Perspectives in Clinical Research最新文献

{"title":"Pharmacovigilance and spontaneous adverse drug reaction reporting: Challenges and opportunities.","authors":"Mira Desai","doi":"10.4103/picr.picr_169_22","DOIUrl":"10.4103/picr.picr_169_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/c5/PCR-13-177.PMC9635349.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468448","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":"An observational study to monitor and report radiation-related adverse events by a clinical pharmacist to achieve a better therapeutic outcome and suggest preventive measures in a tertiary care teaching hospital.","authors":"Rajesh Hadia,&nbsp;Dhaval Joshi,&nbsp;Trupal Rathod","doi":"10.4103/picr.PICR_272_20","DOIUrl":"https://doi.org/10.4103/picr.PICR_272_20","url":null,"abstract":"<p><strong>Objectives: </strong>This study was conducted to investigate the potential role of clinical pharmacists in monitoring and developing a reporting system of radiation-related adverse events (RRAEs) in cancer patients and provided suggestive measures to prevent RRAEs to achieve a better therapeutic outcome for improving patient health-related quality of life.</p><p><strong>Methodology: </strong>This study was a prospective observational study conducted for a period of 2 years at a private academic oncology teaching care hospital. Patients on radiation therapy or chemoradiation therapy were enrolled and followed by clinical pharmacists on daily basis to identify adverse event(s) if any. Upon identification, adverse events were discussed with concerned radiation oncologists for authentication and graded as defined by the radiation therapy oncology group. Enrolled patients were also followed to ensure if they were provided adequate supportive care for RRAEs.</p><p><strong>Results: </strong>A total of 715 patients were followed during the study period. A total of 422 RRAEs were identified in patients who were on radiation therapy or chemoradiation therapy. The most common reported events were fatigue (<i>n</i> = 64, 15.16%), followed by mucositis (<i>n</i> = 55, 13.03%), diarrhea (<i>n</i> = 37, 8.76%), vomiting (<i>n</i> = 31, 7.34%), gastritis (<i>n</i> = 29, 6.87%), and dryness of the mouth (<i>n</i> = 22, 5.21%). Among the study patients who developed RRAEs, majority (<i>n</i> = 253, 60%) of them received a combination of chemotherapy and radiation therapy and 169 (40%) of 442 patients received radiotherapy alone. Cisplatin weekly monotherapy or cisplatin-based chemotherapy was commonly used pharmacological treatment in patients on chemoradiation therapy. Clinical pharmacists intervened to initiate adequate supportive care for nearly 20% (<i>n</i> = 84) patients.</p><p><strong>Conclusions: </strong>Clinical pharmacists may be contributing to monitoring and development of reporting systems for radiation-related toxicities/RRAEs in cancer patients. Teamwork of clinical pharmacists with radiation oncologists can improve the safety reporting of radiation and can ensure required medical and supportive care to manage RRAEs.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ad/97/PCR-13-205.PMC9635345.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468447","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":"Training on anti-plagiarism and referencing: A step toward sensitizing and improving scientific authenticity in medical literature writing among academicians.","authors":"Manisha Naithani,&nbsp;Rajesh Kathrotia,&nbsp;Tarun Goyal,&nbsp;Ashi Chug,&nbsp;Manisha Bisht,&nbsp;Sandeep Kumar Singh,&nbsp;Shalinee Rao","doi":"10.4103/picr.picr_260_21","DOIUrl":"https://doi.org/10.4103/picr.picr_260_21","url":null,"abstract":"Scientific writing skill is vital for individuals in academia for professional growth, originating with the Philosophical Transactions of the Royal Society in 1665.[1] Over the years, publications have become indispensable being a prerequisite for promotions and recognition. The pressing culture of “publish or perish” has been forcing many to embrace unethical practices of transgression and plagiarism in scientific pursuits.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/52/db/PCR-13-211.PMC9635351.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468449","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":"Compliance with International Committee of Medical Journal Editors policy on individual participant data sharing in clinical trial registries: An audit.","authors":"Ronak Borana,&nbsp;Soumyadeep Bhaumik","doi":"10.4103/picr.picr_85_22","DOIUrl":"https://doi.org/10.4103/picr.picr_85_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f6/2d/PCR-13-213.PMC9635347.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40682860","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":"Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019.","authors":"Ravindra Bhaskar Ghooi","doi":"10.4103/picr.picr_251_21","DOIUrl":"https://doi.org/10.4103/picr.picr_251_21","url":null,"abstract":"<p><p>The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/d3/PCR-13-129.PMC9345253.