Frequently Asked Questions – “What should I know before starting a clinical trial?”
Are you considering participating in clinical trials? Chances are you have lots of questions! Participating in clinical research can be a difficult decision since there is not a lot of information available.
You may be left wondering what exactly clinical research is, what are the risks and benefits and ultimately if you should even participate.
At TheClinResearcher we are here to help you understand more about clinical research and empower you to make an informed decision when it comes to your health.
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Learn everything you need to know about participating in clinical trials
1. What is Clinical Research?
- Question: What exactly is clinical research, and what does it involve?
- Answer: Clinical research is used to discover new medications, devices and treatments for different health conditions. Clinical trials are done to find out if a new medication, device or treatment is safe and effective. Many clinical trials involve taking medication but for others you may be trying a new device such as a heart rate monitor, or a new blood pressure machine.
Click here to learn more about what clinical research is.
2. Why Should I Participate?
- Question: What are the benefits of participating in a clinical trial?
- Answer: There are many reasons why you should participate in a clinical trial. Some of the benefits include having access to new medication and treatments, getting paid to participate, gaining a better understanding of your health and helping to improve healthcare for others.
3. What Are the Risks?
- Question: What risks are involved in participating in clinical research?
- Answer: Just as there are risks in taking medication that has already been approved, trying medications that are still in research can have an inherent risk. There may be side effects or discomfort from procedures such as getting blood work. There is also the risk that the medication or treatment is not effective. The research doctors and nurses will however keep a close eye on your health throughout your participation in the study. You will also report any potential side effects to make sure your participation in the study is as safe as possible.
4. How is My Safety Protected?
- Question: What measures are in place to protect my safety during the study?
- Answer: Clinical trials are regulated by ethical guidelines and oversight committees such as Institutional Review Boards (IRBs). These bodies ensure that the study is ethical and that participants’ rights and safety are protected. Researchers must also follow strict protocols to minimize risks.
5. What is Informed Consent?
- Question: What does the informed consent process entail?
- Answer: The informed consent process is very important as it is usually the first step in your participation in clinical trials. At this stage the clinical research team will give you lots of information about the trial you are interested in participating in. You will also have all of your questions answered by the doctor and nurses. Once you feel comfortable with all of the information, you will be asked to sign the consent form. By signing the form you are giving the research team your permission to start the clinical trial process. You can however, take back your consent at any time if you decide you no longer wish to participate.
6. What Will Be Required of Me?
- Question: What will I have to do if I participate in the study?
- Answer: Your participation will depend on the clinical trial you enroll into. Every clinical trial will be different, however, this can involve procedures such as physical exams and blood work. You may also be expected to fill out diaries or take surveys to track your symptoms. The research team will make sure you understand what is expected from you while you participate in the trial.
7. Will I Be Compensated?
- Question: Is there any compensation for participating in the study?
- Answer: Most clinical trials offer payment for your time and efforts in participating. There are however studies that may not offer compensation. The research team will inform you whether there is compensation for the clinical trial and if so, what the amount will be. Usually you will be paid for each study visit and sometimes you can also be compensated for your travel to the site.
8. Can I Withdraw from the Study?
- Question: Can I leave the study if I change my mind?
- Answer: Yes, it is important to understand that you can leave the study or “withdraw your consent” at any time. If you decide you no longer wish to participate, let the research team know and they will instruct you on the next steps to end your participation.
9. How Will My Privacy Be Protected?
- Question: How is my personal information kept confidential?
- Answer: Researchers are required to protect participants’ privacy by using coded numbers instead of names, storing data securely, and only sharing information with authorized personnel. You can read more about how your data will be stored in the informed consent for the specific trial. And of course you will be able to ask additional questions when you visit the clinic.
10. What Happens After the Study Ends?
- Question: Will I receive any follow-up care after the study concludes?
- Answer: Sometimes follow-up care is included in the clinical trial and this will be outlined in the informed consent for each specific trial. If follow-up care is not included in the clinical trial, care returns to the patient’s healthcare provider.
11. How is the Research Funded?
- Question: Who is funding the study, and why is it important?
- Answer: Clinical trials can be funded by pharmaceutical companies, government agencies, academic institutions, or non-profit organizations.
12. What if I Have More Questions?
- Question: Who can I contact if I have more questions about the study?
- Answer: Participants should be provided with contact information for the research team, including a primary investigator and study coordinator, who can answer any additional questions.
13. How Do I Find Clinical Trials?
- Question: How can I find clinical trials that I might be eligible for?
- Answer: There are resources available such as clinicaltrials.gov which is a registry with thousands of clinical trials. You can sort through trials based on filters such as whether they are enrolling and which medical condition they are for.
Using clinicaltrials.gov can be confusing and is not very user friendly, we suggest using our article here for detailed step by step instructions.
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To wrap up
Understanding the answers to these common questions can help you make the best decision when it comes to your health. Clinical trials can seem confusing as there is not a lot of information available.
At TheClinResearcher we are passionate about bridging the gap in clinical research by raising awareness and education. We hope you find this site helpful and that you will feel empowered to make the right decision for yourself when it comes to clinical research!