Protecting people during Clinical Translation Process

The medical community has established a number of checks to protect the rights of people during the process of developing new therapies through clinical trials and innovative medicine / single case studies.

Important elements that are fundamental to this process are:

 - The monitoring of experimental treatments for patient safety and ethical practice

- The oversight by a regulatory agency

- Monitoring of experimental treatments for patient safety & ethical practice

Clinical trials are conducted before a treatment becomes available to the general public. Before a trial begins, it should first be carefully reviewed by a group of those, who together have broad expertise and experience in research, medicine and ethics. These groups, often called Institutional Review Boards (IRBs) or medical ethics review committees, evaluate a number of factors including the potential risks weighed against the potential benefit.

Clinical trials should be conducted in a setting that provides appropriate medical care.

Participating people should be made fully aware of the medical procedures they are undergoing and the potential risks and provide their consent.

The progress of the people in the trial should be continuously monitored by medical practitioners who are both knowledgeable in the field and who have the authority to stop the trial for the benefit of the people.

Treatment should be reviewed by a medical ethics committee to make sure that the patient is being treated in an ethical manner.

Overview by Regulatory Agencies

Drug regulatory agencies monitor the development of new treatments. The nature and methods of regulatory agencies and their responsibilities vary from country to country. They adopt a code of conduct or guidelines for researchers and health professionals to follow to promote safe and effective medical practice. These agencies judge the scientific principles, the level of danger to the patient, and potential benefits of the proposed therapy at several stages in the clinical translation process.

However, many clinical trials appear to be undertaken without following due procedures and amongst unknowing people, such as.

Drug trials should follow procedures: Azad

Monday, February 6, 2012

   

Bangalore: The union health minister Ghulam Nabi Azad said on Monday drug trials should be as per laid down procedures.

"Clinical trials have to be there, but going for a clinical trial for testing any medicine on human being, there is a laid down procedure," Azad said, reacting to the apex court's notice to the central government on a plea seeking investigation into illegal and unethical clinical trials.

"…Sometimes the companies don't go by the laid down procedures and it causes great harm to persons and individuals on which this test is carried out," the health minister said on the sidelines of a conference in Bangalore.

"Supreme Court might have said that if any test has to be carried out, it has to be carried out based on procedures."

A Supreme Court bench of Justice R M Lodha issued notice on a plea by Madhya Pradesh-based Swasthya Adhikar Manch that, in a large number of cases, multinational corporations were using contract research organisations for carrying out clinical trials of their drugs, which are not even approved.

Counsel Sanjay Parikh, appearing for the petitioner NGO, told the court that, as a consequence of these illegal clinical trials, a total of 1,727 patients have died in four years from 2007 to 2010.

So what is going on?  We are constantly being told that clinical trials are the gold standard. Are they? This may depend on who is doing the saying and who is doing the asking.