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Who is behind a clinical trial? Meet the people who make clinical research possible.

When you take part in a clinical trial, you may mainly interact with a doctor, research nurse or study coordinator. But behind every appointment, test, study medication and piece of information collected is a much larger team. Clinical research brings together healthcare professionals, scientists, coordinators, data specialists and independent organisations, each with a different responsibility.

In this article, we take a closer look at some of the main people involved in a clinical trial, including those you may meet during the study and many others working behind the scenes.

The people you are most likely to meet

The exact team will depend on the study and where it takes place. However, these are some of the people participants are most likely to come into contact with during a clinical trial.

The Principal Investigator (PI) leads the trial at a particular research site, overseeing the study team and making sure the research is conducted correctly and participants are properly protected.
Study doctors and investigators help care for participants and carry out the study. They may review your health, perform examinations, discuss possible side effects and answer medical questions about the trial.
Research nurses and clinical research practitioners are often key points of contact for participants. They may explain study procedures, organise visits, carry out assessments, collect information and answer questions throughout the study.
The study coordinator helps organise the day-to-day running of the trial, arranging visits, coordinating the research team, maintaining study records and helping ensure study procedures happen at the right time.
Pharmacists and other specialist teams may manage study medicines, analyse samples, perform scans or carry out other tests required by the trial, depending on the type of research.
The people working behind the scenes

Many of the people involved in your trial may never meet you personally. Their work nevertheless helps make sure the research is properly organised, monitored and analysed.

The sponsor is the organisation responsible for setting up and managing the trial. It may be a pharmaceutical company, university, hospital, public healthcare organisation or another research organisation.
A Contract Research Organisation (CRO) may carry out some activities on behalf of the sponsor, such as coordinating research sites, monitoring the trial, managing data or supporting safety and regulatory activities.
The clinical project manager coordinates different parts of the trial, keeping track of timelines, research sites and specialist teams and helping the study progress according to plan.
A Clinical Research Associate (CRA), or monitor, checks research sites to make sure the study protocol and relevant requirements are being followed and important study information is recorded correctly.
Data managers organise and check the information collected during a clinical trial, helping ensure that study data is complete, consistent and ready for researchers to analyse.
Biostatisticians help plan how study results will be measured and analysed, using statistical methods to help researchers understand what the collected data tells them about the treatment being studied.
Safety and pharmacovigilance specialists review medical problems and possible side effects reported during the trial, looking for important safety concerns and helping ensure they are assessed and reported appropriately.
The people providing independent oversight

The people running a trial are not the only ones looking at how it is conducted. Independent organisations and committees also play an important role in protecting participants and reviewing whether the research meets the necessary standards.

A Research Ethics Committee (REC) independently reviews the study, paying particular attention to participants’ rights, safety and wellbeing, as well as areas such as informed consent and participant information.
The MHRA regulates clinical trials of medicines, reviewing applications before trials begin and maintaining an oversight role while research is underway.
An Independent Data Monitoring Committee, used in some trials, reviews study information such as safety data and may recommend whether the study should continue as planned or whether changes should be considered.
Patients are part of the research team too

None of these roles would have a purpose without the people who volunteer to take part in research. Participants are not members of the study staff, but they play an active role in making research possible. Attending study visits, completing questionnaires, reporting symptoms or changes in health and sharing their experiences all contribute information that researchers need to answer the questions the study was designed to investigate.

Patients and members of the public can also contribute before and beyond participation in a particular trial. This is often known as Patient and Public Involvement, or PPI. People with lived experience may work alongside researchers to help identify questions that matter to patients, review participant information, comment on whether study procedures are realistic and help researchers communicate their findings more clearly.

Clinical research is therefore much more than the interaction between a participant and a study doctor. It depends on many people working together, often without ever meeting the participant.

Within the British Research Panel, our clinical research nurses are among the professionals who help members navigate the first steps towards a clinical trial: answering questions, discussing relevant health information and helping assess whether a particular study might initially be compatible with their situation before formal screening by the research site. They work alongside other members of our team to help patients understand the process and what may happen next.

You have to be absolutely transparent from the start. You need to create a relationship with the patient very quickly and give them time to think about it and speak to family, friends, their GP. You support them and you give them a lot of time, you absolutely don’t rush them.

~ Paula, Research Nurse

If you have questions about clinical research, our Community or one of our studies, you can write to us at info@britishresearchpanel.co.uk