Clinical Trials and Drug Development
HOW THE ARTHRITIS CENTER BECOMES INVOLVED
- First, when a pharmaceutical company is ready to test a new drug, it searches internationally for sites best suited for the trial. The company looks for sites with experienced and qualified staff and appropriate medical facilities. After the sites are chosen, their local or regional institutional review board will review the project to safeguard the interests of the trial subjects.
- Second, the pharmaceutical company launches the study by educating the research staff who work on the clinical research project.
- Third, representatives of the pharmaceutical company visit the Arizona Arthritis Center to initiate the site and ensure that all regulatory documentation has been completed and processed. Sponsor personnel also review the project with the study coordinator and appropriate research staff.
- Lastly, when all this has been completed, recruitment for "human subjects" begins. Recruitment can happen in many ways. Rheumatologists from the community or from the Arizona Arthritis Center may refer clinic patients and local and national advertising campaigns may also be used for subject recruitment.
Early in the development of a new therapy, some subjects may receive placebo (an inactive therapy). This is done in comparison with the investigational treatment to see whether or not the investigational treatment is effective. Later, the new therapy is compared with the best treatment dose available. Finally, there are long-term extensions of, generally, one to two years to ensure the safety and effectiveness of the new medication. Many subjects who enter these trials may receive the therapy long before it is approved for the general public. The information gathered from these trials is then submitted to the FDA for approval in the United States.
For more information on clinical trials visit clinicaltrials.gov.