Over the past couple of weeks, we have introduced you to clinical trials and the reasons why people should participate in clinical trials. In the midst of the COVID-19 pandemic, clinical trials have taken the spotlight and everybody is closely observing the developments for a cure or vaccine. Research studies are, however, fairly new to many people. Over 50% of Americans are not aware that clinical trials even exist in the United States. We want to change this! Without clinical research, there is no innovation in medicine and thus no cures or life-saving treatments can be brought to market. But what can you expect when signing up for a clinical trial? Let’s get into the nitty-gritty.
Signing up for a clinical trial
Signing up for a clinical trial might seem like a daunting thought, but it’s actually something that millions of people are taking part in every year to make a difference for their health communities and drive medical innovation further, with numbers of volunteers increasing constantly.
It is totally ok to have reservations about volunteering for a research study and important to make a well-informed decision whether clinical trial participation is for you and if you can commit your time and efforts to a research study. Therefore, it is crucial to look into the benefits and risks of participating and the commitment needed in order to feel comfortable with your decision and understand what happens over the course of a clinical trial.
Before the Trial - understanding the research set-up
You have decided to participate in a clinical trial? That is exciting news! After filling out a pre-screener (survey) with the information needed by the research site, you will be matched with the best suitable trial for your health condition (or as a healthy volunteer). Your information will be strictly used for clinical trial purposes and your data privacy will be secured.
Once you have been matched, you will be contacted by the doctor or researcher conducting the clinical trial. They will explain the purpose of the clinical trial, how long it will be conducted and the treatment that will be studied. They will also provide more information on the commitment they are looking for, the reimbursement that you will receive, risks and benefits associated with the clinical trial, and how long the trial will last. This depends on the trial protocol and may be between 6 and 24 months.
Further, you will also be given an informed consent form, that states that you have been informed about the clinical trial and that participating is absolutely your choice. During this conversation, you can also ask questions, express concerns, and clarify what is unclear for you. As a reminder, you can drop out of a clinical trial at all stages of the process if you feel in any way uncomfortable.
In addition to the conversation, you will also be pre-screened - this means the research site will determine whether you are meeting the requirements of the trial. Pre-screening involves a variety of questions and sometimes some medical check-ups in person or via phone. Once you have passed the screening, the researcher will enroll you in the study, if you still wish to do so.
What happens during a clinical trial?
Once you are enrolled in a clinical trial, you will be put into a treatment group with other participants, depending on the type of trial you are participating in. During your time with the research study, your health will be monitored on a regular basis in order to understand how treatments are working and to detect possible side effects. This is a great benefit, as you will have access to medical experts and care (for free) and the likelihood of any sudden changes in your health being detected extremely quickly.
The medical check-ups might be conducted in the form of regular visits to your physician, writing a health diary, or filling our regular surveys, depending on what the trial protocol states. In general, it depends on every individual trial on how they would like to monitor your health and will be discussed with you beforehand. As mentioned before, it is, however, essential to understanding the time commitment linked to participating in clinical trials before you sign up.
Concluding your clinical trial
After the study has concluded and you have completed your participation in the clinical trial, you will receive access to the results. They are likely to be published by the researchers regardless of the outcomes, which gives the public the opportunity to become more informed and make decisions about their healthcare.
Regarding the treatment that you have received over the course of the clinical trial, it might not always be possible to continue with this treatment as long as bringing the treatment to the mass market is not approved yet. In addition, the costs involved in continuing with the treatment can be significant and depend on your healthcare plan. This should not discourage you from taking part in a clinical trial as the benefits of these treatments are significant for millions living with certain health conditions and yourself in the future.