How To Get Into A Clinical Trial
Discover the risks and benefits of participating in a clinical trial. Learn more about each of the four phases of a clinical trial. Clinical trials are a type of medical study involving volunteer patients. Many clinical trials provide payment to the participants, while others are entirely volunteer based. Some trials are even used as alternative forms of treatment if traditional medicines or procedures are not having an effect. These trials normally require an invitation to join, while the others are open to a wider audience.
There are two primary types of clinical trials, with several different subsections. The first type of trial is an interventional trial. These trials involve patients being placed into separate groups and provided with different treatments to determine which is more effective. The majority of interventional trials only involve two groups, but there are some projects with a larger focus that compare multiple treatments among several groups. The other option is an observational study, where all the patients receive the same medication or treatment. Many studies require a doctor recommendation to participate, while others are open to any participant.
Benefits of Clinical Trials
There are many benefits associated with clinical trials. For many, the biggest benefit of a clinical trial is the ability to help advance research and treatment options for an otherwise untreatable condition. If you are suffering from one of these medical conditions, participating in a clinical trial provides access to healthcare options you would otherwise be unable to receive. Not only are you getting new treatment, but your health is frequently monitored. Researchers looking to treat your condition are experts and may be able to provide different knowledge or insights compared to your previous medical team.
There are also some social benefits of participating in a medical trial and already have an ongoing condition. Everyone else in the trial shares the same condition, so you can openly discuss your issues and have them understood in a way others are unable to comprehend. You may even receive new advice from patients who have dealt with symptoms longer than you have.
Payment for Clinical Trials
If you are participating in a paid study, compensation is another benefit. How much you receive greatly varies depending on the trial. In most cases, the longer the trial, the more you receive. However, more intensive trials will also pay more, even if they only require a few sessions. According to a 2021 study, the average pay for clinical trials was around $3,000 to $4,000. The most intensive clinical trials, which sometimes last over the course of several years, may pay as much as $10,000 to $13,000.
How you are paid also varies depending on the trial. Many trials pay small amounts for each session. Some will also deny payment if you miss a certain number of studies. In addition to a base price, you may also be compensated for travel expenses or having to take time off from work, but this largely varies on a trial-by-trial basis.
Risks Associated with Clinical Trials
While there are many benefits to participating in a clinical trial, there are also some downsides. For many, the most common issue is potential side effects. Keep in mind, getting a clinical trial approved is a long and difficult process. Before researchers can move ahead with human trials, they must present all their studies, including the suspected side effects. Researchers are not blindly guessing with suggested treatments, and clinical trials are not nearly as dangerous as some skeptics believe.
If you are already suffering from a medical condition, there are a few additional risks. Many researchers warn participants not to get their hopes up. New treatments often require refinement and multiple tests. While it may help alleviate your symptoms, a cure may still be years away. There is also the possibility the treatment does not work at all.
If you are in an interventional trial, you cannot guarantee you are given a new medication. You may be given an existing medication, perhaps even one you took before, so researchers can compare if the new medication is more effective than the older one. Finally, there are practical concerns. Clinical trials can be demanding and time consuming, so you may have to take time off from work or cancel social events to travel to the clinical site. Some studies, such as sleep clinics, require you to stay overnight.
Phase One of a Clinical Trial
Clinical trials are divided into four phases. Any new medications must proceed through all of the phases in order to get approval from the Food and Drug Administration (FDA) which is responsible for determining whether a new medication or treatment is safe to release. Each phase has a different length. Some phases use different participants each time, while others will accept participants from previous phases.
Phase one typically involves anywhere from 20 to 80 participants without any medical conditions. During this phase, researchers primarily look for potential side effects to determine whether there are any risks for patients who do suffer from medical conditions. Researchers also experiment with different dosage amounts to help minimize potential side effects. How long this phase lasts varies based on the initial results, but it is often finished over several months. According to the FDA, roughly 70 percent of clinical trials move onto the next phase.
Phase Two
Phase two involves a larger pool, commonly several hundred participants. Most of these participants have a medical condition, but some trials still include a smaller control group. All participants are closely monitored while taking the medication. Monitoring lasts anywhere from several months to multiple years. How effective the medication is as well as any additional side effects are both studied. If the result is not satisfactory, the trial ends and must restart at phase one. About one third of phase two trials successfully go to phase three.
Phase Three
Phase three is the largest clinical trial, typically involving several thousand participants with the existing medical condition. Phase three is also the longest, on average lasting two to four years. During phase three, many clinics switch to an interventional trial, comparing how effective the new medication or treatment is compared to the existing option. Otherwise, this phase is identical to phase two. Only about one quarter of phase tree treatments move onto the final phase.
Phase Four
Phase four initially does not involve any participants. During the beginning, the researchers present all the data gathered from the clinical trials to the FDA. The FDA asks questions to determine both the effectiveness and safety of the new medication. If it is approved, another trial is run to determine long-term side effects. It involves roughly the same number of participants as phase three and takes place over several years. Participants from phase three may be asked to return for phase four.
