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!

1/4

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

…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)

3/4

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

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

1/2

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

2/2

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

1/2

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.

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.

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 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

@EditageInsights

Connect with us

For more useful resources and tips on publication, visit our website: