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  • Jack Elkes

My experience designing a contemporary clinical trials course


As an academic clinical trial unit (CTU) it has always been an ambition to develop our training portfolio. We felt it was important to develop a training course that would provide a learning environment for researchers to develop the necessary skills they need to run a scientifically rigorous trial. Not only does training allow a CTU to support more early-career researchers, or those interested in learning more, in their journey to understanding but also helps build a network of researchers that hopefully remain familiar to the CTU throughout their careers.


Early career clinicians and other health professionals often have very limited experience working on clinical trials, but as they progress through their research career there is an increasing expectation that they will need to run one to evaluate novel treatments or interventions they are researching. Therefore, having the right opportunities for this population of researchers to gain relevant experience in designing a trial is essential.


Development


At the start of last year, it was only an idea that we should develop a course, but by mid-April Victoria set the wheels in motion and we began creating the course. The focus was to provide an introduction into how contemporary trials are designed and a high-level overview of various aspects of trials. This would allow us to exposure the researchers to a host of many trial designs and provide them a host of resources not just to help in their immediate projects but also in the future.


Designing the course was challenging, and required expertise from the different teams across the CTU. We devised 8 weeks of teaching using a hybrid approach. Each week we would release recorded lectures to introduce the topic for the week, then host an in-person tutorial session to apply the learnings. Our topics covered all the core elements of trial design, from formulating a research question and the different phases of trials to the logistical, operational, and statistical components. During these tutorials, researchers were encouraged to use their own project ideas. The intention was that this would provide a more bespoke offering of the course where the researchers would develop their own skills by applying knowledge to their own project, and ultimately help them work towards creating a formed project protocol they could use when applying for funding.



After some late nights and an awful lot of coffee in August, we finally had a first iteration of the course ready to test, the whole team worked tirelessly to make sure everything was finished in time. So then once we had found 10 researchers from a variety of backgrounds willing to become our first cohort, we were ready to pilot our course. Building a course from scratch is not just about generating content but also includes a lot of organisation, management, and logistical challenges to overcome to ensure it runs smoothly. Our course was hosted on a SharePoint website I created, acting as a central online repository to upload content each week and to communicate with the researchers about each session. Below is a snapshot of our website homepage, with shortcuts to access material, the calendar, further reading material and to contact us.


Delivery


The first tutorial sessions came around so quickly, this was our first chance to meet these researchers in person and hear their expectations from the course and whether we were matching them with the first weeks material. We were definitely both excited and nervous about this. However, after a round of introductions and in-depth discussions about the projects we realised there was a good feeling from the researchers about the course. We were also glad that our plans to focus student discussions as a key element of the tutorials were working.



After the first tutorial they came thick and fast, we may have only been meeting with the researchers for 2 hours each week but the time flew by, with so many great discussions and questions on each topic. It was great to see that the researchers journey where each week we would see their project in a new form as this continually developed. However, the work did not stop there, after every tutorial there was still plenty to do, from uploading the next weeks content, meeting facilitators to finalise plans for the next tutorial, answer queries, mark homework and most importantly arrange snacks for the next session.


The Final Evening


After the last week of teaching we planned to host a presentation evening where researchers could to consolidate what they had learnt from the course. The idea was for researchers to present a summary of their projects and include elements from the topics covered from teaching. We designed the night as a mock interview panel where after the presentations researchers would be asked questions about their studies from one of the senior team at the trials unit. The evening was in mid-November and we felt it was so important to make sure this was a success to celebrate our fantastic first pilot run of the course. Although COVID meant we were not able to invite the whole of the department and the researchers’ supervisors or teams there was still enough people that it felt like a real professional event.


This event was a great way to hear how much the researchers had learnt and taken away with them from the course and a chance to network. All the presentations were so detailed we were so impressed with just how much the researchers had learnt from the course in just 10 weeks since we had first introduced them to clinical trials.



My Learnings


The course felt like it went by so quickly, 10 weeks went past in a blink of an eye. The experience has taught me so much about what’s needed when designing and running a short course. Developing and running a course is a challenge, it requires patience and a lot of hard work to not only make sure the content is written in time but that there is a clear plan of how this is going to be delivered.


I took on the role as one of the core facilitators where I was present at every tutorial and responsible for managing the weekly content on the website. The role was challenging as it required wearing different hats, and I have recognised the importance of a team to divide up tasks to ensure the course runs smoothly. Each week I would be responsible for setting up the room and welcoming the researchers, but another facilitator would take charge and lead the session and introduce each task. This worked really well and we were able to stick to time. The researchers were always so engaged with the content, they would always arrive with many questions and this would lead to some really interesting discussions. However, there is a balance that must be taken to ensure the discussions remain relevant to most of the group rather than just one or two people.


This year we are running the course again, and we have added more content and taken the feedback on board from last year. I am very much looking forward to the course again and seeing how this year’s cohort of researchers develop their trial knowledge through the course.

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