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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.
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.
Background: Immunization is the most cost-effective intervention for infectious diseases which are the major cause of morbidity and mortality worldwide. There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India. Objectives: Present study explored the adult vaccination status and influence of income and education of parents on adult vaccination status in university students from Mumbai, India.
Methods: On the basis of the eligibility criterion 149 students were selected for the present study. A total of 8 vaccines namely Tdap/DTP, Varicella, MMR, Influenza, Pneumococcal, Hepatitis A, Hepatitis B and Meningococcal were included in this study for all the respondents. In addition to these vaccines, Human Papilloma Virus vaccine was also included for female respondents.
Results: There were total of 149 (75 male and 74 females) respondents with the mean age of 21.5 years. The top 3 immunizations were Td/Tdap (97.3%), MMR (66.4%) and Hepatitis B (55%) among the respondents. Only 4 (5.5%) female respondents have been immunized against the HPV. Conclusions: Td/Tdap (97.3%) and MMR (66.4%) coverage was in line with the recommendations. For all the other vaccines the coverage was low varying from 5.5% to 35.4%. The vaccination coverage was better in respondents with higher educated and higher income parents. We suggest that patient education, planning by government for the implementation of policy for adult vaccination and involvement of physicians are must for better adult vaccination coverage.
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.
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: Pharmacovigilance (PV); also known as drug safety surveillance, is the science of enhancing patient care and patient safety regarding the use of medicines by collecting, monitoring, assessing, and evaluating information from healthcare providers and patients. Pharmacists are pivotal players in adverse drug event (ADE) monitoring and reporting. However, most pharmacists are unaware or not knowledgeable about the guidelines used by their respective countries’ drug regulatory bodies. It is the need of the hour to train pharmacy students on the concept of pharmacovigilance.
Methods: A cross-sectional study was carried out among pharmacy students from Mumbai University, India during May-June 2017. On the basis of the eligibility criterion 352 students were selected for the present study. Four hundred students were approached to participate in the study of which 201 agreed to participate (males: 179; females: 173). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Overall pharmacovigilance knowledge (44%) and perception (58%) was low among the participants of the present study. Seventy four percent of the participants felt that adverse drug reaction (ADR) reporting should be made compulsory for healthcare professionals. And only 21% agreed that the topic of Pharmacovigilance is well covered in pharmacy curriculum.
Conclusions: Pharmacy council of India, pharmacy teacher’s association and respective pharmacy college should take necessary steps to increase the knowledge and create awareness regarding pharmacovigilance and adverse drug reaction reporting among pharmacy students.
A systematic review of the literature on survey questionnaires to assess self-medication practices
(2017)
Self-medication is of great public health importance as it often bypasses regulatory mechanisms to assure quality of health care. Nevertheless there are no established standards on how to assess self-medication. We therefore intended to systematically retrieve questionnaires and survey tools used to capture self-medication, with the aim to identify the scope of information investigated in this context and commonalities between the tools. We conducted a systematic review of the literature on questionnaires used for self-medication assessment by searching PubMed and Web of Science databases using the combinations of following keywords; self-medication, self-prescription, non-prescription, questionnaire. Truncation was used to ensure retrieval of all possible variations of search terms. The search was limited to articles published between 1st January 2000 and 31st December 2015, human studies and English language. Duplicate and irrelevant studies were excluded from the final review. A total of 158 studies were included in the review. Studies were from diverse geographical locations, most of the studies were from Nigeria 16 (10.1%) followed by India 10 (6.3%) and Iran 8 (5%). Forty-three studies (27.2%) focused on antibiotic self-medication. Majority of the studies (106; 67%) were done with adult populations. The components addressed by the questionnaires covered: reasons for self-medications in 147 (93%) studies, purchasing source in 136 (86%) studies, medical conditions to be treated in 153 (96.8%) studies, adverse events in 67 (42.4%) studies, use of prescribing information in 24 (15.1%) studies and antibiotic resistance awareness in 20 (46.5%) antibiotic studies. For 74 (46.8%) studies, survey questionnaires were self-administered and most studies (57; 36%) were done at homes of respondents. Thirty-seven (23.4%) studies did not report any recall period for self-medication practices. Study response rates varied from 17.9% to 100%, and while validity of the study questionnaire was reported for 100 (63.3%) studies, 15 (9.5%) studies reported reliability test of the study questionnaire. There is a large variety of questionnaires being used for investigating self-medication practices making comparability and meta-analyses very difficult. It is desirable to have a basic set of standardized survey questions on this topic to make available for future research groups in this field.
Monitoring of clinical trials is a fundamental process required by regulatory agencies. It assures the compliance of a center to the required regulations and the trial protocol. Traditionally, monitoring teams relied on extensive on-site visits and source data verification. However, this is costly, and the outcome is limited. Thus, central statistical monitoring (CSM) is an additional approach recently embraced by the International Council for Harmonisation (ICH) to detect problematic or erroneous data by using visualizations and statistical control measures. Existing implementations have been primarily focused on detecting inlier and outlier data. Other approaches include principal component analysis and distribution of the data. Here we focus on the utilization of comparisons of centers to the Grand mean for different model types and assumptions for common data types, such as binomial, ordinal, and continuous response variables. We implement the usage of multiple comparisons of single centers to the Grand mean of all centers. This approach is also available for various non-normal data types that are abundant in clinical trials. Further, using confidence intervals, an assessment of equivalence to the Grand mean can be applied. In a Monte Carlo simulation study, the applied statistical approaches have been investigated for their ability to control type I error and the assessment of their respective power for balanced and unbalanced designs which are common in registry data and clinical trials. Data from the German Multiple Sclerosis Registry (GMSR) including proportions of missing data, adverse events and disease severity scores were used to verify the results on Real-World-Data (RWD).
A decline in the CD4 count is a common feature in HIV/AIDS, suggesting a compromise in immunity of patients. In response, highly active antiretroviral therapy (HAART) is prescribed to slow-down a diminution in the CD4 count and risk of AIDS-related malignancies. However, exercise may improve both the utility and population of innate immune cell components, and may be beneficial for patients with HIV infection. Comparing the effects of different exercises against HAART, on CD4 count, helps in understanding the role and evidence-based application of exercises to ameliorate immune deficiency.
Objective: To determine the burden and factors associated with post-stroke depression in East central Nigeria.
Method: We carried out this cross-sectional study of 50 stroke survivors (mean age=54.8 ± 8.8 years), at the physiotherapy Department of the University of Nigeria Teaching Hospital, Enugu. Data were collected using Becks Depression Inventory , it was analyzed using Z-scores, Chi-square test and univariate logistic regression.
Results: PSD was more common in females (45.45%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%). Self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (p=0.03), and was related to the risk ofOR3.7 (95% CI 1.1-12.0 )
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.