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 the 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 a
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.
The Indian scenario
As
per a recent news item, 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 18 months, according to Drug Controller
General of India (DCGI). Regulatory inspectors will visit trial sites
with updated check-list 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.
Why selecting external auditors is a better choice?
Below are some of the important reasons why external auditors should be chosen for conducting audits
?
They are not associated with either the sponsor or the CRO or any
other interested party, independent audit agencies can offer unmatched
insight in the auditing process.
? A skilled and experienced
auditor is able to pick up a minor inconsistency, deduce possible
reasons, and then investigates, uncovering significant underlying
issues.
? An external auditor has handled various projects so has a
wide exposure and in depth understanding of how and when things can go
wrong.
? He/she could be an out of box thinker as he is not physically present, related to any one in the CRO/ Sponsor’s group.
?
These insights and findings can then be used to fix the gaps but also
those to create a robust system to avoid the costly mistakes in the
future.
Overall the benefits offered are:
? Getting the job done by skilled and experienced resources
? No conflict of interest.
? Cost saving as we have region based auditors who will audit the vendor/site/lab wherever it is.
? By outsourcing the auditing job, sponsor can enjoy better relationship with the CRO.
The author is Head & Lead Auditor, CRQA , New Delhi