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The quest for quality in clinical trials

Source: Dr Faiz Kermani
Published: 06/01/07
Click here for jobs in Quality Assurance

What is Quality?

Although many people like to use the word to describe an object or illustrate the level of their performance, quality is rather a difficult concept to describe. In a sense quality implies a degree of excellence in the way a process is carried out. Therefore, it is not surprising that when it comes to the process of drug development high quality is expected. Understanding its implications can have an important bearing on whether a drug is successful in reaching the market and is accepted by patients who use it.

Why do we need Quality Assurance in clinical trials?

The pharmaceutical and biotech industries are highly regulated industries and so it is necessary for everyone involved in clinical trials to adhere to ICH-GCP and international and national regulatory standards. This is because the impact of the work going on extends beyond the clinical studies carried out. At the end of the day, it is the general public that will take the drug(s) being investigated and their safety is paramount. Therefore, it is vitally important that those in the industry ensure that all the procedures carried out during the conduct of clinical studies meet the high quality that will be expected. Yet despite this there are many misconceptions about the work of Quality Assurance (QA) departments and the role they play in clinical trials. Hopefully, this article will dispel some of these…

Misconception 1: The QA department is here simply to criticize personnel over errors.

To be honest, the QA department would be delighted to carry out their work and find that everything had gone perfectly to plan during a project – but the reality of life is that things do sometime go wrong! The QA department is here to ensure compliance with regulations and agreed procedures and so when they report an incident it is usually because there is a non-compliance issue. Given the cost and complexity of clinical trials and the workload involved, preventative action is better than corrective action in resolving any problems. Thus any recommendations taken on board will benefit not only ongoing projects but also future ones.

Misconception 2: Quality is the responsibility of the QA department

Actually, all staff are responsible for the quality of clinical work. The QA department’s role is to ensure that everyone meets these requirements before, during and after the project. Everyone has the responsibility to produce high standard quality work daily and so quality control within different department backed up by following standard operating procedures (SOPs) will ensure that this is the case.

Misconception 3: QA departments only carry out site audits

QA is indeed involved in many aspects of the work performed during the clinical development of a new drug and site audits to ensure that everything is going to plan is one part of the job. However, aside from take charge of site audits on behalf of a client, QA personnel might audit a supplier to ensure that they meet the client’s standards if they carry out a task for the company. Furthermore, the QA department also looks at the work carried out by other departments and offer advice on process and system improvements.

As QA departments work across a number of diverse clinical projects they can often understand the ways in which problems can be resolved – it is very likely that they would have had to deal with such a situation elsewhere. Thus QA personnel can provide others, who are immersed in the heavy detail of a project, with an independent viewpoint that will help them re- focus on the project objectives.



Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomas’ Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from King’s College, London. He has written extensively on international healthcare issues, and is on the editorial board of a number of publications. In March 2006, he was a delegate on the UK Government’s Trade and Investment Biotech Scoping Mission to China and was a speaker at the subsequent presentation.

You can contact Dr Kermani via jobs@leaddiscovery.co.uk
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