Compliance assessment avoids harsh criminal penalties.(R&D)

WASHINGTON -- Staying out of trouble with FDA in clinical research requires sponsors to undergo a careful R&D compliance assessment. Areas that should be closely scrutinized include leadership and accountability, training, policies, communication and reporting, monitoring and auditing, performance and disciplinary standards and process for follow-up/remediation.

Cephalon compliance officer Elizabeth Jobes and Nikki Reeves, Partner, King & Spalding LLP, spoke at the Nov. 7-9 forum sponsored by PharmaCongress.

First, they noted, determine what areas to review. What are the areas of greatest risk? Take a look at the amount of activity, including payments to HCPs, consultants and investigators. Also worthy of scrutiny are the consequences of non-compliance, likelihood of discovery and the relationship to other risks.

Also, consider the ability to assess against objective standards, the speakers added, and the areas where remediation is most likely to take hold.

Next, determine what to assess, such as, activities, controls and recognizable limits.

Documents should be reviewed in the risk assessment: compliance documents, clinical trial agreements, consultant agreements and grant/funding requests.

Then, said Reeves, interviews must be conducted. Personnel to talk to include legal, finance, clinical research operations ("they really know how things work," said Reeves), medical affairs, scientific communications and marketing (Phase IV).

Other documents that should be reviewed include organizational charts and SOPs. The latter include investigator selection, financial disclosure procedure, terminating a clinical investigator as a corrective action, and concept approval processes for investigatorsponsored studies.

Other documents to review are:

* Chart of active clinical trial sites;

* Template agreement for clinical services;

* Sample master clinical trial agreements;

* Chart of investigator-initiated trials; and

* Financial information. Employees to interview include:

* Executive VP of medical and regulatory operations;

* Senior VP of clinical research;

* Clinical research associates;

* Medical science liaisons;

* Senior director of medical science liaisons;

* VP/Director of scientific communication/medical affairs; and

* Senior director of medical affairs.

If sponsors are not careful in conducting such assessments, Reeves warned, ugly enforcement actions can result.

She pointed out the InterMune case, settled in 2006. The product involved was Actimmune, which was approved for the treatment of chronic granulomatous disease.

The alleged misconduct related to research involved the firm's ASAP [Actimmune Safe and Appropriate Use Program] Registry to collection information about patients.

"The stated purpose [of the program] was to make information available to doctors and InterMune for research/analysis and support publications."

In reality, the program was run by InterMune sales and marketing staff. "Sales representatives received incentives for each patient enrolled in the registry," said Jobes.

There were numerous GCP issues with the registry raised by a third party administrator, including the representatives' involvement with the registry.

A qui tam lawsuit was filed in the case by a former sales representative who "claimed she was fired for refusing to promote Actimmune for unapproved uses."

Fines levied in the case totaled $36.9 million.

By Joseph Pickett Managing Editor

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