Friday, March 15, 2013

Who's Looking Out for the Investigator Sites?

Almost universally, it is the sponsor or CRO that arranges and pays for independent audits of their investigator sites.  It’s no surprise, then, that these audits are designed primarily to benefit the sponsor or CRO, not the site.  As a clinical investigator, wouldn’t it be a comforting change of pace if the auditor assessing your facilities, reviewing your documents, and evaluating your quality systems were looking out for your interests – organizing audit results and tailoring recommendations to help your business?  Many types of organizations do routinely hire independent 3rd party consultants to be conduct audits of their own facilities, for their benefit.  Contract pharmaceutical manufacturers have been doing it for decades.  Might not clinical investigators benefit from the same practice?

How would Investigator Sites benefit from hiring their own Auditors?

Any GCP site auditor that a sponsor hires can assess the site’s compliance with regulations and with the protocol. Any instances of noncompliance that are encountered will be documented and the findings will be reported back to the sponsor.  Auditors you hire yourself are, by definition, on your side, and will do more than identify compliance problems; they will help you determine and implement the optimal solutions.  Unlike most site staff, professional auditors have seen how dozens, if not hundreds, of sites have remediated deficiencies similar to yours and have prevented them from reoccurring – or from occurring in the first place.  They can share best practices and recommend which ones would work best in your particular environment.  They can advise you against bad practices and prevent you from becoming the subject of cautionary tales they may have witnessed at other sites.  They can help you identify inefficiencies in site operations and optimize resources and procedures.

It’s not unusual for an investigator site to hire a consultant when a sponsor threatens to drop them from a study, but periodic 3rd party audits could avoid that crisis altogether.  A proactive auditing program would also prepare an investigator site for sponsor site evaluation visits, even those that occur on short notice.  Favorable audit results demonstrate regulatory compliance and overall study fitness to prospective sponsors, giving the study site a competitive edge over others.  Some sites derive a substantial part of their revenue from conducting clinical research; the impressions they create and the reputation they have in the industry are particularly important to their businesses.  The very existence of an audit program would demonstrate a site’s willingness to invest both time and money in ensuring the quality, safety, and integrity of the research they conduct.

Why relying on Monitoring may not be sufficient

Of course, part of the study monitor’s job is to look for areas of noncompliance, so why couldn’t a site simply rely on that?  As a matter of fact, most investigator sites do, but there are several advantages to retaining a 3rd party auditor.  A study monitor who finds a compliance issue may recommend a set of corrective and preventive actions for the site to take.  Are these remedies the only ones that could be pursued by the site, or are they the ones that this sponsor is most familiar with?  Would other remediation actions correct the deficiency equally well, and fit more seamlessly into the site’s operations?  That’s not really the sponsor or CRO’s primary concern.

Many sites conduct research for more than one sponsor or CRO.  The manner in which each sponsor or CRO plans to meet regulations may differ; the philosophies they follow may not entirely align, and the guidance they offer the site may conflict.  An independent auditor who has worked with numerous sites, sponsors, and CROs, and on a variety of studies, can help the site staff to reconcile any disparate input it receives.

It can be difficult for a site to determine whether it is receiving an appropriate level of monitoring, especially with the introduction of risk-based techniques.  How much source data is being verified?  Are monitoring visits frequent enough?  Are the remote monitoring techniques being used effective?  These are concerns with which sponsors themselves wrestle.  DIA offers a training course entitled, “Who’s Monitoring the Monitor?”  A key learning objective of the course, “identify common errors and warning signs of problems in site monitoring,” suggests that this very human activity is far from flawless.  Not all monitoring plans are adequate, not all monitors are effective.  An investigator site that relies too heavily on its sponsor or CRO for compliance assurance could be putting itself at risk come regulatory inspection time.  An independent pre-inspection auditor would identify violations before an FDA inspector could encounter them, and prepare site staff for the types of questions and documentation requests the inspector is likely to have.

A clinical investigator site who recently hired us to perform a pre-inspection audit was the inspiration for this blog post.  Site audit requests from sponsors and CROs are quite common; requests from the sites themselves are far less typical.  Curious, I asked one of our senior auditors, a DIA instructor herself, if this might be a new trend in the industry.  “Not in my experience,” she replied, “but it should be.”

If you are one of the small number of investigator sites that hire your own auditors, we’d love to hear how that’s working out.  If you’re not, it might be something to consider.

by Laurie Meehan