Question: If you're a project lead at a sponsor company, how do you determine the difference between Governance and Oversight?
According to Wikipedia, the term Governance relates to "the processes of interaction and decision-making among the actors involved in a collective problem that lead to the creation, reinforcement, or reproduction of social norms and institutions. On the other hand, Oversight, as Merriam Webster defines it, is "the act of directing work that is done," or "a mistake made because forgets or fails to notice something."
When it comes to running a trial, the difference between governance and oversight can at times be unclear. The goal of oversight is for both sides to hold teams accountable on the day to day execution of the study. The sponsor, meanwhile, constantly looks for opportunities to improve performance levels of their vendor, while manages their team's overall performance. In instances where issues come up where the team as a whole can't resolve, the matter goes up to the governance group.
However, the goal of governance is to create a partnership where sponsors and CROs strive to share accountability in the programs they are involved in. Additionally, they should also share milestones and goals on a regular basis, ensuring there is a consistent process with each of your vendors.
For sponsors looking to develop an effective governance structure, here are five things to consider:
Tailor your Governance Strategy
If you're a sponsor, naturally, not all CROs are the same size, so it's imperative the sponsor tailors their governance strategy to that of the CRO's. What's more, ensure your strategy aligns with the company's corporate philosophy. Governance differs in that you won't be involved in the daily activities of your study. So if you're looking to take a more hands-on approach in your trial, sponsors should be aware of this when considering at the kind of reports they want to receive. Furthermore, be cognizant of the number of studies the CRO may be assigned to (would your study be their only focus, or are they involved in several trials?).
One Size does not fit all
For a phase 1 study, governance might require either a monthly or quarterly management call for all parties involved (the program lead and the CRO contact) to touch base. When it comes to multiple studies and larger studies, governance committees should look to do study performance reviews and carry out metric assessments. They should also look at resource allocation on a routine basis, either biannually, quarterly or monthly through conference calls (or face to face, should opportunities arise).
Make your governance strategy is fit for purpose. Sponsors should understand the CRO's governance process and align it with their own. Understand the CRO's philosophy and be able to articulate your own. Agree and document a Governance Charter which will in essence establish your working relationship. The charter is crucial as it enables you to empower your team. In the charter, be sure to include:
- Relationship Definition;
- Clinical Study team R&R;
- Governance Committee - Decide its composition, establish guiding principles, agree upon a schedule of meetings (how frequently will you meet, etc.); Operations/Quality Management;
- Escalation Process;
- Review Process/Frequency*
*Source - Sameena Sharif
Recognise the Challenges and Pitfalls
Sponsors should always be aware of the common challenges and pitfalls that can often derail a clinical trial. Missed timelines, quality issues, cost increases - these some of the issues that can give a project lead many a headache. Therefore, the sponsor and CRO must have the foresight to address these common issues pre-emptively. Establish timelines early and create a risk log that plans for mitigation when generating your timeline. Additionally, when deliverables are not met, the study team must be transparent about any failures, but they should also be empowered to resolve them. Lastly, the governance team should put in place monthly executive reports that address key deliverables and KPI's.
It is the sponsor's responsibility to define expectations early with their CRO (strive for alignment). Focus on enabling trust, emphasising the importance of open communication and transparency. As touched upon previously, empower your CRO and study team to be proactive (focus on the quality, not just timelines). Evaluate whether you can set up a shared risk model. Although this is not very common - with sponsors reticent to place it in the contract - it does encourage rewards for when teams achieve milestones or beat timelines. This is key in developing your governance strategy. By establishing trust you can build a strategic partnership with your preferred provider.
Sameena Sharif, Astex Pharmaceuticals - Implementing effective governance models instead of "oversight" strategies to ensure a successful partnership for both sponsor and vendor (Presentation)