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International Clinical Trials

Comment from the Editor

Clinical trials are, of course, at the heart of drug development, and the regulatory frameworks that seem to shape and burden our industry in equal measure are vital. Over the years, the rules for trials across Europe have moved from national guidelines through pan- European directives and now to the incoming Clinical Trials Regulation, which will again change how trials are governed and organised. In this latest edition, Dr Laura Brown of LB Training and Development Ltd provides a timely ‘primer’ to the new regulation, helping readers navigate their way along the legislative path.

Regulations in the US naturally differ, and many smaller non-US companies often find that the preparation and submission of an investigational new drug to the FDA is a daunting challenge, to say the least. TKL Research’s Roxanne Tavakkol assists with a comprehensive overview of the process. She describes how study timelines can often be speeded up by selecting a consultant integrated with the CRO conducting the trial.

But regulation is only a part – albeit an essential one – of the clinical trial process. Nuala Ronan at Databean emphasises how planning is also a crucial element. She comments that if there is a 'magic bullet' that can help a company move more smoothly to the trial phase, it would be a planning focus and a management team that understands what is needed. If the business is not as strong as it should be in one of these key areas, the time to fix it is early in the process. We all know the dictum ‘failing to plan is planning to fail’, and clinical trials are no exception.

A further aspect of the planning necessary within successful studies is explored by María Proupín-Pérez from PPH plus: namely, the manner in which quality is built in from the starting point. Increasingly, risk-based monitoring (RBM) of trials is being introduced, and quality planning is even more important in such cases. In order to assist the study team with the adaptation to procedural changes inherent in RBM deployment, she advises that functions and their definition of respective roles and responsibilities, as well as training requirements, need to be revised and trained into the management teams.

Moreover, continuous improvement of the quality risk management system should be performed according to knowledge gained before, during and after its implementation in a clinical study. After all, the increased cost of ensuring quality often pays for itself in the long run by alleviating the need for hasty and unsatisfactory study rescue measures.

A post-authorisation safety study is a particular type of late-phase clinical study which is often mandated by regulatory agencies as a condition of the product's marketing authorisation. The organisation of such programmes can be markedly different from the way in which early pre-authorisation studies are conducted. Jess Sohal of United BioSource Corporation offers a useful summary of the current international, national and local guidelines governing these, and outlines strategies to help ensure their successful completion. These articles set the trend for this edition of ICT, which contains a multitude of practical advice on the conduct and planning of clinical trials that I hope you will find both useful and illuminating.

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