Joining an IBS Clinical Trial: What to Expect

Joining a clinical trial can sound intimidating if you’ve never taken part in research before. People often picture sterile clinical environments, unfriendly people in white coats, and being constantly poked and prodded.

The experience varies between studies. Participation is completely voluntary, and you should always understand what you’re agreeing to before taking part. Clinical trials also give people the opportunity to contribute to medical research and, in some cases, access investigational treatments that are still being studied.

If you have IBS-C and your current treatment has not provided enough relief, you can also learn more about this current IBS-C trial in London, Manchester and Cambridge.

What Is a Clinical Trial?

A clinical trial is any form of research study involving people that investigates a medicine, treatment, diagnostic approach, or other healthcare intervention.

Depending on the trial design, participants may receive the intervention, an existing treatment, or a placebo. This allows researchers to compare outcomes fairly. The number of participants and length of the study also varies between studies.

Each trial is slightly different and has its own:

• research question

• eligibility criteria

• procedures

• duration

• potential risks and inconveniences

Who Checks That a Clinical Trial Is Appropriate?

Clinical research in the UK is subject to ethical oversight. Trials of investigational medicines also require regulatory approval. The bodies involved include:

• the MHRA oversees the regulatory approval of trials involving medicines

• a Research Ethics Committee (REC) independently considers participant rights, safety, dignity, and welfare

• the Health Research Authority (HRA) supports the research approvals process in England

No clinical trial is risk-free. The research team assesses and monitors risks but cannot guarantee an outcome or eliminate every risk.

What Is Informed Consent?

Informed consent means a participant understands what they’re agreeing to. This can include:

• why the research is being carried out

• what taking part involves

• foreseeable risks and inconveniences

• how personal information will be used

• who to contact with questions

Participants always have the right to withdraw at any time. Consent is ongoing, not a one-off signature.

What Are Randomisation and Placebo?

Clinical trials rely on two key concepts to make them fair and accurate.

Randomisation

A computer may allocate participants to different groups at random. Each of these groups may receive a different intervention. That could be the new intervention, an existing intervention, or a placebo.

Placebo

A placebo is designed to resemble the treatment being studied but does not contain the active intervention being tested. It’s the control being compared to.

In a placebo-controlled trial, one group may receive the investigational treatment while another receives the placebo where that is scientifically and ethically appropriate.

Some trials are also blinded, meaning participants, researchers, or both may not know which group someone is in during the study.

What Does Taking Part Usually Involve?

Every trial is different. Taking part may involve an intervention and some level of testing and communication, such as clinic visits or symptom reports.

That could mean clinic appointments, questionnaires, symptom diaries, blood tests, physical measurements, symptom reporting, or follow-up appointments.

Can You Leave a Clinical Trial After Joining?

Absolutely. Participation is always voluntary. You can withdraw at any point in the trial without having to justify your decision.

That said, withdrawal does not necessarily mean that the information collected by the research disappears. It may still be used in the final analysis.

Are Clinical Trials Safe?

Clinical trials are designed with safeguards to minimise the risk to participants. The study protocol sets out how safety will be monitored.

Even with these safeguards, there may be side effects and unknown risks, particularly with a new treatment.

Questions to Ask Before Joining a Clinical Trial

Before agreeing to take part, make sure you understand what the study involves and what your rights are. You do not need to remember everything at once, but these are the main questions worth asking.

About the Study

• What is the study trying to find out, and why might I be suitable?

• What will I actually have to do, including appointments, tests, samples, questionnaires, or diaries?

• Could I receive a placebo, and will I know which treatment I receive?

About Safety and Your Current Care

• What risks or side effects are already known?

• Can I continue taking my usual IBS medication?

• What happens if my symptoms get worse, and who should I contact?

About Your Rights

• Can I withdraw at any time, and will this affect my normal care?

• What happens to my data and samples, and will I be told the study results?

How Do You Join an IBS Clinical Trial?

If you hear about a trial you’re interested in, you can volunteer. The research team will check whether you meet the eligibility criteria before you join.

It’s best to start by reading the study information and contacting the research team. They can answer any questions about the study.

If you have IBS-C and would like to explore current research, you can read more about this IBS-C trial in London, Manchester and Cambridge.

Check out the next article: What Causes IBS-C? Why Constipation-Predominant IBS Is Hard to Treat