Maximising Efficiency and Quality Gains in Clinical Trial Study Start-Up
For decades, delays to the study start-up process have plagued the pharmaceutical industry, and are regularly cited as one of the top sources of frustration and stumbling blocks for research sponsors.
The study start-up phase lays the foundations for all new clinical trials and is critical to the overall success of any research project.
So, how can we maximise efficiency and quality gains during the clinical trial study start-up process, so that clinical trials run on time and patients are able to access new treatments, when and where they need them?
We sat down with Sarah Amos, GenesisCare Research & Insights Research Business Operations and Start-Up Manager, to learn more about her role and how her team have turned the traditional stumbling block that is the dreaded study start-up stage, into stepping stones for our sponsors.
Q: Sarah, can you tell us a bit about your career background?
I originally trained as a radiation therapist at the University of Newcastle, later completing a Master of Public Health, majoring in Health Economics and Financial Management. I was a clinical radiation therapist in a private hospital in Sydney for five years before I made the jump into research.
I began my research career as a Clinical Trial Coordinator, manging oncology clinical trials across medical oncology, radiation oncology and surgery. In my role as a coordinator I saw first-hand the barriers and delays associated with starting a new clinical trial, which is what sparked my interest in the regulatory space - ethics and research governance. I moved into a research ethics officer position where I supported a public hospital Human Research Ethics Committee in the review of research projects. I later transitioned into a research governance management position where I conducted institutional risk assessments on research projects and made recommendations on projects to the hospital executive.
Q. You originally trained as a Radiation Therapist. Can you tell us what prompted your move into oncology research?
I was immediately drawn to radiation therapy as it is a field of oncology that is continually changing and evolving, as is the technology that is used to deliver treatments. To be in a profession where you are continually learning and evolving with those changes was exciting, it was also rewarding to see patient outcomes improve with changes to practice. Little did I know these changes in practice were underpinned by research and clinical trials.
I began working with a few doctors on meaningful quality improvement projects, where we were assessing current standard-of-care treatment and seeing whether the results of our projects could result in practice change. Our projects did result in local changes to practice, and I found this instantly rewarding. It was during this time that I realised I wanted to be part of the team that asks the unanswered questions, that develops new and innovative ways to treat patients, and improve standard of care options.
Q. How important is oncology research in advancing cancer care and improving patient outcomes?
Research is incredibly important in breaking new ground, filling gaps in knowledge and changing the way that healthcare professionals deliver care to their patients. Research plays a critical role in improving patient outcomes and changing clinical practice.
On a personal level, my grandfather was diagnosed with Pancreatic cancer. Having personally experienced cancer in my family, I experienced firsthand how clinical trials provide new hope and a treatment option for patients where no standard of care options are available to them. I was fortunate enough to have my grandfather for two years after he was diagnosed, and those two years our family had with him meant everything to us all. His involvement in the clinical trial also contributed to meaningful scientific data, and it has been amazing to watch the progress and see new therapies be approved and funded for patients living with pancreatic cancer.
I’m also particularly passionate about removing access gaps to clinical trials for patients living in regional and rural Australia. I believe investing in research, coupled with continued investment in new services such as radiation oncology centres, is one of the key ways we are going to reduce the cancer care gap and improve outcomes for our rural patients.
Q. Tell us about your current role as GenesisCare’s Research Business Operations and Start-Up Manager. What does an average day look like?
Gosh, every day is so different in this role and no day is the same. That’s what I love about it!! My day consists of supporting my team of Study Start-Up Specialists, submitting high quality ethics committee submissions, reviewing clinical research agreements, and conducting risk assessments. The goal of the ethics review and risk assessment process is to ensure our patients’ rights, safety and welfare are protected, and the trials we are conducting at GenesisCare do not impede on this in any way.
Another aspect of my role is to partner really closely with our clinicians, allied health professionals, and physicists, supporting them with their own research projects and removing any of the administrative and time constraints associated with conducting research. Our clinicians have huge clinical loads and go above and beyond to drive and participate in research, so our team is really focused on setting their projects up for success and removing a lot of the barriers they face in the start-up process.
Q. Can you tell us about GenesisCare’s unique global approach to the study start-up process?
Delays to clinical trials can mean delays to patients accessing potentially life-saving new therapies. The Study Start-Up team at GenesisCare have created a unique global study start-up process framework and I’m very proud to say that our average timeframe from initial sponsor contact to our sites being open for first patient enrolment is 8 weeks. We have worked closely with our clinicians and sponsors to refine our framework to ensure our patients are able to access clinical trials in lightning speed. Our model and processes facilitate equitable clinical trial access for our patients no matter where they live.
We’ve invested in a team of study start-up specialists who have deep expertise in the ethics committee submission process and who are able to work with our sponsors and clinicians to provide advice and guidance throughout all stages of the study start-up process. Our deep expertise in the ethics review process, coupled with our standardised documents and processes, significantly reduces the number of queries from the ethics review panel. Before submitting to ethics we anticipate any and all questions the committee may ask and ensure we have covered these off prior to submission. Reducing the number of queries from the ethics committee is one of the key ways we are able to consistently deliver projects in our 8 week timeframe.
Our team conducts risk assessments for each project, in parallel to the ethics submission process, which is quite a unique approach, as many research organisations wait for ethics approval before commencing the risk assessment. By running the two processes in parallel, when we do get the tick of approval from ethics, we are able to finalise the risk assessment and provide site governance approval, in a much more streamlined and effective way.
Q. Can you tell us about a research project you are most proud of?
This is a difficult one as to be honest I’m proud of all of the research projects our team has supported and delivered.
If I could pinpoint down one thing, and it isn’t specific to a particular trial, I’m proud of the fact that we are able to consistently deliver on our “partner promise” of running efficient, high quality clinical trials. As I mentioned before, we average 8 weeks from the time the sponsor initially reaches out, through to site activation. Time is everything in oncology and I am extremely proud of my team, their passion and drive to deliver quick study start-up timelines. I am also proud to work for an organisation alongside my colleagues within Research and Insights who embed innovation and support “thinking outside of the box” for the benefit of our patients.
I think people forget that clinical trials are effectively a treatment option for our patients. GenesisCare delivers a highly efficient clinical service for our radiation oncology, theranostics and medical oncology patients and the research team wants to complement this with a well-run, high quality and efficient clinical trial service.
Interested in joining the GenesisCare Research & Insights team? We are actively recruiting for several roles across our Site Research Organisation and Contract Research Organisation.
Learn more about current opportunities today.