Clinical trials driving excellence in healthcare industry

Once a new drug is developed, it is essential to conduct clinical trial that allows the drug to be tested regarding safety and efficacy in human volunteers. Generally, the company files an “investigational new drug” application with the Food and Drug Administration to allow the investigational drug to be tested in human volunteers in clinical trials. A clinical trial is a study that is carefully designed to test the benefits and risks of a specific medical treatment or intervention, such as a new drug. Every clinical trial is led by a principal investigator, who is usually a medical doctor, and a research team of nurses and others. The authority requires a multi-phase clinical trials process to be completed before deciding if an investigational medicine is safe and effective for a broader patient population; progress in the development of innovative medicines cannot be made without the people who volunteer to participate in clinical trials.

Unfortunately, a high proportion of trial does not adequately describe important methodological details, decreasing their utility for trial implementation and critical appraisal of trials, all of which have been associated with biased trial results and conclusions. There is no difference in Bangladesh as there was no guideline for trials on pharmaceutical products.

But to drive excellence in the healthcare industry, the Directorate General of Drug Administration of Bangladesh has introduced a new guideline on clinical trial as one of the six functions according to the World Health Organisation. This guideline for good clinical practice for trials on pharmaceutical product has been prepared harmonising with ICH (International Conference on Harmonisation), GCP (Good Clinical Practice) guideline, WHO GCP guideline, Malaysian GCP guideline, Pan American Health Organisation GCP guideline, and Indian GCP guideline. A working committee was made to prepare this GCP guideline suitable for Bangladesh in every aspect. This guideline not only introduces an escort to conduct a trial but also a landmark for time-saving and safe clinical trial.

The guideline contains eight chapters and four annexes. There is a detailed glossary list to understand the terminologies. The chapters discuss details about the principle of GCP, formation of ethics committee, role of sponsors, monitors, investigators, ethics committee and regulatory authorities. It also contains structure of protocol, informed consent form and investigators' brochure. There are two specific annexes -- one is for regulatory requirement for BE studies and another one is for regulatory requirement for clinical trials of bio-similar and vaccines.

This guideline is addressed not only to investigators, but also to ethics review committees, pharmaceutical manufacturers and other sponsors of research and drug regulatory authorities. By providing a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of the findings, the guidelines serve the interests of the parties actively involved in the research process. The guidelines thus also protect the rights and safety of subjects, including patients, and ensure that the investigations are directed to the advancement of the healthcare system. In response to the gaps in protocol content of different trial projects in Bangladesh, the guidelines introduce a well-directed proposal guideline that will facilitate an appropriate assessment of scientific, ethical, and safety issues before a trial begins; consistency and rigor of trial conduct; and full appraisal of the conduct and results after trial completion.

Moreover, the guideline should also provide a resource for editors to determine the acceptability of reported research for publication and, specifically, of any study that could influence the use or the terms of registration of a pharmaceutical product. Not least, they provide an educational tool that should become familiar to everyone engaged in biomedical research and, in particular, to every newly-trained doctor.

After getting approval of guideline of GCP by the health ministry, DGDA is now giving permission for two CROs (contract research organisation) and in future it will increase. The quality of biosimilar products will increase in Bangladesh. The increasing number of clinical trials will attract more international organisations to Bangladesh. All these activities will generate new employment. DGDA is ensuring safe, effective and quality products for the people of Bangladesh. 

The writer is the director general of the Directorate General of Drug Administration, Ministry of Health & Family Welfare.