The potential consequences for patients can be severe, impacting their quality of life or even resulting in death. Only 25-30 percent of drugs that undergo clinical trials successfully reach the market, as they often fail to demonstrate benefits that outweigh the associated risks. Some of these risks include serious side effects, which can be permanent or, with some luck, may subside after the trial. These side effects can manifest during the trial or emerge much later. The inherent risks and unknowns necessitate that patients are thoroughly informed about all relevant information before participating in a trial. Knowledge gaps, uncertainties, and missing information can arise when there is insufficient diversity among the volunteers selected for the trial. Even with comprehensive information, there remains the pressure of uncertainty regarding side effects, challenges, and the varying effects of drugs on different individuals. Inadequate information or lack of detail in the trial can lead to misinformation, posing risks to future patients. The support of the FDA is crucial, as it provides guidance and structure for the studies. The FDA oversees clinical trials, ensuring that the process is monitored and supported. Protecting the rights, welfare, and information of patients is essential for maintaining the quality and integrity of the data under review (FDA, 2014).
Ultimately, there are no guarantees regarding treatment outcomes; however, these trials offer hope to patients when other options may be exhausted. The decision rests with the patient, and understanding the reasons for participating in the study adds value to the research. Providing informed consent and allowing patients to make their own decisions enhances the value of both the experimental study and the patient experience.
References
Deinhammer, R. (2016). Can natural law ethics be tenable today? Towards a critical natural law theory. Heythrop Journal, 0018-1196.