January 19, 2019
This is need of an hour. Third eye is always useful while working in the regulated environment.
“Quality needs to be built into every step of the clinical trials process”, insists a leading US Food and Drug Administration (FDA) official.
While working in Pharmaceutical industry, our department often felt the need to outsource GCP audits either due to resource constraints or because of specialized skills. We were always looking out for an agency who is dedicated into this space rather than outsourcing it to a CRO who offer QA along with other services. With large CROs, there were occasionally conflict of interest issues. It was seen that most of the CROs were uncomfortable to be audited by a competitor CRO.
Furthermore, every CRO and Pharma company has a QA unit but to do a reality check of their own systems and procedures, they need to be evaluated by some external auditor who could give them an holistic view of how they can do better.
Quality assurance for clinical studies the world over is a critical function. It takes on a greater level of criticality when such studies are conducted in a distant country.
To ensure consistent quality in clinical trials, it is mandatory to make the quality assurance team an integral part of the whole process, from design to submission of reports.
As per recent report, The US Food and Drug Administration has been criticized for reviewing only a fraction of foreign drug trials, despite an increase in the number of pharmaceutical companies moving drug testing overseas. Findings show 80% of marketing applications contain foreign trial data and FDA inspected clinical investigators at less than 1% of foreign sites and only 1.2% of clinical trial sites for applications approved in FY 2008. The agency inspected 1.9% of domestic clinical trial sites and 0.7% of foreign clinical trial sites.
Indian Scenario
As per the recent published news, Indian regulatory officers will carry out random on-the-spot inspections on clinical trial sites to check deviations from July 2010. Random on-the-spot inspections on clinical trial sites to ensure their compliance with the current Good Clinical Practice (GCP) norms is among a series of new reforms to have an extensive regulatory system for clinical trials the regulatory agency is planning to bring in the next eighteen months, according to Drug Controller General of India (DCGI). Regulatory inspectors will visit trial sites with updated checklist in random to verify the compliance of standard practice norms from July.
Also, The Drug Controller General of India (DCGI) brought out a notification to this effect informing the applicants to register the clinical trial in ICMR Clinical Trial Registry before initiating the trial process.
Registration of clinical research organizations which conduct human studies on drugs, cosmetics and medical devices would also be made mandatory in India.
With these new developments, it is therefore mandatory to keep a tight control on the quality brick by brick for all the key stakeholders. Thus, external agencies are helpful to doing this for sponsors due to several compelling reasons. Independent audit of a clinical trial can bring a fresh perspective and new insights into the study.
An external auditor can be more effective than an in house QA in identifying lacunae and calling for any needed changes.
Below are some of the important reasons why external auditors should be chosen for conducting audits·
Overall the benefits are:
