Have you heard of clinical trials? Or are you one of those who are afraid of participating in clinical trials? Most people, especially in the past, are hesitant in participating in these kinds of studies. Many individuals hesitate to sign up for research. However, today there are strict rules implemented by the Federal Government to keep your health and privacy safe. Voyage Medical’s goal is to provide knowledge regarding the advancement of medicines through clinical research. Hence we are here to cite important facts that the general public should know about the safety of clinical trials:
- Clinical research is heavily regulated
Through the years, Congress has passed laws to protect study participants. In today’s trials, every clinical investigator is required to monitor and make sure that every participant is safe. To review and monitor biomedical research involving human subjects, under FDA regulations, an Institutional Review Board (IRB) was developed. An IRB as a constituted group that has been formally designated has the authority to approve, require modifications, or disapprove research. This regulated body is concerned with protecting the welfare, rights, and privacy of human subjects.
- Studies are reviewed with physician team prior to initiating any trial
The clinical research team is made up of experts (physicians) in your condition who initially review the studies before recruiting participants. Majority of studies are nationwide/international, with extensive data, collected and reviewed carefully by the experts. Physicians follow a set of criteria’s per study in recruiting participants. They consider your past and present health conditions to determine if you are suitable to sign up for the study. Even if you showed your willingness to participate in a certain study, if they see that you are not a good fit or if they know that it will make your condition worse, they won’t sign you up.
- “Do No Harm” is central to clinical research.
Investigators or physicians also periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away. They are required to follow strict rules to make sure that participants are safe through the rules enforced by the Federal Government. Participants have the right to leave the trial at any time and for any reason without being judged or put in a difficult position. Researchers are required to keep health and personal information private.
These three are only a few of the many strict rules that researchers must follow in order to ensure the safety of its individual participants. Clinical research benefits both the participants and the patients suffering from different diseases. The duty of the medical experts is to ensure that continuous studies are being conducted to further improve the treatments of the common and rare diseases.