Expert Interviews
How to Tackle Clinical Trial Challenges and Ensure Success
Cecile, with over 20 years of experience in clinical research within the pharmaceutical and medical device industries, is an expert in project management, site monitoring, and regulatory submissions. Her knowledge spans various therapeutic areas, such as cardiology, oncology, and neurology. In this interview, we will delve into her career and gain her perspective on best practices for overcoming challenges and optimizing processes in clinical trials.
ABRS: Can you walk us through your experience managing CRO activities in a Phase I vaccine study? What were some of the key challenges you faced, and how did you address them?
Cecile: A phase I vaccine study is never dull and comes with a lot of unforeseen challenges. Think about finding the right subjects, production and transport of the Investigational Product, many parties and vendors that need to be contracted and trained, dose escalation meetings, and thorough safety and data checks. I was involved in a first-in-human trial and a lot of things had to be done that hadn’t been done before. One of the most important tasks was to select the right CRO partner and establish a collaborative relationship. Together with the expertise of the CRO, we were able to complete the trial with good results and only a very small delay.
ABRS: How did you approach the selection process for CROs in your previous projects? What criteria did you prioritize when making your decision?
Cecile: CRO selection is an important process. Most of the time, the focus is mainly on costs. For the recent selection process of a CRO, an evaluation matrix that weighs several crucial factors was made.
The experience with similar compounds and therapeutic areas, technical expertise and the regulatory track record of the CROs were reviewed. But in the end the cultural fit and communication style made the difference. The dedicated team and proactive communication approach better suited our needs while running a trial in a setting where many things change rapidly.
ABRS: In your role, you were involved in bid defenses and contract management. Could you share an example where your negotiation skills were crucial in achieving a favorable outcome for the project?
Cecile: One situation involved a trial design where the initial CRO quotes exceeded our budget by 20%. Instead of seeking alternatives, the cost breakdown was thoroughly analyzed and areas were identified where we could optimize without compromising quality. During bid defense meetings, a milestone-based payment structure in combination with enrolment targets and quality metrics was proposed. This approach actually incentivized performance while reducing upfront costs. The negotiation resulted in a cost reduction and included performance bonuses that motivated the CRO to meet expectations.
ABRS: What strategies have you used to maintain effective sponsor oversight throughout the course of a clinical trial, especially during the early stages of a Phase I study?
Cecile: Early-phase studies require vigilant sponsor oversight. A strategy of continuous monitoring, clear communication, and corrective action planning was used. In the initial phase, weekly meetings were held with the team, phase I site and vendors on the progress and planning of the trial and in the maintenance phase regular data review meetings were done to examine safety signals in real-time. In addition, a co-monitoring protocol was set up and a risk-based monitoring strategy was used to identify risks in time. This approach is invaluable in a Phase I study to identify potential safety signals early, allowing a sponsor to modify the protocol if needed and continue the trial safely without delays.
ABRS: Managing budgets is a key aspect of project management. How do you ensure that budget negotiations align with the project scope and timelines while still meeting sponsor expectations?
Budget management in clinical trials requires both accuracy and flexibility. Usually we start by developing a detailed cost model that accounts for several potential scenarios and also includes contingencies, providing us with a realistic estimation of the expected costs. It’s also important to look at the relationship between budget and quality. Together with the CRO, we look to see where processes can be improved and where costs can be saved. In the end, good communication between the sponsor, vendors, and sites is most important so as not to be surprised by cost exceedances.
We would like to sincerely thank Cecile for sharing her valuable experience and insights during this interview. Her perspective on clinical trials and best practices for tackling challenges has been truly enlightening. We are confident that her contributions will be highly beneficial to everyone working in this exciting field.