a researcher's guide to understanding clinical trials

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A GUIDE TO UNDERSTANDING CLINICAL TRIALS Created by (PART 1 – THE BASICS)

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Page 1: A researcher's guide to understanding clinical trials

A GUIDE TO UNDERSTANDINGCLINICAL TRIALS

Created by

(PART 1 – THE BASICS)

Page 2: A researcher's guide to understanding clinical trials

Topics covered

PART 1 – THE BASICS

What are clinical trials?

Types of clinical trials

Phases of clinical trials

Page 3: A researcher's guide to understanding clinical trials

What are clinical trials?

Clinical trials involve research conducted on humans that is designed to evaluate the effectiveness of a drug or treatment and add to

medical knowledge

Source: A young researcher's guide to a clinical trial. Available from http://www.editage.com/insights/a-young-researchers-guide-to-a-clinical-trial (Accessed March 07, 2016)

Page 4: A researcher's guide to understanding clinical trials

Clinical trials as defined by NIH*

*NIH: National Institutes of Health, USASource: What are clinical trials? Available from http://www.nhlbi.nih.gov/studies/clinicaltrials (Accessed March 07, 2016)

Clinical trials are research studies that

explore whether a medical strategy,

treatment, or device is safe and effective for

humans. These studies also may show which

medical approaches work best for certain

illnesses or groups of people.

Page 5: A researcher's guide to understanding clinical trials

Human subjects volunteer to participate

Last for about 5-7 years

*First, a new medical strategy, drug, treatment, or device is developed in the lab, then it is tested on animals, and finally tested on humans to see how safe or effective it is.

Approval of relevant governing and ethical committees is essential

Usually medical or clinical studies

Constitute the last step of the research

process*

Investigations are carefully conducted following a pre-

determined research protocol

Characteristics of clinical trials

Page 6: A researcher's guide to understanding clinical trials

Types of clinical trials

Clinical trials could be of two types:

Interventional

Observational

• Specific treatments or interventions are given to the participants by the investigators.

• The outcomes are then compared to a group that has been given a different treatment or no treatment.

• The investigators or the researchers observe the treatments or management techniques that are given to a group of patients and note the outcomes.

• The researchers do not give the interventions.

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Page 7: A researcher's guide to understanding clinical trials

More trials types defined by the NIH

Test new treatments, combinations of drugs, surgical

approaches, or radiation therapy

Find ways to prevent diseases; include medicines, vaccination,

or lifestyle change

Treatment

trials Prevention

trialsScreening

trials

Test the best way to detect specific diseases or health

conditions

Come up with better tests or procedures for diagnosing a disease or health

condition

Explore ways to improve the comfort and quality of life of people with a chronic illness (also known

as supportive care trials)

Diagnostic

trials Quality of life

trials

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Page 8: A researcher's guide to understanding clinical trials

Phases of clinical trialsClinical trials are conducted in several phases and each phase has a different purpose.

PHASE I TRIALSA new drug or treatment is tested on a small

group of people (20–80)

PurposeTo evaluate its safety and identify the side

effects, and to obtain early signs of effectiveness

PHASE II TRIALSThe drug or treatment is given to a larger

group of people (100–300)

PurposeTo evaluate its effectiveness and obtain more information about the side effects and risks

of the treatment

PHASE III TRIALSThe drug or treatment is administered to very large groups of people (1,000–3,000)

PurposeTo confirm its effectiveness, compare it with other modes of treatment, and evaluate the

overall risk-benefit equation

PHASE IV TRIALSThese studies are conducted after the drug’s

approval and launch in the market (also called post-marketing surveillance studies)

PurposeTo obtain additional information about its

risks, benefits, and optimal use

Page 9: A researcher's guide to understanding clinical trials

END OF PART 1

We hope you found this useful. Here’s a list of topics we will cover in Part 2:

• Protocols to be followed

• Informed consent from subjects

• Approval for trials

• Registration of trials

• Reporting guidelines for trials

• Manuscript structure of a clinical trial

COMING SOON!

Part 2 - T

hings to remember when

working on a clinical trial

Page 10: A researcher's guide to understanding clinical trials

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