Coronado GD, Petrik AF, Spofford M, Talbot J, Do HH, Taylor VM Clinical perspectives on colorectal cancer screening at Latino-serving federally qualified health centers. Health Educ Behav. 2015 Feb;42(1):26-31. doi: 10.1177/1090198114537061. Epub 2014 Jun 20.
Coronado GD, Petrik AF, Vollmer WM, Taplin SH, Keast EM, Fields S, Green BB Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1174-1181. doi: 10.1001/jamainternmed.2018.3629.
Coronado GD, Sanchez J, Petrik A, Kapka T, DeVoe J, Green B Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center. J Cancer Educ. 2014 Mar;29(1):86-90. doi: 10.1007/s13187-013-0551-4.
Coronado GD, Schneider JL, Sanchez JJ, Petrik AF, Green B Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center. Transl Behav Med. 2015 Mar;5(1):60-7. doi: 10.1007/s13142-014-0276-x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
