What is a clinical trial?
A clinical trial is essentially an experiment with human subjects. Don’t let this scare you, though. Clinical trials are the last stage of testing, so by the time a drug or treatment reaches this stage, it has been proven to be fairly safe and effective. Also, clinical trials are regulated by ethics and safety committees, so while there are risks involved, every precaution is taken to ensure these are minimal.
Not all clinical trials involve medications or treatments. The types of clinical trials include:
Why are clinical trials important?
Clinical trials are the only way medical professionals can know how a particular drug or treatment works on people. They are also essential for determining the potential side effects of the drug or treatment and deciding whether these side effects are outweighed by the benefits.
Who conducts clinical trials?
Clinical trials are usually sponsored (that is, funded) by government agencies or private companies and conducted by experienced medical researchers in a variety of settings.
Why should I participate in a clinical trial?
Participating in a clinical trial offers many benefits. You’ll get access to cutting-edge treatments and therapies, usually free of charge. You’ll also have access to doctors and researchers at the very forefront of knowledge about your particular condition. If the treatment works, you may experience an increase in your quality of life. At the very least, you’ll be contributing to medical knowledge about your disease, which in turn will help others with the condition down the road.
What are the risks of clinical trial participation?
The biggest risk with clinical trial participation is that you will end up in the control group, meaning that you don’t receive the new treatment or therapy. However, even if this happens, you will still receive the free medical care and attention from doctors and researchers, and you will be no worse off than before.
Specific risks related to the particular drug or treatment being tested vary widely and may include permanent injury or death, but in general, such dire effects are rare. Pain or discomfort of some form (headaches, nausea, vomiting, dizziness, etc.) is not uncommon but does not affect everyone. Often, patients in clinical trials find the benefits of the drug or treatment worth any unpleasant side effects.
How do I sign up for a clinical trial?
If you’re interested in participating in a clinical trial, visit our Patients page for a list of trials currently seeking participants. Enter your information into the form, and we’ll match your condition and other particulars with the list of trials from our sponsors. You will receive an e-mail notification of active trials and a link to the screening form, which will take between 10 and 15 minutes to complete. Once you’ve filled out this form, your file will be reviewed against the study requirements, and if you qualify, you will be entered into the study.
The process and location of the study will vary according to the particular trial. The trial sponsor will provide more specific information upon your acceptance.
Will I be compensated for my participation?
Compensation depends on the particular trial. Almost all trials include free medication or treatment, as well as free medical attention. Some also provide monetary compensation for time and/or travel.
How long will the trial take?
Clinical trials range in length from hours to years. Furthermore, the number and frequency of visits to the laboratory or research site will also vary depending on the specific trial. Once you are approved for entry into the study, the trial sponsor should provide all the details and timelines.
Although you have the right to quit a clinical trial at any time, this can skew the results, so you are encouraged to participate only if you intend to complete the trial in full.
Will my name or information be published?
No, your name and personal information will not be published. In fact, your information will remain confidential, except in cases where it must be shared by law. Trial sponsors and government or regulatory bodies may review the research files, but they, too, are bound by confidentiality protocols not to share that information with outside parties.
Will I have to pay?
You should not have to pay for a clinical trial. What expenses are not covered by the sponsor should be covered by insurance and vice versa. In the case that you incur travel expenses, the trial sponsor will usually reimburse you.
What is informed consent?
Informed consent is the principle by which participants in a clinical trial must know and understand all of the procedures, risks and benefits before they decide to participate. When you qualify for a clinical trial, you will be given a document that outlines this information, which you should then read over carefully before signing. By signing the document, you are acknowledging that you understand the clinical trial and agree to participate in it.
Even if you sign an informed consent form, you can still leave the trial at any time, and don’t be afraid to ask questions or seek clarification throughout the trial. Clinical researchers are dedicated to making the trial work, and part of that is ensuring the comfort (physical and mental) and safety of the participants. You will likely find that they are happy to provide explanations and reassurances as necessary.