The Knowledge and Opinions of Indian Researchers Regarding India’s New Drugs and Clinical Trial Regulations:An Online Survey (Preprint)

2019 ◽  
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Online Survey ◽  
New Drugs ◽  
Multiple Sources ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Previous Clinical Trial ◽  
Post Trial ◽  
Trial Drug

BACKGROUND Although a few studies examined possible problems regarding the previous clinical trial regulatory guideline issued in 2016, no study investigated the awareness and opinions of researchers about the new regulatory guidelines issued in 2019. OBJECTIVE This study aimed to describe the Indian researchers’ knowledge and views regarding India’s new drug and clinical trial rules of 2019. METHODS A cross-sectional online questionnaire study was carried out by randomly selecting various Indian researchers (men and women) from multiple sources between July 2019 and September 2019. The survey questionnaires, which had already been validated, were developed using Google Forms. A web link was generated for participants to take the survey. Descriptive statistics, such as counts and percentages or means and standard deviations, were computed to describe the demographic characteristics, knowledge, and views of Indian researchers. RESULTS Out of 106 researchers, 75 researchers (70.8%), and 65 their managers, and clinical staff (61.3%) knew the new regulations. Further, 36 (63.2%), 32 (53.1%), and 31 (54.5%) researchers were agreed with the reduction in the timeline, free post-trial drug access, and welcoming equality, respectively. Further, 37 researchers (64.9%) agreed with the new changes on how to deal with severe adverse effects and compensation. Overall, 34 researchers (59.6%) accepted the new rules. Additionally, 71 researchers (67%) said that the new regulations would mostly impact on profit clinical trial studies. Generally, 91 researchers (87.5%) deemed that the new rules are highly favorable to the promotion of clinical research in India. CONCLUSIONS The majority of researchers have the knowledge, agreed with the changes and deemed that the new regulations of 2019 are highly favorable to the promotion of clinical research in India.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

10.2196/14744 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14744
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study (Preprint)

2019 ◽  
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

BACKGROUND Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. OBJECTIVE This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. METHODS In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. RESULTS The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. CONCLUSIONS The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14744

scholarly journals Emotional Bonding and Sexual Activity During COVID-19 Lockdown: A Cross-National Pilot Study

2021 ◽  
pp. 263183182110274
Author(s):  
Deblina Roy ◽  
Sujita Kumar Kar ◽  
SM Yasir Arafat ◽  
Pawan Sharma ◽  
Russell Kabir
Keyword(s):  
Online Survey ◽  
Sampling Technique ◽  
Sexual Relationships ◽  
Sexually Active ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Emotional Bonding ◽  
Significant Difference ◽  
The Mean ◽  
Study Participants

Background: The COVID-19 pandemic and lockdown measures have affected the sexuality and emotional bonding among the couple across the world. Objectives: We aimed to assess the effects of the COVID-19 pandemic and lockdown on the married people’s emotional bonding and sexual relationships in 3 south Asian counties (Bangladesh, India, and Nepal). Methods: A cross-sectional online survey was conducted among Bangladesh, India, and Nepal residents from April 3 to April 15, 2020. The survey was designed in English. The participants were selected through convenience sampling technique, the link of the online questionnaire was shared with the participants. Only participants older than 18 years and above, married, and living with their spouses were included in the study. Results: A total number of 120 respondents were included finally for analysis from the participating countries (India, Nepal, and Bangladesh). The mean age of the participants was 35.42 (±5.73) years; the majority were males under the age of 40 years and had completed postgraduation as their qualification. Among the study participants, more than half (53.8%) of the women reported being sexually active during the lockdown, whereas 41% of the men reported being sexually active. Among the sexually active participants, most women (57.7%) reported that they perceived positive emotional bonding with their partners. Nevertheless, there was no significant difference observed when compared with men. There are variations in responses. However, no significant association was identified. Conclusion: There are a few insights from the study, that is, there was no significant difference found in almost 3 countries in emotional intimacy. There had been a trend that there is improved emotional bonding with their partners, although no significant difference was observed.

scholarly journals Physicians’ Knowledge, Attitude and Practice of Generic Substitution in China: A Cross-Sectional Online Survey

2021 ◽  
Vol 18 (15) ◽  
pp. 7749
Author(s):  
Mingyue Zhao ◽  
Lingyi Zhang ◽  
Zhitong Feng ◽  
Yu Fang
Keyword(s):  
Online Survey ◽  
Generic Substitution ◽  
Generic Drugs ◽  
Final Analysis ◽  
Generic Medicine ◽  
Generic Medicines ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Ordered Logistic Regression ◽  
Tertiary Hospitals

