Over the past few years, we have seen a major increase in the consolidation of smaller central IRBs into larger organizations. Where there used to be a couple dozen independent central IRBs, we are seeing the pool shrink to single digits as these organizations join forces to make one larger company. Chesapeake has acquired 5 IRBs since 2013, and WIRB acquired Copernicus along with two other smaller IRBs recently. What does the consolidation of IRBs mean to the industry, and what do things look like for the future?
With any acquisition or merger, there are bound to be some growing pains as not only companies merge, but as processes and personnel merge as well. Some have chosen to silo the process and have the entities remain somewhat independent as they work to merge systems. Others are more aggressive and begin merging processes quickly under one name. Sites and sponsors are dealing with a learning curve of sorts in these situations. Where they used to have a level of comfort in the submission and oversight process, they now have to figure out how much of the old process remains at those IRBs that were formerly independent entities.
There can be advantages to fewer and larger IRBs. With consolidation, there are fewer variances in forms and processes. These IRBs will be able to take on larger trials and manage a larger number of sites. Additionally, implementation of new agency regulations will likely be streamlined and communication of regulation changes enhanced. As IRBs continue to grow and establish processes, we can also hope that document flow for protocol amendments or new documents is streamlined as well.
The process of consolidation is not new to the medical research industry. There were periods of site consolidation in the 1990s and we saw many CROs join forces in the last decade. While there is some initial turmoil during these mergers, in the end we seem to end up with better process overall and a more consistent workflow across all companies as standards are established.
As for DaVita, our network of sites will continue to rely heavily on the central IRB system and we will take our directive from the sponsor as to which IRB will be used. Undoubtedly, we will end up with our familiar IRBs, but I think we can anticipate more consolidation over the coming years so our favorites today may not be our favorites tomorrow. One thing is certain; the industry is clearly saying that the central IRB system is here to stay.