At the annual SCOPE conference in Orlando, Fla., clinical trials experts agreed that the traditional relationship between contract research organizations (CROs) and sponsors is evolving, alongside accelerated pursuits in big data and patient centricity — with more CROs expected to share in the risks of drug development as more of a partner than a vendor.
“[CROs] are increasingly tasked with doing things that sponsors can’t do quickly,” said Nancy Mulligan, UBC’s executive director of patient and physician services. “A year ago that wasn’t the case, but it’s becoming the norm.”
For example, large pharmaceutical companies aren’t nimble enough to bring in specialized vendors on their own, such as patient advocacy services, in less than 45 or 90 days, Mulligan said, while some CROs can jump in and deliver subcontracts within a matter of weeks. In addition, data collection, analytics and software development skill gaps on both sides are increasingly being provided by niche companies.
“Pharma companies are incredibly bureaucratic,” said Jeffrey Kasher, founder of Patients Can’t Wait and a former VP at Eli Lilly & Co., describing how even the lower-risk projects proposed by vendors require jumping through several hoops in legal, ethics and contract reviews.
To share in the risk with their sponsor clients, some CROs will conduct early feasibility or proof-of-concept studies, or draw up the protocol itself — even refunding those costs back to the sponsor if the relationship continues to build, said Janet Baldwin, VP of real world and late-phase studies at Syneos Health.
And a broader industry focus on patient centricity is driving shifts in the sponsor-CRO relationship, as well as in the pharmaceutical industry as a whole — including moves from a product-based model to a service economy model, said Michelle Crouthamel, head of GlaxoSmithKline’s clinical innovation and digital platforms unit.
“We have this belief that if you make a great product, people will buy it and take it. We know that’s not true. Patients know it’s easy to switch their pill,” Crouthamel said, describing how some companies will develop a competitive advantage by moving from being a pill provider to offering services such as health coaching and patient engagement teams in their clinical studies, as well as their final products.
Roslyn Schneider, global patient affairs lead at Pfizer, described how her company brought together a group of patients with knowledge of clinical research and had them cross out everything they thought didn’t need to be in the proposed protocol or informed consent document.
“Just because something was reported by patients in a study doesn’t mean it was important to them,” Schneider said. The group also helped design a more readable consent form, one that held the interest of the patient so that they would pay attention to the entire document.
“Two questions we now ask are: did we ask patients, and did we do anything differently once we asked them?” she said. They found that patients want a different kind of clinical trial experience and approach to site visits, more akin to making a hotel or restaurant reservation.
“They also want summary results, and to find out what happened. They want their own results as well,” Schneider said, adding that Pfizer is currently piloting those ideas in a few U.S. studies.
Meanwhile, sponsors’ evolving use of data — to pinpoint patient populations and engage them digitally — is also affecting changes between sponsors and CROs, with high expectations that they be able to perform in this space.
More and more companies are using big data to come up with the right sites and to target referring physicians, said Mulligan. “The data is less expensive than doing it wrong,” she added.
Some analyses can be done before protocols are even written, such as identifying how many people are in your population, and where they are.
“It allows you to be much more targeted in accrual,” Mulligan said. “We used census data. It’s non-intricate data. We just need to know where people of a certain age who may have diabetes happen to live. That way we can be better at reaching our patients.”
But problems come with trying to integrate a wide array of diverse, disparate data and rapidly place analytics on top of it, Kasher said, describing how most companies seem to be trying to do it by brute force.
In the past few years, mergers, acquisitions and consolidations have become less about getting larger or covering additional countries or regions, and more about pursuing the trifecta of data, analytics and expertise, he said. As the rate of M&As continues — bringing higher expectations for profitability from investors — many companies are now looking to obtain these complementary skill sets.
Kasher said it’s time for many in the industry to reskill: “We need people who are not afraid of data and can use the data. It’s hard to change that.”
Data itself is becoming more of a commodity, said DrugDev CCO Brett Kleger, but simply having data alone can’t help collaborations between sponsors, CROs and startups. “They might have an interesting piece of data, but they don’t actually know how to run a trial,” Kleger said.
“There’s so much greater value to get out of data, and we’re all scared: ‘Let’s do a pilot and take incremental steps,’” he said. “Right now we’re just taking baby steps.”