The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) have jointly published new guidance on Insurance and Compensation in the Event of Injury in Phase I Clinical Trials (Guidance). The Guidance is intended to apply to Phase I studies sponsored by industry that involve healthy volunteers or patient volunteers not suffering from the target disease to obtain additional pharmacokinetic data about the medicine under research.
Significantly, the Guidance recommends minimum levels of insurance cover of £5 million in aggregate per protocol for “first into man” studies, reducing to a minimum of £2.5 million in aggregate per protocol in respect of other studies. The Guidance marks a change from the ABPI's 2007 "Guidelines for Phase I Clinical Trials", which did not make any specific recommendations on minimum levels of insurance cover.
The Guidance further recommends that insurance cover is in place for a period of at least three years following completion of the study, to cover claims made by subjects during that period. This effectively allows individuals up to three years to notify insurers of potential claims, rather than a single year as provided for under the 2007 Guidelines.
Published alongside the Guidance is a template Statement of Insurance Cover to give sponsors a consistent document to provide to the ethics committee. The statement is intended to provide a summary of the insurance cover and to call out any unusual conditions or exclusions. The statement will be incorporated into the standard application for Phase I clinical trials within the Integrated Research Application System for health and social care research in the UK.
The Guidance is partly in response to issues that arose out of the testing of the experimental drug TGN1412 by TeGenero, a German biotech company, at Northwick Park hospital in London in 2006 that left six participants seriously ill. TeGenero's insurance cover was just £2m and only allowed for a single "once and for all" payment that made no allowance for the risk that illnesses resulting from the administration of the drug could manifest some time after the time at which the drug was first administered.
The hope is that the Guidance will help enhance the clinical development environment in the UK by (i) providing comfort to volunteers in clinical trials and ethics committees alike that adequate insurance for Phase I clinical trials is in place; and (ii) speeding up the ethics committee review process so that clinical trials can get going sooner.
Whether the Guidance has the desired effect of enabling clinical trials to start more quickly should emerge in the coming months; whether the minimum insurance levels prove to be sufficient cover in the event of a trial going wrong will hopefully not be tested for a good while longer.