Ensuring CRO Accountability in Clinical Research

I recently had the opportunity to interview Paula Arranz Gutiérrez, an experienced clinical research professional, and Head of Clinical Operations at FAES FARMA, to get her perspective on promoting CRO & vendor accountability in clinical trials.

Paula will be presenting at this year's COG Europe on 'How to Drive CRO Accountability'. Speaker referral code: COG-PA.

Read the full Interview below

David (PBC Group):

How do you ensure CRO accountability in clinical research projects?

Paula (FAES FARMA):

" CROs are critical partners for clinical research projects. They should not be considered merely as execution service providers. CROs should be involved from the very beginning of a project, providing knowledge and support based on their wide experience.

CROs and sponsors form one team with the same objective: the success of clinical research projects to obtain new treatments to help patients.

With this in mind, accountability is a very broad concept. While there is no one-size-fits-all solution, some basic approaches can reduce risk and ensure adequate CRO accountability:

• Agreements: Invest time in elaborating, discussing and reviewing the contracts.

• Communication: implement clear, direct, respectful, and transparent communication between Sponsor and CRO.

• Oversight: Supervise CRO activities in the specific project in a planned manner avoiding the micromanagement.

• Governance: Set up a framework for accurate, ethical, and compliant conduct of research activities to maximize the partnership and gain efficiencies from the Sponsor-CRO relationship. "

David:

How do you establish clear expectations and deliverables with CROs to promote accountability in clinical research?

Paula:

" Accountability is critical to ensure the accuracy, integrity, and validity of clinical research projects, protecting patients’ safety and rights.

There are different type of Sponsor-CRO involvement in clinical research projects but it is mandatory to have a clear and detailed scope of work in the agreement with as much detailed as necessary to ensure expectations from both sides, not only Sponsor’s, are clearly covered and described. As a result of the tasks outlined in the agreement the deliverables should be defined along with the agreed timelines.

Expectations may be discussed in a face-to-face meeting or by VC prior drafting the agreement to confirm the alignment between both parties. In this meeting several topics should be discussed: quality standards, reporting requirements, regulatory compliance, risk management, data management, personnel and expertise requirements, termination clause, audit and inspection readiness, confidentiality…

Investing time in stablishing a solid foundation of Sponsor-CRO relationship with clear expectations from both sides will contribute to have a smooth and effective collaboration, strengthen the responsiveness of the team when facing the potential issues that may arise. "

David:

Can you share an experience where you encountered challenges in holding a CRO accountable for their actions or deliverables?

Paula:

" Considering the CRO as your team and having in mind that “the hunt for the guilty” is not going to solve the issue, we should perform an analysis of why the Sponsor considers the CRO is not accountable for their actions.

Let me share some brief steps of how could we handle this situation:

1. Review the agreement: Identify the expectations considered as not met. Are the expectations clearly defined in the agreement? Further detailed may be necessary?. Is there any clause related to failure to meet obligations?

2. Document the issues

3. Clear, direct and open communication: escalate the issue to higher level management within the CRO and Sponsor, discuss root cause…

4. Create, agreed and execute an action plan: this plan may include issue identification, root cause analysis, CAPA, responsibilities and ownership, timeline, resource allocation, communication and reporting, training and skill enhancement, process and continuous improvement (lessons learned)…

Additional support may be found outside the Sponsor and CRO by contracting a third party/ expert mediation to help in the process.

If the accountability issues persist despite efforts to resolve them or the effectiveness of the action plan after implementation is not as agreed, the Sponsor should assess alternative CROs, assess the impact and implement the termination clause for the current CRO.

In any case, remember that handling these types of situations is not comfortable for any of the parties involved and we should focus on finding a solution maintaining a constructive and respectful attitude. "

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In summary, the importance of accountability, clear communication, and collaboration between sponsors and CROs is clear. Strategies like investing time in contracts, aligning expectations, monitoring activities, and following robust processes can lead to greater oversight and accountability. Focusing on constructive solutions, not blame, when addressing accountability issues will lead to a positive relationship between trial sponsor and vendor.

To learn more on this topic, Paula will be presenting at this year's COG Europe on 'How to Drive CRO Accountability'. Speaker referral code: COG-PA. Complimentary attendance is reserved for pharmaceutical, biotech, health and academic representatives.