Perspectives in Clinical Research最新文献

{"title":"Stakeholder perspectives on ethical issues in genetic data reuse within clinical trials.","authors":"Revanasiddappa Devarinti, Madiwalayya Shivakantayya Ganachari, Amaresh Kurubara","doi":"10.4103/picr.picr_92_25","DOIUrl":"10.4103/picr.picr_92_25","url":null,"abstract":"<p><strong>Purpose: </strong>The ethical reuse of genetic data in clinical trials poses significant challenges, particularly concerning informed consent, data privacy, and governance on genetic data re-uses. Understanding stakeholder perspectives is essential to developing responsible and transparent practices in genetic research.</p><p><strong>Aim: </strong>To explore the perspectives of key clinical trial stakeholders on the ethical issues associated with the reuse of genetic data.</p><p><strong>Settings and design: </strong>A cross-sectional and questionnaire-based study was conducted at the Clinical Research Department of KLE Society's Dr. Prabhakar Kore Hospital and Medical Research Center, Belagavi, Karnataka, India.</p><p><strong>Subjects and methods: </strong>The study involved 225 stakeholders, including clinical trial participants, investigators, ethics committee members, pathologists, and pharmaceutical sponsors/CROs. Data were collected using structured questionnaires designed to assess the ethical issues regarding genetic data reuse.</p><p><strong>Statistical analysis used: </strong>One-way ANOVA was applied to compare perceptions across stakeholder groups.</p><p><strong>Results: </strong>Potential misuse of genetic data emerged as a key concern, particularly among clinical trial participants (96%) and pathologists (82%). Ethical and legal uncertainties in data governance were reported by 62% of pharmaceutical sponsors. In addition, 56% of ethics committee members emphasized the importance of returning research results to individuals as a critical ethical issue.</p><p><strong>Conclusion: </strong>The study highlights pressing ethical concerns surrounding genetic data reuse in clinical trials, particularly in the context of consent, data security, and result disclosure. These insights can guide policy development and assist clinical researchers and ethics committees in fostering trust and ensuring ethically sound data practices.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"156-161"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148723365","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":"Quality of real-world registry studies.","authors":"Arun Bhatt","doi":"10.4103/picr.picr_3_26","DOIUrl":"10.4103/picr.picr_3_26","url":null,"abstract":"<p><p>Registry studies are types of real-world studies (RWS), which are used to generate clinical evidence regarding therapeutic use, potential benefits, or risks of a medical product in real-world medical practice, and to support regulatory decisions. RWS are conducted using real-world data (RWD), which are collected for patient care management, but not collected in compliance with good clinical practice standards for documentation. Hence, ensuring data quality, integrity, and reliability for studies using RWD is difficult. It is important to ensure the quality of research, data, and evidence during the planning and conduct of registry studies. This brief review discusses the elements critical to ensuring quality during planning and reporting of RWS.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"167-170"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148722549","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":"Knowledge, attitude, and practices regarding assessment of risks and benefits of clinical research studies by ethics committee members in India: A questionnaire-based study.","authors":"Padmaja Anil Marathe, Sandhya Kaustubh Kamat, Harshad Vijay Kesari, Sonali Rajiv Karekar, Kruttika Rajiv Chitnis, Murugananthan Krishnan","doi":"10.4103/picr.picr_110_25","DOIUrl":"10.4103/picr.picr_110_25","url":null,"abstract":"<p><strong>Purpose: </strong>Balancing risks to research participants against benefits to science or future patients is the most challenging part of the Ethics Committee (EC) review process. Explicit guidance to conduct risk-benefit assessment (RBA) of research studies is not available in the guidelines and existing regulations. RBA, while reviewing research studies by ECs, is largely based on long-term clinical experience and tends to be subjective. This study was undertaken to capture knowledge, attitude, and practices (KAP) among ECs across India about the RBA of clinical research proposals.</p><p><strong>Materials and methods: </strong>A cross-sectional, observational questionnaire-based study was conducted after obtaining approval from the Institutional EC. Members of registered ECs across India with a minimum 1-year of experience were approached to respond to a validated questionnaire regarding assessment of KAP of EC members about RBA; through direct contact or by sending Google Forms. Data were analyzed using descriptive statistics.</p><p><strong>Results: </strong>Of 114 participants, 90% agreed on the need to carry out RBA for every study. Eighty-nine percent stated that studies with vulnerable participants need more attention for RBA. Fifty-five percent of participants considered payment received for research as a benefit. Regarding types of potential risks in research, 35 (31%) precisely selected all five types of risks. For conducting RBA, five participants reported using a specific checklist, while others mentioned reference to the Indian Council for Medical Research, ICH-GCP, and EC SOPs.</p><p><strong>Conclusion: </strong>EC members were aware of concepts of risks and benefits and the need for RBA in clinical research. A few gaps were identified in the awareness and approaches followed.