Perspectives in Clinical Research最新文献_第8页

Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research 医药赞助商和合同研究组织对未来研究中基因数据再利用的看法

Perspectives in Clinical Research Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_220_22

R. Devarinti, M. S. Ganachari

{"title":"Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research","authors":"R. Devarinti, M. S. Ganachari","doi":"10.4103/picr.picr_220_22","DOIUrl":"https://doi.org/10.4103/picr.picr_220_22","url":null,"abstract":"Pharmaceutical sponsors and Contract research organization plays vital role in the preparation and implementation of clinical trials and give rise to ethical predicaments that pertain to various aspects such as general or genetic consent, optional research, storage and utilization of genetic data and specimens, as well as disclosure of research findings to study participants. The current investigation is to assess the knowledge, attitudes, and practices of Clinical Research Organizations and Pharmaceutical Sponsors in relation to re-use of genetic research data for future research. A cross-sectional study conducted on pharmaceutical sponsor and their representatives from the metro cities, India. The present research encompassed N=50 of pharmaceutical sponsors and contract research organizations. Among these, 84% evinced cognizance regarding the re-use of genetic data in clinical trials. Furthermore, 62% of pharmaceutical sponsors and contract research organizations articulated apprehensions with respect to ethical and legal quandaries might arise due to the re-use of genomic data. A considerable proportion of participants are a willingness to share and reuse genetic data for future studies. However, it is observed that the perception towards practice is low, particularly in relation to the return of genetic results and ethical concerns while storing genetic samples. There are presently no universally accepted international Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in place for the management of genetic sampling and data at the global level. In India, however, ICMR regulations exist to provide direction for the use of biological materials and datasets in research.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"3 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139272302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college GENESIS--以指导、教育、联网和赋权为基础的学生医疗保健研究智能倡议：一所新成立医学院的研究模式经验

Perspectives in Clinical Research Pub Date : 2023-11-10 DOI: 10.4103/picr.picr_88_23

Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati

{"title":"GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college","authors":"Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati","doi":"10.4103/picr.picr_88_23","DOIUrl":"https://doi.org/10.4103/picr.picr_88_23","url":null,"abstract":"The importance of undergraduate medical research has been undermined in Indian medical education. Various studies show there is a drastic difference between the research output of Indian medical graduates in comparison to Western counterparts. With all the challenges identified, a student-oriented research committee was formed –Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students (GENESIS) research in health care – A research modeling experience from a newly established medical college. The structure was established to serve the needs of students in the field of research. Problems were identified with the help of a survey, and steps were taken to address the issues through its 4-pronged strategy that includes conducting regular journal clubs. Journal clubs follow a peer-to-peer learning strategy and provide an open stage for discussion. Second, a research tracker which helps in increasing the sustainability of a research project. The third strategy includes a research live matchmaker which helps in bridging the gap between the students and the faculties. Lastly, involving alumni in the initiative will help students get guidance and acts as a gateway to opportunities at the national level. For maintaining the integrity and sustainability of the initiative, the involvement of students from all the batches is made sure. Inputs from faculties and administration are taken on a regular basis. Interinstitutional collaborations and regular assessment and evaluation are done to ensure positive outcomes. With its focus on peer-to-peer mentoring and attempt to eliminate the barriers for research enthusiasts, GENESIS has the potential to make a lasting impact in promoting research culture in colleges.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study COVID大流行对机构伦理委员会运作的影响:一项比较研究

Perspectives in Clinical Research Pub Date : 2023-10-27 DOI: 10.4103/picr.picr_79_23

Yashashri Chandrakant Shetty, Urmila Mukund Thatte, Amitrajit Pal, Janhavi Katkar

{"title":"Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study","authors":"Yashashri Chandrakant Shetty, Urmila Mukund Thatte, Amitrajit Pal, Janhavi Katkar","doi":"10.4103/picr.picr_79_23","DOIUrl":"https://doi.org/10.4103/picr.picr_79_23","url":null,"abstract":"Abstract Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann–Whitney U -test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed, more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"67 5","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136312543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Clinical trial trends over the last 5 years among the BRICS (Brazil, Russia, India, China, and South Africa) nations 金砖国家(巴西、俄罗斯、印度、中国和南非)过去5年的临床试验趋势

Perspectives in Clinical Research Pub Date : 2023-10-27 DOI: 10.4103/picr.picr_179_23

