Clinical trial coordinators play an important role in the successful running of clinical trials. So much so that drug companies are unlikely to select a hospital to run a trial if a clinical trial coordinator is not in post. To help build clinical trial capacity in the UK, we’re currently funding two clinical trial coordinator positions. Read our interview below with Hinal Patel – a senior clinical trial coordinator from the Dubowitz Neuromuscular Centre at Great Ormond Street Hospital (GOSH) – to learn more about her role.
Can you tell us a bit about yourself and your role?
From a young age I have always enjoyed learning about science and after completing my Masters degree in Cancer Therapeutics I knew I wanted to work in a clinical research environment. Initially, I worked at Queen Marys University helping to coordinate cancer trials before moving to a MDUK-funded clinical trial coordinator position at GOSH in 2011. As a trials coordinator, I help with the setting-up and running of neuromuscular clinical trials at the hospital. This involves a range of tasks such as trial administration, informing clinical staff about trial protocols as well as organising participant travel.
What’s involved in setting up a clinical trial and how long does it take?
Setting up a clinical trial in the UK can be a lengthy process as it involves many stages. Firstly, a drug company needs to decide which hospital(s) will run the trial – also known as clinical study sites. To be selected, the hospital needs to complete a questionnaire to show it has the right resources to successfully conduct the trial (e.g. research staff, patient population and facilities). The speed of this selection process depends on the drug company; it can be as quick as two months but may take longer. Once selected, the hospital then needs to get approval from different regulatory bodies (ethics committees; MHRA, HRA and others as required). They make sure the trial is safe, well planned and in the patients best interest. In addition, all staff working on the trial need to be trained so that they know what the study protocol involves and what is expected from them. From my experience, once a hospital is selected to run a trial it usually takes six to nine months before patient recruitment can start.
Can anyone take part in a clinical trial taking place in the UK?
Yes, regardless of where someone lives in the UK they can take part in a trial as long as they are registered to a GP, have an NHS number and meet the eligibility criteria of the trial. The eligibility criteria will vary from study to study; you can find out about a trial’s eligibility criteria on clinicaltrials.gov or through the MDUK Research Line. You can also speak to your doctor to find out if you meet the criteria for a particular trial.
Will individuals have to pay any costs when participating in a trial?
Any travel, refreshments and accommodation (if required) costs are paid for. The way these expenses are paid can vary depending on the study. For some trials, participants are required to pay for their expenses and then they will be reimbursed. For other studies, we/parents can pre-book any travel/accommodation costs and have reimbursement through a travel system for refreshments. Before starting a trial, participants are told how the expenses during the study will be paid for.
Is it possible for a UK resident to take part in an international trial?
Every country has their own guidelines regarding trial recruitment, so it’s difficult to say if a UK resident would be eligible to participate in an international trial. I would recommend getting in contact with the trial’s clinical study site(s) for further information on its trial recruitment policy.
If someone has previously taken part in a trial can they take part in another one?
Individuals can usually take part in another study but may have to wait a certain period between trials. This is known as the wash-out period and usually is three to six months. This is to make sure an experimental drug is completely removed from the body before taking another one.
However, at the moment individuals that take part in a gene therapy study (when a virus is used to replace or modify a gene) will not be able to take part in future trials. This is because it is not known how long it takes for the virus to leave the body and is therefore difficult to define the wash-out period.
What advice would you give to individuals interested in taking part in clinical trials?
I would recommend speaking to your neuromuscular consultant/nurse and signing-up to your condition specific registry. At GOSH, we recruit participants for clinical trials from our research database. We select individuals (who meet the eligibility criteria) in the order they were added, essentially a first come first serve approach. Anyone in the UK with a neuromuscular condition can be added to our database, just contact me (firstname.lastname@example.org) or our senior research nurse, Katie Groves (Katie.email@example.com).