|
When Your Vendor Screws Up: Pfizer and Care Access for Lyme Trial
(Thursday, March 2, 2023) A couple of weeks back Pfizer announced that it is dropping about 3500 patients recruited to its Phase 3 clinical trial for a vaccine for Lyme disease due to GCP compliance issues related to its “clinical trial site operator”, Care Access. This is not normal; rather this is likely the only incidence of its kind ever reported publicly. And it raises some very important questions about the sponsor’s role in managing its vendors. Neither Pfizer nor Care Access have publicly disclosed the specific violations of the Good Clinical Practices (GCP) that could only be resolved by discontinuing more than 3500 of the 7000 patients recruited to an 18000-patient study being conducted at 79 sites across the US and several European countries, on track to be completed in about a year. Site management organizations are critical for finding and recruiting large number of eligible patients needed for Phase 3 clinical trials. Care Access is a “decentralized site operator”, that uses mobile clinics and remote staff to increase access to clinical trials for patients located at remote locations. Lyme Disease is prevalent in remote and relatively inaccessible communities where conventional sites are not feasible. With its “Sites on Demand” service, Care Access was able to recruit patients at such locations, apparently too well since it recruited more than half of all patients recruited to the trial worldwide. Without knowing all the facts of the matter, one can only speculate what could have gone wrong to result in this rare and drastic action, and who to blame. Clinical trials are team projects where the sponsor and vendors work collaboratively. It is the sponsor’s responsibility to select and supervise vendors diligently. The role of site management organizations, like Care Access, is to conduct IRB-approved recruitment campaigns, do informed consents of participants, conduct study-required operations, generate source document and fill case report forms, and responding to queries. The sponsor is responsible for monitoring of the trial conduct, audit of the vendors, payments, and informing the regulators – IRBs and FDA. For decentralized trials, the data is mostly uploaded to online data warehouses and monitored remotely. And since data is monitoring remotely, the monitoring of the data can be conducted in real-time, meaning any errors or issues are identified within days of the site posting any given data, allowing quality issues to be detected earlier and addressed before they become disasters. The more critical the vendor, the more work for the Sponsor to monitor for quality operations. It seems the quality systems at the sponsor did not perform as expected. It would have likely taken several months, maybe even longer than a year, for Care Access to recruit 3500 patients to this trial. It is very hard to envision how the sponsor missed or overlooked egregious GCP violations during that time. Pfizer insisted that there were no safety issues with the patients dropped from the trial but if there were major GCP violations, how can that be true? One can speculate that Pfizer’s investigation found that patients were non-compliant, and Care Access facilitated the patients’ non-compliance, hence the patients were punished by being dropped from the trial. But the sheer number of patients impacted raises doubts about that as well. The participants apparently had no fore-warning of the discontinuation and are unhappy with the sponsor. Care Access announced that it will present the “facts” to the IRBs and FDA to clear itself. It needs to. According to its website, Care Access has been involved in hundreds of sites involving thousands of participants. If gross GCP violations are confirmed at the Pfizer trial, it would inevitably flag all the other trials run by Care Access. There is obviously a lot of clarity needed from Pfizer, the sponsor, about the specific violations as the vendor is legally bound to not discuss the facts of the matter publicly. Till we know more, we must assume that the Sponsor was equally responsible, if not more than the vendor, for the major GCP non-compliance on its trial. This raises questions about all the other sites and trials managed by the Sponsor as well. The case is far from closed. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
