The Clinical Research industry is projected to reach 68.9 billion dollars by the year 2026. The growing prevalence of disease continues to greatly boost the clinical trial market. The increasing number of patients fighting against specific disease serves as a strong stimulus for the Biopharmaceutical companies to invest more in clinical trials to aid in winning the fight against these diseases. A strong component of the fight against is having Clinical Research Sites dedicated to Clinical Research. This means that Biopharmaceuticals and Clinical Research Organizations need more Clinical Research Sites and you can meet this need by becoming a Clinical Research Site Owner

3. THE GOALS OF CLINICAL TRIALS ARE TO:
1. Determine the safety of the new drug or treatment.
2. Determine the efficacy of the new drug or treatment.
3. Discover new & innovative approaches to medical treatment.
4. Develop ways to improve the quality of life for people living
with acute or chronic illnesses.
5. Gain insight on innovative ways to diagnose, treat and/or cure
disease and disability.

4.  REGULATORY BODY - The Food & Drug Administration
 ETHICS COMMITTEE - The Institutional Review Board (IRB)
 CLINICAL TRIAL SPONSORS
 CLINICAL RESEARCH ORGANIZATIONS
 CLINICAL RESEARCH SITES
 THE INVESTIGATIONAL SITE TEAM/RESEARCH STAFF
 CLINCAL RESEARCH PATIENTS

5.  PHASE I TRIALS: The experimental drug or treatment is tested
on a controlled group of healthy patients – To evaluate the
safety of the experimental drug or treatment, identify a safe
dosage range & potential side effects.
 PHASE II TRIALS: The experimental drug or treatment is given
to a small group of unhealthy patients - To evaluate the
effectiveness of the experimental drug or treatment and
further evaluate its safety.

6.  PHASE III TRIALS: The experimental drug or treatment is tested on
a large group of unhealthy patients – To confirm the experimental
drug or treatment’s effectiveness, monitor side effects, compare it
to commonly used treatments and collect data on its safe
utilization.
 PHASE IV TRIALS: Post-marketing studies for the experimental drug
or treatment after FDA approval – To provide additional
information such as treatment or drug’s risks, benefits and best
use.

15. Doing clinical research can put my license at risk!
AS A CLINICIAN WHO IS LEGALLY & ETHICALLY PRACTICING MEDICINE…
DOING CLINICAL TRIALS DOES NOT PUT ADDITIONAL RISKS TO YOUR
LICENSE!

16. Doing clinical research can cause problems with the FDA
and affect my practice
THE ROLE OF THE FDA IS TO ENSURE THAT CLINICAL TRIALS ADHERE
TO GOOD CLINICAL PRACTICE & ARE PROPERLY CONDUCTED.

17. My malpractice insurance does not cover clinical research!

18. The paperwork! It is time consuming and I’ll drown in it!

19. I don’t have the time for clinical research

20. AS A CLINICIAN WHO IS A CLINICAL TRIAL SITE OWNER -
THERE ARE BASICALLY 4 POTENTIAL LEVELS YOU CAN
GROW INTO!

23. MEET SPONSOR REPRESENTATIVES WITH ACCESS TO RESOURCES YOU CAN USE
FOR YOUR OWN TRIAL AND/OR TO SIMPLY GAIN FUTURE STUDIES.