Clinical trials refer to the research studies that investigate new treatments for diseases or new combinations of treatments. They help to achieve progress in research, improved treatment options, and better outcomes for patients.
Many people participate in the clinical trial for two main reasons: the hope of getting better treatment and helping the research community. But before deciding whether to participate in a clinical trial or not, many concerns need to be addressed.
The principal investigators play a critical role in the safe onboarding and retention of the participants. They are responsible for providing the participant and their caretakers all the information and clarifying their doubts about the trial.
Let’s look at some of the most common questions that arise in the participant’s mind:
1. Is it risky?
Yes, all clinical trials, like any medical procedure, have risks. These trials are new; hence the unknowns are more. The risk factor increases. Some potential risks can include the treatment not working on you, unknown and unexpected side-effects, more doctor visits, and the greater the time commitment. If you are a part of randomized trials, you may not have your choice of treatment. There can be issues with the costs, as insurers may not cover all of them.
However, the bigger question is if these risks outweigh the possible benefits. You have the chance to get a treatment that might be safer or work better on you than available treatments. You will have access to your team of doctors who would be monitoring you and your side effects. The research you are a part of may help others with the same disease. Always discuss with your insurer beforehand about the insurance coverage before you take part in a trial.
2. Would I be a guinea pig?
No, you will not be a guinea pig. Although the purpose of a clinical trial does involve answering a medical question, that does not mean the participants do not get the best care from the team. It is crucial to take your time, clarify any doubt, and feel good about the decision.
3. Would I get the drug or placebo?
A placebo is a treatment, sometimes called the sugar pill, used in some clinical trials. They help make sure the results are from the new treatment or drug. They are seldom used alone in trials unless there is no alternative treatment. If used, it would be with an active drug. It is not ethical to use a placebo on someone if there is a treatment that is known to work. In rare cases, trials use a placebo to prove that the treatment is better than nothing.
4. Safety & Confidentiality
Your personal information and your medical data will be kept confidential as much as possible. The doctors would, of course, need the data to give you the best possible care. All the required data would be put on systems and is shared only with the team that analyzes the study results. Your personal information will be safe and not used in any published clinical trial results.
5. Do I have to pay?
In most cases, the sponsors of the study pay the cost for the treatment and tests. Some even cover doctor visits and travel. You should find out what will be paid for before you get involved in a clinical trial. Insurance coverage for clinical trials for some life-threatening diseases is also available. Make sure to go through all the requirements and conditions before the clinical trial.
6. Can I quit?
Yes. The consent of participants is the most vital thing in a clinical trial. You have the right to quit the clinical study at any time.
7. How long and what follow-up procedures precautions to follow after treatment?
This is the duty of the Principal investigator/physician, to provide information about the duration, frequency of tests, follow-up visits and provide all necessary precautions for the participant. The follow-ups may vary based on the study/treatment etc. It is however a critical question for the participants to know before they enroll in the study.
Decision: Should I participate?
It can be a difficult question to answer. The answer won’t be the same for everyone and While deciding, ask yourself some questions:
- Why do you want to take part?
- What are your goals and expectations? How realistic are these goals?
- How sure are the doctors about this clinical trial?
- Do you have all the details you need to make an informed decision?
- Have you weighed the benefits against the risks?
- Do you thought about other factors, like travel, time, and money?
- Have you looked at your other options?
These questions may not have clear answers but will help you start thinking about them. Each person’s situation and reason for participating or not participating may be different. The participant can make their decision based on the responses to the queries from the principal investigator at the time of consenting.
We hope it addresses the common concerns about clinical trials and will help you make an informed decision. In case you would like to know more about why you should participate in a clinical trial read our blog for more information.