Professor Bruce Morland is a recently retired paediatric oncologist from Birmingham Children’s Hospital. Here, he tells us about his work as a chief investigator on a global clinical trial.
Behind the scenes of a trial are a number of people ensuring it runs properly and smoothly, that treatments are being followed carefully, and that patients are not getting excessive side effects, particularly when new treatments are introduced. I was the chief investigator for a liver tumour trial called the Paediatric Hepatic International Tumour Trial (PHITT), effectively making me ‘head doctor’ for the trial’s European arm.
The chief investigator has usually been very close to the science and design of the trial from the start, and in the case of PHITT we first started to put ‘jottings’ down 10 years ago. In this case, it was literally around the table with friends from Europe, the USA and Japan over coffee at one of the conferences we were attending, which are always fantastic networking opportunities.
Each clinical trial must have a sponsor - the organisation which is ultimately responsible and legally accountable for the conduct of the trial. For PHITT, this was the University of Birmingham, supported by the Cancer Research Clinical Trials Unit, which runs most of the UK-based trials for childhood cancer.
At the start of PHITT I spent a lot of time helping to turn those original jottings into a formal trial protocol which is a large, comprehensive document outlining all the procedures and requirements for treating patients. There are complex legal and regulatory hoops to go through before the trial opens too and once the trial is open and running the chief investigator, along with the management team, keeps a very close eye on things - there are lots of Zoom calls and hundreds of emails!
There are strict rules as to whom may or may not be suitable for a particular trial, termed ‘eligibility criteria’. For example, if a patient already has underlying kidney failure and the trial treatment may make kidney function worse, then that patient wouldn’t be able to participate. As chief investigator, I was regularly contacted to arbitrate on these decisions by colleagues from around Europe.
Patients’ safety is paramount, and the chief investigator also reviews all serious toxicities. We had regular discussions with the team and doctors in the USA and Japan who were also using the PHITT protocol to ensure that we weren’t seeing anything of concern.
The chief investigator, along with the management team, keeps a very close eye on things - there are lots of Zoom calls and hundreds of emails!
Sometimes, clinicians just want help and advice with the best way to manage a particular patient. Liver tumour patients can be exceptionally challenging with regards to decisions around surgery and liver transplantation, for example. What’s important, and one of the things I regularly tell colleagues, is that despite what’s written in the trial protocol, clinicians must always act in the best interests of their patient. This sometimes means deviating from the protocol. Because I’d seen and heard about a lot of patients as chief investigator, this meant I was able to use my knowledge to support doctors from all over Europe in helping make the right decision for their patient. At least once a week I had such a query come my way. We learn so much from all these experiences and use that information to improve trials for the future.
The job of a chief investigator is very rewarding. And while the administrative burden of things like calls and emails can be overwhelming, the support team in Birmingham are fabulous and the regular dialogue with colleagues and clinicians over the world is a joy. For me personally, seeing our original ideas from 10 years ago develop into one of the biggest clinical trials ever undertaken in childhood cancer - making a difference to so many young lives - is something I’ll always treasure and be proud of.
From Contact magazine issue 96 - Autumn 2022
