A clinical trial is a scientific study that helps us understand the efficacy and safety profile of new treatments for human diseases. Clinical trials are rigorously monitored and scrutinized by regulating agencies to ensure the rights and well-being of its participants are always taken into account.
Each clinical trial may seek a certain population of volunteers to participate to answer questions of a certain new medication or disease. There are inclusion and exclusion criteria that are dictated before the clinical trial starts, which helps researchers identify how the treatment affects certain populations of patients. Volunteers of all ages, racial and ethnic backgrounds, and genders are encouraged to participate in clinical research trials as we strive to make a better world for future generations.
Everyone has a different reason for participating in clinical trials. Some patients are looking for new and novel ways to treat a terminal disease where medications out on the market have failed. Others have an altruistic approach and genuine interest behind the science of developing new treatments for diseases. Whatever the reasons are, know that volunteering for clinical trials helps push our understanding of medicine and provide a better and brighter future for generations to come.
There is a saying time is money and this is something we understand very well. For that very reason, any participant of a clinical trial will be compensated for their time and inconvenience of a procedure. The forms of compensation will include, but not limited to, cash, gift cards, or bitcoin.
There are four phases of clinical trials:
Phase I Trials
Phase I trials typically have a small number of participants, who are often healthy. The primary goal is to determine what dosages are safe and the side effects of the treatment.
Phase II Trials
Phase II trials build off of the knowledge of Phase I trials and employ a larger number of participants to determine how helpful and effective the treatment may be. Safety, efficacy and side effects are still monitored during this time.
Phase III Trials
Phase III trials employ thousands of participants to evaluate the overall risks and benefits of the treatment, as well as confirming what was learned in the previous Phase I and Phase II trials.
Phase IV Trials
Phase IV trials occur after the treatment is approved by the FDA and are designed to provide more information on the risks/benefits and how it is best used in the general population.
Every clinical trial has its own set of risks and benefits which will be detailed on the informed consent given to each participant before the clinical trial starts. While there may be some benefits that involve access to experimental treatments that would not otherwise be available, there can be considerable risk involved as well.
In life, the benefit of progress is made by taking risks and in clinical trials, it is no different. We are here today with amazing treatments for various types of cancer, lupus, rheumatoid arthritis, diabetes and much more, but not without the unselfish time and effort put forth by the participants and clinical researchers of those trials.
Informed consent is by far one of the most important parts of a clinical trial as it informs the participant of the purpose, risks, benefits, procedures and duration of the trial. The research staff will review these items at length before the participant signs the document and proceeds with the clinical trial. Any changes to the trial that would affect the participants of the study will be informed as they occur.
Because participating in a clinical trial is voluntary, the participant is encouraged to ask any questions they may have. Participants also have the option to withdraw from the study at any time.