spacer
home > ict > winter 2009 > blow by blow
PUBLICATIONS
International Clinical Trials

Blow by Blow

 

Methods of ensuring the quality of spirometric data have had to develop radically over the years. I recall a time when two nurse technicians produced widely differing forced vital capacity (FVC) results due to their unique approaches with patients, revealing the importance of sequential manoeuvres. Thankfully, since I noticed this, spirometers and computers have dramatically evolved, and the tedious checking of individual spirometric paper traces has been eliminated.

For the majority of clinical trial measurements, the patient remains relatively passive; conversely, lung function testing (LFT) requires the patient to exert maximum force, and the technician’s full concentration and effort with one eye on the patient and the other on the computer screen whilst shouting encouragement. Thus, there are a multitude of variables to be considered when measuring lung function.

Doctors make diagnosis and treatment decisions of respiratory conditions based on the multiple factors of symptoms, spirometric measurements and other data, together with a large dose of clinical judgement. Participation in clinical trials as an investigator requires a paradigm shift, as the spirometric data is paramount especially when it is the primary endpoint. Hence accurate and precise data are vital especially when small changes in lung function may determine the viability and license registration of a study drug.

The variability of spirometric results in clinical trials can be reduced when attention is paid to the four main variables: equipment, technician, patient and environment.

EQUIPMENT

It has become accepted that in multi-centred pharmaceutical trials using the same model of spirometer ensures standardisation of flowhead together with computer programs, quality assurance checks, algorithms, calibration and data presentation.

Reviewing the literature, it is encouraging to see that many study publications include the spirometer model and manufacturer in the methodology section (2,3).


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Initially qualifying as an entomologist in agricultural research, Aleck Harrison swiftly moved from ‘bugs to drugs’ and spent 34 years with Boehringer Ingelheim Ltd. Evolving from CRA to managing respiratory international studies before semi-retiring and starting the consultancy of AJH Partners (Contract Research and Consultancy). Amongst his recent activities he has supported Vitalograph Ltd with the introduction and development of their centralised spirometry system.

 

spacer
Aleck Harrison
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals and Nordic Nanovector have extended partnership for Betalutin® late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment

The non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system
More info >>

White Papers

Autoinjector testing made safe efficient and flexible

ZwickRoell

The autoinjector market is one of the fastest growing markets across almost all pharmaceutical applications. Studies expect a global market volume of approximately USD 2.5 billion by 2020, with pre-filled autoinjectors representing the largest market segment. There are a variety of tests that can be performed on autoinjectors, and these are well-demonstrated by the Zwick product portfolio. The Ulm-based company and specialist in testing systems offers a variety of testing systems that are already being successfully used by multiple pharmaceutical companies.
More info >>

 
Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement