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European Pharmaceutical Contractor
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The Growth of Paediatric Clinical Trials
Parallel initiatives introduced in the US in the late 1990s have led to unprecedented growth in the field of paediatric clinical trials and the globalisation of activities in this area (see Figure 1). In brief, the Paediatric Rule of 1998 (1) mandates sponsors to collect data from children for labelling purposes. The paediatric provisions of the FDA's Modernisation Act of 1997 (2), recently incorporated into the US Best Pharmaceuticals for Children Act 2002 (3), provides sponsors with an incentive to conduct the trials - an additional six months of patent life for the drug under study. This carrot and stick approach has had a twofold effect. Firstly, the sheer number of trials has increased enormously. Recent FDA data shows that since the incentives came into effect, the FDA has requested nearly 600 trials involving around 35,000 children.
Secondly, paediatric trials are now being seen at a much earlier stage of the drug development process. Indeed, the recent ICH document E-11 (4) recommends the early and urgent initiation of trials for compounds that will treat serious childhood diseases, or those that may be thought of as a considerable therapeutic advance. Traditionally, such trials - if conducted at all - were not usually seen until the drug's adult programme had reached Phase IV, or at least until a significant amount of adult data had been gathered.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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