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Jill Wechsler is ACT's Washington Editor
Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.
The importance of ensuring that all parties involved in a clinical trial understand and adhere to all relevant rules and regulations governing biomedical research has become a critical challenge for sponsors and their contractors. Even when a biopharma company engages a CRO to fully manage and monitor all sites in a clinical research program, the sponsor remains accountable for any violations of good clinical practices (GCPs), human subject protections, safety reporting requirements, protection of patient privacy and other laws. Increased focus on adherence to anti-bribery and anti-corruption laws makes these issues particularly important for clinical research conducted in foreign countries. And corporate integrity agreements (CIAs) negotiated by companies with the U.S. Department of Justice (DoJ) and other enforcement agencies increasingly include provisions to ensure GCP adherence.
As compliance issues move to the fore in the clinical research community, sponsors are paying more attention to the resources and capabilities of CROs when negotiating research contracts and agreements, reported experts at the CBI Pharmaceutical Compliance Congress April 26. Key considerations in evaluating CROs, said Elena Adolphus, executive director of compliance for global R&D compliance & audit at Amgen, are the firm’s compliance infrastructure, training programs, capacity for remediation, familiarity with local regulations and requirements in foreign countries, and ability to ensure compliance controls at their subcontractors. To meet such needs, CROs are building internal anti-bribery/anti-corruption (ABAC) compliance capabilities, explained Dennis Barnes, vice president and chief compliance officer at Parexel International. Fifteen years ago, Barnes noted, CROs had little awareness of compliance risks and the need to train professionals to address global control issues. Now biopharma companies are requiring CROs to have fully capable compliance functions, and the costs and responsibilities of carrying out such responsibilities have become an important item in contractual agreements. CROs can take cues for establishing compliance operations from guidance issued by the Securities and Exchange Commission that outlines the components and operations of “effective” compliance programs. Key components include written policies and procedures, effective employee training and education, internal monitoring and auditing, disciplinary guidelines for enforcing standards, and the ability to take prompt corrective action when offenses are detected. To ensure effective collaboration on these issues, sponsors are looking for CROs to have a full compliance infrastructure and to demonstrate familiarity with regulations and requirements in regions where the research will be performed, Adolphus added. Contracts are being drawn to spell out expectations and accountabilities of all parties, including reporting pathways for non-compliance, the sponsor’s right to investigate and audit the CRO, and compliance contacts on both sides. Barnes advised that all expectations, processes and compliance/legal functions should be discussed in detail and spelled out in the contract. The sponsor should make its compliance expectations very clear, and CROs should identify their resource needs and costs associated with client requirements.