Clinical Trials & Ethical Practices

8/2/2019 Clinical Trials & Ethical Practices

1/17

PRESENTED BY:

DR.SWATY SHARMA


2/17

CLINICAL TRIALS

Research studiesinvolving peoplecontribute to

knowledge and

progress againstdisease. translate results of

basic scientific

research into betterways to prevent,diagnose, or treatdisease.


3/17

Different Types of Clinical Trials

TREATMENT

PREVENTION

EARLY DETECTION/SCREENING

DIAGNOSTIC

QUALITY OF LIFE/SUPPORTIVE


4/17

Clinical trials take place in phases :

Phase 1 trial

Phase 2 trials

Phase 3 trials


5/17

PHASE 1 TRIAL

first step in testing a new agent

15 to 30 participantsto find the safest dose of a new agent

evaluate whether the new agent

benefits patients


6/17

PHASE 2 TRIALS

new agent given to groups of peoplewith the disease in question

using the dosage found to be safe inphase 1 trials

If new agent works against the disease

and is safe for people in phase 2 trials,it enters a phase 3 trial.

have less than 100 participants.


7/17

PHASE 3 TRIALS

Participants have equal chance of beingassigned to one of two or more groups (

randomization )

hundreds to thousands of participants

find out if true differences exist in theeffectiveness of the treatments beingtested.


8/17

Clinical trials follow strict scientific

guidelines

-Principle Investigator

-Protocolexplains what the trial will do, how the study will

be carried out, and why each part of the study isnecessary.

- Participants are treated identically- Patient Protection


9/17

HISTORY first formal statement of protection for individuals

in research emerged from the Nuremberg trial inGermany

Nazi scientists and physicians who conductedexperiments on World War II concentration camp

victims were convicted.

Nuremberg Code outlined broad concepts for the protection of

human subjects

forms the basis of todays international code of

ethics for the conduct of research.


10/17

1932 to 1972, the infamous Tuskegee Syphilis

Study followed poor African American menwith syphilis but did not treat them.

1960s

a series of experiments with mentallyretarded children; another involveddebilitated elderly participants.

-regulations and policiesto ensure that people are told about thebenefits, risks, and purpose of research forwhich they volunteer.


11/17

Participant rights and safety are

protected in many ways: Informed consent

Scientific review

Institutional review boards (IRBs)Data safety and monitoring boards

Essential Elements of Ethical Research :

-Balance of Risks and Benefits

-Non-maleficence and Beneficence


12/17

INFORMED CONSENT a process where potential participants learn the

purpose and the potential risks and benefits of a studybefore deciding whether they wish to participate.

The team explains the trials:

- Purpose

- Procedures

- Risks and potential benefits

- Participant rights, including the rights to:

Make an independent decision about participating


13/17

SCIENTIFIC REVIEW

-different types of panels that includeexperts who review the scientific and

technical merit of the proposed research.INSTITUTIONAL REVIEW BOARDS

-people who are qualified to evaluate new

and ongoing clinical trials on the basis ofscientific, legal, and ethical merit


14/17

DATA & SAFETY MONITORING

BOARDS

Ensure that risks are minimized

Ensure data integrityStop a trial if safety concerns arise or

objectives have been met


15/17

BELMONT REPORT

National commission for protection ofhuman subjects of biomedical and

behaviouralresearch.Ethical principles underlying the conduct of

research:

Respect for personsBeneficence

Justice


16/17

Ethical framework: 7 principles

Valuable scientific question

Valid scientific methodology

Fair subject selectionFavorable risk-benefit evaluation

Independent review

Informed consent

Respect for enrolled subjects


17/17

Clinical Trials & Ethical Practices

Documents

Transcript of Clinical Trials & Ethical Practices