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International Clinical Trials

Editors Comment

The US Food and Drug Administration (FDA) MedWatch programme states: “There are intrinsic limitations to premarketing human clinical trials with respect to their ability to detect adverse events. Short duration, narrow populations, narrow sets of indications and small size are major factors in this regard, irrespective of the type of medical product being studied.

“The capability of pre-marketing clinical trials to discover rare adverse events is particularly affected by their size. In order to have a 95 per cent chance of detecting an adverse event with an incidence of one per 1,000, some 3,000 patients at risk are required. With no more than 3,000 to 4,000 individuals usually exposed to a medical product prior to marketing, only those adverse events with about one in 1,000 or greater incidence can be expected to be found.” Such events are defined as being “uncommon”. Rare and very rare events are less frequent than one in 1,000.

Complex Picture

Adverse event recording may prove time-consuming and burdensome; it will follow a specific procedure that may vary from one regulatory agency to another. The large amount of data to be entered, their codifi cation and consistency – and also the expected output formats of the periodic safety reports – make the collection and reporting process evermore complex.

As adverse events are frequently underreported in clinical trials, it is thought that only half of serious adverse events are detected and documented within seven years of drug approvals. At the present time, adverse events are only detected if they occur early during treatment, if they are frequent, or if they are expected in trial planning. No recommended procedures seem to exist for detecting drug-related unexpected side-effects.

It is little wonder then that, over the last 20 years, at least 60 drugs have been withdrawn from sale globally – including thalidomide, phenacetin and temazepam – usually due to serious but rare adverse events. To detect, assess, understand and help prevent them, sophisticated pharmacovigilance (PV) is required.

In this edition of ICT, Mieke Notenbaert at Emtex outlines the recent European experience of detecting adverse events through PV, including new legislation introduced by the European Medicines Agency (EMA).

Small companies, in particular, find it difficult to put in place adequate PV activities of drugs they market. Underlining this, Donelle Bussom of ICON Clinical Research makes a strong case for outsourcing all PV departments, compared with handling it in-house. Not only can significant financial savings be made, but compliance and cost-effectiveness may also be superior.

Market Viewpoints

Another focus area is Central and Eastern Europe. Marcin Ernst and Cristina Stefanescu from INC Research discuss this regional landscape as a whole, while Pavle Vukojevic and Oleksandr Iaroshkevych at Pharm-Olam International extol the virtues of trials in Ukraine. The advantages of patient availability and cost that first emerged 20 years ago have been eroded to some extent, but still remain significant.

One of the challenges of running trials in this and other regions is the diverse linguistic capability that companies must possess – and Vince Postill of PRISYM ID explores this from the viewpoint of clinical supply. Addressing the labelling of drugs, he recommends a collaborative approach to managing the process of preparing and updating labels in numerous languages.

Frank Jäger and Nurdan Citamak at Faubel also note that labels are tools which convey data in various languages, blind trial participants to the contents, help prevent tampering and support the ease-of-use of the drug. As they explain, some 40 different versions may be necessary in a single trial, all of which will be regulated by EMA and FDA regulations and guidelines.

As usual, then, an impressively wide selection of articles run through this autumn edition, and I thank all our contributing authors for their insights and support.

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