Kaviya Manoharan, Juanna Jinson, Kalaivani Ramesh, Melvin George

{"title":"Clinical trial trends over the last 5 years among the BRICS (Brazil, Russia, India, China, and South Africa) nations","authors":"Kaviya Manoharan, Juanna Jinson, Kalaivani Ramesh, Melvin George","doi":"10.4103/picr.picr_179_23","DOIUrl":"https://doi.org/10.4103/picr.picr_179_23","url":null,"abstract":"Abstract Purpose: Although the Americas and Europe have historically dominated the global research landscape, emerging economies – Brazil, Russia, India, China, and South Africa (BRICS) have significantly increased their contributions in recent years. This article studies clinical trial trends in the BRICS nations between 2018 and 2022 and compares it with trends in the G7 nations (comprising Canada, France, Germany, Italy, Japan, the UK, the USA, and the European Union). This will help stakeholders in planning drug development strategies. Materials and Methods: Data were collected from the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and the World Bank database. An electronic search was done for the total number of trials registered between January 1, 2018, and March 15, 2023. Information was analyzed based on the year of registration, therapeutic area, type of intervention, sponsorship, and type of special population. The trial density indices (TDIs) were calculated based on population (Xi) and gross domestic product (GDP) (Yi) using author-derived formulae. Results: Altogether 2, 77, 536 trials from the BRICS and G7 were registered. China and the US had the most trials among the BRICS and G7, respectively. Between 2018 and 2022, the gap between the BRICS and G7 steadily reduced. The most common indication for clinical trials among the BRICS was cancer. Based on population, the TDI was the highest in China and the lowest in Russia. In proportion to the GDP, the TDI was maximum in Russia and minimum in India. Conclusion: There is a remarkable reduction in the gap in clinical trial trends between the BRICS and G7 nations. Among the BRICS, India and China are at the forefront in drug development. There is scope for improvement in trial density based on India’s population and GDP. Stakeholders are likely to utilize the strengths of the BRICS as an attractive destination for investment in this area.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"18 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136311656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Perception and practices on COVID-19 vaccination and booster dose acceptability among health-care workers – A questionnaire-based study 卫生保健工作者对COVID-19疫苗接种和加强剂可接受性的认识和做法——一项基于问卷的研究

Perspectives in Clinical Research Pub Date : 2023-10-27 DOI: 10.4103/picr.picr_64_23

Nivethia K. Rathinakumar, Anandabaskar Nishanthi, Shanthi Manickam

{"title":"Perception and practices on COVID-19 vaccination and booster dose acceptability among health-care workers – A questionnaire-based study","authors":"Nivethia K. Rathinakumar, Anandabaskar Nishanthi, Shanthi Manickam","doi":"10.4103/picr.picr_64_23","DOIUrl":"https://doi.org/10.4103/picr.picr_64_23","url":null,"abstract":"Abstract Aim: To assess the perception and practices on COVID-19 vaccination and to determine the predictors of booster dose acceptability among health-care workers (HCWs) in South India. Materials and Methods: We conducted an anonymous cross-sectional survey on the perception and practices on COVID-19 vaccination and booster dose acceptability among the HCWs in South India. We prepared an online self-administered validated questionnaire, and the Google form link to it was circulated from March 28, 2022 to April 27, 2022, in the social media groups of the HCWs. We used binary logistic regression to identify the predictors of booster dose acceptability among HCWs. Results: Overall, we obtained 572 valid responses, of which the majority were from paramedical workers compared to doctors. Most of the respondents were unmarried females aged <30 years. Around 31.6% had been previously diagnosed with COVID-19. About 97.9%, 88.8%, and 12.6% of the participants have taken the first, second, and booster doses of the COVID-19 vaccine, respectively. Among the respondents, 19.7% refused to take the booster dose. The main reason for booster dose refusal is the belief that two doses of the COVID-19 vaccine are sufficient to confer disease protection. Believing vaccination to be one of the most effective measures in COVID-19 prevention and being doctors by profession were the chief predictors of booster dose acceptance among HCWs. Conclusion: While the uptake of the primary COVID-19 vaccination series was commendable among Indian HCWs, booster dose was taken only by a minority of them.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"24 5","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136312541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials 回顾2008年至2022年在印度注册的临床试验，描述首次人体试验

Perspectives in Clinical Research Pub Date : 2023-10-16 DOI: 10.4103/picr.picr_124_23

Sowparnika Treasa Sabu, Shravan Venkatraman, Jerin Jose Cherian, Saibal Das, Monika Pahuja, Tulsi Adhikari, Shoibal Mukherjee, Nabendu Sekhar Chatterjee, Nilima Arun Kshirsagar

