ETHICAL ISSUES IN CLINICAL TRIALS

ETHICAL ISSUES IN CLINICAL TRIAL

      Ethics is an integral part of new drug molecule development. The main ethical issues are the needs and rights of each part of clinical trial kept maintaining as per as Guideline. Government appointed regulators and investigators who are involved in every study conducted on human beings have to be reviewed by an independent regulatory committee.

Ethical issues

     Clinical trial which form the best way to a new chemical molecule poses the big challenge to the Ethicist, as the potential clinical trial subject who is likely to benefit from a marketed drug, is also at the risk of adverse effects or adverse events of the investigational product (IP). If the human subjects participate in the clinical trial, the benefit risks ration of Investigational product can not be displayed and the new molecule can not be developed into a useful therapy.

      Ethical issues are mainly provided to ascertain the ensure about the requirement of clinical trial, available information about investigational product such as its benefits or risks to the subjects, benefit risk ratio of IP, study methodology, any physical risks or inconveniences that may occur in any time to the subjects. It also make sure that the subjects are informed about the risks and benefits of participating in the trial, the reimbursement provided for the participating in the trial. This must check the investigstor's compatibility to conduct the clinical trial and give the proper care to the subjects during each step of study. It includes the methods of listing the identification of the subjects and medical information and also tell when the trial results will be published. 

     Good Clinical Practice (GCP) provides the guidelines which helps to show the way to manage the ethical issues in a clinical trial.the investigator makes sure about the compliance the trial procedure and regulatory requirements as per as GCP guideline and Declaration of Helsinki to protect the life, health, privacy and dignity of the human subject.