What to expect when joining a clinical trial?
Taking part in a clinical trial might seem like a daunting prospect, but it’s actually something that millions of people do every year, and the number of active volunteers is steadily increasing all the time!
That said, it is understandable to have reservations about volunteering for a study, they require a significant commitment in terms of time and effort. Perhaps the biggest concern potential participants have is the fear of the unknown. Without knowing what exactly a trial will involve, it's hard to make an informed decision about whether to take part or not.
So what exactly can you expect if you participate in clinical research?
Before The Trial Begins
Understanding the Trial
When you are initially contacted by the doctor or researcher, they will go over the details of the trial with you and explain the purpose of the trial and the treatment being studied. They will also outline the practicalities of what your participation would involve and the risks and benefits of your participation. This presents a great opportunity for you to ask further questions and seek clarification about anything that you may be unsure of.
You’ll also undergo a screening process to determine if the trial is right for you and if you meet the eligibility requirements. This will involve a series of questions and perhaps some medical checks, which may be completed through a combination of phone conversations and a visit to your nearest study site. Once this is complete, the researcher will confirm if you are eligible to enroll in the study, should you wish.
Once you have been enrolled in a clinical trial, you will be divided into treatment groups with other participants, with the group type depending on the type of trial.
In a controlled clinical trial, you will be allocated to a group before the study begins. If you are in the trial group, you will be given the new treatment that is being tested. But if you are in the other group (the control group), you may be given a similar treatment, a placebo, or no treatment at all.
Control groups play an important role in helping researchers to determine if the new treatment has a stronger effect than existing treatments or has any effect at all as opposed to not having any treatment.
Blind and double-blind trials
If you’re taking part in a ‘blind’ clinical trial, you won’t know whether you are in the trial group or the control group. The treatments given to each will be designed to look as similar as possible, meaning that you won’t be sure whether it is a placebo, an existing treatment, or the new treatment. This enables researchers to collect results without the knowledge of which treatment you’re taking affecting the way you feel or report your symptoms.
In a double-blind trial, both you and the doctors administering the treatment are blind as to who is getting which treatment, and this is only revealed at the end of the trial.
A ‘randomized’ trial is where you are allocated to a study group completely at random, usually with the help of computer software. This ensures that the researchers cannot interfere with the selection in any way.
During your trial
While you are taking part in a clinical trial, the researchers conducting the study will want to monitor your health regularly. This will help them understand how the treatment is working, and detect any possible side effects you may be experiencing. This might mean regular visits to your physician, keeping a health diary, or completing frequent questionnaires. It's important to understand the time commitment that is needed to be part of a clinical trial and determine whether it is right for you at the time before you sign up to participate. However, being monitored so closely by medical practitioners provides the benefit of having access to expert advice and the likelihood of any sudden changes in your health being detected extremely quickly.
After Your Trial
After you’ve completed your participation and the study has concluded, the results will be made available to you, should you want them. They are likely to be published by the researchers regardless of the outcomes. This allows the wider public to become more informed and make decisions about their healthcare.
You may want to continue the treatment you were on as part of the trial. However, that might not always be possible. Even if a trial is successful, getting the approval to bring a new drug to the mass market can be a lengthy process. There may also be significant costs involved in continuing with the treatment, depending on your healthcare plan. This should not deter you from participating, however, as clinical trials are crucial to understanding and perfecting new treatments and bringing them to those who need them. In the long term, the benefits are significant not just for yourself, but for millions living with conditions like yours both now and in the future!