The purpose of this study is to investigate physicians’ knowledge, attitudes and practice of generic medicine substitutions in China. We conducted a cross-sectional online questionnaire survey on physicians from secondary or tertiary hospitals in China from 2020 December to 2021 April. Descriptive statistical and ordered logistic regression were used for analysis. A total of 1225 physicians were included in the final analysis, and only 330 (26.94%) of them scored 4 or above in the knowledge part, which means that the physicians have a good knowledge of generic substitutions. Of the total, 586 (47.83%) agreed or strongly agreed that generic drugs could be substituted for originator drugs and 585 (47.75%) always or often prescribed generic medicines. The percentage of physicians with a positive attitude toward or that practice prescribing generic medicine is below 50%, which needs to be improved in China. Physicians’ knowledge, their attitude toward generic substitution, if familiar with the policy of generic substitution, and incentives for prescribing generic medicines are influencing factors for the practice of generic substitution. Our studies show that the practice of generic substitution by physicians could be improved by several measures in China. We suggested that the physicians should be taught more about the bulk-buy policy and the generic-originator equivalence evaluation policy. Moreover, government incentives to promote generic substitution should be established. Our study also suggested that physicians with less working experience and female physicians should learn more about generic substitution.

scholarly journals Intention to Be Vaccinated for COVID-19 among Italian Nurses during the Pandemic

Vaccines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 500
Author(s):  
Marco Trabucco Aurilio ◽  
Francesco Saverio Mennini ◽  
Simone Gazzillo ◽  
Laura Massini ◽  
Matteo Bolcato ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Online Survey ◽  
Vaccine Development ◽  
Vaccine Coverage ◽  
World Health ◽  
Vaccine Hesitancy ◽  
Effective Vaccine ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Female Sex

Background: While the COVID-19 pandemic has spread globally, health systems are overwhelmed by both direct and indirect mortality from other treatable conditions. COVID-19 vaccination was crucial to preventing and eliminating the disease, so vaccine development for COVID-19 was fast-tracked worldwide. Despite the fact that vaccination is commonly recognized as the most effective approach, according to the World Health Organization (WHO), vaccine hesitancy is a global health issue. Methods: We conducted a cross-sectional online survey of nurses in four different regions in Italy between 20 and 28 December 2020 to obtain data on the acceptance of the upcoming COVID-19 vaccination in order to plan specific interventions to increase the rate of vaccine coverage. Results: A total of 531 out of the 5000 nurses invited completed the online questionnaire. Most of the nurses enrolled in the study (73.4%) were female. Among the nurses, 91.5% intended to accept vaccination, whereas 2.3% were opposed and 6.2% were undecided. Female sex and confidence in vaccine efficacy represent the main predictors of vaccine intention among the study population using a logistic regression model, while other factors including vaccine safety concerns (side effects) were non-significant. Conclusions: Despite the availability of a safe and effective vaccine, intention to be vaccinated was suboptimal among nurses in our sample. We also found a significant number of people undecided as to whether to accept the vaccine. Contrary to expectations, concerns about the safety of the vaccine were not found to affect the acceptance rate; nurses’ perception of vaccine efficacy and female sex were the main influencing factors on attitudes toward vaccination in our sample. Since the success of the COVID-19 immunization plan depends on the uptake rate, these findings are of great interest for public health policies. Interventions aimed at increasing employee awareness of vaccination efficacy should be promoted among nurses in order to increase the number of vaccinated people.

scholarly journals Assessment of Physician's Knowledge of Potential Drug-Drug Interactions: An Online Survey in China

2021 ◽  
Vol 8 ◽  
Author(s):  
Jing Yuan ◽  
Chunying Shen ◽  
Chengnan Wang ◽  
Gang Shen ◽  
Bing Han
Keyword(s):  
Drug Interactions ◽  
Online Survey ◽  
Mobile Apps ◽  
Least Square ◽  
Common Source ◽  
Potential Drug ◽  
Cross Sectional Survey ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Source Of Information

