Applied Clinical Trials
The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based global non-profit collaborative, is distributing an online tool for collection and analysis of real world data on predisposing conditions, treatment strategies, outcomes and side effects experienced by COVID-19 patients. This 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. According to Dr Valdova, “Our survey tool was designed with the care providers in mind, to make it as easy as possible to capture the value of their front-line experience to better inform our efforts to confront this viral pandemic.”
ACRES, which uses systems approaches to improve health science and medicines development, has implemented the tool, publishing the link to it on its website. Dr. Greg Koski, President and CEO of ACRES said, “In a time of crisis like this, the information that can be gleaned from real world experience can help us find our way, to ask the right questions, and learn from experience-not to replace science, but to better inform its pursuit.”
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 uses well-established rating scales that are routinely used in clinical practice.
The survey tool captures real-world data to generate evidence to address the most pressing knowledge gaps relating to the treatment of patients affected by COVID-19, such as:
Fully HIPAA compliant, the survey does not capture identifiable patient level data.
Data will be securely processed and stored by Veracuity LLC, utilizing the eVERATM, platform and the results shared gratis with the medical and scientific community. Interactive visuals based on collected data, as designed and developed by the Veracuity team, will be displayed on the ACRES website.
Currently, there are no medications approved for the causal treatment of COVID-19. Hospital interventions consist of supportive care and off-label administration of medicines approved for different conditions and experimental products. Additionally, the precise mechanism of action of many therapeutic options (e.g. hydroxychloroquine, ivermectin or azathioprine) against SARS-CoV-2 is often unclear.
As a result, all COVID-19 patients are, in fact, subject to innovative and sometimes unproven therapeutic approaches. In the absence of evidence from randomized controlled trials, it is imperative to gain insight into treatment effectiveness from real-world experience to enable rapid adjustment of clinical protocols as more data becomes available. At the same time, for the sake of patient safety, it is essential to improve clinical care and to understand the harmful effects of drugs in specific clinical scenarios as early as possible to avoid potential harm: Primum non nocere (first, do no harm).
The web-based tool is available through ACRES global network. The target audience for the survey are teams caring for COVID-19 patients. Caregivers are encouraged to complete the survey on their patients with COVID-19 upon case closure, i.e. discharge from hospital or death.