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"91-95"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942511","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":"Qualitative research - Part 1.","authors":"Priya Ranganathan, Dylan E Graetz, Julia Hanebrink, Asha Mathew, Vinitha Ravindran, C S Pramesh","doi":"10.4103/picr.picr_82_26","DOIUrl":"10.4103/picr.picr_82_26","url":null,"abstract":"<p><p>Previous articles in this series have explored various aspects of quantitative research. We now discuss qualitative research methods. This paper provides an overview of the differences between quantitative and qualitative research, and designs and data collection methods used in qualitative research. In subsequent articles, we will focus on sampling in qualitative research as well as techniques of data analysis.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"118-120"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942529","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":"Accountability or acknowledgment? Untangling authorship and medical writing support in scientific publishing.","authors":"Hetal Shah, Pooja Banerjee, Natasha Das","doi":"10.4103/picr.picr_254_25","DOIUrl":"10.4103/picr.picr_254_25","url":null,"abstract":"<p><p>The evolving landscape of scientific publishing has brought renewed attention to the concepts of authorship, contributorship, and acknowledgments. While authorship is a marker of intellectual contribution and accountability, the role of professional medical writers in the development of scientific and biomedical publications has evolved significantly, particularly in the context of industry-supported research. Drawing upon established guidance such as the International Committee of Medical Journal Editors (ICMJE), Good Publication Practice (GPP) 2022, the Contributor Roles Taxonomy (CRediT), and other international standards, this review highlights credible authorship criteria, clarifies the role of medical writers in the publication process, and underscores the necessity of transparent and appropriate acknowledgment of their contribution to a publication. The current frameworks and perspectives are synthesized to support informed decision-making for authors and foster responsible recognition of medical writers as contributors in scientific publishing.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"108-114"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942404","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":"Cross-tool evaluation of artificial intelligence-drafted informed consent documents: A 3-level study.","authors":"Shama U Rao, Akuma Ifeanyichukwu, Uma Kulkarni","doi":"10.4103/picr.picr_376_25","DOIUrl":"10.4103/picr.picr_376_25","url":null,"abstract":"<p><strong>Background: </strong>Informed Consent Documents (ICDs) comprising both the Participant Information Sheet and the Consent Form represent a cornerstone of ethical research involving human participants. The advent of generative Artificial Intelligence (AI) has introduced novel tools capable of drafting ethically oriented documents with high linguistic fluency. However, empirical evidence comparing their ethical robustness, completeness, and readability against institutional standards remains limited.</p><p><strong>Aims and objective: </strong>This study aimed to compare the performance of five generative AI tools ChatGPT, Gemini, Copilot, Meta AI, and Perplexity AI in drafting ICDs across six simulated research scenarios, representing survey, observational, and interventional study designs.</p><p><strong>Materials and methods: </strong>An experimental, cross-sectional, cross-tool comparative design was adopted. Each AI tool generated six ICDs (N = 30), which were evaluated by three trained assessors (blinded workflow) using a validated 4-point rubric (1 = poorly addressed; 4 = strongly addressed) covering completeness and ethical robustness. Readability was assessed using the Flesch-Kincaid Grade Level (FKGL) index, and inter-rater reliability was determined using Fleiss' Kappa.</p><p><strong>Results: </strong>Mean ethical robustness scores ranged from 2.8 to 3.1 and completeness from 2.3 to 2.7, indicating moderate adequacy. Meta AI demonstrated the highest ethical robustness (mean = 3.1), while Gemini achieved the highest completeness (mean = 2.7). ChatGPT showed balanced overall performance (mean = 2.9). Readability indices (FKGL 9.3-10.6) indicated that most AI-generated ICDs exceeded the plain-language level recommended for informed consent. Inter-rater reliability was low (κ = -0.063, p < .001), reflecting variability in ethical judgment.</p><p><strong>Conclusion: </strong>Generative AI tools can emulate the structural and linguistic characteristics of ICD templates with moderate ethical and procedural adequacy. However, they frequently omit context-specific ethical details, necessitating human oversight to ensure compliance and participant protection. A hybrid human-AI co-creation model is recommended for ethically robust and efficient ICD development.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"96-104"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942443","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":"Evaluating patients' approach toward participation in a clinical trial: A multicentric study.","authors":"Simran Parle, Snehalata Vijayanand Gajbhiye, Firoz Mubarak Tadavi, Akshay More, Pankaja Biradar, Chaitali Chindhalore, Ganesh Natthuji Dakhale, Sudhir Pawar","doi":"10.4103/picr.picr_27_25","DOIUrl":"10.4103/picr.picr_27_25","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical trial enrollment remains a challenge as participants have their viewpoints. The study aims to determine the perception of awareness and interest in participation in clinical trials and the reasons for acceptance or declining participation among outpatient department patients.</p><p><strong>Materials and methods: </strong>The study is a prospective questionnaire-based survey of 500 participants from two centers. The questionnaire consisted of three items on awareness regarding clinical trials and 16 items assessing factors affecting participation, with responses recorded in a 3-point Likert scale. The associations between demographic factors, awareness about clinical trials, and interest in participation in clinical trials were evaluated using the univariate model. <i>P</i> < 0.05 were considered to be significant.