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European Pharmaceutical Contractor
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Spirometry is the gold standard diagnostic lung function measurement used in clinical trials of respiratory diseases such as COPD, asthma and cystic fibrosis; and for monitoring respiratory side effects in therapeutic areas such as influenza or diabetes where insulin is administered via an inhaler.
Unlike many diagnostic tests, spirometry is effort dependent and since we are often looking for small changes in lung function in response to a study drug, it is essential that such changes can be accurately measured. This requires that the patient be properly coached so that acceptable and reproducible results are obtained. This in turn requires that the technician at the site is expert in performing the test procedure. However, this is often not the case, particularly where general practitioners or office doctors are involved. Some countries, such as the US, commonly have trained respiratory therapists; however, many countries do not have a high availability of similarly skilled personnel. Instead, the hospital-based pulmonary function laboratory is used. In large global studies, there are an inadequate number of such centres, so GP clinics are often used to make up the numbers and then the quality of data can frequently be poor. Even in the US, office-based doctors and nurses are used, so too undermining data quality.
Fortunately, help is at hand through improved feedback supplied to the technician both on site and via remote quality checking technology. This article describes the background to COPD and asthma studies, examines areas where data quality can be compromised, and how this can be improved today.
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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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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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