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

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 ELECTRONIC INFORMED CONSENT MODEL DEVELOPMENT FOR IMPLEMENTATION IN CLINICAL TRIALS IN UKRAINE

2017 ◽  
Vol 10 (12) ◽  
pp. 238
Author(s):  
Dobrova Vy ◽  
Zupanets KО ◽  
Kolodyezna Ty ◽  
Yuriytimchenko Timchenko
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
System Analysis ◽  
Model Development ◽  
New Drugs ◽  
Electronic Systems ◽  
New Drug

Objectives: The process of signing the informed consent (IC) is one of the essential procedures during organizing and conducting the clinical trial (CT) of any new drug. During this procedure, the volunteers should read the IC form that is often difficult to understand. Analysis of literature showed lack of experience in use of electronic systems in the IC signing in Ukraine. Abroad such systems are quite new. Thus, the aim of this work is the rationale for the introduction of electronic IC to CT drugs in Ukraine and the development of its general model.Methods: Experience in the use of electronic systems in IC signing analysis was carried out using methods of system analysis, synthesis, abstraction, and generalization.Results: Thus, during the signing process of paper forms risks and errors may arise such as loss of paper copies and signing of an incorrect version of the document by the volunteer. With the use of electronic forms, it is possible to prevent three categories of risks in preparation and signing, such as risks in the development, use, and auditing of IC forms. The opportunities of the electronic IC system to protect trial subjects in its use during organizing and conducting of CT were showed.Conclusions: The study showed that such systems are effective. Therefore, it seems appropriate to introduce electronic IC in CT of new drugs in Ukraine. We have formulated requirements to the system and determined its structure for optimal use.

scholarly journals New drug and clinical trial rules, 2019: an overview

2020 ◽  
Vol 7 (4) ◽  
pp. 278
Author(s):  
Swathi A. Annapurna ◽  
Srinivasa Y. Rao
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
New Drugs ◽  
Development Method ◽  
New Drug ◽  
The Government

<p>Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review gives an idea about the recent changes regarding the regulations of clinical trials.</p>

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

scholarly journals Canadian Recommendations for Clinical Trials of Pharmacologic Interventions in Rheumatoid Arthritis: Inclusion Criteria and Study Design: Table 1.

2011 ◽  
Vol 38 (10) ◽  
pp. 2095-2104 ◽  
Author(s):  
JACOB KARSH ◽  
EDWARD C. KEYSTONE ◽  
BOULOS HARAOUI ◽  
J. CARTER THORNE ◽  
JANET E. POPE ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Activity ◽  
Study Design ◽  
New Drugs ◽  
Nominal Group ◽  
Consensus Method ◽  
Inclusion Criteria ◽  
Design Features

Objective.Current clinical trial designs for pharmacologic interventions in rheumatoid arthritis (RA) do not reflect the innovations in RA diagnosis, treatment, and care in countries where new drugs are most often used. The objective of this project was to recommend revised entry criteria and other study design features for RA clinical trials.Methods.Recommendations were developed using a modified nominal group consensus method. Canadian Rheumatology Research Consortium (CRRC) members were polled to rank the greatest challenges to clinical trial recruitment in their practices. Initial recommendations were developed by an expert panel of rheumatology trialists and other experts. A scoping study methodology was then used to examine the evidence available to support or refute each initial recommendation. The potential influence of CRRC recommendations on primary outcomes in future trials was examined. Recommendations were finalized using a consensus process.Results.Recommendations for clinical trial inclusion criteria addressed measures of disease activity [Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) > 3.2 PLUS ≥ 3 tender joints using 28-joint count (TJC28) PLUS ≥ 3 swollen joint (SJC28) OR C-reactive protein (CRP) or ESR > upper limit of normal PLUS ≥ 3 TJC28 PLUS ≥ 3 SJC28], functional classification, disease classification and duration, and concomitant RA treatments. Additional recommendations regarding study design addressed rescue strategies and longterm extension.Conclusion.There is an urgent need to modify clinical trial inclusion criteria and other study design features to better reflect the current characteristics of people living with RA in the countries where the new drugs will be used.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

scholarly journals Clinical Trial Regulations In India : Past, Present and Future

JMS SKIMS ◽  
2017 ◽  
Vol 20 (1) ◽  
pp. 5-17
Author(s):  
Haroon Rashid
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Burden ◽  
International Standards ◽  
New Drugs ◽  
Safety And Efficacy ◽  
Long Time ◽  
Regulatory Bodies ◽  
Guidance Documents ◽  
Human Use

Clinical trials are the only way of establishing the safety and efficacy of any new drug before its introduction in the market for human use. Clinical trials (with safeguards) are necessary for introduction of new drugs for a country like India, considering its disease burden and emergence of new variants of disease.The regulatory bodies need to frame guidelines and regulatory approval processes on a par with international standards. Many of the new laws, guidance documents, notifications and initiatives for regulating pharmaceutical industry were in the charts for quite a long time. Indian regulatory authorities have started looking into speedy implementation and providing support in terms ofnecessary infrastructure and investment. JMS 2017; 20(1):5-17

scholarly journals COVID-19 lockdown impact on physical activity and anxiety levels among physiotherapy practitioners, teaching faculty and students in Mumbai: a cross-sectional web-based e-survey study

2021 ◽  
Vol 8 (5) ◽  
pp. 2406
Author(s):  
Farzan Kamdin ◽  
Kruti Khemani ◽  
Annamma Varghese
Keyword(s):  
Physical Activity ◽  
Short Form ◽  
Significant Proportion ◽  
Mental Wellbeing ◽  
Survey Study ◽  
Cross Sectional ◽  
Web Based ◽  
Teaching Faculty ◽  
Anxiety Levels ◽  
Physiotherapy Students

Background: Coronavirus (COVID-19) has spread rapidly throughout the world leading to an emergency global pandemic. Among the varied affected sections of the population and healthcare, physiotherapy is no exception. To what extent, both the physical activity and anxiety levels have been affected amongst the physiotherapy practitioners, teaching faculty and students is not completely known. Hence, this study was undertaken.Methods: Among a potential 400 participants, 357 responded (response rate=89.25%). Cross-sectional web based open e-survey was sent using google forms via emails and social media platforms such as Whatsapp, facebook, instagram and linkedin messenger. The primary outcome measures were international physical activity questionnaire-short form (IPAQ-SF) for self-reported physical activity and general anxiety disorder (GAD-7) questionnaire for measuring self-reported anxiety.Results: Out of the 357 participants, 40 were inactive (<600 METs/week), 175 were minimally active (600-3000 METs/week) and 142 were health enhancing physically active (>3000 METs/week). The GAD-7 score showed a significant proportion of participants (74%) to have mild to moderate anxiety and only 26% had moderately severe to severe anxiety. Physiotherapy students were found to do least amount of physical activity in a week (mean METs/week of 2590) and were also more anxious with an average GAD-7 score of 7.7. Practicing physiotherapists and teachers had better scores of 3285 and 3028 METs/week and also better mean GAD-7 scores at 6.4 and 5.3, respectively.Conclusions: The lockdown caused by the COVID-19 pandemic has affected the physical activity levels and mental wellbeing of physiotherapy students more than the physiotherapy practitioners and teaching faculty.

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