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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).


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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.

 

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