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Institute
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparative, interventional clinical trial. But has this now 20-year-long ethical debate truly been put to rest? The choice of standard of care in clinical trials remains a complex issue, particularly for comparative trials conducted in emerging countries.
Immunization is the most cost-effective intervention for infectious diseases, which are the major cause of morbidity and mortality worldwide. Vaccines not only protect the individual who is vaccinated but also reduce the burden of infectious vaccine-preventable diseases for the entire community.
1 Adult vaccination is very important given that >25% of mortality is due to infectious diseases.
2 There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India.
Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease.1 India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India.2 Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized.
Hypertension is a serious global public health problem. It accounts for 10% of all deaths in India and is the leading noncommunicable disease.1 Recent studies have shown that the prevalence of hypertension is 25% in urban and 10% in rural people in India.2 It exerts a substantial public health burden on cardiovascular health status and health care systems in India.3 Antihypertensive treatment effectively reduces hypertension-related morbidity and mortality.1 The cost of medications has always been a barrier to effective treatment.
Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
Setting: USA, the EU, India and South Africa.
Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
The drugs we use to treat any condition – from an innocuous cough to a life-threatening cancer – are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. In recent years there has been a clear shift in clinical trial sites from core developed countries like USA, European countries to developing countries like India, China, South American countries. This shift is related to challenges and opportunities like costs of trials, recruitment issues, and regulatory challenges in developed vs. developing countries. Developing countries and developed countries have their unique disease burden patterns based on various parameters like but not limited to age, health care facilities, health insurance, sanitary conditions, environmental issues, education, nutrition
and GDP. Previous studies have reported that many of the important global diseases are not much explored in clinical trials and many published clinical trials have very less international health relevance. This study was aimed at finding the correlation between disease burdens, number of clinical trials done and trial success rates. We compared 2005 - 2010 Global Burden of Disease data for Germany, India and number of clinical trials from clinicaltrials.gov database done in the same period. Our findings indicated that there was a good correlation between the disease burden and clinical trials for Germany in 2005 and 2010. For India in 2005 there was a moderate positive correlation, 2010 data showed the improvement in India in terms of match between disease burden and clinical trials. But careful observation of the data shows still a need for more trials on Communicable, maternal, neonatal and nutritional disorders.
Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide range of sectors that can benefit citizens. Nanomedicine is an application of nanotechnology in the areas of healthcare, disease diagnosis, treatment and prevention of disease. Nanomedicines pose problem of nanotoxicity related to factors like size, shape, specific surface area, surface morphology, and crystallinity. Currently, nanomedicines are regulated as medicinal products or as medical devices and there is no specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.