In the PharmaVOICE 2018 Year in Preview article, Michael Murphy, M.D., Ph.D., Chief Medical and Scientific Officer of Worldwide Clinical Trials, predicted an accelerated move toward strategic relationships between sponsors and contract research organizations (CROs).
For additional perspective on the role of a Contract Research Organization (CRO) in clinical trials, plus other projections for the year ahead, Talking Trials spoke with Peter Benton, Worldwide’s President & Chief Operating Officer.
What is behind the projected increase in strategic sponsor-CRO relationships?
Every parameter you define for your study, using every expert opinion, external and internal databases, and personal experience is wrong! Will it need more or less sites? Which recruitment plans will work, and which patients will enroll? Will the serious adverse events you identified cause the biggest risk or something less obvious? The set of questions that are meticulously vetted during the planning phase may be tossed out the window once the study starts and reality hits.
I am not saying you don’t need to put your best thinking into the study plan. In fact, you’d better. But more than that, make yourself ready to manage the ever-changing study demands. You must partner with a CRO who is continually looking at the data and information available and adapting. To do this successfully, you must have trust. To have trust, you must build a partnership early before things shift.
Let’s be honest, folks, these are clinical trials and “shift happens.” Sometimes it’s more, sometimes less, but change is inevitable and part of the process. The amount of time you put into building a relationship with every level at both the sponsor and the CRO will pay back significant dividends. That’s why we’ll see these strategic relationships grow in depth and number – because there is real value when it’s done right. If you treat your CRO like a vendor, you’ll get an expected common outcome. If you treat your CRO as your partner, you will achieve uncommon success.
Too often, efficiency wins the day and relationships lose. Here’s a common tradeoff we all see every day: “email is efficient, but email is ineffective.” We all know this, but are we acting on it? You must make the time for face-to-face meetings. Get to know each other so that your telephone calls and team calls will be more valuable. Tighter engagement sounds good; it sounds easy. But strategic relationships take a real commitment and deliberate steps to make them happen.
When it comes to technology integration in the year ahead, what will be the role for CROs in clinical trials?
As a sponsor, I’ve used cutting-edge technology. As the former head of a leading eClinical technology company, I’ve built, sold, and delivered technology. From where I sit, I can tell you that we as an industry don’t do technology that well.
We overcomplicate things, try and combine too many different systems and vendors, thinking we need the bleeding edge and coolest new things. (The 4-dimensional interactive colored bubble chart portfolio system is my favorite, by the way.) That is a flawed strategy. Good enough is always good enough. Keep things as simple as you can, stay flexible, and be wary of anything new and cool.
Remember to focus on the block-and-tackling of running your trial effectively. I have said it many times, and it bears repeating: The technology and tools that really drive our business forward are office productivity and communications platforms like Office365, signing documents faster with DocuSign, managing your documents in electronic trial master file (eTMF), and making payments better and faster to sites with Medidata Payments. Those fundamental systems and tools help.
It’s not that the wearables and site-less trials aren’t going to be valuable someday, but this industry takes a long time to change. I think 2018 still will be more about efficiency, speed, and trying to get your trial complete and your data for submission faster.
Will we continue to see more mergers and acquisitions among CROs?
It may be hard to top 2017, a year with some big M&A activity, with Quintiles and IMS becoming IQVIA, INC and Inventive merging, LabCorp buying Chiltern, and other smaller deals. There will be some digestion of that activity, but the long-term trends of CRO consolidation will continue. We’ll soon see the number of top CROs cut in half. Large pharma will continue to rely on large CROs for their resourcing and staffing. They will continue to focus on efficiency and cost reductions, leaving the small-to-midsize market to others.
When you look at other industries, there’s a pattern. In markets served by merging companies, you see less competition, of course. What follows is the opportunity to boost pricing, plus little incentive to improve quality or innovate.
The largest CROs cannot grow faster than market rates, yet their investors demand higher growth. This will cause continued diversification into other areas, such as real-world outcomes, site networks, technologies, etc. These are not core to their mission. But companies must continue to grow to be successful. I think this leaves the midsize CROs with the responsibility to create the innovation in speed and agility that small-to-midsize pharma and biotech companies need.