{"title":"A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials","authors":"Sowparnika Treasa Sabu, Shravan Venkatraman, Jerin Jose Cherian, Saibal Das, Monika Pahuja, Tulsi Adhikari, Shoibal Mukherjee, Nabendu Sekhar Chatterjee, Nilima Arun Kshirsagar","doi":"10.4103/picr.picr_124_23","DOIUrl":"https://doi.org/10.4103/picr.picr_124_23","url":null,"abstract":"Abstract Aim: This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. Materials and Methods: The data were extracted from the Clinical Trials Registry – India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug–drug interaction studies) were excluded from the study. Results: A total of 1891 trials were retrieved and 220 were included in the analysis. Most of the investigational products were drugs (55%) followed by vaccines (38.2%). The most common therapeutic class of drugs was cancer chemotherapy (19.8%), followed by antimicrobial chemotherapy and endocrinology (18.2% each). The most common vaccine was the influenza vaccine (21.4%), followed by the measles–mumps–rubella vaccine (15.5%). The pharmaceutical industry was the predominant sponsor for most (91%) of the Phase 1 trials. Of the top five sites where most of the Phase 1 trials were conducted, three were private nonacademic centers (cumulatively 31%) and two were tertiary care medical colleges (cumulatively 9%). Conclusion: Phase 1 clinical trials seem to be conducted in India predominantly with industry sponsorship. There is a need to have an alternate ecosystem to take forward molecules that do not receive adequate attention from the industry and molecules that are of national health priority other than areas such as chemotherapy, antimicrobials, and endocrinology. The Indian Council of Medical Research is setting up Phase 1 clinical trial capacity for molecules that predominantly may arise from nonindustry channels.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials 远程数据采集、可穿戴设备和数字生物标志物在分散临床试验中的作用

Perspectives in Clinical Research Pub Date : 2023-10-13 DOI: 10.4103/picr.picr_219_22

Deepa Chodankar, Tapan K. Raval, Jeyaseelan Jeyaraj

{"title":"The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials","authors":"Deepa Chodankar, Tapan K. Raval, Jeyaseelan Jeyaraj","doi":"10.4103/picr.picr_219_22","DOIUrl":"https://doi.org/10.4103/picr.picr_219_22","url":null,"abstract":"Abstract Decentralized clinical trials (DCTs) are gaining momentum in clinical research as these studies can be executed remotely through telemedicine and mobile/local health-care providers. The COVID-19 pandemic has further accelerated advances and adoption in this area. In the past few years, there has been significant development and growth in the use of remote data that are electronically transmitted from a clinical trial (CT) participant, from outside the clinical setting, to a data repository. Such data may include laboratory data, safety data, or outcome measures reported by the participant, the clinician or the observer. Similarly, wearable health monitoring devices are being increasingly used in health-care and CT settings. Digital biomarkers, which can support continuous measurement of physiologic parameters outside the physical confines of the clinical environment, are also creating new and improved opportunities for patient care and biomedical research, enabling remote monitoring and DCTs. There are several benefits to using remote data capture, wearables, and digital biomarkers in clinical health-care research; however, several questions and challenges still need to be addressed. In an effort to understand the adoption of these technologies in DCTs, and the challenges therein, the authors of this workstream conducted an online survey of clinical research stakeholders across India and reviewed 80 responses. The review article summarizes the key findings from this online survey.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135922796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploring the trend of use of qualitative methods in randomized controlled trials. 探讨在随机对照试验中使用定性方法的趋势。

Perspectives in Clinical Research Pub Date : 2023-10-01 Epub Date: 2022-11-14 DOI: 10.4103/picr.picr_131_22

S R Disha, K Merin Eldhose, Yashashri Shetty

引用次数: 0

Adherence to Consolidated Health Economic Evaluation Reporting Standards guidelines for published pharmacoeconomic studies in PubMed-indexed medical journals over a year (2021-2022). 在一年内(2021-2022年)在pubmed索引的医学期刊上发表的药物经济学研究遵循综合卫生经济评估报告标准指南。

Perspectives in Clinical Research Pub Date : 2023-10-01 Epub Date: 2023-04-17 DOI: 10.4103/picr.picr_7_23

Miteshkumar Maurya, Renuka Munshi

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Virtual clinical trials. 虚拟临床试验。

Perspectives in Clinical Research Pub Date : 2023-10-01 Epub Date: 2023-03-08 DOI: 10.4103/picr.picr_184_22

Priya Ranganathan, Rakesh Aggarwal, C S Pramesh

引用次数: 0