The Allure of Clinical Trials Research

Abstract

Clinical research studies play an important role in the development of new pharmaceutical and phytopharmaceuticals dosage form design. This is required for the product of its efficacy and safety determination and market valuation. The clinical trials are usually executed by the industry, university and hospitals forming a study group. Clinical trials are experiments and observations carried out in clinical research involving clinical and medical experts for the intervention of treatment. This is done because clinical trials generate data on safety and efficacy of medicine product to alleviate diseases. These trials are conducted after receiving ethics committee approval by the competent professional experts. As a first step investigator initially enrolls volunteers and patients into pilot or large scale comparative study either at single or multiple researches canters such as clinic for outpatients or hospitals in case of inpatient ward. In absolute terms the clinical study design objective is to ensure scientific medical validity and reproducibility of the results. In Pakistan Drug Regulatory Authority Pakistan (DRAP) has already initiated to regulate the conduct of clinical trial/studies on investigational drugs involving human subjects. Clinical trials basically pertain to phase I, phase II, phase III, and phase IV trials with different purpose for efficacy and safety to asses risk and benefit. There are many challenges facing clinical research today, such as issues, prioritizing, divide clinical research and practices, globalization role, funding are being tackles at various forums and circles to find the way out. Clinical trials and research is a developing field in Pakistan, however, substantial investment can be attracted in this area, there by the academia in the universities can gain in research output and participation in public health, and ultimately make the country in reliance in drug development and drug marketing for export promotion. Pakistan is the sixth populace country in the world, so the patient’s population is also very large, we can attract outsourcing clinical trials and business development. The clinical trial research and its management will improve the overall impact on research contribution in the country and form part of knowledge base world.