Adams M, Lee TH, Busch MP, Heitman J, Marshall GJ, Gjerset GF, Mosley JW Rapid freezing of whole blood or buffy coat samples for polymerase chain reaction and cell culture analysis: application to detection of human immunodeficiency virus in blood donor and recipient repositories. The Transfusion Safety Study Group. Transfusion. 1993 Jun;33(6):504-8.
Buckley JD, Pike MC, Mosley JW Statistical approaches to evaluating prognostic indices in HIV infection. The Transfusion Safety Study Group. AIDS. 1991 Nov;5(11):1398.
Busch MP, Donegan E, Stuart M, Mosley JW Donor HIV-1 p24 antigenaemia and course of infection in recipients Transfusion Safety Study Group. Lancet. 1990 Jun 2;335(8701):1342.
Busch MP, Young MJ, Samson SM, Mosley JW, Ward JW, Perkins HA Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. The Transfusion Safety Study Group. Transfusion. 1991 Jan;31(1):4-11.
Diaz RS, Sabino EC, Mayer A, Mosley JW, Busch MP Dual human immunodeficiency virus type 1 infection and recombination in a dually exposed transfusion recipient. The Transfusion Safety Study Group. J Virol. 1995 Jun;69(6):3273-81.
Donegan E, Busch MP, Galleshaw JA, Shaw GM, Mosley JW Transfusion of blood components from a donor with human T-lymphotropic virus type II (HTLV-II) infection. The Transfusion Safety Study Group. Ann Intern Med. 1990 Oct 1;113(7):555-6.
Donegan E, Pell P, Lee H, Shaw GM, Mosley JW Transmission of human T-lymphotropic virus type I by blood components from a donor lacking anti-p24: a case report. The Transfusion Safety Study Group. Transfusion. 1992 Jan;32(1):68-71.
Edwards VM, Mosley JW Reproducibility in quality control of protein (Western) immunoblot assay for antibodies to human immunodeficiency virus. Am J Clin Pathol. 1989 Jan;91(1):75-8.
Gjerset GF, Vyas GN, Bhat R, Operskalski EA Phenotypes for group-specific component among patients exposed to human immunodeficiency virus by transfusions. J Infect Dis. 1988 Mar;157(3):609-10.
Hilgartner MW Changes in CD4 count relative to product usage: findings from the transfusion safety study. Semin Hematol. 1993 Oct;30(4 Suppl 5):7-9. Review.
Kaplan J, Sarnaik I, Lusher J Increase in Leu 2+ Leu 7+ lymphocytes in HIV 1-seropositive patients with hemophilia repeatedly treated with clotting factor concentrates. Clin Immunol Immunopathol. 1988 Mar;46(3):337-41.
Kedes DH, Operskalski E, Busch M, Kohn R, Flood J, Ganem D The seroepidemiology of human herpesvirus 8 (Kaposi's sarcoma-associated herpesvirus): distribution of infection in KS risk groups and evidence for sexual transmission. Nat Med. 1996 Aug;2(8):918-24. Erratum in: Nat Med 1996 Sep;2(9):1041.
Miller K, Donegan E, Curran P, Shelley TJ Effects of counselling on knowledge about HIV-1 among transfusion recipients and their partners. Transfusion Safety Study Group. AIDS Care. 1990;2(2):155-62.
Mosley JW Has hepatitis A virus been transmitted by clotting factor concentrates among hemophiliacs in the United States? Vox Sang. 1994;67 Suppl 4:12-5; discussion 24-6. Review.
Mosley JW Low CD4+ counts in a study of transfusion safety: correction. N Engl J Med. 1993 Apr 15;328(15):1128.
Niland-Weiss J, Azen SP, Odom-Maryon T, Lui F, Hagerty C A microcomputer-based distributed data management system for a large cooperative study of transfusion associated acquired immunodeficiency syndrome. Comput Biomed Res. 1987 Jun;20(3):225-43.
Norman GL, Barker SS, Rasheed S Immunoblot reactivity of a non-HIV protein with human sera. Transfusion Safety Study Group. J Clin Lab Anal. 1989;3(3):148-51.
Odom-Maryon T, Langholz B, Niland J, Azen S Generalization of normal discriminant analysis using Fourier series density estimators. Transfusion Safety Study Group. Stat Med. 1991 Mar;10(3):473-85.
Operskalski EA, Busch MP, Mosley JW, Stram DO Comparative rates of disease progression among persons infected with the same or different HIV-1 strains. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Jun 1;15(2):145-50.
Operskalski EA, Mosley JW, Busch MP, Stram DO Influences of age, viral load, and CD4+ count on the rate of progression of HIV-1 infection to AIDS. Transfusion Safety Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Jul 1;15(3):243-4.
Vasil'eva VF, Vorob'eva KP [Study of magnesium transport in the dog kidney by the method of stopping urine emission in chronic experiments]. Fiziol Zh SSSR Im I M Sechenova. 1975 Jan;61(1):130-5. Russian.
Wilkinson DA, Operskalski EA, Busch MP, Mosley JW, Koup RA A 32-bp deletion within the CCR5 locus protects against transmission of parenterally acquired human immunodeficiency virus but does not affect progression to AIDS-defining illness. J Infect Dis. 1998 Oct;178(4):1163-6.
Wong WY, Zhou Y, Operskalski EA, Hassett J, Powars DR, Mosley JW Hematologic profile and lymphocyte subpopulations in hemoglobin SC disease: comparison with hemoglobin SS and black controls. The Transfusion Safety Study Group. Am J Hematol. 1996 Jul;52(3):150-4.
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.