Growing concerns over CROs’ ‘lack of experience’

22nd March 2016 (Last Updated March 22nd, 2016 10:34)

Henry Kerali identifies one of the key concerns sponsors have when managing CROs

One of the main issues continuing to envelop sponsors is the apparent lack of experience in a number of service providers. For the small to medium-sized companies that depend heavily on the services of vendors this has become a predominant issue. What's more, experts say in some cases this can have a deleterious effect on the way trials are run. As a result, sponsors are becoming more engaged in trial processes, overseeing and actively spot-checking trials on the ground at the sites.

While this is a growing concern, this problem is not new to the industry. Speak to industry professionals and many will say this has been the case for years. Some point to a generational shift in commitment and attitudes (on the part of CRO staff) as reasons behind this malaise. So what can be done to counter these problems? When it comes to seeking new CROs, what best practices should sponsors employ to ensure their needs are met?

"There needs to be strong emphasis on the level of experience required from the staff on the CRO side," said Jessica Jackson, director, Clinical Development, Opexa Therapeutics.

While this approach can potentially remedy the problem, the high turnover rate in CROs complicates matters further. So managing the constant influx of new CRO staff in the midst of a trial can be a challenge at the best of times. For Jackson, there have been many occasions where she has worked with an experienced CRA (clinical research associate) only for them to be replaced by a one/two-year CRA with little to no experience.

As a result, she said her company is now working with a niche CRO that employs mostly experienced CRAs. Considering the high level of turnovers, finding that level of experience in a CRA is incredibly rare to come across. Having that sort of continuity in a CRO is extremely important as it can safeguard the integrity of a clinical trial, something Jackson stresses.

"Finding an experienced CRO who's the right fit means more work on the sponsor's side," she said. "What's crucial is we need to have CRAs who are experienced enough to collect data while ensuring the quality of that data - which is key in clinical trials - is where it needs to be."

When it comes to guarding against high staff turnovers, one clinical professional, who's had experience working for sponsors and vendors, feels there must be strong project management on the CRO side. Kathleen Findlen, head of Clinical Operations, Piramal, says one of the ways to guarantee that is by placing a right of refusal on a project leader into the contract.

"Sponsors need to make sure that it's written into the contract upfront that the key members are contingent upon and make or break a contract, so that if you lose your project lead you would get some sort of return and not be charged for new training," Findlen said.

What's more, it's important sponsors look for operational teams that are balanced and experienced. Nevertheless, Findlen warns it's important a team is not so experienced that people look to move on at the first opportunity.

"Don't take everyone that's handed to you," she said. "Really scrutinise and examine each resume and interview people as though you were interviewing them for a job because you are."

Findlen says she has experienced some of the issues Jackson has, but across the board, there are things one can do to incentivise CROs, such as putting bonuses into the contract to reward and engage monitors in becoming affiliated and engaged with the study.

"Sometimes limiting the number of people involved can be helpful because it keeps them busy and makes sure they're not spread across several different sponsor projects," Findlen said. "If you can isolate them onto your project you can have them as dedicated as possible without being sponsor staff."

Including CRAs in team meetings is one way to do that as it demonstrates to them their value to the study. While some sponsors may be reticent to do that because of the potential cost having a CRA sitting in on a meeting might incur. So it can be a balancing act for sponsors in terms of managing its resources. But if CRAs are kept engaged and understand the value they bring to trials, it could go some way to remedying the issues between sponsors and CROs.