An Introduction to Clinical Trials

What is clinical research?

Human volunteers with certain illnesses or medical problems have a clinical study carried out on them to test the effectiveness of a new drug, device, biologic such as a vaccine or other interventions or treatments. This is the safest and quickest way to find out if treatments work in people and to find methods for improving health.

- Interventional trials – show if experimental treatments or other ways of using already used therapies are safe in a controlled environment.

- Observational trials – research health issues in natural environments for large groups of people or even populations.

Why would you consider participating in clinical research?

1) You will help your fellow human beings by contributing to medical research.

2) You have access to new methods or treatments before they become publicly available.

3) You will be taking more of an active role in your own medical care.

4) You will be receiving expert medical care in leading health care facilities.

Can you participate in a clinical research study?

You have to qualify to take part in a study. There are clear guidelines on who can and cannot participate in clinical research.

· Inclusion criteria show you if you are eligible to take part.

· Exclusion criteria show you when you cannot take part.

· These criteria are used to make sure that reliable results are obtained.

· The criteria include your sex, age, the type of disease you have and what stage it is at, any other medical conditions you have and any medical treatment you have already had.

Some studies need people with an illness or condition and some studies actually require people who are in good health. The important thing is to keep all research study participants safe. The criteria are in place for that reason as well as finding appropriate people to participate.

What is the clinical trial process?

This depends on what type of research study is being carried out, but the team involved has health care professionals along with doctors and nurses.

1)As a participant, your health is checked at the beginning before the trial starts.

2)You are given specific instructions.

3)You are carefully monitored throughout the trial. In fact, a lot of clinical trials need you to have more tests and doctor visits than are normally involved with your condition or illness.

4)The research team keeps in touch with you after the trial has finished.

5)There will be a plan, known as the protocol, which you have to follow to the letter. The protocol will have been designed to bring answers to particular research questions and most importantly to safeguard you and your health.

The protocol includes:

· A description of the types of people who are able to participate in the study.

· How long the study will be for.

· Depending on the type of trial, the schedule of medical dosages, the procedures and tests.

There are different types of trials. Those trials that do not involve treatment or intervention include surveys, questionnaires, and interviews. Those trials that involve treatment or intervention require regular monitoring of the health of the participant as well as the effectiveness and safety of the treatment.

Informed consent

You should only take part in a clinical trial if you have been fully informed of what the research process entails and the risks involved. The research team should also keep you informed throughout the study. Once you have been informed you will be given a consent document to sign, with all the information about the study including how long it will be, the process and the risks, along with the potential benefits.

If you sign the informed consent form you are not binding yourself to a contract and you can stop participating whenever you choose to during the research study.

Experimental and control groups

When you participate in a clinical trial you may be in an experimental or control group. This means that the experimental treatment is compared with one already being used or with what is known as a placebo which is an inactive pill, powder or liquid. It is used as a control and has no value treatment wise.

So, some participants will receive an active experimental drug or treatment and others will receive a placebo. These are randomly assigned and you have no choice in the matter. You and the research team do not usually know which the active or inactive treatment is until the study is finished.

Risks involved

We looked at the benefits under the why you would consider clinical research section. Now let’s look at the risks involved:

· The study may take up a lot more of your time in doctor visits and extra treatment and stays in hospital.

· You may find your condition or illness getting much worse due to the experimental treatment or receiving a placebo.

· There could be serious side effects.

· The experimental treatment may have no effect on you.

Before deciding to take part in a clinical trial make sure that you are well informed about the whole process and the risks involved.