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| home > pmps > summer 2002 > providing global access to medicines - the role of manufacture and supply |
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Pharmaceutical Manufacturing and Packing Sourcer
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A universally held objective is patient 'access' to health care interventions in general and medicines in particular - both patent-protected and generic. This represents a particular problem for patients in developing countries, many of whom (for a variety of reasons) do not currently have access. The barriers are multi-factorial: physical and health care infrastructures are often inadequate; financial resources are limited; military, social and political issues abound and country economic policies can have negative effects on health care provision. It is clear that these problems cannot be solved by initiatives in manufacture and supply (M&S), but at the same time some attention has been focused on whether local production, generic competition and technology transfer might make a significant contribution.
Unfortunately, much of the policy discussion within this area has been undertaken without an understanding or appreciation of modern pharmaceutical M&S. This article describes some of the key considerations, and highlights the access-related policy implications. There are five principal considerations, which largely apply equally to branded products and generics:
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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.
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