Brian Neman, MHA
The coronavirus pandemic has altered virtually every aspect of life. Pharmaceutical research, specifically clinical trials, are no exception. To slow the virus’ spread, the Centers for Disease Control and Prevention has recommended social distancing—essentially, avoiding close contact with others. Yet clinical trials typically require patients to make frequent visits to hospital settings, where a number of sick individuals may be present, increasing their risk of infection.
What effects will COVID-19 have on clinical trials? Will it cause patients to stop showing up for collection? Are there ways we can continue to keep trials moving forward, rather than risking potential deviations, jeopardizing data integrity and data quality, and most of all avoiding risking adverse events for the patients?
Participant recruitment has always been a key challenge in clinical trials. Over 50 percent of studies and trials fail to meet their enrollment deadlines, and over 40 percent of test subjects drop out mid-way through the trial. These hurdles existed before. COVID-19 is complicating things further.
But researchers needn’t stall their clinical trials until the pandemic subsides. Those whose trials require non-invasive patient samples have an option: in-home specimen collection, which involves acquiring samples from patients within the comfort of their own homes, removing concerns about them traveling to, and remaining in, a hospital setting.
It’s important for researchers to continue conducting clinical trials, even amid global crises such as this one. Otherwise, patients will miss their visits, which can cause deviations from the protocol that can compromise the integrity of the data and quality of the results. Missing visits—which often include procedures to monitor patient safety—can also increase the risk of adverse events.
It is too early to know all the ramifications that COVID-19 will have on the pharmaceutical industry. Telemedicine and home visits used to be viewed as risky, but now pharmaceutical and biotechnology companies are looking at telemedicine and home visits as a risk mitigation strategy. As a biopharma community, we need to look for ways not to delay research and clinical trials but continue to make strides for treatments and cures. Home visits are an alternative to keep studies and trials moving forward.
In-home specimen collection allows researchers to avoid delays and keep collecting data that can be crucial to not only the study results, but also patient health. This way, they can move forward with their studies and or clinical trials, despite the far-reaching effects of the current pandemic.