Globalization of drug research has increased the likelihood of bribery according to new analysis, which suggests the risk is greatest for international, multi-center trials.
Running clinical trials is an increasing international affair. Drug companies seeking to reduce costs often choose to study candidate medicines in regions where access to healthcare is otherwise limited to accelerate recruitment.
In addition, a growing number of pharmaceutical markets around the world require that products are tested locally. As a result, the number of multi-center, multi country trials has increased markedly in recent years.
And globalization has been a boon for CROs as drug developers have come to rely on contractors with local knowledge to run such studies.
But there are also new challenges – notably the increase risk of bribery according to analysis by Anglo-US law firm Hogan and Lovells.
“Conducting international clinical trials poses various bribery compliance risks because of complex regulatory environment, including extensive oversight by local government regulatory agencies and review boards that are charged with the responsibility for ensuring that the trial is conducted in accordance with applicable regulatory requirements, global industry standards and good clinical practices."
The authors add that, “The need to obtain regulatory approvals in connection with clinical trial activity creates bribery compliance risks given the substantial financial incentives that exist for expediting the regulatory approval process, and these risks can be heightened when sponsors work with CROs that are outside of their direction and control.”
The also pointed out that CROs are usually instructed to coordinate large parts of the trial they may also be interacting with officials and authorized to pay regulatory fees, thereby increasing the overall bribery risk profile associated with their activity on behalf of the sponsor.
Oversight
To address the bribery risk, the Hogan and Lovells analysts urge trial sponsors to use a check list to ensure they engage with trustworthy CROs.
Potential red flags include when a CRO claims it has “good relations” with health care professionals (HCPs) and or public officials/government agencies in the relevant jurisdiction.
Sponsors should also be wary of contractors that offer guarantees of expedited regulatory submissions as well as those that meet or exceed patient recruitment milestones in a timely manner without disclosing how.
The lawyers also advise drug firms to avoid CROs that are wholly or partly owned by public officials in the relevant jurisdiction or their family members.
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