A researcher's guide to understanding clinical trials part 2
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This guide outlines essential steps in conducting clinical trials, including developing a research protocol, obtaining informed consent, seeking IRB approval, registering trials, and manuscript preparation. Key aspects such as ethical considerations, participant safety, and specific reporting guidelines for different trial types are emphasized. The document serves as a comprehensive resource for researchers navigating the complexities of clinical trial processes.
A researcher's guide to understanding clinical trials part 2
- 1. A GUIDE TO UNDERSTANDING CLINICAL TRIALS Created by PART 2 Things to remember when working on a clinical trial
- 2. What did we talk about in Part 1? THE BASICS What are clinical trials? Types of clinical trials Phases of clinical trials
- 3. What next? 1 2 3 Developing a research protocol Getting informed consent from all subjects Seeking IRB approval Registering a trial Preparing a manuscript 4 5
- 4. 1 — Developing a research protocol Why do you need a research protocol for your clinical trial? Because it involves human subjects! 1/4
- 5. A research protocol is a detailed plan, like a roadmap. What is a research protocol? It answers specific questions and safeguards participants’ health at the same time. 2/4
- 6. …a clinical trial needs a lot of careful planning. Since it involves human subjects, it has to abide by strict scientific standards and ethics that are designed to protect the rights and ensure the safety of the patients or participants who enrol for the trial. Once the research team is clear about the research idea and study design, it is time to start developing a research protocol. Kakoli Majumder A young researcher's guide to a clinical trial (available on Editage Insights) 3/4
- 7. Elements of a research protocol Background & rationale of the trial Informed consent Subject selection criteria: Inclusion & exclusion criteria Treatment plan & study procedures Statistical analysis plan Assessment of safety & efficacy 4/4
- 8. What next? 1 2 3 Developing a research protocol Getting informed consent from all subjects Seeking IRB approval Registering a trial Preparing a manuscript 4 5
- 9. 2 — Getting informed consent from all subjects Always get informed consent BEFORE your trial begins. Remember • Be transparent: Provide potential participants with information about the study so that they are aware of the process, potential benefits, and the risks involved before they decide to participate in the trial. • Document: The document providing the details of the trial is known as the informed consent document. This is what you must share with participants. • Exceptions: If your trial includes minor participants or participants whose decision making capacity is impaired due to clinical conditions, you must seek consent from a parent or close relative.
- 10. What next? 1 2 3 Developing a research protocol Getting informed consent from all subjects Seeking IRB approval Registering a trial Preparing a manuscript 4 5
- 11. 3 — IRB/ethics committee approval What is IRB? A US-based committee of physicians, nurses, researchers, statisticians, & members of the community Outside of the US, an ethics committee is usually the equivalent of an IRB. IRB makes sure that: A clinical trial is ethical Participants’ rights and welfare are protected Research risks are minimal and worth the potential benefits
- 12. What next? 1 2 3 Developing a research protocol Getting informed consent from all subjects Seeking IRB approval Registering a trial Preparing a manuscript 4 5
- 13. 4 — Registering a clinical trial Register your clinical trial with a clinical trial registry. Registry name Link ClinicalTrials.gov (USA) https://clinicaltrials.gov/ WHO clinical trials registry (global) http://www.who.int/ictrp/trial_reg/en/index1.html EU Clinical Trials Register https://www.clinicaltrialsregister.eu/ EudraCT (EU) https://eudract.ema.europa.eu/ ANZCTR: Australia New Zealand Clinical Trials Registry http://www.anzctr.org.au/ ISRCTN registry (global and includes trials from Canada) http://www.isrctn.com/ DRKS (Germany) http://www.drks.de/ Registro Brasileiro de Ensaios Clínicos (ReBEC) (Brazil) http://www.ensaiosclinicos.gov.br/ Netherlands trial register http://www.trialregister.nl/trialreg/index.asp 1/2
- 14. Registering a clinical trial Some more registries... Registry name Link Japan Primary Registries Network • University Hospital Medical Information Network (UMIN); http://www.umin.ac.jp/ctr/new-registration/ • Japan Pharmaceutical Information Center - Clinical Trials Information (JapicCTI) http://www.clinicaltrials.jp/user/cte_main.jsp • Japan Medical Association - Center for Clinical Trials (JMACCT) https://dbcentre3.jmacct.med.or.jp/jmactr/Default_Eng .aspx Clinical Research Information Service (CRiS), South Korea https://cris.nih.go.kr/cris/en/use_guide/cris_introduce.jsp Chinese Clinical Trial Register (ChiCTR) http://www.chictr.org.cn/abouten.aspx South African National Clinical Trial Register http://www.sanctr.gov.za/ Pan-African clinical trials registry (PACTR) http://www.pactr.org/ The Clinical Trials Registry- India (CTRI) http://ctri.nic.in/Clinicaltrials/login.php 2/2
- 15. What next? 1 2 3 Developing a research protocol Getting informed consent from all subjects Seeking IRB approval Registering a trial Preparing a manuscript 4 5
- 16. Different types of clinical trials follow different reporting guidelines. 5 — Preparing a manuscript CONSORT – for randomized trials STROBE – for observational studies STARD – for diagnostic studies Sections of a clinical trial manuscript: • Title page • Abstract • Introduction • Methods • Results • Discussion 1/2
- 17. Preparing a manuscript Title page should include the article title, author information, disclaimers, sources of support, word count, and sometimes the number of tables and figures. 2/2 Abstract should include items identified as essential in the CONSORT guidelines, and clinical trial registration number. Introduction should include background information about nature of the problem and its significance as well as the statement of purpose or research objective. Methods should include all the details of how and why the study was conducted, selection and description of participants, technical information, and statistics. Results should include text, tables, and figures as well as data on all primary and secondary outcomes mentioned in the Methods section. Discussion should include the main findings and comparison of results with other relevant studies, the limitations of the study, and implications for future research and clinical practice.
- 18. Your clinical trial is now ready for journal submission! 1 2 3 Developing a research protocol Getting informed consent from all subjects Seeking IRB approval Registering a trial Preparing a manuscript 4 5
- 19. End of part 2 We hope you found this useful. Here’s the link to Part 1: An introduction to clinical trials: http://www.editage.com/insights/an- introduction-to-clinical-trials-part-1-the-basics Note: This series is based on the article A young researcher's guide to a clinical trial by Kakoli Majumder, published on Editage Insights: http://www.editage.com/insights/a-young-researchers-guide-to-a-clinical-trial
- 20. www.editage.com/insights @EditageInsights Connect with us For more useful resources and tips on publication, visit our website: