tailieunhanh - A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10

Phát hiện phản ứng thứ cấp mang lại lợi ích bất ngờ trong giai đoạn thiết kế (ví dụ, thuốc an thần hoặc hiệu lực một thuốc giải nhiệt Ngoài ra một chất chống viêm) thường có thể lượm lặt từ các tài khoản giai thoại của các nhà điều tra. | Detection of secondary beneficial responses that were unanticipated during the design stage for example a sedative or an antifebrile effect in addition to an anti-inflammatory can often be gleaned from the anecdotal accounts of investigators. This is a major reason for including all the investigators in the trial postmortem. Such accounts may suggest a basis for future trials or for future pre-clinical investigation. Interactions Breaking down the data into subsets female patients patients with ostial lesions and analyzing each subset separately often reveals both those patients who are most likely to benefit from the treatment as well as those who are least likely. A new treatment that is at first judged to be unsuccessful may actually prove to have demonstrated potential in specific groups of patients. Subgroup analyses may also suggest new subsets of covariates to use in patient selection and in baseline adjustment. Adverse Events Adverse effects of treatment may remain undetected during clinical trials for at least three reasons 1. Restricted set of participants 2. Limited follow-up 3. Inadequate sample size particularly for relatively rare side effects Your eligibility criteria may have limited the original trials to males under sixty not suffering from collateral conditions. But physicians are always tempted to extend the range of application of a successful treatment regardless of what it might say on the package insert. To avoid potential litigation you should consider engaging in follow-up clinical trials that would focus on individuals who were excluded from the original study. Additional long-term monitoring of at least a subset of those patients for which you already have such a great store of data is recommended. It offers a way of discovering both 1 additional beneficial effects and 2 delayed adverse effects thus avoiding or minimizing the impact of subsequent litigation . Postmarketing analysis typically is based solely on anecdotal accounts. .