The European Medicines Agency (EMA) has selected the first six drugs for its fast-track “adaptive pathways” pilot programme.
The adaptive pathways programme was announced in March last year and was intended to make it faster for patients to gain access to test drugs for which there are currently no alternative treatment.
By definition, an approval granted under the programme is highly specific – either restricted to a very narrow indication or for use by a well-defined group of patients. If subsequent data proves positive, the approval can be widened later.
This scheme is not alone. Since 1992, the US FDA has also offered a fast-track pathway, accelerated approval, for drugs used to treat unmet medical needs. There is also a UK scheme specifically aimed at allowing cancer patients access to as-yet unapproved drugs.
So what is the ethical position of apparently short-cutting good clinical practice?
The fact that both programmes restrict approvals to very tight criteria means that the risk:benefit equation can still be positive. Although there is inherently more risk, this particular group of patient has potentially far more to gain.
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