A researcher's guide to understanding clinical trials part 2
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Transcript of A researcher's guide to understanding clinical trials part 2
A GUIDE TO UNDERSTANDINGCLINICAL TRIALS
Created by
PART 2
Things to remember when working
on a clinical trial
What did we talk about in Part 1?
THE BASICS
What are clinical trials?
Types of clinical trials
Phases of clinical trials
What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript4
5
1 — Developing a research protocol Why do you need a research protocol for your clinical
trial?
Because it involves human subjects!
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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.
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…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 MajumderA young researcher's guide to a clinical trial(available on Editage Insights)
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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
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What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript4
5
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.
What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript4
5
3 — IRB/ethics committee approvalWhat is IRB?A US-based committee of physicians, nurses, researchers, statisticians, & members of the community
Approved!
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
What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript4
5
4 — Registering a clinical trialRegister 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
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Registering a clinical trialSome more registries...
Registry name LinkJapan 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
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What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript4
5
Different types of clinical trials follow different reporting guidelines.
5 — Preparing a manuscript
CONSORT – for randomized trials
STROBE – for observational studies
STARD – for diagnostic studiesSections of a clinical trial manuscript:• Title page• Abstract• Introduction• Methods• Results• Discussion
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Preparing a manuscriptTitle page should include the article title, author information, disclaimers, sources of support, word count, and sometimes the number of tables and figures.
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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.
Your clinical trial is now ready for journal submission!
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2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript4
5
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
www.editage.com/insights
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