Califf noted that the agreements around data that are being linked for RECOVERY in the UK were worked out over a weekend and the data are already flowing.Ĭaliff concluded with what he perceives as some of the most important steps to move evidence generation in the right direction, including evaluating what has worked and what hasn’t worked in the changes that have been made in response to the crisis. Being conducted by the University of Oxford, it involves data from more than 130 NHS hospitals across the country.
NIH COLLABORATORY GRAND ROUNDS TRIAL
Healthcare workers eligible for the HERO-HCQ trial will work at one of the 40 PCORnet sites participating in the trial.Īnother example he mentioned is the UK’s RECOVERY trial examining experimental drugs as potential treatments for Covid-19. “In the normal era of randomized trials, that would have been years in the planning.” This is the type of quickly organized project envisioned when PCORI invested in the PCORnet National Patient-Centered Clinical Research Network.
We went from talking about this to things happening at speeds that were previously unimaginable.” Califf said a great example is the PCORI-funded Healthcare Worker Exposure Response and Outcomes (HERO) registry research program to engage healthcare workers so researchers can understand their physical and emotional health status or gauge interest in addressing the COVID-19 pandemic or facilitate their enrollment into future studies. He noted that the project went from idea to roll-out in one month. “The NIH Collaboratory and PCORnet have made progress on these issues,” he said, “but not enough at this point.”īut when COVID came along, he added, many regulatory and data-sharing obstacles to gathering real-world evidence vanished because the need for answers is so great.
He said in some cases the expertise in doing clinical trials at our best health systems is less about designing trials to solve important questions and more about optimizing profitability. The current research paradigm is too slow, too expensive and not reliable and doesn’t answer questions that matter most to patients. “COVID has shined a spotlight on the disparities we have,” he said. He noted that learning from real-world patient experiences can support better informed healthcare decision-making by a range of stakeholders.Īmong the flaws Califf mentioned in our current healthcare system are that a high percentage of decisions are not supported by evidence and that healthcare disparities are getting worse. healthcare system to move more quickly to a system that was envisioned but has not yet been enacted in which evidence generation and clinical practice are more closely linked. “We can make changes to deal with the emergency, hoping we can revert back to the ‘good old days,’ or we can learn from the innovations in this time of crisis and implement changes in the system that are permanent.” He said that would allow the U.S. “My argument is the COVID pandemic gives us basic options to shape the evidence generation ecosystem in recovery,” he stressed. It is going to go on for a while,” Califf said. Speaking during a May 1 presentation to the NIH Collaboratory Grand Rounds, Califf highlighted some of the reasons why our current evidence generation ecosystem, including the capability to run pragmatic clinical trials, is falling short and he offered some potential avenues for change coming out of the response to COVID-19. But he adds that there may be opportunities in the midst of the COVID-19 tragedy to move the system to a better place. Of the 83 requests we fulfilled, 52 consultations guided further research, 17 led to follow up investigations and 10 directly informed patient care.This 3 minute animation summarizes the workflow of the service we offered during the study.Despite progress being made by groups like the NIH Collaboratory and PCORI, our nationwide national clinical research system remains well-intentioned but deeply flawed, says former FDA Commissioner Robert Califf, M.D., head of clinical policy and strategy for Verily Life Sciences and Google Health.
We responded to 100 consultation requests by 53 users from multiple specialties. Given a specific clinical question, we provided a report with a descriptive summary of similar patients in Stanford’s clinical data warehouse, treatment choices made, and observed outcomes. We used demographics, diagnoses, procedures, medications, laboratory values, clinical notes, mortality, and length of stay information for millions of patients to inform clinical care decisions by summarizing “what happened to patients like mine”. The Informatics Consultation service was an IRB approved project to study the use of routinely collected data on millions of individuals to provide on-demand evidence in those situations where good evidence is lacking.
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