Isobel Hawley – Quality Assurance Manager
When I was a child my father drummed into me the importance of paying attention to detail. His actual words were, “always pay absolute attention to absolute detail”. I remember a lot of rolling of eyes (on my part), but he was right (and still is for that matter – thanks Dad!). Now it’s my job to pay attention to detail – as Quality Assurance Manager at the Cancer Research UK Clinical Trials Unit (CRCTU). It certainly wasn’t what I was planning when I graduated with a degree in Russian and French…but many years later, my focus in life changed when a friend’s 3 year old child died of cancer. My previous mild interest in things medical (a lifelong addiction to watching Casualty on Saturday nights) developed into an earnest desire to make a contribution to cancer research, and in 2006 I applied for a job as a Clinical Trial Monitor at CRCTU in the University of Birmingham and I’ve been a member of the Quality Management Team ever since.
Clinical Trials are vital for improving cancer treatments and making them available to patients. The Quality Management Team plays an important role in supporting the conduct of clinical trials at CRCTU, by developing and maintaining a Quality Management System which provides a framework of Standard Operating Procedures, tools and templates to assist all staff in conducting trials to the highest possible standards and ensures adherence to relevant legislation. In the UK, the conduct of clinical trials of Investigational Medicinal Products (trial drugs) is governed by complex legislation and guidance including the 2004 Medicines for Human Use (Clinical Trials) regulations, the Data Protection Act, the Research Governance Framework, Good Clinical Practice and the Declaration of Helsinki.
The regulator in the UK is the MHRA (Medicines and Healthcare Products Regulatory Agency) and CRCTU is subject to inspection at regular intervals. The legislation has recently undergone a review and will soon be replaced by a new European Clinical Trials Regulation which aims to speed up and streamline the conduct of trials across Europe. It is hoped that the new Regulation will achieve its aims – many of the paediatric trials coordinated by CRCTU need to embrace international collaboration in order to recruit sufficient patients to complete the trial in an appropriate timeframe; recently the BEACON trial for children with neuroblastoma opened to recruitment in France and will open in further European countries over the coming months.
Our team of dedicated Monitors travel the length and breadth of the UK, visiting the hospitals where the clinical trials take place. The team is currently responsible for on-site monitoring of more than 30 trials, across multiple diseases (breast cancer, prostate cancer, lung cancer, leukaemia, sarcoma and all paediatric cancers) including the AdUP prostate cancer trial mentioned in Monday’s blog and the STOMP trial for lung cancer patients discussed in Tuesday’s blog. The Monitors meet with the Clinicians and Research Nurses to discuss the trial, providing training, updates and feedback from the Trials Office and a friendly face to help out with any queries. They perform checks on the paperwork at the hospital site – reviewing the medical notes of the trial patients to ensure that all patients are eligible for the trial according to the protocol criteria, checking that the patients have given their written consent to participate in the trial, that the correct trial treatment protocol has been followed and any adverse effects of the treatment have been reported to CRCTU. These on-site monitoring visits help to safeguard the rights and well-being of the trial patients and ensure high-quality data is obtained for analysis by the trial statisticians, ultimately leading to evidence-based improved treatments for patients with cancer.
Further useful links:
- Clinical Trials Toolkit
- Declaration of Helsinki
- Research Governance Framework
- Data Protection Act
- Good Clinical Practice