What to know about clinical trials
We are at a moment in history where science and medicine are advancing at a phenomenal pace. There are many doctors, researchers and nurses who have contributed to that work, but you know what, there are many patients who have made enormous contributions as well. These patients have participated in clinical trials, which are research studies designed to either compare the effects of one treatment to another or evaluate the effects of a new treatment. These studies are often performed in people who have the disease and need treatment; sometimes in the early phases of drug discovery, the treatments may be given to healthy volunteers.
There are several basic ethical principles that now exist in clinical trials specifically to help safeguard clinical participants from harm.
The first one is respect for persons which means that people should be treated as their own autonomous agents and should be allowed to voluntarily choose whether or not to participate after being provided with all the information, a process known as informed consent. Additionally, this principle recognizes that some populations are vulnerable, e.g. children, and need special protections in the informed consent process.
The second ethical principle is beneficence which means that there must be social and clinical value to participation and the potential benefit to participation in the study must greatly outweighs the risks.
The third ethical principle is justice which in this context means that the selection of subjects should be equitable, with those participating being those who can potentially benefit from the study, and also being the ones undertaking the risk. It also means that populations should not be excluded from a study because it may be difficult to include them if they may also be likely to benefit from the research and the clinical findings.
Part of the reason these formal structures exist is to prevent a repeat of times in history where researchers ignored the fundamental human rights of human subjects. These examples include the Tuskegee experiments (hyperlink) which occurred from the 1930s to the 1970s, the 1940s Nuremberg experiments (hyperlink)and the 1970s San Antonio experiments (hyperlink).
In today’s world, these safeguards exist to protect people who participate in research from harm, as well as additional strong oversights over research such as Internal Review Boards which include not just researchers but also community members in vetting research studies and approving studies to go ahead only if they pass the standards for safety.
Regarding the benefits of clinical trial participation, there are several potential benefits. At a minimum there is the knowledge that one is participating in science and adding to our understanding of diseases and their treatment options. In some scenarios clinical trial participation may enable a patient to have access to extended treatment options or revolutionary treatment options than they otherwise would not have had. And modern technologies are making it easier to participate in clinical trials, with some trials allowing remote participation through telemedicine, making them more accessible.
In 1993, the National Institutes of Health (NIH) Revitalization Act was passed, mandating the inclusion of women and minority groups in all NIH supported biomedical and behavioral research projects involving human subjects to achieve diverse representation.
It is essential that people from all walks of life participate in clinical trials that study treatments for diseases they are reasonably at risk for, to generate information that is reflective of society, and reliable, both in terms of identifying benefits of the treatment or potential risks, early on.
If you would like to learn more about clinical trials, contact us on our clinical trials page. You can also visit https://www.cancer.gov/research/infrastructure/clinical-trials/nctn
