Your Role in Clinical Research: A Participant’s Guide

All new treatments, including medications, surgical procedures, devices, and preventative care, must undergo rigorous testing before they are administered to the public; one of the ways treatments are investigated is through the clinical trial process.

What are clinical trials and why do we need them?

Clinical trials are a form of research that studies the efficacy and safety of treatments in humans, using patients, healthy volunteers, or both¹. The purpose of trials is to evaluate whether a treatment or diagnostic technique works, whether it works better than existing treatments or techniques, and whether there are any adverse effects in its use. A clinical trial only occurs after many years of stringent testing, a safety panel and ethical review, ensuring that the study design is thorough and respects the rights, dignity, safety, and wellbeing of the participants.

Biomedical clinical trials have four phases:

• Phase I: Usually this will involve testing a new medication for the first time in humans, most likely a small group, known as a cohort, of healthy volunteers to note any adverse effects (tolerability) and determine a safe dosage range.  Often there is an additional cohort or a separate phase 1 study which tests the investigational medicine in the patient population, known as first in patient.
• Phase II: This phase expands on medications found to be safe in Phase I with a larger group of people (usually people with the disease that is being targeted by the medication) to monitor side effects and understand if the medication is effective in the treatment of the condition.
• Phase III: In Phase III, the investigational treatment is further tested on a larger population of patients with the condition, usually in different regions, and countries. This is often the step before a new medication is approved for general use.
• Phase IV: This takes place after country-level approval to examine the medication further in a wide population over a longer time period².

For the next phase of a trial to commence, the data of the previous trial must be fully assessed, and each phase must undergo a safety panel and ethical review. Clinical trials are heavily regulated by both national and international bodies and are a necessary part of the development of new treatments. Without clinical trials, there would be exceptionally limited advancement in medicine.

What to expect during a clinical trial

Clinical trials will vary depending on the phase and treatment type, however, there are some constants. Typically, in a clinical trial:

1. After you apply to be on the study, research staff will contact you and explain the trial in detail. They will answer any questions and collect further information about you to explore whether the study is the right fit for you.
2. If you choose to participate, you will sign an informed consent form confirming your understanding of what to expect from the study.
3. You will then be screened, which can include a comprehensive health check and assessment of your medical history, to ensure that it is safe for you to take part and that you meet the required criteria of the study.
4. If eligible, you will schedule a first ‘baseline’ visit, where researchers may conduct additional health tests.
5. You may be randomly assigned (usually by computer) to a participant group. You will not know which group you have been assigned to. In most cases, clinical trials are ‘double-blind’ which means that the medical personnel and researchers administering your treatment also do not know your group assignment⁴. You will be assigned to either:
   1. The treatment group, where you will receive the treatment that is under assessment, or,
   2. The control group, where you will be given an existing treatment or a placebo¹ (a treatment that has no active properties, like a sugar pill³).
6. You will then follow the trial procedures⁵.

You may withdraw from this process at any time for any reason and should be honest with researchers and doctors if you are experiencing adverse effects – the wellbeing of our participants at MAC is our utmost priority.

Why participate in a clinical trial?

Without clinical trials and clinical trial participants, we would not have many of the medications, treatments, and preventative care that we currently benefit from. This includes but is not limited to, vaccines, chemotherapy, and cognitive behavioural therapy⁵. Clinical research can, and does, save lives.

If you live with a mental or physical health condition, you may want to take part in a clinical trial to have access to the newest treatments in development, particularly if previous treatments have been unsuccessful or without sufficient benefit. You may also want to be a part of advancing healthcare for people living with your condition, or in general. By taking part in clinical research, you can take an active role in your own healthcare and contribute to improving healthcare for future generations! You may also receive payment for your participation.

How to get involved in a clinical trial

There are several different ways to find out about clinical trials near you. You can ask your doctor or a patient organisation if they are aware of suitable trials for you or take advantage of the NHS and WHO websites, ClinicalTrials.gov, and charity pages for certain health conditions. There are also organisations like MAC Clinical Research who are dedicated to testing new and improved treatments for a broad range of medical conditions such as depression, non-alcoholic steatohepatitis (NASH), OCD, and more.

If you decide to take part in a study with MAC, you will be closely monitored by our research doctors and nurses, and your GP will be fully informed of your participation. Many trials will also provide a patient payment, and all MAC studies endow reasonable travel expenses or transportation for site visits.

To find out more about our upcoming studies and to register your interest in taking part in a clinical trial, visit our current studies webpage.

References

1 NHS – Clinical trials

2 WHO – Clinical trials

3 Better Health Channel – Placebo effect

4 NCI – Definition of double-blind study – NCI Dictionary of Cancer Terms

5 National Institute on Aging – What Are Clinical Trials and Studies?