Clinical Trials
An important concept that has been increasingly recognised in the biomedical research community is the ‘bedside-bench-bedside’ concept. Once a new biomaterial is found to exhibit a pre-clinically acceptable biocompatibility, the final and the most importa
- PDF / 546,484 Bytes
- 26 Pages / 439.37 x 666.142 pts Page_size
- 15 Downloads / 232 Views
Clinical Trials
9.1
Introduction
Many developing nations, like India, are is in the state of a major shift in demographics towards elderly populations. As per the 1991 census, the population of the elderly in India was 57 million as compared with 20 million in 1951. Since then there has been a sharp increase in the number of elderly persons between 1991 and 2001 and it has been projected that by the year 2050, the number of elderly people would rise to about 324 million [1]. India, having the highest elderly population by 2025, has thus acquired the label of “an ageing nation” with 7.7 % of its population being more than 60 years. The increase in life expectancy of Indians has a direct and amplifying effect on the prevalence of edentulism. With the increase in age, there is a greater risk of hip fractures, knee fractures or other life-threatening diseases, like cardiac problems. Apart from the use of relevant drugs, hip/knee replacements require the use of biomedical devices, which have to undergo clinical trials. It needs to be categorically mentioned that the clinical trial is the final endpoint experiment for any biomedical device prototype with the aim of ensuring the performance validation in patients. Typically, clinical trials are sponsored by a governmental organization or a pharmaceutical, biotechnology or medical device company and are very common in drug or new medical devices. These experiments generate data on safety and efficacy [1]. They are conducted only after they have received health authority/ethics committee approval in the country where the trials are to be conducted. The responsible institutional/national authorities are responsible for vetting the risk/benefit ratio of the trial and it needs to be understood that their approval does © Springer Nature Singapore Pte Ltd. 2017 B. Basu and S. Ghosh, Biomaterials for Musculoskeletal Regeneration, Indian Institute of Metals Series, DOI 10.1007/978-981-10-3017-8_9
191
192
9 Clinical Trials
not mean that the therapy is ‘safe’ or effective, but only that the trial may be conducted. In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical experts within the Food and Drug Administration, including inspections of primary data collection at selected clinical trial sites. In the context of prosthodontics, the edentulism has also an indirect effect on the oral health related quality of life. The Quality of life is improved with good oral health that allows one to speak, chew, taste, smile, live without pain or discomfort and interact socially without embarrassment. The current status of the Indian population reveals that over half of the population has experienced tooth loss. The Level of complete edentulism in the general population varies from 14–16 % mostly in the 60-year age group. Studies have reported a higher rate of edentulism in both the urban and rural elderly populations with around 91.2 % in the elderly above the age of 65 years [2]. Considering the goals above
Data Loading...
