Clinical Trials Presentation (1)

Clinical Trials
• Clinical trials are sets of tests in medical research and drug

development that generate safety and efficacy data (or more
specifically, information about adverse drug reactions and adverse
effects) for health interventions (e.g., drugs, diagnostics, devices,
therapy protocols).
• They are the primary way that researchers find out if a new treatment,
like a new drug or diet or medical device (for example, a pacemaker) is
safe and effective in people.
• Clinical trials aim to improve existing
treatments or to replace them with new
and better ones.
• Before a new treatment is made available
Clinical for patients, it must be tested in clinical
trials for efficacy and safety.
Trials
Contd.
• Before new drug treatments are tested in patients in
clinical trials they must be carefully evaluated in
laboratories.
• If the results of laboratory studies of a possible

treatment are promising, clinical trials are designed to
assess its possible beneficial and adverse effects in
patients
Clinical Trial Process
• Every clinical trial is designed to answer questions about
the effects of treatments being compared.
• The quality of a clinical trial and its results depend

heavily on a well- chosen question, building on existing
evidence, and on good clinical trial design.
• When conducting a clinical trial, researchers must
follow a written study plan, also called a study
protocol.
• The protocol helps to ensure patients‘ safety and is

essential for achieving high quality and reliable
results.
Clinical Trial Protocol
A protocol is the clinical trial plan that explains the purpose and process of the trial.
A protocol will include information such as:
• Who can participate
• How many people will participate
• What the treatment plan involves
• Type and frequency of tests
• How the results will be measured
• Reasons why the clinical trial may be stopped
• Reasons why the researchers may stop giving the experimental treatment to a
participant
• Known and likely side effects of the experimental treatment
• Potential benefits of the experimental treatment
Clinical Trial Informed Consent
• Informed consent is the process of learning about the clinical
trial before deciding to participate. Before someone can
participate in a clinical trial they must review and sign an
informed consent form. As part of the informed consent
process, participants also will be able to review the trial
protocol with the clinical trial team.
• A clinical trial team consists of doctors, nurses, social workers,

and other healthcare professionals.
The informed consent form will include the
following information:
 Clinical trial process, including tests that

may be conducted
 Known risks and benefits of experimental
treatment
 Length of clinical trial
 Clinical trial contact information
NB: Even after signing the informed consent form, participants may
choose to stop participating in the clinical trial at any time.
Phases of Clinical Trials
• Clinical trials advance through four phases to test a treatment, find

the appropriate dosage, and look for side effects.
• If, after the first three phases, researchers find a drug or other
intervention to be safe and effective, the regulatory body approves it
for clinical use and continues to monitor its effects.
• These phases include;
Phase I
Phase II
Phase III
Phase IV
• A Phase I trial tests an experimental treatment on a small group of

often healthy people (20 to 80) to judge its safety and side effects
and to find the correct drug dosage.
• A Phase II trial uses more people (100 to 300). While the emphasis
in Phase I is on safety, the emphasis in Phase II is on effectiveness.
This phase aims to obtain preliminary data on whether the drug
works in people who have a certain disease or condition. These
trials also continue to study safety, including short-term side
effects.
• A Phase III trial gathers more information about safety and
effectiveness, studying different populations and different dosages,
using the drug in combination with other drugs. The number of
subjects usually ranges from several hundred to about 3,000 people.
If the regulatory body agrees that the trial results are positive, it will
approve the experimental drug or device.
• A Phase IV trial for drugs or devices takes place after the regulatory
body approves their use. A device or drug's effectiveness and safety
are monitored in large, diverse populations. Sometimes, the side
effects of a drug may not become clear until more people have taken
it over a longer period of time.
Clinical Trials Design – Controlled or Uncontrolled
• A controlled study compares a minimum of two groups of
patients: the patients receiving the drug to be tested and a
control group in which patients will receive a comparator. A
comparator can be an inactive compound (placebo) or a reference
drug that is marketed for the same indication (active comparator).
• Because clinical studies normally compare treatments,

uncontrolled studies are very rare but may be the case for
indications where there is no existing treatment or for terminal
conditions such as some cancers or HIV where previous
treatments have failed, and no other options are available.
Clinical Trials Design – Blind or Open Label
Single and Double-Blind Studies
• To prevent the bias that could result from people knowing
which treatment is allocated to patients, methods such as
blinding, and randomization are used in clinical trials.
• In a single-blind study, the participants in the clinical trial
do not know if they are receiving the placebo or the real
treatment.
• In a double-blind study, both the participants and the site

do not know which group got the placebo and which got
the experimental treatment.
Open or Open-label trials
• The opposite of a blind trial is called an

open or open-label trial.
• In this situation, all parties (patient,
Investigator, CRO, and Sponsor) know the
identity of the patient's treatment.
Medical History, Adverse Events and Serious
Adverse Events
• Medical History: A record of information about a person’s health.
• includes information about allergies, illnesses, surgeries, immunizations,
and results of physical exams and tests.
• Adverse Events: An unexpected medical problem that happens during
treatment with a drug or other therapy. Adverse event may be caused by
something other than the drug or therapy being given.
• AEs can be classified as:
Mild
Moderate
Severe
Serious Adverse Events (SAEs)
An Adverse Event is Serious and should be reported to a regulatory body
when the patient outcome is:
Death
Life threatening
Hospitalization (initial or prolonged)
Disability or permanent damage
Congenital anomaly or Birth defects
Required Intervention to Prevent Permanent Impairment or Damage
(Devices)
Other serious condition that the PI feels should be an SAE
NB: Severity is not synonymous with seriousness.
• A severe rash is not likely to be an SAE.
• Likewise, a severe headache is not necessarily an SAE.
• However, mild chest pain may result in a day’s
hospitalization and thus is an SAE.
THANK YOU FOR LISTENING

Clinical Trials Presentation (1)

Uploaded by

Copyright:

Available Formats

Clinical Trials Presentation (1)

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Clinical Trials Presentation (1)

Uploaded by

Copyright:

Available Formats

Clinical Trials

• Clinical trials are sets of tests in medical research and drug

• If the results of laboratory studies of a possible

• The quality of a clinical trial and its results depend

• The protocol helps to ensure patients‘ safety and is

• A clinical trial team consists of doctors, nurses, social workers,

 Clinical trial process, including tests that

• Clinical trials advance through four phases to test a treatment, find

• A Phase I trial tests an experimental treatment on a small group of

• Because clinical studies normally compare treatments,

• In a double-blind study, both the participants and the site

• The opposite of a blind trial is called an

You might also like