Shasky D A, Coppedge S H, Boyle R M, Chan J C
Medical College of Virginia, Health Sciences Division of Virginia Commonwealth University, Richmond 23298.
J Pediatr. 1990 Feb;116(2):S22-3. doi: 10.1016/s0022-3476(05)82919-1.
Ensuring the integrity of a study such as the GFRD Study requires close cooperation among all groups involved with the study and the patient. Many factors may influence the outcome and validity of a multicenter, double-masked, randomized trial. Any dosage modifications that may need to be made rely totally on established communication between the centers, the DCC, and the Core Pharmacy. When the procedures outlined above are followed, masking is ensured and patient compliance can be measured.
确保像全球疾病负担研究(GFRD Study)这样的研究的完整性,需要参与研究的所有团队与患者之间密切合作。许多因素可能会影响多中心、双盲、随机试验的结果和有效性。任何可能需要进行的剂量调整完全依赖于各中心、数据协调中心(DCC)和中心药房之间已建立的沟通。当遵循上述程序时,就能确保设盲,并且可以衡量患者的依从性。