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Institute
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.
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.
Background: Patient satisfaction is considered as an indicator of the healthcare quality. Information on patient satisfaction based on medical expertise of the physician, interpersonal skills, physician-patient interaction time, perception and needs of the patient allow policymakers to identify areas for improvement. Primary care services and healthcare structure differ between the countries. The present study was done to determine and analyze the determinants associated with patient satisfaction in India, Pakistan, Spain and USA.
Methods: This descriptive study was performed in January to August 2019 among students from Mumbai University, India, Dow University of Health Sciences, Karachi, Pakistan, University CEU Cardenal Herrera, Valencia, Spain, Texas State University, Texas, USA. On the basis of the eligibility criterion (those who gave a written informed consent and were registered students of respective university) 890 (India: 369, Pakistan: 128, Spain: 195, USA: 99) students were selected for the present study.
Results: India had almost similar male (49%) to female (51%) ratio of participants. For other 3 countries (PK, ES, US), female participant percentage was nearly 20% or even more as compared to male participants. Overall participant’s satisfaction score about medial expertise of the doctor were highest in India (71%) and were lowest in Spain (43%). Overall satisfaction score about time spent with doctor were highest for India (64%) and were lowest for Spain (41%). Overall satisfaction score about communication with doctor were highest for US (60%) and were lowest for PK (53%). Overall satisfaction score for medical care given by the doctor was lowest in PK (43%) and was highest in US (64%). Overall satisfaction about doctor, highest number of US (83%) and lowest number of PK (32%) participants were satisfied about medical interaction with doctors.
Conclusions: These multi-country findings can provide information for health policy making in India, Pakistan, Spain and USA. Although the average satisfaction per country, except Pakistan is more than 60%, the results suggest that there is ample room for improvement.
Background: India has the third largest HIV epidemic in the world. The Indian epidemic is characterized by low levels in the general population and elevated concentrations among high-risk groups. The present study was planned to determine the awareness of HIV among students from Mumbai University.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May–June 2017. Two hundred and fifty students were approached to participate in the study of which 199 agreed to participate (males: 132; females: 67). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Study participants had high knowledge (86%) and attitude score (87%). There was no significant difference between males and female participants for attitude and knowledge, except for one question regarding knowledge about HIV transmission via breastfeeding to child.
Conclusions: Present study showed that there are no misconceptions or negative attitudes regarding HIV among students. A longitudinal study with a larger sample size across India is recommended for further investigation.
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.
Background: Epilepsy is a chronic disorder of the brain that affects people worldwide. The overall prevalence (3.0-11.9 / 1,000) and incidence (0.2-0.6/1,000) of epilepsy in India are comparable to the rates of high-income countries. The high prevalence of negative attitudes towards epilepsy has been highlighted by several studies. Pharmacy students represent a better-educated section of society regarding drugs and have the potential to create awareness, and influence attitudes towards the disease. Thus, it is important that they have the appropriate and updated knowledge and appropriate attitude towards epilepsy and antiepileptic drugs. Objective of the present study was to determine the Mumbai University pharmacy student’s awareness about epilepsy, so as to know the kind of education and awareness strategies that would be applicable to them.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. Two hundred and fifty students were approached to participate in the study of which 213 agreed to participate (males: 107; females: 106). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Response rate for this study was 85.2% (213/250). Ninety six percent (204/213) of the participants had heard or read about epilepsy. Overall knowledge was poor (40.2%) and attitude was fair (75.3%). None of the participants were aware about recent research regarding hereditary nature of epilepsy. Only 2 (0.98%) students were aware how to perform the first aid in epilepsy. Only 6.8% participants felt that epileptics should participate in sports.
Conclusions: The findings of this study show that, even with extensive curriculum covering diseases, drugs and relevant laws of land, the knowledge and attitude scores were low. There is a need to have focused education and campaigns to increase the knowledge and attitude towards epilepsy.
