What Clinical Research Means to You.

Clinical Research Volunteers are Medical Heroes.

Part 1: What is Clinical Research?

What do we learn from studies? How well does a new drug work or not work? Is there a better way to treat a disease like cystic fibrosis?

How do genes affect illness?

Do peoples environments affect their health? •Where they live? •What they eat? •How much they exercise?

What is a clinical trial?

Scientific study that answers a medical question. “ Is a treatment safe? “ Does it improve a certain medical condition? “ Does it have side effects? “ How should people take it? “ Is it any better than medicines that are already on the market? " A clinical trial is NOT the same as standard of care. " Standard of Care. “ Routine care. “ Has been tested and approved. “ Works for most people.

Clinical Trial

“ Looks for answers to a question. “ Still learning how it works. People are different. We need all types of volunteers.

Clinical trials: a 4 step process.

Phase 1: Is it safe?

And what should be the dose in patients?

Phase 2: More safety and dosing data. Early data on whether it works (efficacy).

Phase 3: Does it improve patients health or make them feel better?

May be new treatment or comparison to an existing therapy. Tested in large and diverse group of patients.

Phase 4: Real world experience Clinical trials.

Clinical Trial Sponsors: “ Government. “ Academic Medical Centers. “ Pharmaceutical Companies. “ Biotechnology Companies. “ Medical Device Companies.

Part 2: The Research Team and Informed Consent. All members of the team are important. Principal Investigator. (PI) Like the head coach. “ Organizes the study. “ Records and studies the data. “ Directs the study staff. “ Follows a protocol (play book).

Clinical Research Coordinator (CRC).

Like the assistant coach. “ Handles day-to-day activities. “ Works with principal investigator (PI). “ Main contact for volunteers.

Volunteer Protections.

Like the referees. “ Review the study before it starts. “ Make sure the team follows the rules. “ Keep you safe and informed.

Volunteer Protections.

Institutional Review Boards (IRB).

“ Make sure a trial is ethical and fair. “ Make sure a trial is not too risky for volunteers. “ Receive continuous updates on trial status. " Serious side effects from study drugs. " Change in study plan. “ Can end a trial if it feels volunteers are not safe.

Volunteer Protections.

Food and Drug Administration. “ Reviews studies. “ Inspects research centers. “ Monitors research groups. “ Has the final say as to whether or not a treatment is approved.

Volunteers.

Like the players. “ The MOST important team member. “ Wide range of studies available (clinicaltrials.gov). “ Healthy volunteers needed too!

Friends, family and your supporters.

Like the fans. “ People to talk to about the study. “ Help you ask questions about the study. “ Support you during the study.

Eligibility Criteria.

Who is the right player for the game?

Informed Consent.

A process to make sure you understand and agree to be in the study. “ A conversation between you and the study staff. “ A form to sign. “ Answers all your questions.

You have rights and responsibilities.

“ To understand the. “ To ask questions and get answers. “ To quit at any time.

Part 3: Should I or Shouldnt I?

Whats right for me? " Understanding the study design. " Study Methods. “ Randomized: coin flip. “ Blinded : you do not know what treatment you are receiving. “ Placebo: sugar pill.

Possible benefits. “ Access to new therapies. “ Advance science and help others in the future. “ The research staff will observe your health closely. Possible risks.

“ Physical. “ Emotional. “ Financial. “ Privacy and confidentiality.

Things to consider.

“ Requires your time and commitment. “ The clinical trial could end at any time. “ You may not feel better. “ All your doctors need to know you are in a clinical trial.

Education before participation.

“ Do your homework. “ Take your time. “ Ask questions.

Your decision at every step.

Where should you go to learn more?

“ Your doctor. “ Advocacy groups. “ Pharmaceutical and biotechnology companies. “ The Internet. “ www.clinicaltrials.gov “ www.centerwatch.com “ www.researchmatch.org “ www.ciscrp.org

Thank you,to the millions of people who give the gift of participation in clinical trials each year and to the rest of us who admire them for doing so.

Article courtesy of www.ciscrp.org CISCRP

and

ClinicalTrials.gov.