NCT01200823 - Clinical Trial References

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.

Citation(s)

Cole M, Boddy AV, Kearns P, Teh KH, Price L, Parry A, Pearson AD, Veal GJ; UKCCSG Pharmacology group
Potential clinical impact of taking multiple blood samples for research studies in paediatric oncology: how much do we really know? Pediatr Blood Cancer. 2006 Jun;46(7):723-7.
Wolthers OD
A questionnaire on factors influencing children's assent and dissent to non-therapeutic research. J Med Ethics. 2006 May;32(5):292-7.
Wood AJ, Darbyshire J
Injury to research volunteers--the clinical-research nightmare. N Engl J Med. 2006 May 4;354(18):1869-71.

Collection of Blood, Bone Marrow, Leukapheresis, and Tissue Biopsy Samples From Patients and Their Family Members for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies

Details for clinical trial NCT01200823

Clinical trial NCT01200823 - References