Klinik Araştırma Türleri
Özet
Klinik araştırmalar sağlık alanındaki bilginin gelişmesinde, hasta bakımı ve tedavilerinin iyileştirilmesinde ve sonuçta sağlık hizmetlerinin geleceğini şekillendirmede çok önemli rol oynamaktadır. Düzgün tasarlanmış çalışmalar, yeni tedavilerin, müdahalelerin ve tıbbi cihazların güvenliğini ve etkinliğini değerlendirmeyi amaçlamaktadır. Klinik araştırmalar, her biri belirli bir amaca hizmet eden ve bilim camiasına benzersiz bilgiler katan çeşitli türlerde oluşmaktadır. Bu makale, çeşitli araştırma türlerini inceleyerek bunların amaçlarını, metodolojilerini ve tıbbi araştırma alanındaki önemini vurgulamayı amaçlamaktadır.
Clinical trials play a fundamental role in advancing medical knowledge, improving patient care, and ultimately, shaping the future of healthcare. These carefully designed studies aim to evaluate the safety and efficacy of new treatments, interventions, and medical devices. Clinical trials are classified into several types, each serving a specific purpose and contributing unique insights to the scientific community. In this article, we will state into the various types of clinical trials, highlighting their objectives, methodologies, and significance in the field of medical research.
Referanslar
Cancer Research UK. clinical-trials 2024 (19/01/2024 tarihinde https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/types-of-clinical-trials adresinden ulaşılmıştır)
National Institutes of Health. NIH Clinical Research Trials and You 2024 (19/01/2024 tarihinde https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics adresinden ulaşılmıştır).
Wang JJ, Attia J. Study designs in epidemiology and levels of evidence. Am J Ophthalmol. 2010 Mar;149(3):367-70. doi: 10.1016/j.ajo.2009.08.001. PMID: 20172064.
Gupta S, Bansal RN. Curricular adequacy on basics of clinical trials. Indian J Pharmacol. 2019; 51(2): 109-115.
Rezigalla AA. Observational Study Designs: Synopsis for Selecting an Appropriate Study Design. Cureus. 2020 Jan 17;12(1):e6692. doi: 10.7759/cureus.6692. PMID: 31988824; PMCID: PMC6970097.
Sabin CA. Clinical trials: a practical guide to design, analysis and reporting. Clin Med (Lond). 2006 Nov 1;6(6):619–20. doi: 10.7861/clinmedicine.6-6-619a. PMCID: PMC4952780.
Aartman IH, van Loveren C. Onderzoeksontwerpen en de ladder van evidence [Research designs and levels of evidence]. Ned Tijdschr Tandheelkd. 2007 Apr;114(4):161-5. Dutch. PMID: 17484412.
Süt N. Study designs in medicine. Balkan Med J. 2014 Dec;31(4):273-7. doi: 10.5152/balkanmedj.2014.1408. PMID: 25667779; PMCID: PMC4318396.
FDA. Guidance on Statistical Principles for Clinical Trials. (19/01/2024 tarihinde https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection adresinden ulaşılmıştır).
Cardwell JM. An overview of study design. J Small Anim Pract. 2008 May;49(5):217-8. doi: 10.1111/j.1748-5827.2008.00594.x. Erratum in: J Small Anim Pract. 2008 Sep;49(9):487. PMID: 18445164.
Gelband H. A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms. Washington (DC): National Academies Press (US); 1999. COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA. (19/01/2024 tarihinde https://www.ncbi.nlm.nih.gov/books/NBK224010/. adresinden ulaşılmıştır).
Venkataramana Kandi , Sabitha Vadakedath. Clinical Research: An Overview of Study Types, Designs, and Their Implications in the Public Health Perspective. American Journal of Clinical Medicine Research. 2021, 9(2), 36-42. DOI: 10.12691/ajcmr-9-2-1.
Malik L, Cooper J. A comparison of the quality of informed consent for phase I oncology trials over a 30-year period. Cancer Chemother Pharmacol. 2018 Nov;82(5):907-910. doi: 10.1007/s00280-018-3673-x. Epub 2018 Aug 27. PMID: 30151620.
American Society of Clinical Oncology. American Society of Clinical Oncology policy statement: oversight of clinical research. J Clin Oncol. 2003 Jun 15;21(12):2377-86. doi: 10.1200/JCO.2003.04.026. Epub 2003 Apr 29. PMID: 12721281.
Wen G, Liu X, Huang L, Shu J, Xu N, Chen R, Huang Z, Yang G, Wang X, Xiang Y, Lu Y, Yuan H. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China. PLoS One. 2016 Oct 4;11(10):e0164251. doi: 10.1371/journal.pone.0164251. PMID: 27701471; PMCID: PMC5049790.
Loo VC, Kim S, Johnson LM, Kay H, Yi A, Chen J, Asmar-Abdien LO. Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation. J Patient Saf. 2023 Oct 1;19(7):460-464. doi: 10.1097/PTS.0000000000001154. Epub 2023 Aug 25. PMID: 37616191; PMCID: PMC10545059.
Febbraro M, Kazemi G, Juergens R, Pond GR. Trainee Evaluations of Preparedness for Clinical Trials in Medical Oncology-A National Questionnaire. Curr Oncol. 2023 Aug 15;30(8):7627-7637. doi: 10.3390/curroncol30080553. PMID: 37623034; PMCID: PMC10453465.
Mueller KF, Briel M, Strech D, et al. Dissemination Bias in Systematic Reviews of Animal Research: A Systematic Review. PLoS One. 2014; 9(12): e116016.
Wu C, Wang N, Wang Q, Wang C, Wei Z, Wu Z, Yu S, Jiang X. Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis. PLoS One. 2024 Jan 2;19(1):e0295784. doi: 10.1371/journal.pone.0295784. PMID: 38166097; PMCID: PMC10760836.
