Clinical Trials and Research

A Guide for Community Advisory Board Members

Trainer Manual

Clinical Trials & Research 2

This teaching tool was developed by the François-Xavier Bagnoud Center at the University of Medicine and Dentistry of New Jersey, with the support of the Pediatric AIDS Clinical Trials Group.

Excerpts from this publication may be freely reproduced or adapted with acknowledgement of the source, provided the material reproduced is for non-profit distribution.

PACTG Global Training Initiative

Clinical Trials & Research 3

Glossary Clinical Trial: A way to test new medications

Eligibility: Deciding if a person is qualified to join a clinical trial

Phases: Stages

Placebo: Dummy tablet

Protocol: A written plan for the clinical trial

Study sample: People to be studied in the clinical trial

Volunteers: People willing to join the trial

Clinical Trials & Research 4

What is a Clinical Trial?

Identify a health question.

Develop a plan.

Enroll volunteers and follow the plan.

Study the information collected.

Share the results with others.

Improve treatment.

Clinical Trials & Research 5

Example of a Research Question

Is Medicine A more effective for preventing mother-to-child transmission thanMedicine B?

Medicine “B”

Medicine “A”

Clinical Trials & Research 6

Phase I:Safety

(15–30 people)

Phase II: Safety and Effectiveness(Fewer than 100 people)

Phase III: Effectiveness compared to standard of care; Safety

(More than 100 to a few thousand)

A A A

A

A A A

A

A A A

A

A A A

A

A A A

A

A A A

A

A A A

A

A A A

A

Phases of Clinical Trials

A A A

A

Clinical Trials & Research 7

Structure of a Simple Trial Comparing Two Treatments

Study

Sample

R= Random assignment of patients to a treatment arm

R

Medicine “A”

Medicine “B”

Result “A”

Result “B”

A A A

A

B

B

B B

B

Clinical Trials & Research 8

RandomisationA A

A A

B

B

B B

B

Investigational Group

Control Group

Clinical Trials & Research 9

Ethics Committees

The ethics committee reviews a protocol before the study is allowed to start. Their job is to ensure that the risks of being in the study are not greater than the potential benefit.

Clinical Trials & Research 10

Informed Consent

To make informed decisions, patients need to hear and understand specific information about the research.

Clinical Trials & Research 11

Informed Consent

Purpose

Medicine to be studied

Procedures and schedule

Risks

Potential benefits

Alternatives to participation

Confidentiality

Clinical Trials & Research 12

Informed Consent

Participation in clinical trials is always voluntary.

No, thank you, I’d rather not participate.

Yes, I would like to

participate.

Clinical Trials & Research 13

Research Protocol

How

Why

Where

When

What

Who

Protocol

Clinical Trials & Research 14

Objectives: Clear and Specific Statements

Which medicine is more effective in reducing mother-to-child transmission of HIV—Medicine “A” or Medicine “B”?

Medicine “B”

Medicine “A”

Clinical Trials & Research 15

Eligibility Who may participate in this study Who may not (X) participate in this

study

X X

X

X

Clinical Trials & Research 16

Data Safety and Monitoring Boards (DSMB) The job of the DSMB is to monitor the

study for any problems with the safety or effectiveness of the medicines.

Clinical Trials & Research 17

Safety

A protocol must describe known risks or side effects and exactly what will be done to protect and monitor patients.

Clinical Trials & Research 18

Schedule of Events

To evaluate the effect of the medicine on their health, all patients in a trial have certain tests or procedures at regularly scheduled intervals.

Mon Tue Wed Thurs Fri Sat Sun

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 23 24 25 26 27 28

29 30

Clinical Trials & Research 19

Endpoints An endpoint is what researchers will

measure to evaluate the results of a new medicine.

+ +

+++

+

Clinical Trials & Research 20

CAB: Part of the Research Team

Clinical Trials & Research 21

The Research Team CAB members and volunteers who

join clinical trials are part of the team dedicated to finding better ways to prevent and treat HIV.

Clinical Trials & Research 22

How Have Clinical Trials Helped People with HIV?

Clinical trials are critical in the effort to find better ways to treat HIV and AIDS.

Clinical Trials & Research 23

How Have Clinical Trials Helped People with HIV? Antiretroviral

medicines can greatly reduce the chance an infant will be HIV-infected during or after birth.

Clinical Trials & Research 24

How Have Clinical Trials Helped People with HIV? They have

greatly decreased sickness and death among patients who receive antiretroviral medicine.