How can changes to regulation help drug development?

Posted on April 12, 2012 by

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We have just responded to the government’s Red Tape Challenge on the regulation of clinical trials of new medicines in the UK.  We have highlighted some of the good steps that are already underway to improve this regulatory process and flagged up some of the future challenges for regulators that will emerge as completely different types of drugs are developed.

Background

The red tape challenge was launched by the coalition government to look at all the different regulations in place across the UK and identify where they can be simplified. It is open to everyone to respond, from organisations down to individuals.

The challenge looks at regulations in turn and has just been focused on the regulation of medicines by the Medicines and Healthcare Regulatory Authority (MHRA).

What did we say?

We welcomed the improvements that are being made to make regulation more proportionate to the risks involved in trials and improve the information available for funders and researchers to help them navigate the approvals process and get research projects off the ground. But there is only so far we can go until the EU Clinical Trials Directive, which governs clinical trials conducted across Europe, is revised. This is underway at the moment and we are following the process and feeding in.

We also flagged up the challenges that are posed by new, innovative treatments which may not suit the classic drug trial design that regulators require before they license a new drug. For example, drugs may now be targeted to a very small group of individuals and it might be difficult to enroll enough suitable patients in a trial to satisfy regulators. Similarly, regenerative medicine needs special consideration because you are dealing with cells rather than drugs, which act in a very different way.

It is important that regulation doesn’t become a barrier to medical advances that could deliver better healthcare for patients. We called on the government and regulators to work with researchers and the public to consider more adaptive licensing models. These include systems where new treatments can be made available to those who need them most at an earlier stage of the evaluation process than is currently allowed, and finding ways to collect data on treatment efficacy as the treatment is rolled out allowing real-time monitoring. This would involve a different approach to managing the risks and benefits involved in trialing a new drug and improving the systems for prescribing and gathering data on efficacy. We emphasised that any changes to regulation must be developed closely with the public, considering all our views on acceptable balances of risk and benefit.

The consultation on an early access scheme announced by the prime minister in the UK Life sciences strategy is a good first step towards this. We welcomed this and hope it will go some way to addressing these issues. The PM also announced in the strategy a plan to establish a group of experts:

A group of experts drawn from government, regulators, the NHS, industry, and the academic and third sector communities will meet quarterly to discuss healthcare regulation issues, including the development of newinitiatives and innovations

so hopefully they will be looking at some of these ideas.

What next?

The planned consultation on the early access scheme should be out soon. The revision of the EU Clinical Trials Directive is moving forward in Europe.

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