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40585091","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":"Audit of principal investigator's compliance for submission of continue review application and decisions taken on lapses in validity of approval by the Institutional Ethics Committee at tertiary oncology center in Navi Mumbai.","authors":"Bhavesh Bandekar,&nbsp;Kasturi Awatagiri,&nbsp;Sadhana Kannan,&nbsp;Pallavi Rane,&nbsp;Prafulla Parikh","doi":"10.4103/picr.PICR_102_20","DOIUrl":"https://doi.org/10.4103/picr.PICR_102_20","url":null,"abstract":"<p><strong>Context: </strong>A failure to obtain continued Institutional Ethics Committee (IEC) approval for the study before the expiry date assigned by the IEC is considered as \"lapse of the IEC approval\" to continue the study at the site by the Investigator. Considering this, we had conducted an audit of principal investigators (PI ') compliance for Continuing Review Application (CRA) submission timelines and decision taken on the lapses in the validity of IEC approval continuation.</p><p><strong>Aim: </strong>The aim of this study is to assess the pre- and post-policy trends of non-compliance management of delayed CRA submission and compare the PI's compliance for submission of CRA between Investigator Initiated trial (IIT) and Pharma studies.</p><p><strong>Setting and design: </strong>The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC.</p><p><strong>Materials and methods: </strong>The data from total 199 CRAs submitted for review to the IEC between the year January 2016 and December-2017 were collected and maintained in Microsoft Excel sheet, and later, the data were exported into the SPSS software version 21 for the analysis.</p><p><strong>Statistical analysis: </strong>All categorical data were presented in numbers and percentage. The first primary objective was assessed by calculating the duration between the dates of approval for any study to the date of next CRA submission. The CRAs submitted after the project expiry date were considered as a lapse in following the IEC SOP.</p><p><strong>Results: </strong>This retrospective audit revealed that CRA reminder sent by the IEC to the PI played an important role in compliance w. r. t timely in following the IEC SOPof the CRA by the PI. As a result, overall, 90% of CRAs showed compliance in submitting CRAs to IEC in both IIT and Pharma study. The number of lapses were reduced to 7 in the postpolicy period as compared to 15 lapses in the prepolicy period.</p><p><strong>Conclusion: </strong>This retrospective audit reveals that CRA reminder sent by the IEC to the PI played an important role in improving the compliance of PIs in submitting CRA to IEC. Each IEC should develop the policy to minimize the delays in CRA submission by the PI and prevent lapses in following the IEC SOP.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/dc/PCR-13-145.PMC9345251.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40585094","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":"An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals.","authors":"Jeffrey Pradeep Raj,&nbsp;Ambika Mamde,&nbsp;Keya Ganatra,&nbsp;Nithya Jaideep Gogtay,&nbsp;Urmila Mukund Thatte","doi":"10.4103/picr.picr_159_21","DOIUrl":"https://doi.org/10.4103/picr.picr_159_21","url":null,"abstract":"We analyzed minutes of the SEC meetings on COVID-19 (April 8, 2020–January 31, 2021) and excluded items that were postponed/deferred or were internal discussions. Each item was classified as initial/ repeat application; category of the interventional product was classified as repurposed/novel and the therapeutic area was noted down. The purpose of the application was classified as permission to conduct computed tomography [CT]/amendment of approved protocol/ Marketing authorization (MA) with CT waiver or MA post-CT].","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0a/6f/PCR-13-172.PMC9345249.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40585821","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":"Effects of antihypertensive agents on the quality of life in diabetic hypertensive patients: A prospective study.","authors":"Raj Kumar Bhardwaj,&nbsp;H L Kazal,&nbsp;Kamlesh Kohli,&nbsp;Rajnish Raj,&nbsp;Nagma Bansal,&nbsp;Baltej Singh,&nbsp;Hobinder Arora","doi":"10.4103/picr.PICR_15_20","DOIUrl":"https://doi.org/10.4103/picr.PICR_15_20","url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus is a chronic noncommunicable disease, and hypertension (HT) is the most common comorbidity which affects their quality of life (QoL).</p><p><strong>Aim: </strong>The aim of the study was to assess the effects of antihypertensive agents (viz., amlodipine, ramipril, telmisartan, and ramipril with telmisartan) on the blood pressure (BP) and QoL.</p><p><strong>Methodology: </strong>It was an open-labeled prospective intention-to-treat study done in diabetic hypertensive patients (<i>CTRI</i>/2016/10<i>/007340</i>). Patients were randomly assigned antihypertensive agents, namely, amlodipine, ramipril, telmisartan, and a combination of ramipril with telmisartan (RT) in four groups. They were evaluated for BP, blood sugar level, and QoL at baseline and 24^th week.</p><p><strong>Results: </strong>After 24 weeks of therapy, systolic BP (SBP) and diastolic BP (DBP) were significantly reduced in all groups. In amlodipine, there was a mean percentage fall of SBP by 15.85% (confidence interval [CI]: 21.38-28.13) and DBP by 11.22% (CI: 8.41-12.70); in ramipril - 14.4% (CI: 18.61-25.15) and 12.4% (CI 8.88-13.99); telmisartan - 18.4% (CI: 24.89-10.79) and 14.6% (CI 10.79-16.24); and in RT group, SBP 17.7% (CI: 23.38-29.18) and DBP 12.4% (CI: 9.05-13.02). QoL score increased by 30.56% (CI: 14.30-10.90), 30.94% (CI: 14.21-10.68), 28.07% (CI: 14.89-11.20), and 28.84% (CI: 15.49-11.77), in respective groups (<i>P</i> < 0.0001, each). However, they were nonsignificant between the study groups (<i>P</i> > 0.05).