In a clinical trial, researchers enroll volunteers based off study guidelines to evaluate a medical, surgical, or behavioral intervention and report results to a drug sponsor company who then performs an analysis on all data collected throughout the study’s entirety.
Most medicine or medical treatment that is widely available now, has undergone clinical trials in order to get approval from the FDA.
A clinical trial is often used to understand if a new treatment could be more safe, more effective, and less harmful than the currently existing FDA approved standard treatments.
Before it can be studied in humans, the study must be tested in animals and approved by the FDA for human intervention.
Once it is done being studied in humans, the sponsor drug company can submit the results to the FDA to try and get the treatment approved for use in real world settings.
Clinical trials are monitored by the Institutional Review Board (IRB) which is comprised of a panel of expert physicians and other professionals to ensure the safety of the patients as well as to ensure that the study is being conducted ethically and as per research protocol.
Informed consent is obtained from the participants before they are able to participate in any studies.
A physician or a research staff responsible for conducting the research will explain to the participant about the side effects, risks, and possible benefits in as much detail as possible until the participant is fully satisfied.
Privacy of participants is strictly maintained per the HIPAA Laws. Participants remain anonymous at all time.
Before, during and after the trial, the OtriMed team will stay in touch with the research participant on an ongoing basis to ensure compliance with the research protocol and the safety of the research participant.
There are many reasons why participating in a clinical trial could be the right course of action for you. Regardless of why you choose to participate, please understand that participating in a clinical trial is a great way to play an active role in your own healthcare which could lead to a better quality of life.
Current treatments don't work
A lot of subjects in clinical trials participate because the current treatments they have tried for their health problems have not worked as planned.
Access to new treatment(s)
Others participate because there is no standard of treatment for their current health problem(s); and by participating in a clinical trial, they could be getting access to new treatment(s) before they are widely available.