McGrath TA, Alabousi M, Skidmore B, et al. Recommendations for reporting of systematic reviews and meta-analyses of diagnostic test accuracy: a systematic review. Syst Rev. 2017; 6: 194.
National Institutes of Health. NIH Clinical Research Trials and You 2024 (19/01/2024 tarihinde https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics adresinden ulaşılmıştır).
Wang JJ, Attia J. Study designs in epidemiology and levels of evidence. Am J Ophthalmol. 2010 Mar;149(3):367-70. doi: 10.1016/j.ajo.2009.08.001. PMID: 20172064.
Gupta S, Bansal RN. Curricular adequacy on basics of clinical trials. Indian J Pharmacol. 2019; 51(2): 109-115.
Rezigalla AA. Observational Study Designs: Synopsis for Selecting an Appropriate Study Design. Cureus. 2020 Jan 17;12(1):e6692. doi: 10.7759/cureus.6692. PMID: 31988824; PMCID: PMC6970097.
Sabin CA. Clinical trials: a practical guide to design, analysis and reporting. Clin Med (Lond). 2006 Nov 1;6(6):619–20. doi: 10.7861/clinmedicine.6-6-619a. PMCID: PMC4952780.
Aartman IH, van Loveren C. Onderzoeksontwerpen en de ladder van evidence [Research designs and levels of evidence]. Ned Tijdschr Tandheelkd. 2007 Apr;114(4):161-5. Dutch. PMID: 17484412.
Süt N. Study designs in medicine. Balkan Med J. 2014 Dec;31(4):273-7. doi: 10.5152/balkanmedj.2014.1408. PMID: 25667779; PMCID: PMC4318396.
FDA. Guidance on Statistical Principles for Clinical Trials. (19/01/2024 tarihinde https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection adresinden ulaşılmıştır).
Cardwell JM. An overview of study design. J Small Anim Pract. 2008 May;49(5):217-8. doi: 10.1111/j.1748-5827.2008.00594.x. Erratum in: J Small Anim Pract. 2008 Sep;49(9):487. PMID: 18445164.
Gelband H. A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms. Washington (DC): National Academies Press (US); 1999. COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA. (19/01/2024 tarihinde https://www.ncbi.nlm.nih.gov/books/NBK224010/. adresinden ulaşılmıştır).
Venkataramana Kandi , Sabitha Vadakedath. Clinical Research: An Overview of Study Types, Designs, and Their Implications in the Public Health Perspective. American Journal of Clinical Medicine Research. 2021, 9(2), 36-42. DOI: 10.12691/ajcmr-9-2-1.
Malik L, Cooper J. A comparison of the quality of informed consent for phase I oncology trials over a 30-year period. Cancer Chemother Pharmacol. 2018 Nov;82(5):907-910. doi: 10.1007/s00280-018-3673-x. Epub 2018 Aug 27. PMID: 30151620.
American Society of Clinical Oncology. American Society of Clinical Oncology policy statement: oversight of clinical research. J Clin Oncol. 2003 Jun 15;21(12):2377-86. doi: 10.1200/JCO.2003.04.026. Epub 2003 Apr 29. PMID: 12721281.
Wen G, Liu X, Huang L, Shu J, Xu N, Chen R, Huang Z, Yang G, Wang X, Xiang Y, Lu Y, Yuan H. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China. PLoS One. 2016 Oct 4;11(10):e0164251. doi: 10.1371/journal.pone.0164251. PMID: 27701471; PMCID: PMC5049790.
Loo VC, Kim S, Johnson LM, Kay H, Yi A, Chen J, Asmar-Abdien LO. Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation. J Patient Saf. 2023 Oct 1;19(7):460-464. doi: 10.1097/PTS.0000000000001154. Epub 2023 Aug 25. PMID: 37616191; PMCID: PMC10545059.
Febbraro M, Kazemi G, Juergens R, Pond GR. Trainee Evaluations of Preparedness for Clinical Trials in Medical Oncology-A National Questionnaire. Curr Oncol. 2023 Aug 15;30(8):7627-7637. doi: 10.3390/curroncol30080553. PMID: 37623034; PMCID: PMC10453465.
Mueller KF, Briel M, Strech D, et al. Dissemination Bias in Systematic Reviews of Animal Research: A Systematic Review. PLoS One. 2014; 9(12): e116016.
Wu C, Wang N, Wang Q, Wang C, Wei Z, Wu Z, Yu S, Jiang X. Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis. PLoS One. 2024 Jan 2;19(1):e0295784. doi: 10.1371/journal.pone.0295784. PMID: 38166097; PMCID: PMC10760836.
McGrath TA, Alabousi M, Skidmore B, et al. Recommendations for reporting of systematic reviews and meta-analyses of diagnostic test accuracy: a systematic review. Syst Rev. 2017; 6: 194.
Sayfalar
3-4
Yayınlanan
11 Mart 2024
Telif Hakkı (c) 2024 Akademisyen Yayınevi Kitap Portalı
Lisans
LisansNasıl Atıf Yapılır
1.
Sakin A. Klinik Araştırma Türleri. Içinde: Sakin A, editör. Kanser Hastalarının Başvurduğu Geleneksel ve Tamamlayıcı Tedaviler - Tıbbi Onkolog Gözü ile Bakış ve Onkolojik İlaçlarla Etkileşim [Internet]. Türkiye: Akademisyen Yayınevi Kitap DOI Portalı; 2024 [a.yer 13 Temmuz 2026]. ss. 3-4. Erişim adresi: https://www.omp35.books.akademisyen.net/index.php/akya/catalog/book/2380/chapter/13880
