Perspectives in Clinical Research最新文献

{"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}

{"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}

{"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}

{"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}

{"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}

{"title":"Exploring the trend of use of qualitative methods in randomized controlled trials.","authors":"S R Disha, K Merin Eldhose, Yashashri Shetty","doi":"10.4103/picr.picr_131_22","DOIUrl":"10.4103/picr.picr_131_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":"207-208"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adherence to Consolidated Health Economic Evaluation Reporting Standards guidelines for published pharmacoeconomic studies in PubMed-indexed medical journals over a year (2021-2022).","authors":"Miteshkumar Maurya, Renuka Munshi","doi":"10.4103/picr.picr_7_23","DOIUrl":"10.4103/picr.picr_7_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":"209-210"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual clinical trials.","authors":"Priya Ranganathan, Rakesh Aggarwal, C S Pramesh","doi":"10.4103/picr.picr_184_22","DOIUrl":"10.4103/picr.picr_184_22","url":null,"abstract":"<p><p>Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs. The use of such trials increased manifold during the COVID-19 pandemic and is likely to continue in the future.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":"203-206"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prescribing patterns and pharmacoeconomic analysis of antihypertensive drugs in South Indian population: A cross-sectional study.","authors":"S Shanmugapriya,&nbsp;Saravanan Thangavelu,&nbsp;Aashiq Ahamed Shukkoor,&nbsp;P Janani,&nbsp;R Monisha,&nbsp;Varsha Elsa Scaria","doi":"10.4103/picr.picr_122_22","DOIUrl":"10.4103/picr.picr_122_22","url":null,"abstract":"<p><strong>Background: </strong>Global evidence-based recommendations for hypertension management are periodically updated, and ensuring adherence to the guidelines is imperative. Furthermore, the current high prevalence of hypertension effectuates a high health-care cost.</p><p><strong>Purpose: </strong>To evaluate the prescribing patterns of antihypertensive drugs and other factors affecting blood pressure (BP) with the objective of assessing the proportion of patients achieving the target BP and to perform a pharmacoeconomic analysis in a South Indian population.</p><p><strong>Materials and methods: </strong>In a cross-sectional study, 650 patients previously diagnosed with hypertension and already on treatment with one or more drugs were included. A prospective interview of patients was done using a prevalidated questionnaire on various factors in BP control. Prescribing patterns and pharmacoeconomic analyses, namely, cost acquisition, cost of illness, and cost-effectiveness analyses were carried out.</p><p><strong>Results: </strong>Of 650 subjects, 257 (39.54%) achieved the target BP, while 393 (60.46%) did not. A significant association of age, occupational status, monthly family income, and area of residence in addition to physical activity and diet scores, with achieving target BP was noted. A significantly higher cost of anti-hypertensive drug treatment in achieving target BP (<i>P</i> = 0.02) was observed. Among patients who achieved target BP, 37.35% were on monotherapy and 48.25% on multiple drug therapy compared to 46.31% and 35.62%, respectively, in patients who did not. Average cost-effectiveness ratio were found to be Rs. 20.45 and Rs. 57.27, respectively, for single and multiple drug therapies, with incremental cost-effectiveness of Rs. 194.14 per additional patient treated with multiple free drug combinations.</p><p><strong>Conclusion: </strong>This study identified the anti-hypertensive prescribing pattern and provided insight into the various pharmacoeconomic factors that play a significant role in attaining target BP in the treated population.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"114-122"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f2/c8/PCR-14-114.PMC10405530.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9965186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical studies with Cannabis in India - A need for guidelines for the investigators and ethics committees.","authors":"Prakash Nayak,&nbsp;Gouri Pantvaidya,&nbsp;Priya Ranganathan,&nbsp;Sabita Jiwnani,&nbsp;Shalaka Joshi,&nbsp;Nithya Jaideep Gogtay","doi":"10.4103/picr.picr_159_22","DOIUrl":"10.4103/picr.picr_159_22","url":null,"abstract":"<p><p>Cannabis is one of the world's oldest cultivated plants and the most commonly used recreational drug worldwide. The plant relevant for medicinal use is <i>Cannabis</i> <i>sativa</i> that has two pharmacologically active ingredients - delta-9-tetrahydrocannabinol that is psychoactive and cannabidiol that does not have psychotropic activity. The policy tapestry of Cannabis has undergone a significant change in the past few decades worldwide. Different countries have diverse policies, ranging from classifying use of Cannabis as illicit, to legalization of its use, both for medicinal and recreational purposes. Cannabis products are approved for use, for instance, in multiple sclerosis and Dravet syndrome (US Food Drug and Administration). Against this backdrop, we find that the knowledge foundations for use of Cannabis in clinical trials in India are still evolving. Conducting ethical research within a clinical trials framework is essential to understand dosing, formulation, shelf life, drug-drug interaction, tolerability, and safety before establishing its utility for various indications. In the absence of guidelines or a regulatory framework for conduct of these studies, the various Institutional Ethics Committees (IECs), which are responsible for reviewing projects related to Cannabis, face unique challenges with respect to the basic requirements. The principal investigators (PIs) are equally strained to find local guidance, recommendations, and literature in support of their application to the respective IEC, thus leading to an impasse and delay in initiating the proposed clinical studies with Cannabis. The present article addresses considerations, questions, and issues that affect the conduct of these clinical studies and recommends mandatory documents and some suggested guidelines for use by both PIs and IECs to take studies with Cannabis forward until such time that an interdisciplinary regulatory framework is firmed up by regulatory authority.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"146-151"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9c/e0/PCR-14-146.PMC10405537.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9956237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}