Background: Drug interactions are the most common preventable cause of adverse drug reaction, which may result in drug toxicity or undesired therapeutic effect with harmful outcomes to patients. Given the rising use of combination therapies, the main objectives of this study were to estimate the degree to which physicians can identify potential drug-drug interactions (PDDIs) correctly and to describe the common source of information used by physicians when they need to check PDDIs.Methods: A cross-sectional survey utilizing a self-administered online questionnaire was conducted among physicians in China. Participants were asked to classify 20 drug pairs as “no interaction,” “may be used together with monitoring,” “contraindication,” and “not sure.” We also collected data on the physician's source of information and altitude toward the PDDIs. An ordinary least square regression model was performed to investigate the potential predictors of PDDI knowledge.Results: Eligible questionnaires were obtained from 618 physicians. The respondents classified correctly 6.7 out of 20 drug pairs, or 33.4% of the drug interactions investigated. The number of drug pairs recognized by respondents was ranged from 0 to 16. The percentage of physicians who recognized specific drug pairs ranged from 8.3% for no interactions between conjugated estrogens and raloxifene, to 64.0% for the interaction between dopamine and phenytoin. When the respondents want to check PDDI information, the most commonly used source of information was package inserts (n = 572, 92.6%), followed by the Internet or mobile Apps (n = 424, 68.6%), consultation with clinical pharmacists (n = 384, 62.1%), medical textbooks (n = 374, 60.5%), knowledge base in Chinese (n = 283, 45.8%), and other physicians (n = 366, 59.2%). In the multiple regression analysis, the significant predictors of a higher number of recognized drug pairs were years of practice and altitudes toward PDDIs.Conclusion: In this online survey accessing physician's ability to detect PDDIs, less than half of the drug pairs were recognized, indicating unsatisfactory level of knowledge about the clinically significant drug interactions. Continuing education and accessible electronic database can help physicians detecting PDDIs and improve drug safety.

scholarly journals A Cross-Sectional Survey of Personal Hygiene Positive Behavior Related to COVID-19 Prevention and Control among Indonesian Communities

2021 ◽  
Vol 14 (1) ◽  
pp. 169
Author(s):  
Fatma Lestari ◽  
Abdul Kadir ◽  
Muhammad Idham ◽  
Fahrul Azwar ◽  
Ganis Ramadhany ◽  
...  
Keyword(s):  
Prevention And Control ◽  
Online Survey ◽  
Cross Sectional Study ◽  
Positive Behavior ◽  
Personal Hygiene ◽  
Cross Sectional Survey ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Health Council ◽  
And Control

People’s behaviors can affect the spread of the COVID-19 virus. Public behaviors, including proper personal hygiene and healthy life practices, the use of appropriate masks, and the application of good disinfectants, have an important role in human health and protection towards prevention and control of COVID-19 spread. This study aims to perform a survey of public behavior and best practices related to COVID-19 prevention and control among Indonesian communities. A cross-sectional study was designed to collect information using an online survey. Respondents were gathered from 34 provinces in Indonesia through the Indonesia National Safety and Health Council network and Universities network. Respondents voluntarily submitted their response to a predesigned online questionnaire. The collected data was then analyzed using SPSS 24.0. A total of 771 respondent subjects (male 386; female 385) were recruited. The results show that 96% of participants implement positive behavior of personal hygiene, including wearing a mask when going outside their house, and almost 67.3% of respondents sprayed a disinfectant in their house. The majority of participants hold a door handle (37.2%) and desk (28.1%) at a frequency of more than six times a day. There were 8.2% of participants implementing good personal hygiene, including hand-washing at least once a day and maximum of more than six times after going to the toilet. At-risk behaviors were conducted by respondents in which they touched part of their face at a frequency of once during an hour. It was identified that males are less likely to perform better hand hygiene as opposed to females. In conclusion, the study showed that positive behavior of personal hygiene related to COVID-19 has been implemented among Indonesian communities. This result suggests that positive behavior based on community-based prevention and control needs to be continually maintained in order to prevent and control COVID-19 spread.

scholarly journals Knowledge, Attitude and Practice of Saudi Parents Towards Their Children's Oral Health: An Online Questionnaire Survey

2019 ◽  
Vol 1 (4) ◽  
Author(s):  
Malaz Mohamed Elrafie Mustafa ◽  
Ebtehaj Saleh Albeshri ◽  
Mashael Khaled Althobati
Keyword(s):  
Oral Health ◽  
Young Children ◽  
Breast Feeding ◽  
Online Survey ◽  
Family Income ◽  
Dental Treatment ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
On Demand ◽  
Children’S Oral Health

Children's oral health is of paramount importance as it governs the oral health status of the upcoming generation. Their oral hygiene is a vital part of general childcare. This under-appraised issue is often neglected by young parents, which can result in poor children's oral health. Aim: To assess standard knowledge, attitude and behavior of Saudi parents pertaining to the oral health of their young children. Materials and Methods: a prospective cross-sectional online survey was conducted in Saudi Arabia in 2017. The questionnaire included a total of 16 questions which were divided into two parts; the first part asked about parents' general information such as the name, age, gender, educational level, occupation and total family income. The second part included questions related to knowledge, attitude and practices toward children on selected oral health issues. Results: 1038 Saudi parents responded to the online questionnaire (70% Females and 30% male). Majority Saudi parents recognized many preventive dental aspects like importance of early acquisition of tooth brushing, avoidance of caries-related diet and nocturnal on demand breast feeding. Seventy three percent were convinced that it is better to take their children to a specialized pediatric dentist rather than a general dental practitioner. However, it was revealed that there was limited knowledge and awareness of Saudi parents about the significance of the routine dental checkups, ideal timing of first dental visit and importance of topical fluoride. Hypothetical myths and social beliefs associated with dental treatment like endodontic treatment were common; creating barriers to early preventive and curative dental care of young Saudi children. Conclusion: Parents were found to have inadequate knowledge in regard to oral health of their young children. The present research points to a need for enhanced dental education of parents, particularly in planning for their children's first visit and effect of prolonged on-demand at night breast feeding on development of early childhood caries. Community based oral health programs are required in order to raise parents' awareness regarding their children's oral health.

