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European Pharmaceutical Contractor
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It was on 7th October 2000 that the 52nd World Medical Association (WMA) General Assembly, meeting in Edinburgh, Scotland, adopted the new, sixth version of the Declaration of Helsinki, subtitled Ethical Principles for Medical Research Involving Human Subjects.
The original version of the Declaration was adopted by the 18th General Assembly, meeting in Helsinki in June 1964 after an intense debate lasting 12 years. Between 1964 and 2000 the Declaration was revised, in some cases in a relatively minor manner, on four occasions, in 1975, 1983, 1989 and 1996. We regard these new changes in a very positive light. We also regard it as one of the objectives of the current revision of the Declaration to make quite sure that the patient is optimally protected in a changing global research environment.
Before detailing what these changes are, I think it is useful to put this Declaration into a wider context. It is fair to say that the WMA came into being because of the lack of research ethics. The Second World War facilitated research of the most inhumane, horrific kind. During this war, physicians and others were involved in subjecting prisoners and patients to research that could only be described as a brutal violation of any sort of human right and dignity. In response to these atrocities, physicians from 27 nations met in 1946 to establish an organisation promoting ethical conduct and practice, and so the WMA was born.
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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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