Background: Oral cancer is among the top three types of cancers in India. Severe alcoholism, use of tobacco in the form of cigarettes, smokeless tobacco, and betel nut chewing are the most common risk factors for oral cancer. Often individuals with pre cancer even notice the alterations, such as reduced mouth opening in oral submucous fibrosis (OSMF), but they are not aware about the causes and consequences of these changes. Awareness about causes and features of oral cancers can be very helpful in prevention, control and early diagnosis of oral cancer.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. Five hundred students were approached to participate in the study of which 400 agreed to participate. Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: There were 199 (49%) males and 201 (50%) females in the study and response rate was (80%). Respondents had good knowledge about oral cancer. Seventy four percent (268/362) respondents correctly identified smoking, and tobacco chewing as possible causes of oral cancer. Almost all (96%; 348/362) respondents correctly responded that oral cancer does not spread from person to person through touch or speaking. Seventy two percent (260/362) respondents believed that oral cancer is curable. Significantly higher number of male (98%) compared to female participants answered correctly to questions regarding spread of disease and occurrence of oral cancer in AIDS patients.
Conclusions: Participants showed good knowledge about oral cancer. Female participants showed lesser knowledge compared to male counterparts. Details about oral cancer should be incorporated in the undergraduate curriculum and periodic awareness programs should be organized for students.
Public knowledge and awareness towards antibiotics use in Yogyakarta: A cross sectional survey
(2020)
Irrational use of antibiotics is a public health problem. Our study aimed to evaluate knowledge and awareness of antibiotics, and to examine its’ associated factors. We conducted a cross sectional survey. The questionnaire was adapted from WHO Multi-country survey. Adults aged 18 years old and were receiving prescription from eight outpatient clinics and pharmacies in Yogyakarta province completed the survey. The questionnaire was consisted of three sections, i.e. socio-demographic factors, knowledge of antibiotics, and experiences in using antibiotics. Scores on questions and data were presented descriptively and analyzed using logistic regression to evaluate the influence of variables on knowledge of antibiotics. Out of 268 respondents, a cumulative 76% of them used antibiotics in last six months. Majority of respondents (58%) had low level knowledge on antibiotic use and awareness, and incorrectly identified that cold and cough are treatable with antibiotics (75%). Interestingly, 71% of participants agreed that internet is a major source of information on antibiotics (71%), while only 58% and 45% of respondents see pharmacists and medical professionals respectively. The antibiotics were received from prescription (79%) and 70% of respondents completed the full course of antibiotics prescribed, but only 32% of them became more cautious about antibiotic use. We found the highest association between gender, age, education level, with the knowledge of antibiotics. The overall level of knowledge and awareness on antibiotics use among residents in Yogyakarta is low. This mandates public health awareness intervention programs to be implemented on the use of antibiotics.
Lack of knowledge regarding antibiotics use has been widely identified as a main reason for inappropriate antibiotics use which leads to antibiotic resistance phenomenon. This study aimed to evaluate the effects of pharmacist-initiated educational intervention on promoting appropriate use of antibiotics and reducing self-medication with antibiotics. A pre and post intervention study using two validated self-administered questionnaires was performed in Yogyakarta province. A-two hour session of course and case discussion was delivered as method of intervention. Pharmacy customers attended Gema Cermat program were invited conveniently to complete both of pre- and post-educational questionnaires. Descriptive presentation was conducted to show scores on questions. Knowledge scores were categorized as poor, adequate and high. Of 268 respondents, 34.22% respondents had poor level of knowledge before receiving educational intervention, but this number decreased into 12.21% after post-interventional phase. Another 28.23% respondents had adequate level of knowledge before and then elevated into 38.28% after receiving education about appropriate use of antibiotics. Pre-education, 37.43% participants had a high level of knowledge about antibiotics use and resistance, whereas after education the number became slightly higher (49.25%). A vast majority of respondents (75.24%) became more aware about appropriate antibiotics practice after receiving educational inter- vention. Overall, didactic educational intervention imposed higher knowledge and better practice regarding antibiotics use (p < 0.05). This study showed that using didactical education intervention towards antibiotics use and resistance can be an initial strategy that led to substantial improvement of appropriate antibiotics use. Further systemic interventions to educate people should be performed and evaluated in order to promote the appropriate use of antibiotics.
The use of secondary data in health care research has become a very important issue over the past few years. Data from the treatment context are being used for evaluation of medical data for external quality assurance, as well as to answer medical questions in the form of registers and research databases. Additionally, the establishment of electronic clinical systems like data warehouses provides new opportunities for the secondary use of clinical data. Because health data is among the most sensitive information about an individual, the data must be safeguarded from disclosure.