</p><p><strong>Results: </strong>The study found that the participants were unaware of the clinical trial (87%), and most study participants had not participated in the clinical trial (99%). Most participants said they would not like to participate (76%) in the clinical trial if given an opportunity. The major reasons for participation identified were that research benefits society (89%), advances medical science (90%), and medicines and investigations will be provided free of cost (88%). The major reasons for nonparticipation were the fear of the side effects of the drug (83%), repeated visits would cause inconvenience (87%), and consume time (86%). The demographic factors that determined awareness regarding clinical trials were lower age (<i>P</i> = 0.0001), higher education levels (<i>P</i> = 0.0001), and higher socioeconomic classes (<i>P</i> = 0.0000). A significantly greater number of participants with lower education levels were associated with lower interest in participation in clinical trials (<i>P</i> = 0.0004).</p><p><strong>Conclusion: </strong>Our findings provide valuable insights into the public's awareness of clinical trials. The public's awareness and willingness to participate in clinical trials in India are relatively low and significantly influenced by their education and socioeconomic status. Scientific outreach initiatives to spread clinical trials-related knowledge in the future are crucial.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"77-82"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942439","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 trends of clinical trials for medical devices registered under Clinical Trials Registry of India.","authors":"Praveen Punniyamurthy, Jerin James, P Kala, Mridula Murali Manohar, R Jamuna Rani","doi":"10.4103/picr.picr_237_25","DOIUrl":"10.4103/picr.picr_237_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"123-124"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942401","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":"The Consolidated Standards of Reporting Trials Statement-2025: New epoch for improving the transparency of randomized trials reporting.","authors":"Jennee Moirangthem, Manali Deshpande, Anant Patil","doi":"10.4103/picr.picr_193_25","DOIUrl":"10.4103/picr.picr_193_25","url":null,"abstract":"<p><p>Randomized controlled trials (RCTs) are considered gold standard study designs. With increasing knowledge and experience, the requirements for designing, conduct and reporting of RCTs is becoming more demanding. The Consolidated Standards of Reporting Trials (CONSORT) has been recommended as reporting guideline for the RCTs. After its first publication in 1996, there have been updates in 2001 and 2010. After almost 15 years of last update, recently revised CONSORT-2025 guideline has been published. Interestingly, the Standard Protocol Items: Recommendations for Interventional Trials guideline first published in 2013 has also undergone revision. The wording of these two guidelines has been harmonized. In this article, we have discussed important updates in the CONSORT 2025 checklist.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"105-107"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171126/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942491","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":"Competencies and operations of research ethics committee members and the protection of research participants: A scoping review.","authors":"Preeti Vivekanand Kalel, Seeta Devi","doi":"10.4103/picr.picr_30_25","DOIUrl":"10.4103/picr.picr_30_25","url":null,"abstract":"<p><p>Ethical oversight is essential since clinical research involves animal and human participants. Despite being established to uphold moral standards, the effectiveness of ethics committees (ECs) in protecting participants remains uncertain. This scoping review examines EC members' competency and operational performance. We searched PubMed, Scopus, and Web of Science for papers assessing EC members' competence and operational performance from 2013 to May 2024 in compliance with PRISMA guidelines. After removing duplicates and irrelevant studies, 16 publications were reviewed. Findings were compared across countries and institutions to identify patterns and areas requiring improvements in EC. Out of 16 articles, 6 (37.5%) exclusively assessed the competency in knowledge, attitude, skills, and practices, while 10 (62.5%) papers evaluated the competencies related to EC members' structure, functioning, and procedural performance. The current study report shows that knowledge scores range from 11.3% to 62.5% across the six studies. Most studies suggested that standardized, periodic training should be for EC members. Proficiency in reviewing complex study designs ranged from 14% to 53%, and substantial gaps were noted in understanding ethical principles, particularly among ECs with heavier workloads despite accreditation. On-site monitoring identified frequent ethical breaches, including missing documentation and incomplete serious adverse event records. Access to formal ethics education was limited to approximately 25% of members, with 20% of ECs reporting inadequate staffing and limited resources. In addition, delays in the communication of EC decisions are observed. The findings highlight the need for standardized ethics training, national oversight mechanisms, and adequate resources to improve the effectiveness of ECs in making the right decisions and enhancing their competency in execution.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"58-64"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942459","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}