The case of study A

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A British based pharmaceutical company was preparing to do a pivotal pharmacokinetic study on a new clinical lead. The study was aimed at establishing the pharmacokinetics of the new product in an elderly population.

The company had not carried out pharmacokinetic studies in elderly patients in the United Kingdom before and so had problems in selecting a suitable centre. A literature search was carried out and a centre was chosen on the basis of published work. The centre was visited by the clinical projects manager concerned to check that it was capable of doing the study according to the company's standard operating procedures.

At this visit the project manager spoke with the head of department, who reassured him by reference to previous work, both published and unpublished, and a review of the documentation from previous studies that the unit was equipped and able to do the work required. The principal investigator emphasised that the work would be carried out in a six-bedded unit which was an offshoot, separate from the main ward of another hospital. A protocol was developed, based on a protocol provided by the parent company and all the appropriate signatures were obtained.

At this time the medical director of the company was asked to sign the protocol but remembered the investigator's name from previous conversations with colleagues at a pharmaceutical function a few weeks before. On checking up with his colleagues he found that the centre had an unreliable track record over the past six months or so, but had been a reliable unit before that. The medical director refused to sign the protocol and instructed the project manager to return to the unit to confirm that it was suitable and able to do the work required.

On this occasion the project manager made an appointment to visit the unit concerned, although this was difficult. On arrival he was greeted by a rather harassed registrar, who explained that the "unit" was in fact a curtained off area in one of the main geriatric wards and was currently full of routine admissions because of a flu epidemic. The junior staff member also confirmed that there was a backlog of studies waiting in the unit but staff cuts over the past six months, owing to hospital cutbacks, had made it more and more difficult to carry out the work.

Needless to say the study never actually went ahead but it is problematical whether it would ever have been completed or, more importantly, whether, if it had apparently been completed, it would have been done fraudulently.

Sometimes visits by clinical research associates can produce unexpected results:

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Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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