The UK is to introduce a “fast-track” scheme allowing seriously ill patients who have exhausted other treatments to be given drugs whilst they are still in the trials stage.
The scheme is intended to provide help for those with diseases such as cancer and dementia but also to boost the country’s position as a trial location. The MHRA will assess whether the benefits are likely to outweigh the risks before giving doctors the go-ahead to use a drug.
The plan means medicines will be given to patients before any assessment has been carried out by the National Institute for Health and Care Excellence (NICE).
This is being seen as not only a potential lifeline for the sickest in society but also a shot in the arm for the trials sector. But it does raise several possible issues.
The patients are likely to be those with the most serious conditions – after all, they will have exhausted alternative treatments to be eligible. The data from their response to the treatment will be hard to handle – e.g. there is likely to be no blinding or control.
- Will drug companies want their pre-launch drugs to be seen to be failing patients?
- Will the patients involved in the scheme be subject to all of the safeguards of GCP, like those in a conventional trial?
- How will consent be handled?
- What happens to patients on these drugs if NICE decides that the treatment is not cost-effective?
Don’t get me wrong. I can see huge benefits for patients and researchers but I suspect there are going to be some major logistical challenges ahead.
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