scholarly journals IMPACT OF THE COVID-19 PANDEMIC ON PSYCHOLOGICAL HEALTH STATUS DURING LOCKDOWN PERIOD: A CROSS-SECTIONAL STUDY

2021 ◽  
Vol 20 (2) ◽  
pp. 217-223
Author(s):  
Sonu Punia ◽  
◽  
Mohini Mohini ◽  
Shailja Sharma ◽  
Varun Singh ◽  
...  
Keyword(s):  
Health Status ◽  
Rural Community ◽  
Psychological Health ◽  
Online Survey ◽  
Demographic Data ◽  
Psychosocial Health ◽  
Cross Sectional Study ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Prevention Measure

Objective. The aim of this research was access the effect of lockdown on the psychological health status of people. Methods. This was an online questionnaire survey developed and circulated among people using snow-ball sampling techniques from April to mid of June 2020. The online survey collected information on demographic data and psychosocial health elements. Results. This study included 604 peoples (59.1% were female and 40.8% were females) of Haryana. Of the total respondents, 57.6% were in age group of 18-30 years, 40.8% were in 31-45 years and 1.5% was in 45-60 years group. 90% of people have normal self- reported BMI, 6.5% were overweight, 3% were underweight and 0.5% people have obesity. 74% respondents were graduate, 11.5% postgraduate, 3.2% were PhD, and 9.2% were 12th pass. 31.8% were unemployed, 35.9% were student, 15.8% regular government employee, 4.7% were self- employed and 2.5% were adhoc/contract employee. 79.5% people reside in urban community and 16% in rural community and 4.5% in semi-urban area. Most of the respondents have agree with the statement that lockdown induced constant sense of insecurity (72.9%); anxiety (58.7%),psychological stress (66.4%); work & financial stress (52.4%), phobia of infection (50.9%); stigma towards symptomatic people, which might be because of simple flu (55.2%); stress from watching & listening COVID-19 news (38.6%); stress from practice of prevention measure (31.9%). Most of people also agree with that behavior-change modification (follow preventive regulations) can improve mental stress (53.2%). Conclusion. Majority of people has realized the lockdown have significant impact on psychological health status of people.

Prevalence and Attitudes towards Using Protein Supplements Among Female Gym Users: an Online Survey

2021 ◽  
Vol 17 ◽  
Author(s):  
Maha H. Alhussain ◽  
Waad S. Abdulhalim ◽  
Laila Naif Al-harbi ◽  
Manal Abdulaziz Binobead
Keyword(s):  
Saudi Arabia ◽  
Online Survey ◽  
Protein Supplementation ◽  
Protein Supplement ◽  
Sources Of Information ◽  
Online Questionnaire ◽  
Exercise Frequency ◽  
Cross Sectional ◽  
Protein Supplements ◽  
Supplement Use

Background: Protein supplements have become a widespread practice amongst athletes and gym users worldwide. However, studies on the use of protein supplements among female gym users in Saudi Arabia are lacking. Objective: The aim of this study was to investigate the prevalence of protein supplement usage among female gym users and their attitudes towards protein supplementation in Riyadh city, Saudi Arabia. Methods: In this cross-sectional study, 502 female gym users aged ≥18 years completed a structured, self-administered online questionnaire on the usage of protein supplementation. Socio-demographic information, anthropometry, health status, exercise frequency, attitudes and knowledge regarding protein supplements were obtained. Results: The overall prevalence rate of protein supplement use among the study respondents was 36.3%. There were significant associations between the use of protein supplements and educational level (p< 0.05), the duration of being a gym member (p< 0.05) and frequency of gym visits per week (p< 0.05). Whey protein was the predominantly used supplement (57.8%), and the reason attributed to the use of protein supplement was muscle building (53.9%). The main sources of information regarding protein supplement use included the internet (30.2%) followed by gym coaches (25.3%). Conclusion: Our findings demonstrated that a considerable number of females exercising in gyms use protein supplements, and most rely on unreliable sources for decision-making of protein supplements use. Nutritional education and consultations regarding protein supplement use are warranted.

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