Pharmaceutical Clinical Trials

Pharmaceutical Clinical Trials

Clinical trials refer to medical and drug checking tests for the purpose of ensuring that they are safe to use and also for finding out possible negative effects and reactions. Clinical Trials are preceded by research regarding safety and quality of the drug, and an approval awarded by a health authority.

There are ten steps in the ethical decision making model, as outlined by (Welfel, 2012). The process begins with the development of sensitivity towards ethical practice, and is followed by determining facts & figures and the impact of the issue on involved stakeholders and society. Step 3 defines the core issue and outlines the available alternatives; step 4 involves that ethical code of conduct and professional standards are being followed, apart from compliance to applicable regulations and laws. Step 5 involves doing research regarding the problem to come across scholarly data. Step 6 is application of solution to the problem, and step 7 involves consultation with superiors and colleagues. Step 8 involves deciding upon a particular solution and is followed by step 9 which entails reporting to the supervisor and documenting the process and action course. The final step is personal reflection of the entire experience.

There exist a number of ethical issues in clinical trials held by pharmaceutical companies, such as the extravagant total cost of getting the drug approved by the IRB (Institutional Review Board) and the IEC (Institutional Ethics Committee), the 'name-less' advertising of drugs for the purpose of preventing possible misuse and unreliable prescriptions, the lawsuits that are filed against companies for unethical conduct, the issues arising out of human and animal testing for research and clinical trials of drugs, and the interference of the government in the entire process. It is necessary to get involve the IRC and the IEC in all these ...