10 Questions to Ask Before Participating in a Clinical Research Study
Being diagnosed with a chronic, progressive, or possibly fatal health condition is always disheartening, overwhelming, and leaves you with a sense of helplessness and uncertainty. Some ailments offer a glimmer of hope by providing aggressive forms of treatment, while others can merely be managed by implementing palliative care — something that will alleviate symptoms but won’t cure you. So if you hear about a clinical trial that may help, you may be wondering whether it would be worth participating in. What, exactly, does it all mean? How can you make sure you know everything you need to before signing up? And, what are the crucial questions to ask before making a decision?
What is a clinical trial?
Clinical trials are research studies designed to find better forms to prevent, screen, or treat certain medical conditions. Prior to trying their efficacy on humans, scientists and physicians create a detailed description of their objectives and methods to be implemented.
Each trial has specific eligibility criteria regarding patients who are most likely to respond well to the treatment. This may include age, gender, stage of the illness, how long the person has been receiving treatment, whether the person is taking other medications, lab test results, and other medical conditions.
Once the researchers have all the relevant information regarding treatment and the ideal patients, an Institutional Review Board (IRB) reviews the proposed trial. The IRB is an independent ethics committee (that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. If the IRB approves the study, the trial is allowed to move forward.
Understanding Informed Consent
Before agreeing to participate in a clinical trial, patients are provided with all the details of the trial — including information about why medical researchers believe it will work, everything involving treatment, dosage, duration, and possible side effects. The patient will also be informed of all associated risks and benefits, including that the trial may mean additional visits to doctor appointments, as well as being able to receive treatment from medications that are currently unavailable on the market — but that may have a good chance of improving symptoms and quality of life.
The purpose of the informed consent process is to ensure that the patient fully understands all of the information and implications of the clinical trial. Patients can ask as many questions as they want and for clarification of points already discussed. In addition, if a patient agrees to undergo a clinical trial and then changes their mind, they may withdraw at any time.
10 Questions to Ask Before Participating in a Clinical Trial
The questions listed below are only a starting point. You may do additional research pertaining to the specific trial you are considering, as well as come up with questions of your own based on your own concerns.
- What is the study medication expected to help with?
- How long will the trial last?
- What are the risks?
- What are the benefits of participating?
- Can I exit the trial at any time?
- Does it cost me anything to participate and are medical tests paid for?
- Will I get paid to participate?
- How often will I need to come to the clinic?
- When will I know if I am accepted into the study?
- Can I discuss with my family and doctor first?
Contact Us For Information About Our Clinical Trials
At Pinnacle Research, we specialize in the exploration of disease. We work with over 70 referring physicians in San Antonio and Austin, providing clinical trials in liver disease.
Contact us to discuss how we can help you.