Staff Profile: Heather Wearing

Heather is a Clinical Trials Auditor at The Royal Marsden NHS Foundation Trust. Events hosted by the NIHR Biomedical Research Centre at The Royal Marsden and the ICR have supported Heather’s professional development by giving her an insight into new research trials and emerging results. 

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Hearing Wearing

What does your role as a Clinical Trials Auditor involve?

I’m part of the Good Clinical Practice Compliance Team, and my role involves working with the research teams to ensure that trials at The Royal Marsden are run correctly.

An audit can range from checking patient notes and reviewing investigator site files to confirming that tissue samples are being stored correctly, and begins with informing a research team that we’ll be conducting an audit of their unit. We work on multiple audits at any one time, with each one usually lasting between one to two weeks and including up to four auditors. After an audit is finished, we review and combine our findings and a report is written and peer reviewed before being sent back to the research team. The research team is then asked to respond to the report and if the responses are satisfactory, the audit is closed. There can be some back and forth at this stage to ensure all findings are addressed and any corrective and preventative actions are implemented. Once the audit is closed, we complete a summary for the Committee of Clinical Research and issue the research team a certificate to recognise that they are operating correctly.

Alongside auditing, I also assist with queries from research teams and provide training on the practical aspects of conducting clinical trials. The team and I also provide support to research teams for external audits and inspections.

Which areas of research are you involved in?

Pretty much all of them! Though we don’t directly conduct the research, we make sure that it’s carried out according to protocol, standard operating procedures, and local, national and international laws and regulations. The team’s remit covers The Royal Marsden/ICR sponsored trials and we can audit anything included on a document called the Audit Universe. This could be clinical areas supporting research (e.g. pharmacy, the Oak Foundation Drug Development Unit etc.), sub-contractors (e.g. third party vendors) participating trial sites, laboratories or clinical research units.

How does your work help patients with cancer?

The safety, rights and wellbeing of patients is paramount, so by auditing trials we can be assured that patients are being assessed for trials appropriately, and that they meet all of the inclusion and none of the exclusion criteria. This ensures patients are being recruited and treated properly and any deviations from protocol are recorded and reported to the right people. If we audit a team’s trial and everything is up to scratch, it gives the team reassurance that they’re doing things right, which hopefully filters through to the patients. If things aren’t quite right, we’re there to help the team improve their processes. Essentially, we help the teams that are helping patients.

How has the BRC supported your professional development?

The BRC hosts patient and public facing events to share the latest clinical research innovations from The Royal Marsden and the ICR, which I’ve found useful for my own professional development. It’s great to get a summary of trials that are going on, and see the emerging results and positivity coming out of them.

What does the future hold for cancer research?

Hopefully cures, or life prolonging drugs that don't have so many side effects. Relatively recent advancements with equipment like the CyberKnife and MR Linac bring a lot of hope and, despite Covid-19, recruitment to research trials at The Royal Marsden has carried on. This brings further hope that different treatments, new treatments, and novel combinations of treatments are going to start giving promising results.