telephone study visits, electronic data monitoring and data capture, home visits by study nurses and use of local laboratories for blood work. In some cases, providing drugs to patients has shifted to use of delivery services. Study leaders must be nimble and prepare for the possibility of additional interruptions or alterations in the trial, should new outbreaks of COVID-19 occur near study sites. Such adaptations are likely since many trials have thousands of patients spread across multiple countries.
Clinical trials are critical to advancing medicine, bringing new therapies to patients, ultimately improving outcomes and saving lives. In recent years, cardiovascular clinical trials have led to huge advances, including better treatments for heart attacks, less invasive replacement of heart valves and improvements in cholesterol management and blood pressure control.
Safety is a commitment researchers take extremely seriously, because we rely on the altruistic participation of patients in research to contribute to future scientific breakthroughs and improve the lives of others with their conditions. For some patients, especially for those with rare or late-stage conditions, clinical trials offer an opportunity to access the latest therapies, which can take years to be available on the market. Every medication accessible to patients today is available thanks to a clinical trial. In 2019, the Center for Drug Evaluation and Research, a division of the Food and Drug Administration, approved 48 new drugs — medications that became available thanks to the nearly 46,000 patients who participated in clinical trials of these drugs.
[READ: Using Telemedicine — and Teletherapy — With COVID-19 Circulating.]
According to clinicaltrials.gov, which tracks trials and results, there are nearly 52,000 trials recruiting patients. To keep pushing medicine forward, we need the study participants to feel comfortable coming back to research — science, society and future patients are depending on it.
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