Produced by Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) in conjunction with the UK’s Department of Health (DoH) and the National Research Ethics Service (NRES), the document sets the standard of insurance cover required to protect volunteers for the first time ever.
Under the advisory, clinical research organisations (CROs) and their sponsors will be asked to submit a new “more straightforward” document detailing they have the correct insurance for their trial - £5m in aggregate for protocol in first-in-man studies, and £2m in aggregate for protocol in Phase I trials.
The insurance will cover participants for injury compensation as well as legal expenses.
Speaking to Outsourcing-Pharma.com,deputy director of policy for NRES – part of England’s Health Research Authority (HRA) – David Neal, said the document is a much-needed move for the UK, which has been lagging behind many other EU countries which already have set legislation in place.
He said: “A number of EU countries has this in place and even differentiate depending on the type of clinical trial. It’s been a difficult issue for ethics committees because they aren’t insurance experts, but they are required to decide whether the appropriate level of cover is in place.
“The new guidance is extremely useful to ethics committees, and we welcome it.”
Head of communications for BIA, Robert Winder, told us that industry also welcomes – and has helped to drive – the change, because it believes it will speed up the trial approval process.
“One of the things it’s designed to do is help the process of getting clinical trials approved. Because of the new form – which is just two and a half sides of A4 paper – it’s now much easier to submit proof of insurance.
“It accelerates the ethics committee too. It’s hoped that by having a clear, open system, people will see use the clinical trial system in the UK more.”
The move also got the thumbs up from CROs such as Quintiles. The firm's VP of Phase I Liz Allen - who was also involved in developing the guidance - told us: "Sponsors and CROs will have more certainty as to what level of insurance cover they need, based on the studies that are being run.”
As for boosting trial enrolment, Winder believes the guidance can only be a help.
“This is valuable for volunteers on clinical trials to show them that if something happened in the trial there is sufficient insurance in place for them,” he said. “This isn’t something that has always been the case in the past.”
However Neal was more sceptical, saying that patients are normally only made aware of the insurance in place once enrolled.
New developments
The guidelines currently apply only to healthy Phase I volunteers, and participants with indications other to that of the trial focus, however the Government has indicated that further advice will be issues soon.
“The original request from the DoH was to develop the guidance for all types of clinical trial. Phase I trials is just the first part of this work,” said Neal.
“The industry bodies are now looking at other types of trials, which we will fully support and contribute to. From an ethics committee point of view, we want the industry to establish a standard that provides a clear reference.”
He also hinted towards the need for more solid regulation, saying that the UK still has no legislation on the matter, whereas many countries in the EU do.
However when asked if he sees a EU-wide legislation for insurance for clinical trial participants, he replied: “No, because it wouldn’t be possible. Practically, there are significant variations in different countries and it would just be too complex for the European Commission to implement it.”