Clinical trials are an essential tool for finding new and effective drugs and treatment options for a variety of diseases and conditions. For the individual, signing up for a clinical trial can be an excellent way to find a new treatment for a condition, or to make some easy money as a healthy person. No matter how lucrative the payout might be, you should never join a clinical trial without doing copious amounts of research first. What sort of questions should you be asking before you sign on the dotted line?
What is This Clinical Trial Treating?
The first question you should ask before joining a clinical trial is what the new treatment or drug is being used to treat. Every day, around the world, there hundreds of clinical trials in various stages going on, looking for new ways to treat everything from cancer and diabetes to Alzheimer’s and multiple sclerosis. These trials are making amazing advances, like the recent announcement of a complete reversal of Alzheimer’s-related memory loss, but in order to make these advances, researchers need healthy volunteers to assess how well these treatments work.
When you join a clinical trial, the first thing you should ask is what condition or disease that this trial is attempting to treat. This will give you an idea of what the trial might entail, and what sort of appointments or tests might be involved.
What Phase is the Trial In?
There are four phases that a clinical trial could potentially be in when you sign up.
- Phase I means the treatment has just passed animals trials, and is moving into the first human tests. These phases are usually made up of healthy adults and are designed to find the optimum dosage.
- Phase II applies the dosages determined in Phase I and monitors trial participants for treatment efficacy and possible side effects.
- Phase III utilizes larger groups of trial participants to further hone the dosages, monitor side effects, and compare to other conventional treatments used for the same condition. This is also the last phase before the drug or treatment is released for public use.
- Phase IV is made up of large-scale studies after the drug is on the market. This allows the researchers to study any new side effects, as well as the effects of the drug or treatment on various demographics.
The phase of the drug trial will change what will be required of you for the trial, which we’ll discuss in a minute. Later phase trials may also be safer, depending on the type of drug or treatment that is being tested.
During the trial, you may also receive a placebo rather than the actual medication. Often referred to as a ‘double-blind’ trial, the doctors conducting the study may not know if you’ve received the medication or a placebo. Only the researchers behind the study will know who is receiving the actual trial drug or treatment. If you are signing up for a double-blind trial, make sure that you receive an informed consent document that explains all the possible risks.
What are the Requirements for the Trial?
This should be the most important question you ask before agreeing to join a clinical trial. The requirements for a clinical trial might include:
- Daily or weekly visits with a doctor or medical professional
- Blood or fluid samples
- A variety of tests, including exercise
- Changes in diet or other lifestyle aspects
The particular trial that you sign up for might have more requirements or less, depending on the phase of the trial and the results that the researchers are looking for. All requirements should be disclosed to you before you agree to the trial. If you’re not sure about any aspect of the requirements, make sure you ask! It’s your right as a trial participant to know what you’re signing up for. If the researchers aren’t willing to answer your questions, or something feels wrong to you, don’t hesitate to get up and leave.
What are the Exclusion Criteria?
Exclusion criteria are conditions that might get you turned away from a clinical trial. These are often no fault of your own. Trials might be looking for participants of a particular age, gender, body type, or other demographic that you don’t fall into. Trials in their later phases may also be looking for individuals who have been diagnosed with the specific condition that they’re trying to treat.
Don’t take it personally if you fall into a trial’s exclusion categories. These trials need to be spread across as many different demographics as possible, to provide the best and most objective data.
Is There Any Access to New Treatment?
One of the biggest benefits of signing up for a clinical trial is that it allows you get access to the newest and most cutting edge treatments before they are available on the open market. If you have been diagnosed with the condition that the trial is treating, it could be an excellent way to get relief if other treatments have failed or become less effective in the past.
On the other hand, though, there is no guarantee that you will receive the treatment. You may receive the placebo instead. Even if you do receive the placebo, you will receive free care throughout the trial and will most likely be compensated for your time and trouble as well.
While clinical trials are a vital part of the research and development of new drugs and treatments, that doesn’t always mean that you need to be a part of the trial itself. The compensation might be enticing, but it’s important to keep in mind that the higher the payout, the more dangerous the trial might be. If you choose to take part in a clinical trial, then make sure you do your research. Ask all the questions before you sign on that dotted line.