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What to Expect from a Clinical Trial

12 September 2016

Taking part in a clinical study may feel like walking into unknown territory. After all, you’re no expert on the drugs that are being trialled. What you are, however, is an expert on the condition that the drugs are designed to treat, and your input could be instrumental to benefitting you and others like you.

You can also take comfort from knowing that over 605,000 people took part in clinical trials last year. The highly-regulated trial process has protected all of their best interests while paving the way for life-saving treatment.

If you’re wondering whether a clinical trial is right for you, then you will no doubt have a lot of questions. We hope to give you an idea of what the process will be like in practice, so that you can make your decision with confidence!

Before the Trial

The first and most important thing you will have to do in any trial is give your full informed consent. This means that you will be talked through the trial’s aims, risks and benefits, and asked once again if you wish to take part. You will sign an informed consent form, which will lay out your rights during the trial - including your right to withdraw at any point.

This is the point at which you should ask any questions that you have about the process - it may help to write them down beforehand, so that you and the doctors conducting the research can start off on the same page!

You will then be randomly assigned to either the treatment group or the control group. You may not be informed of which group that you’re placed in, to prevent bias.

If you’re in the treatment group, you’ll be given the new drug that’s being assessed. If you’re in the control group, you’ll be given an existing treatment or a placebo. All other conditions of the process should be the same for both groups.

During the Trial

Most clinical trials consist of patients taking the treatment they have been assigned, and doctors carrying out regular tests to see how well the drugs are performing.

You may also be interviewed, surveyed or asked to keep a diary about your experience, including any side-effects. That’s why it’s important that you pay close attention to any physical or psychological changes during the trial period. What you may normally pass off as a brief dizzy spell could be important data for your researchers to take into consideration!

Researchers are also interested in your quality of life during the treatment, so any issues such as being unable to work full time or care for your family as a result of increased hospital visits will be taken into account. It is your role to discuss any concerns you may have about any aspect of the treatment - don’t be afraid to speak up!

Clinical trials usually come in several phases, and depending on which phase of a trial you agree to take part in, the process may differ slightly.

Trial Phases

Phase one trials are usually concerned with side effects, and how much of a drug can be taken before negative side-effects occur. Therefore, healthy volunteers may be used as well as or instead of sufferers of the condition. Doctors will gradually increase the dose administered over the course of the trial, but will stop once minor side effects begin to occur.

Phase two trials test an approved dosage on a group of people currently suffering from the condition in question. This phase is concerned with observing positive effects in the short term, and weighing them up against minor side-effects.

Phase three trials are designed to compare the approved drug with an existing standard treatment, considering whether there is any specific improvement over what’s currently on the market. These observations are made over a longer period of time, and on a significantly larger sample size.

Medicines which pass all three phases and are made commercially available may be subject to phase four testing, in which researchers monitor patients using the treatment on a regular basis, keeping an eye out for long-term side effects.

After the Trial

You may decide to leave a trial at any point if you feel the treatment is having no effect or a negative effect. You do not need to state your reason for leaving a trial, although it may be useful information for researchers to use in future trials.

If you do see a trial through to the end, the researchers will publish the official results and results and make them available. It is your right to see these results if you want to, so don’t be afraid to ask if your doctor doesn’t offer them to you. On the other hand, you’re under no pressure to examine the results if you don’t want to.

While you are within your rights to discuss continuing the new treatment with your doctor, this is not always possible immediately. You may need to wait for further trials to conclude before the treatment is publically available.

The researchers and doctors who worked with you during the trial will be available should you wish to discuss any concerns or side-effects once the trial is over. Your comfort, health and confidence are of their primary concern before, during and after the clinical study process.

Have you experienced a clinical trial? What do you wish you’d known going into it? Have your say by joining the discussion on our LinkedIn community!

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