Do regulatory systems for testing treatments get it right?

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Although the level of regulation can be reassuring, current regulatory systems impose very onerous burdens on anyone wishing to study a poorly evaluated treatment rather than offer it to patients in normal clinical practice.

In many countries, the sheer complexity of the system – involving laws, agencies, codes of practice, and so on – is overwhelming and time-consuming. Researchers may need to get multiple approvals from different places, and sometimes have to face resultant contradictory requirements.

“In an ideal world, wherever possible, we could be gathering anonymised outcome data and comparing this against medication history”

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Moreover, taken as a whole, the system can seriously discourage and delay the collection of information that would make healthcare safer for everyone. For example, data protection laws and codes of practice on confidentiality, although introduced with the best of intentions, have made it extremely difficult for researchers to collect routine data from medical records that may help to pinpoint treatment side-effects.

And for researchers planning clinical trials, it can take several years to get from a trial idea to recruiting the first patient, and even then recruitment to trials can be slowed by regulatory requirements.

But while researchers try to get studies through the system, people suffer unnecessarily and lives are being lost.

In practice, what this means is that clinicians can give unproven treatments to patients, as long as patients consent, if therapies are given within the context of ‘routine’ clinical practice. By contrast, conducting any study of the same treatments to evaluate them properly would involve going through the protracted regulatory process.

If a clinician tries a new therapy with the idea of studying it carefully, evaluating outcomes, and publishing the results, he or she is doing research… On the other hand, a clinician may try this new therapy without any intention of studying it, merely because he believes it will benefit his patients.”

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So clinicians are discouraged from assessing treatments fairly, and instead can continue to prescribe treatments without committing to addressing any uncertainty about them. The regulatory system for research, in its preoccupation with risk and protecting potential research participants, has become over-protective and overlooks the fact that patients and the public are increasingly involved as partners in the research process.

However, there is one encouraging note. Research regulators are beginning to acknowledge that the ‘one-size-fits-all’ approach to research ethics review may be unnecessarily burdensome. [1] In the UK, for example, procedures for ‘proportionate review’ are now being evaluated to see whether a simplified and swifter review process can be safely used for research studies that do not raise any material ethical issues.