Your normal healthcare will not be affected by taking part in a clinical trial.

During the trial, you can continue to visit your doctor for any health issues not related to your participation in the trial.

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

Play an active role in their own health care.

Gain access to new research treatments before they are widely available.

Obtain expert medical care at leading health care facilities during the trial.

Help others by taking part in a research trial.

There are risks to clinical trials.

There may be unpleasant, serious or even life-threatening side effects to experimental treatment. All risks are discussed with you before you decide to take part in a trial.

The experimental treatment may not be effective for the participant.

It may require more of their time and attention than would a non-protocol treatment, such as trips to the study site or completing a symptom or drug diary.

Experienced doctors and nurses will closely monitor you during the study. In fact, participants in clinical trials are often more closely monitored than patients treated outside clinical trials.

This is because trial protocol requires detailed collection of health data and frequent patient checkups to assess how patients are doing.

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, clinical research is regulated with built-in safeguards to protect the participants.

The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. An Ethics committee has to have approved a clinical trial before it can begin.

Clinical trials are carefully designed research studies in which people help doctors find ways to improve health and care related to specific diseases or medical conditions.

Each study tries to answer a scientific question and find better ways to prevent, diagnose, or treat that condition.

We are regulated by The Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in the United Kingdom (UK).

The MHRA grants permission for clinical trials to be conducted in the UK in accordance with the MHCTR and the MHCTR2006.

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials look at ways to improve comfort and the quality of life for individuals with a chronic illness.

After you start receiving treatment or care according to the research protocol, you may decide you no longer wish to continue in the trial.

You can withdraw your consent to take part in a trial at any time and you do not have to give a reason.

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies collect additional information including the drug’s risks, benefits, and optimal use.