A healthy relationship between a trial sponsor and the CRO or supplier can be the key to success – here is a list of how to address the biggest challenges.
By 2020, 72% of clinical trials are projected to be outsourced to contract research organizations (CROs), compared to just 23% in 2012. The main reason is that a CRO can add value throughout the whole clinical trial process, from protocol design and study planning to insights into particular sites and investigators, as well as identifying the most common challenges and how to address them.
Working with the right vendor has a significant influence on the ultimate success or failure of a clinical trial. Despite the importance of choosing the right partner and the right way of working together on a project, most CRO-Sponsor relationships fail before they even start. “This is often an unintentional consequence of missing certain key factors that should be addressed from the very beginning,” says Kieran Canisius, co-founder of Seuss Consulting. She and co-founder Sabine Hutchinson are both experts in helping biotechs find the perfect partner. We spoke with them to create a list of some of the most common, preventable reasons why relationships between the sponsor and the CRO fail and how they can be fixed.
1. Unclear selection criteria
Before venturing into partner selection, you need to know what you’re looking for. Otherwise, it is extremely difficult to recognize your ideal partner when you’ve found one. The first step is to determine what will be the biggest threat to the specific trial you want to run. Then, look for a CRO that has the necessary expertise to deal with this challenge during all the process, from study design to the management of possible crises that arise along the way.
For example, if you’re developing a new drug for depression, you should look for a partner experienced in dealing with the placebo effect, the most common cause of failure for trials in this indication. Or if you’re working in Alzheimer’s, make sure that the CRO knows how to select the right patients – experts seem to agree that Eli Lilly’s recent Phase III failure in Alzheimer’s might have been influenced by including patients in a late stage of the disease rather than early. “Make sure to document the essential selection criteria your CRO should have, and use the list during the selection process to find the best partner,” strongly recommended Hutchinson.
2. Overinflated sales promises
CRO selection can be competitive, so it’s not uncommon to find those that embellish their expertise, capabilities and availability a bit. On the other hand, the sponsor is often in a rush to find a supplier. The obvious risk is a misunderstanding that can doom a project before it even begins.
To avoid such a problem, it is necessary to take the time to identify the right questions for the suppliers and complete reference checks. Sabine provided some of the questions that are essential to start off with the right foot: “Does the CRO have effective strategies to ensure the study criteria are met? Can it handle a certain number of centers and patients? Does it have genuine expertise in the locations you’re targeting?”
Applied Clinical Trials reported the case of a sponsor that hired the only CRO who said they could run the trial within the budget. “The trouble started almost immediately,” said an executive from the sponsor. “We realized very quickly that our timelines and protocol didn’t allow anywhere near the right amount of flexibility. Now we’ve learned to ask potential CROs how they would work with us to develop a comprehensive budget as part of our evaluation process.”
3. Failing to establish aligned goals
“Each side in the sponsor-CRO partnership will naturally have different goal priorities. For the biotech sponsor, increasing the speed and reducing the costs of a clinical trial is essential, whereas for the supplier the economic outcome of the deal is the key,” explains Kieran. Clearly, this situation is far from ideal when trying to make a joint project work.
To overcome it, it is vital to align and clarify both the needs and the responsibilities that each partner will undertake. Aligned goals should be established for all relevant areas, including protocols, timelines, and budgets. To create a solid foundation that from the first day meets expectations with reality, input from both sides is absolutely necessary.
“I’ve heard horror stories about CROs taking on projects with no input, and then needing to have ‘the conversation’ about having to meet totally unrealistic goals for recruiting. Why can’t the CRO just say these are unrealistic goals during the proposal process? It’s much better to have the hard conversation before the trial starts,” reports Applied Clinical Trials.
4. Poor communication
No matter how efficiently the process proceeds, if both parties aren’t up to date with all the most recent developments, the smallest inconvenience can turn into a disproportionately big problem. Engaging both teams early and often can prevent it. In fact, the industry is increasingly turning to strategic partnership models in which both the CRO and the sponsor have a closer, more communicative relationship. And the numbers back this transition.
Many CROs have the expertise and resources the sponsor lacks. For example, knowing how to attract patients with certain conditions in a particular country, the quality of performance of specific investigators, and basically what will work and what won’t. Define roles and responsibilities to let each party utilize their expertise to the maximum and avoid the unnecessary duplication of tasks. Ensure both have the flexibility to adapt to the needs of each other.
5. Weak governance structure
A CRO-sponsor relationship is not that different from a marriage: it requires effort to make it work from the beginning to the end. A formal governance structure that emphasizes practical structures and encourages involvement from all levels is key for a successful partnership. This structure should not just be on paper, and it is necessary to invest the time to realize and maintain the roles and responsibilities established at the beginning.
Collaboration should take place in real time, not only when there’s a crisis. One awfully common mistake is for the sponsor to manage the relationship loosely until a crisis comes up and none of the parties is ready to tackle it. No matter how good your plan is, problems will arise. Establishing what risks are most likely to occur, how serious they are, and how they will be tackled will make their resolution easier and faster.
Responsibilities regarding problem management should be pre-established and reinforced all along the way. By setting key performance indicators (KPIs) and deliverables for both parties, when an issue does appear, both sides will be encouraged to sit down together and solve it instead of blaming each other.
Selecting the right vendor for the right project at the right time is essential for clinical trials to run smoothly and, ultimately, have greater chances of success. However, it isn’t easy to find the perfect match. Many, try as they might, never succeed on their own. We hope these tips will help you start steering the ship in the right direction.
For more insights and help on finding that perfect match, head over to the experts at Seuss Consulting!
Images from Zally, Honza Hruby / Shutterstock; Pharma Outsourcing