a researcher's guide to understanding clinical trials
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A GUIDE TO UNDERSTANDINGCLINICAL TRIALS
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(PART 1 – THE BASICS)
Topics covered
PART 1 – THE BASICS
What are clinical trials?
Types of clinical trials
Phases of 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)
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.
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
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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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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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
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
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