The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based global nonprofit collaborative, is distributing a simple online tool for collection and analysis of real-world data (RWD) on predisposing conditions, treatment strategies, outcomes, and side effects experienced by COVID-19 patients.
The survey tool, designed by Veracuity LLC, expands data collection from providers and hospitals in near-real time to enhance understanding of the COVID-19 pandemic, including risk-factor identification, triage, treatment management, and outcome predictors, to gain insight into the safety and efficacy of traditional, experimental, and off-label therapies.
The authors of the survey tool are Veronika Valdova, DVM, Jonathan Fishbein, MD, and Sreeram Penna, MBBS, MRCS, of Veracuity LLC, a Pennsylvania-based biopharmaceutical safety informatics and analytics firm.
“There’s a lot of information out there about COVID,” notes Fishbein. Unfortunately, “a lot of it is filtered and not incredibly accurate. In an ongoing crisis scenario [like this] it’s hard to conduct clinical trials.”
Project advocates hope the data collected can begin to fill in some of the information gaps, says Dr. Mary Tobin, chief strategy officer with ACRES. She’s been a primary liaison with Fishbein and his Veracuity colleagues regarding the RWD tool. “The data can help us know what to focus on, for example, in terms of what underlying conditions” make it harder for the body to combat the virus, she says.
Already validated by a focus group of physicians actively caring for COVID-19 patients, the survey can be completed quickly by healthcare professionals, as it requires minimal text entry and features well-established rating scales that are routinely used in clinical practice.
The survey tool captures RWD to generate evidence to address the most pressing knowledge gaps relating to the treatment of patients affected by COVID-19, such as:
- The impact of the time lag between the onset of symptoms, the time of testing, hospitalization, and the ultimate outcome
- The sensitivity of testing
- Treatment outcomes
- Risk factors for contracting COVID-19 and dying
Fully compliant with the Health Insurance Portability and Accountability Act, the survey does not capture identifiable patient level data.
The survey tool is posted on ACRES’ website here.
Edited by Michael Causey