We’ve all been there. The bid defense meeting where we all get along so well, the kickoff meeting where the sponsor watches as their study, on which so much rides for their company, transfers into the hands of the newly chosen CRO, for better or for worse. We all worked hard on the request for proposal and the protocol, and the bid and its defense, and now we want to start ticking along according to the timelines.
But soon we begin to notice the timelines are starting to slip. Or resources we were expecting are not available. Startup tasks fall behind, contracts and submissions are delayed, money is wasted, investigators are upset and nerves are frayed.
How did we get here, how do we recover sufficiently to get good quality data, and what could we do to keep ourselves out of this predicament next time?
Research shows that by 2020, 72 percent of clinical trials are anticipated to be outsourced, nearly three quarters of all clinical trials. For those of us who do not work for Big Pharma companies, this has been our reality for some time. This trend indicates that we must do better at, and not be indifferent to, establishing and managing our relationships between sponsors and vendors.
It All Starts with the Relationship
Last year Craig Morgan of goBalto Inc. discussed the conflicting goals of the two parties: sponsors want to reduce costs, gain speed and agility, while CROs are looking for economic outcomes for owners and shareholders. This apparent mismatch in organizational goals creates the opportunity for inherent conflict in the shared goals of the project team that needs to be addressed with a two-pronged approach.
The relationship between a sponsor and CRO begins with two distinct components: the contract defining the legal relationship between business entities, and the personal bond between the sponsor’s and CRO’s respective project managers or account leaders. The former defines the delegation of tasks, scope of work, and, if written well, provides structure and governance to the relationship. It is the latter in my view where the work gets done. Corporations may or may not be people, as once famously opined by a US presidential candidate, but they are surely made up of people who have to work together on a shared project to achieve the goals of their organizations. The contract sets up the foundation for the two companies to work together, and the relationship between the project principals – the act of each leader buying into the shared goals of the team and claiming personal accountability not only to the joint team but to each other – creates the environment for the project team to succeed.
This is the reason why some clinical operations directors and account leaders can be adamant about staying with the same vendors – assuming they have had successful experiences with those vendors – even as they change jobs to new sponsors. It is because they are the holders of those personal relationships, they are each vested in the other and they know that it is in the context of their relationship that they have sufficient trust to raise concerns, to identify and communicate potential threats to the timeline or budget to each other and to explore solutions from their shared library of experiences.
An insurance policy that should be defined in the contract and or scope of work for all studies is the escalation procedure. This is where executives or higher management company representatives identified by title if not by name receive regular status reports on the functioning of the team and can be brought together relatively quickly to address any problems that arise as the team works together. Naming these individuals and demonstrating their commitment to the success of the project is an indication of good faith by the parties, which is why names are better than titles. These individuals should have the organizational power to assign resources, including authorizing hiring if necessary, and to use internal means to correct any performance or behavior that may be harming the team’s cohesion.
The escalation team can define themselves as a joint steering team on certain studies and meet at regular intervals from the beginning, or hold themselves in the ready in case the need arises. In any case, taking the time to define this team and its structure in the contract or other binding agreements that define the scope of work can save time later, so that if the project begins to experience slippage in timelines or deliverables the escalation team can be convened quickly to identify root causes and propose solutions. To be effective, this team will need to be briefed with some regularity on the high level project status, as these regular briefings will let them know early if they are needed to step in.
What if we have gone past what an escalation team can fix? What if the relationship has broken down irretrievably, the trust is completely damaged, and all corrective measures have failed? When the sponsor is faced with the high likelihood that their study will not be executed at all or will be conducted in such a way that no good data can come out of it, they have two options: walk away, or launch a rescue operation. Since they need the data the study is meant to generate, rescue may be the only realistic option. However, it is so difficult to mount such an operation – tantamount to changing all four tires while the car is driving down the road – that even here a little planning is advisable.
Start preparing for such an eventuality early, such as when the first line interventions have been implemented without evidence of success, and those indications usually become apparent quickly. Over the years that you have been acquiring contacts in the CRO world, think back to the ones who told you they specialize in rescue. There are some who do exactly that, and it is a unique skillset. Get one or more of those CROs under confidentiality and start discussing how they might be able to help you: maybe by taking over a region, or adding sites that they have relationships, or adding resources such as CRAs or translators or submission specialists. Get bids and know your options. You may never get to deploy the rescue squad, because upper managements sometimes have little appetite for the upheaval associated with such a change, but just being well informed of your options puts you in a better negotiating position with your current vendor.
The days of sponsors running their own trials with their own large staffs of CRAs, project managers, data managers, programmers and the like are long in the rear view mirror for many of us, especially in smaller companies. We must work together with CROs to generate high quality data and we have an obligation to be good partners as well by setting our CRO partnerships up for success and by acting with integrity where we expect integrity. Going beyond bids and budgets and building relationships together with our CRO partners will help us deliver high quality study results within our timelines.
Senior Director, Clinical Operations
1) “Research and Markets: The New 2015 Trends of Global Clinical Development Outsourcing Market.” (2015 January 20). Retrieved from http://www.businesswire.com/news/home/20150130005621/en/Research-Markets-2015-Trends-Global-Clinical-Development#.Vh50c-xVhHx
2) Morgan, C. (18 August 2016). “10 Tips for Enabling Better CRO-Sponsor Collaborations.” Retrieved from http://www.centerwatch.com/news-online/2016/08/18/10-tips-enabling-better-cro-sponsor-collaborations/#_ftn1
3) Romney, M. (11 Aug 2011). “’Corporations Are People,’ Romney Tells Iowa Hecklers Angry Over His Tax Policy.” Retrieved from http://www.nytimes.com/2011/08/12/us/politics/12romney.html