Description
By the time you read this dear reader, the EU directive on clinical trials research will have come into being on May 1st 2004. The latest legislation conceived in Brussels was only revealed in detail by the British Government on April 1st – leaving only four weeks for urgent consultations on
the detail!
The new law was originally designed to deal with the indemnity and sponsorship issues arising out of the carrying out of clinical trials of new unlicensed drugs, by clinical trials organisations in partnership with pharmaceutical companies (what was known as industry sponsored research). Such research is vital to evaluate new therapeutic agents that might bring rapid benefit to patients with a wide variety of cancers. The new directive aimed to standardise and formalise the contractual arrangements between these organisations, including the issue of medical indemnity (insurance) against faulty trial design, which could lead to potentially large claims.
The directive re-emphasises the necessary role for an overall “sponsor” of each trial who is responsible for the design and conduct for the trial,
is legally liable when things go wrong as a result of intrinsic flaws in the trial or its implementation. Which is all very sensible, and poses no problems in the commercial sector, where companies are familiar with fairly rigid laws and legal liabilities involving studies which may be spread over many countries world-wide. What is now clear is that during the drafting of these laws, the EU legislators overlooked the vast amounts of clinical research that is funded by Governmental and Charity organisations. These studies often concern therapeutic agents that are already licensed, and are carried out within cancer units who are, at present, completely unfamiliar with these issues of legal liability. Under the new laws, the main trial centre running the trial, together with the chief investigator, would be required to act as overall “sponsor” for the trial, and be legally responsible for
any problems within the trial.
This is, at present, a new and rather daunting prospect for many NHS Trusts who could, in the event of a mishap, find themselves in a potentially
crippling financial position following claims for compensation. It is therefore no surprise that many are refusing to act as sponsors leading to stalling of the trial, or are requiring chief investigators to pay large “insurance” premiums before a trial can start.
It seems, however, that some sense is now prevailing. Within the UK, the DoH has apparently accepted the principal of shared sponsorship,
whereby one trials centre agrees to act as main sponsor, but has contracts with a number of other trials units involved in the particular trial. These
individual units would each be liable for patients within their own jurisdiction, and thus spread the legal load. Hopefully, such arrangements will lead to speeding up of the current uncertain process, and improve the somewhat confused state of affairs we see now. Watch this space for an update on this in the next issue of CME Cancer Medicine!
