Meet Dingani Mpoko, a Clinical Trial Coordinator at the Royal Brompton & Harefield NHS Foundation Trust in London. Involved in the day-to-day running of clinical trials, Dingani's all-encompassing role covers everything from liaising with sponsors and CROs to recruiting patients. In the first of a series of blog entries, Dingani shares his experiences from the frontline of clinical operations...
Being a relatively new trial coordinator, I entered this role with what I thought was quite a solid understanding of clinical trials. I envisaged working closely with expert doctors and research nurses, recruiting willing patients into exciting clinical trials, and dealing with the pharmaceutical industry. Thankfully, I thought right! What I definitely was not prepared for were the other aspects involved in helping to carry out a successful clinical trial: Ethical approvals, discussions with data monitoring committees, steering committees, GCP, R&D, and every other abbreviation in clinical trials.
What I have learned is that clinical trials are complicated to manage, and the level of organisation needed can be dizzying at times. You are dealing with so many different departments/people each with the aim of getting the trial off the ground, but working within rigid GCP guidelines, which can slow things down a tad.
In my role as a trial co-ordinator the ability to multi-task is key. You are always running numerous studies simultaneously, each with its own research team, each with its own protocol, and each with its own issues. The great thing about being a trial co-ordinator is the variety in the role. I am involved in every aspect of the clinical trial, from the set-up and regulatory demands, to patient recruitment and clinical procedures. It's the best of both worlds!
My week usually begins with an email from my PI with a list of potential patients for me to contact. I'll look through the patient records to confirm suitability for the trial, mainly looking at clinical data. I'll then contact the patient, and if the patient is agreeable, I will send a Patient Information Sheet (PIS) and allow a few days for the patient to digest the information. PIS can be very wordy!
Being able to communicate with the patients is an important part of my role. I need to have a thorough understanding of the protocol in order to answer any questions a patient may have. Additionally, I need to know the patient comprehends what they are agreeing to if they enter the trial. Understanding the visit schedule, the assessments they will undertake and most importantly that there is a chance they may not actually get the study drug are things I need be confident that they understand. Unfortunately these trials may be some patients' last chance, so they can be eager to enter the trial without a proper grasp of the commitment needed which is why it is so important for me to explain it fully to them so they can make an informed decision.
After all that, if the patient is still interested, they can be screened for the study. One down, twenty-nine to go!!