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| home > epc > autumn 2003 > patient diaries: a possible source of data inconsistency? |
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 PUBLICATIONS |
European Pharmaceutical Contractor
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Patient diaries constitute one of the most relevant sources of direct information in clinical research. They contain information provided directly by the most important participant in the clinical trial: the patient. This fact makes the diaries a key element when retrieving and analysing data, but also means that the quality and relevance of these data differs considerably from those recorded in the investigators' standard CRF.
When using patient diaries, it is the patient who fills out the diary forms with the information they consider to be accurate. Therefore, this information cannot be evaluated with the same confidence level as those provided by clinical research or health care professionals.
One of the most relevant problems raised from the use of patient diaries in clinical studies is the fact that inconsistencies are sometimes found between the data introduced in the diaries by the patients and those entered in the CRF by the investigator or the study co-ordinator. This problem is even more serious when patient diaries are used in the scope of multicentre, multinational and multilingual studies, when an additional possible bias can be introduced by the use of the various translated versions of the diaries.
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By Sebastián Pacios Merino, Vice President of Operations, Countries Group, PRA International
Sebastián Pacios Merino is Vice President of Operations, Countries Group at PRA International. Beginning his career as a GP in the Spanish national health service, Sebasti‡n has since moved into clinical research. His roles have included Medical Translator/Advisor for SANED, EDICOMPLET, Project Manager at ITEM-PHARMA and Clinical Research Manager at Verum ITEM-PHARMA/Phoenix International Espa–a, where he later became Director. He has experience in a broad range of therapeutic areas including CNS neurology, gastroenterology, dermatology, cardiology and infectious diseases such as HIV. Sebastián has a degree in Medicine from the Facultad de Medicina, Universidad Aut—noma de Madrid, Spain.
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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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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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