Switching between superiority and non-inferiority

The very mention of ‘Regulatory Authorities’ and the US Food and Drug Administration in particular, can strike fear into the hearts of many clinical investigators. This reaction is all too often reinforced by the pharmaceutical companies. I would have retired a long time ago as a wealthy man if I had £1 for every time that I have been at an investigators' meeting and in response to some very sensible criticism the response from the sponsor has been ‘The FDA requires it to be that way’.

The truth is that the regulators are not ‘big bad wolves’. Rather they are real people, generally approachable, and possessing a wealth of common sense and experience in the design, conduct, analysis and interpretation of clinical trials. Increasingly this wealth of experience is being made even more accessible through initiatives such as the International Conference on Harmonization (ICH), which is bringing together the regulatory requirements from the US, Japan and Europe. So now in my own arena (medical statistics), when I am told that such and such is a requirement of the FDA, more often than not I can reply ‘Oh no it’s not. Have you read ICH E9?'

In parallel with the ICH guidance, the Committee for Proprietary Medicinal Products (CPMP) has issued guid ance on a number of controversial areas under the heading of ‘Points to Consider’ (PtC) and one such PtC is published in this issue of the British Journal of Clinical Pharmacology [1]. I would warmly commend this par ticular PtC and similar guidance from the Regulatory Authorities, so that discussions between sponsors and investigators can be better informed and so that ultimately patients will benefit through the quality of clinical research being enhanced.