By Kunal Sampat, Senior Manager, Clinical Research, Abbott Vascular
You just wrapped up a productive meeting with the FDA. The FDA reviewer has agreed to your clinical strategy. Your leadership team is excited and cannot wait to launch the clinical trial.
Everyone is dreaming about the millions of dollars in revenue the drug or device is going to contribute toward the company’s bottom line. All you need to do is complete the clinical trial and prove the medical product’s safety and effectiveness. The pressure is on.
The next step is forming a team to assemble a clinical team to execute your clinical strategy. Where do you start? You have no internal resources to conduct the study, so you start researching clinical research organizations (CROs). After completing a few rounds of bid defense meetings, you finalize on a CRO to conduct your study. You are confident that the CRO you chose has the capabilities and core competencies needed to conduct the study from start to finish, and you are excited about your partnership with the CRO.
In this post, I’ll share with you four foundational strategies to ensure you stay excited about working with your CRO partner long after the bid defense meetings. By applying these strategies, you and your CRO partner will experience a healthy professional relationship. Our ultimate goal is to ensure productive outcomes for you and your CRO. Let’s learn how we can achieve this goal.
1. Know what you want from the CRO.
Let’s assume you are an investor. Can you guess what an investor wants from his or her investment? Big returns. The investor doesn’t want to experience loss. The same holds true for a sponsor that hires a CRO to run a clinical study. The sponsor wants the trial to start and finish as quickly as possible, spend the right amount of money, and collect just the right amount of clinical data in the most compliant manner. Of course, the overall goal is to meet your primary endpoint and get the medical product on the market.
In theory, this makes perfect sense. But I would challenge you and your team to go deeper. What is most important to you? Is it a short timeline, data quality, or staying on budget? It cannot be all three, because you’re going to make sacrifices to accomplish one goal versus another.
Another trick to knowing what you want from the CRO is to form a cross-functional team and get everyone to share their “wants” from this clinical study. Be very specific. In fact, it would be better if members of the cross-functional team took 30 minutes to think and write down exactly what they expect from the CRO. The more diverse the sponsor team, the better outcomes you’ll have.
Most CRO-sponsor relationships turn sour because expectations are not aligned. The best way to align expectations is to first know what you want and then meet with the CRO to discuss your business needs.
2. Be open to CRO failures.
By definition, a CRO is composed of a group of clinical research professionals who exist to help lead and manage a clinical study. You cannot ignore the fact that these professionals are also human beings and will make mistakes.
As a sponsor, your goal is to create an environment where CRO personnel are allowed to make non-fatal mistakes. For example, if a CRA has to reschedule a site initiation visit (SIV) at the last minute, try not to get upset with the CRO. Instead, take this opportunity to find ways to ensure this does not happen again. It may be possible for the CRO to assign a backup CRA every time an SIV is scheduled. Alternatively, you and the CRO can agree to waive certain charges if the SIV is canceled with less than three days’ notice. These are just examples; you can get creative about what works for you and the CRO.
When working with a CRO, do your best to create a safe environment for the CRO staff to thrive in. If CRO personnel feel threatened, they will be less likely to stay committed to the success of your clinical study.
3. Review and adjust budget assumptions.
When working with a CRO, it would serve you well to take the time to carefully review the proposed contract. As a sponsor, your job is to do the due diligence on the budget proposal. You must review the budget assumptions, ask questions, and have an open discussion about the value you expect to receive from the CRO. The goal is to ensure you are paying the CRO at fair market value and are only paying for CRO services you need.
For example, a CRO may have a fixed monthly project management fee. Ask the CRO about the assumptions behind the fixed monthly fee if it appears unreasonable to you. The CRO may have assumed four team meetings a month during the life of the trial. However, you may only need two meetings a month during the recruitment phase and one meeting a month during the follow-up phase. A minor adjustment in assumptions can save you thousands of dollars.
I also encourage you to have a small bucket of money in your CRO contract for unexpected scope changes.
4. Practice effective communication.
Communicating frequently with the CRO, especially during the early part of your clinical trial and relationship will go a long way in establishing trust and confidence. One of the best ways to communicate frequently is to schedule weekly one-on-one meetings with your CRO partner to discuss key challenges and strategies. During these meetings, you should focus on one or two key topics that will help you make the most progress on your clinical trials. For instance, if patient recruitment is an issue, discuss ways you can improve recruitment and agree on one strategy that the CRO will implement during the week and report back to you on the following week.
As a sponsor, you want to create an atmosphere of collaboration and partnership. A CRO is an extension of your team and, hence, collaboration is necessary. One of the big pitfalls in a CRO-sponsor partnership stems from individuals on both sides not understanding each other’s communication style.
Finally, practice empathy during your communication with the CRO and genuinely take the time to listen and understand the other person’s perspective. These soft skills are not new to us. However, when it comes to putting them to practice, we get in our own way and get lured into power struggles.
As next steps, I encourage you and your team to practice these four foundational strategies the next time you work with a CRO. Once you know what you want from your CRO, are comfortable with minor mistakes by CRO personnel, agree to fair contract terms, and practice effective communication, you will be on your way to a successful sponsor-CRO partnership.
About The Author:
Kunal Sampat is a senior manager, global clinical affairs at Abbott Medical Devices and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. You can find him on LinkedIn.
Note: This article reflects the author’s personal opinions and has nothing to do with his place of employment.