PRESENTED BY: DR.

SWATY SHARMA

CLINICAL TRIALS
Research studies

involving people contribute to knowledge and progress against disease. translate results of basic scientific research into better ways to prevent, diagnose, or treat disease.

Different Types of Clinical Trials

TREATMENT PREVENTION EARLY DETECTION

/SCREENING DIAGNOSTIC QUALITY OF LIFE /SUPPORTIVE

Clinical trials take place in phases :

Phase 1 trial Phase 2 trials Phase 3 trials

PHASE 1 TRIAL
first step in testing a new agent
15 to 30 participants to find the safest dose of a new agent evaluate whether the new agent

benefits patients

PHASE 2 TRIALS
new agent given to groups of people

with the disease in question using the dosage found to be safe in phase 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.

PHASE 3 TRIALS
Participants have equal chance of being

assigned to one of two or more groups ( randomization ) hundreds to thousands of participants find out if true differences exist in the effectiveness of the treatments being tested.

Clinical trials follow strict scientific guidelines

-Principle Investigator -Protocol
explains what the trial will do, how the study will be carried out, and why each part of the study is necessary.

- Participants are treated identically - Patient Protection

HISTORY
first formal statement of protection for individuals

in research emerged from the Nuremberg trial in Germany Nazi scientists and physicians who conducted experiments 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.

 1932 to 1972, the infamous Tuskegee Syphilis

Study followed poor African American men with syphilis but did not treat them. 1960s a series of experiments with mentally retarded children; another involved debilitated elderly participants. -regulations and policies to ensure that people are told about the benefits, risks, and purpose of research for which they volunteer.

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

INFORMED CONSENT
a process where potential participants learn the

purpose and the potential risks and benefits of a study before 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

SCIENTIFIC REVIEW
-different types of panels that include experts 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 of scientific, legal, and ethical merit

DATA & SAFETY MONITORING BOARDS

Ensure that risks are minimized
Ensure data integrity Stop a trial if safety concerns arise or

objectives have been met

BELMONT REPORT
National commission for protection of

human subjects of biomedical and behaviouralresearch. Ethical principles underlying the conduct of research: Respect for persons Beneficence Justice

Ethical framework: 7 principles

Valuable scientific question Valid scientific methodology

Fair subject selection

Favorable risk-benefit evaluation Independent review Informed consent Respect for enrolled subjects