The institutional review board (IRB) was the focus of a GAO investigation that claimed the system is “vulnerable to unethical manipulation”, which resulted in the company suspending some of its operations.
Coast had intended to initiate “immediate and sweeping reforms” in an attempt to overhaul its operations but has now informed the US Food and Drug Administration (FDA), its clients and staff that it is to close “in the near future”.
The IRB is currently arranging the transfer of its ongoing trials to other organisations and has reassured its clients that they will incur “no hassle or additional cost”. This will entail the transfer of around 300 active trials to other accredited IRBs.
To smooth the transition staff associated with these trials may continue to support the studies after the transfer is complete. Coast has said other employees will be assisted with retraining and outplacement.
How Coast collapsed
Coast went from being a growing organisation with revenues of $9.3m (€7.1m) to shutting its doors in under a month, with the GAO probe and FDA warning letter scaring off existing and potential clients.
The decision to approve a fictitious protocol for research in humans, which included false claims that the device was FDA-approved, led to calls for IRB reform and a warning letter for Coast.
Although the IRB initially hoped it could adapt and survive it appears the swift actions of some key clients have forced it to close, highlighting the pressure a scandal can put on a company.