Despite scientific breakthroughs, stellar technological advancements, and strict health authority regulations, the general public is still skeptical and frightened when the topic of clinical trials is on the table. Why wouldn’t they? No one wants to jeopardize their health for unproven medications or methods. Moreover, most of us do not want to feel like laboratory guinea pigs - having our vulnerabilities exploited in the name of science. While it is undeniable that there are inherent risks, participating in a clinical project offers a hefty number of benefits as well. However, if it’s beneficial to join and comply with clinical operations experts, what are all the uncertainties and doubts about? They say that experience is a great teacher, and we have the history of clinical trials to blame for all of the fuss. Taking the time to join and understand the background behind clinical projects can and bridge the gap between the skepticisms of the Pharmaceutical Industry and the rest of the population.
The core principle and general gist of every regulation, principle, law, and standard regarding the protection of human subjects can be summarized into 3 words: “Do no harm.” This general statement encompasses all the guiding theories in different regulatory bodies in the Pharmaceutical industry. Failure to comply with such mandates will result in legal sanctions, termination of the clinical trial, or potential jail time. Predating these complex, exhaustive, and intricate protocols in safety, there have been several “malpractices” or unsafe, unmonitored, and uncontrolled “experiments” in the past that sparked controversies and hostility from people around the world.
The Nuremberg Code
As explained by Ravindra Ghooi, in “The Nuremberg Code - A Critique” (2011), 1947 was a historical day in medical research in terms of ethical standards . Ghooi further explained that this is a response to the inhumane experimentation done by the Nazi physicians and investigators. In the guidelines presented after the surrender of German forces, the adoption emphasized the need for informed consent for only essential clinical testing that would only be conducted by expert clinical staff. It also put weight on the anonymity of participants and the requirement of extensive benefits that outweigh the inherent risks of each patient. The code can be summarized into two phases: prevent human suffering and preserve human dignity.
Tuskegee Syphilis Experiment
According to the report published by the Center for Disease Control and Prevention (CDC), the clinical project was conducted in Tuskegee between 1932 to 1972 . The original intent of the clinical project managers was to confirm the deception committed on African American male participants. The CROs consciously decided not to treat the subjects to further study the effects of the illness. This report was stated in the National Archives at Atlanta . When they were delivering clinical operations, they didn’t collect an Inform Consent Form (ICF) from the participants, nor did they didn’t offer treatment after it became readily available. After the recommendation of the Assistant Secretary for Health and Scientific Affairs in 1972, the operation was stopped, and the National Center for Bioethics in Research and Health Care at Tuskegee University received more funding. After the scandal’s publication in 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research released the Belmont Report. The Belmont Report stresses the importance and requisites of its three principles: Respect of Persons, Beneficence, and Justice.
Protection of Participants
The people can’t be blamed for their reluctance and fear of joining a clinical trial. After all, clinical trials are overshadowed by mishaps and injustices in history. Since this time in history, we are progressively moving forward and learned retroactively from mistakes made in the past. This is why clinical operations are required to follow strict rules from the government and other institutional bodies to ensure that the wellbeing and safety of each individual involved in a clinical project is of the utmost importance.
According to an article by the National Institute on Aging [NIA] (2017), the rules are strictly enforced by the Federal government . For every clinical study, there is a protocol that illustrates how clinical operations management should be properly completed. Every clinical project manager, investigator, and researcher is responsible for following these guidelines.
Institutional Review Board (IRB)
The IRBs ensure that risks in managing the clinical trial are significantly low for participants in the trial. The IRB staff regularly pays a visit to review and examine the results.
Data and Safety Monitoring Committee
The Data and Safety Monitoring Committee is a group of experts in a specialized medical condition that regularly looks at the progress of a clinical project. They have the power to halt a clinical study if they uncover that a treatment isn’t working or if it presents more harm than good to the participants.
Informed Consent Process
The ICF process is a series of steps to document that participants are fully aware of the associated procedures, benefits, risks, and rights that they have during the entire clinical trial.
Benefits and Risks
As also stated in the article by the NIA (2017) and other official government bodies in the health industries such as CIOMS and WHO, clinical trials can offer a participant a new treatment before it becomes publicly available . Potentially discounted medical care, , health check-ups, monetary and non-monetary compensations, support groups, and reimbursement for the expenses incurred in the trial are a few benefits that an individual may receive from participating in a clinical study. As for the risks, adverse side effects could occur when taking a treatment, medication, or during the procedure itself. There is also a chance that an individual may not qualify as a candidate for the treatment or experimental group. Ultimately, discomforts that can be brought upon by various tests, procedures, confinements, or complex dosages are factors worth considering as well.
Looking at the progression and maturity of conducting clinical trials, it can be said that the industry has come a long way. In recent years, many scientific breakthroughs, technological advancements, and government policies have paved the way for more cost-effective, efficient, and low-risk trials to operate within. In reality, the risk of joining a clinical project is not always zero, but as progress and globalization impact our efforts, clinical trials are becoming more reasonable to consider for participation.
- Ghooi RB. The Nuremberg Code-A critique. Perspect Clin Res [Internet]. 2011 [cited 2022 Sep 23];2(2):72–6. Available from: http://dx.doi.org/10.4103/2229-3485.80371
- Tuskegee study and health benefit program - CDC - NCHHSTP [Internet]. Cdc.gov. 2021 [cited 2022 Sep 23]. Available from: https://www.cdc.gov/tuskegee/
- National Archives at Atlanta [Internet]. Archives.gov. [cited 2022 Sep 23]. Available from: https://www.archives.gov/atlanta/exhibits/item470-exh.html
- Clinical trials: Benefits, risks, and safety [Internet]. National Institute on Aging. [cited 2022 Sep 24]. Available from: https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety