Group 2: Clinical Trial Case

Stopping a Clinical Trial By: Gabby, Ceniya, Lanie, Claire, Stefano, Jacob, and Caroline PHI 421 Introduction Subject: ● A multinational clinical trial that was testing a new drug regimen (letrozole) for breast cancer treatment. ○ The trial stopped at 2 ½ years instead of at the originally planned 5 years. 2 Introduction Why Stop? ● Data showed the yearly rate of breast cancer recurrence being cut in half when patients took the new drug. ○ Letrozole was more effective than the placebo in preventing the recurrence of breast cancer. ■ Letrozole blocks estrogen synthesis. ■ The patients had previously taken tamoxifen, which blocks estrogen. 3 Introduction ● ● ● The National Breast Cancer Coalition: a patient advocacy group: argues for the trial to be continued: ○ Only short-term results came from trial results. ○ There is still not enough data for long term effects of the drug. Questions about Letrozole would be answered from a longer trial time: ○ How long should patients take it? ○ Does it promote survival of the patient or mainly blocking recurrence of cancer? Must also acknowledge the major success of Letrozole from the short clinical: ○ Why not put it on the market as fast as possible to allow people suffering from breast cancer to have possibly less recurring cancer? ○ If clinical trial continued, fewer people would have access to life changing and prolonging medications. ■ Product can’t be sold unless the trials have been completed, and approved. 4 Ethical Positions Aristotle: Over this case, he promotes the argument that halting the clinical trial early reflects poor judgement and a lack of practical wisdom, as it sacrifices the long-term benefits and essential data on the drug’s effectiveness. Kantian: This position sees stopping the trial as neglecting the duty to honor patients’ autonomy and the pursuit of optimal treatments. It fails to uphold the moral obligation to seek the best outcomes for all, making the decision to halt the trial, ethically deficient. Virtue Ethics: Virtue ethics emphasizes the importance of honesty and development of virtuous character. Throughout the execution of this clinical trial researchers failed to maintain an honest and virtuous manner. 5 Ethical Considerations Engagement Respect Welfare Social value Risks Test 6 Key Questions ● What potential changes might have occurred had the trial continued? ● What additional effects could have been observed if the study had not been discontinued? ● Does letrozole promote actual survival? ● Was it ethical for the clinical trial to use placebos, given the trial was being conducted on breast cancer patients? ● Is it ethical to prescribe a drug to patients if healthcare professionals are unsure of all the risks and side effects of the drug’s long-term use? 7 Thoughts on the Trial Long-Term Efficacy Concerns - Risk of premature conclusions Placebo Use Ethical Dilemma - Lead to inequalities in access to care Impact on Future Patients - Comprehensive data is needed for establishing best practices and ensuring effective therapies are available Public Confidence in Research - Fostering confidence in patients Ethical Commitment to Research - Ensures both current and future patients receive the best possible care based on evidence 8 Considerations in Decision-Making Patient Safety vs Scientific Integrity: How do we balance the immediate safety and well-being of current participants against the ends for comprehensive data to inform future treatments? Moral Responsibility: If the trial is stopped, what moral responsibility do researchers and sponsors have to inform participants and provide them with alternative treatment options? 9 Counter Arguments This clinical trial like many other relies on the use of placebos to obtain accurate results. Some patients involved in the clinical trial did not see improvement in their cancer diagnosis due to being given a placebo. Since these are critically ill patients, we do not believe that it is ethical to give them a placebo, knowing that they will not improve and could possibly die. The trial was stopped due to having enough data to verify letrozole prevented breast cancer recurrence in patients involved in the study. It is proven that letrozole can prevent cancer recurrence over a short period of time, but the drug was not studied in depth enough to display data for long-term breast cancer recurrence. It was shown that the drug increased the risk of osteoporosis, but other side effects of long-term use were not studied. 10 03 Final Thoughts 11 Final Thoughts on Decision-Making ● ● ● Main Question: - In this case we particularly looked at whether the researchers should have continued their clinical trial or if stopping it was the best for patients and for future cancer patients. Our Group's Decision: - The research should have continued in order to find the best possible outcome for future and present cancer patients. Ethical Theories Used: - We used Kant’s and Aristotle's ethics to guide us in making our decision, as well as virtue ethics. - Kant’s and Aristotle's ethics pushed for the research to continue and found that the researchers were going against their duty to provide the best possible treatment for patients. - Virtue ethics showed that the research also should have continued in order to maintain a virtuous and honest environment for participants involved in this trial. 12 Final Judgement As a group, we determined that termination of the trial and the use of placebos was unethical. We applied Aristotle’s and Kant’s ethics as well as virtue ethics to guide us in our decision-making. 13 The End 14