</p><p><strong>Conclusion: </strong>Amlodipine, ramipril, telmisartan, and a combination of RT are equally effective to improve BP and QoL among diabetic hypertensive patients. However, amlodipine and telmisartan lacked in dry cough and more tolerable than the ramipril and RT therapy. Henceforth, amlodipine and telmisartan are better choice to control HT among DM patients.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fd/30/PCR-13-137.PMC9345252.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40602975","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":"A cross-sectional study on current prescription trends and errors in outpatient department of a Bangladeshi secondary care district hospital.","authors":"Md Mizanur Rahman,&nbsp;Ashfia Tasnim Munia,&nbsp;K M Yasif Kayes Sikdar,&nbsp;Md Raihan Sarkar","doi":"10.4103/picr.PICR_245_20","DOIUrl":"https://doi.org/10.4103/picr.PICR_245_20","url":null,"abstract":"<p><strong>Context: </strong>The rational prescription leads to a healthy and good-quality life of a patient. Irrational, inappropriate, and unnecessary prescriptions are major therapeutic issues in Bangladesh, which can cause severe consequences.</p><p><strong>Aim: </strong>This cross-sectional study was conducted to evaluate the prescription patterns and errors as well as to review the most frequently prescribed drug classes among outpatients at a secondary hospital in Pabna, a district of Bangladesh.</p><p><strong>Methods: </strong>A total of 400 prescriptions were reviewed from March 2019 to May 2019. In this study, statistical data analysis was implemented by IBM SPSS Statistics V22 and data revealed in frequencies, mean, and percentage. Spearman's rank correlation coefficient was calculated to show the correlation between bivariate coded variables.</p><p><strong>Results: </strong>The results revealed that majority of the prescription were prescribed for females (73.5%) where proton-pump inhibitors (PPIs), analgesics, vitamins, and single antibiotics were most frequently prescribed medicine for the female patients compared to male patients. Almost half of the collected prescription contained four medicines (47%). Maximum number of prescriptions contained two (30.5%) essential drugs and among 1402 medicines of 400 prescriptions, antiulcerants were most frequently prescribed medicine (23.32%) where esomeprazole was highly prescribed generic drug (44.75%). Moreover, Spearman's rank correlation coefficient suggested that PPIs and analgesics were frequently prescribed medicines at a time for the patients (0.182). According to the age group, the study also got some significant variations in prescribing pattern. However, most common prescription errors were prescriber's name not mentioned (100%), diagnosis not mentioned (96.75%), dose not indicated (15.41%), and wrong drug name (0.36%).</p><p><strong>Conclusion: </strong>Findings of the current study represent the existing prescribing trends of different therapeutic classes of drugs and common prescription errors in a secondary health facility of Bangladesh. From this study, it is observed that physicians prescribed rationally in some cases but need to ensure rationality in all prescriptions. Continuous monitoring of drug use, development of prescribing guidelines, and training are recommended to ensure and implement good-quality prescribing practices for promoting the rational and cost-effective use of drugs.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/aa/9a/PCR-13-161.PMC9345250.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40602976","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":"Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India.","authors":"Mrunalini V Kalikar,&nbsp;Ganesh N Dakhale,&nbsp;Vishakha V Sinha,&nbsp;Akhil B Giradkar","doi":"10.4103/picr.PICR_124_20","DOIUrl":"https://doi.org/10.4103/picr.PICR_124_20","url":null,"abstract":"<p><strong>Purpose: </strong>Very few studies conducted in India have analyzed insurance policies and clinical trial agreement (CTA) submitted to ethics committee (EC). This study was conducted to review and find out deficiencies in it.</p><p><strong>Materials and methods: </strong>This was a retrospective observational study. All the protocols for regulatory clinical trials and academic research sponsored by the Indian Council of Medical Research or other funding agency were included. Insurance documents and CTA submitted with the study protocols were analyzed.</p><p><strong>Results: </strong>A total of seventy CTA and insurance policies were analyzed. CTA mentioned that parties involved in 60 (86%) forms, scope of the agreement in 15 (21%) forms, responsibilities of the party in 68 (97%) forms, and payment details in 58 (83%) forms. Nearly 88.5% of the insurance policies mentioned whether the policy covers the participants for injury due to all clauses and 91% of the policies mentioned the validity period of insurance.</p><p><strong>Conclusion: </strong>It was found that both the documents contained almost all the required elements. This was probably because this institutional EC insisted on and thoroughly reviewed the documents to ensure that adequate compensation of research-related injuries has been provided for and this fact is informed to the trial subject. As very few studies are available in the literature, we could not compare majority of the findings of this study with others.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2b/ba/PCR-13-151.PMC9345254.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40585089","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}