Carter S K
Cancer. 1977 Jul;40(1 Suppl):544-57. doi: 10.1002/1097-0142(197707)40:1+<544::aid-cncr2820400721>3.0.co;2-#.
The success of cancer chemotherapy has increased greatly the potential areas for its inclusion in clinical trials and therefore has made the experimental design considerations more complex in these trials. New drugs still go through the three classic phases of clinical study beginning with clinical pharmacology (Phase I), efficacy screening (Phase 2) and role delineation (Phase 3). The Phase 2 and 3 trials now need to be considered within the overall therapeutic strategies which are required for each of the many diseases which are called cancer. The exigencies of a disease-oriented strategy which requires a blend of therapeutic modalities many times require a modification of what would be an ideal modality-oriented strategy geared solely to effectively testing a new agent. A new drug may need many Phase 2 and 3 trials in a variety of tumors before it can be considered adequately evaluated. Essential aspects of valid clinical trials include an adequate protocol which details the study and a design which is feasible for answering the question. Historical controls are advocated by many as a valid approach to clinical trials. Unless the numbers in the historical control are large and the prognostic variables well matches this approach should be viewed cautiously by the practicing physician.
癌症化疗的成功极大地增加了其纳入临床试验的潜在领域，因此使得这些试验中的实验设计考量更加复杂。新药仍需经历临床研究的三个经典阶段，从临床药理学（I期）、疗效筛选（2期）和作用界定（3期）开始。现在，2期和3期试验需要在针对众多被称为癌症的疾病中每一种疾病所需的整体治疗策略范围内进行考量。以疾病为导向的策略的紧迫性，这种策略需要多种治疗方式的结合，很多时候需要对仅旨在有效测试一种新药物的理想的以方式为导向的策略进行调整。一种新药在被认为得到充分评估之前，可能需要在多种肿瘤中进行多次2期和3期试验。有效临床试验的基本要素包括一份详细说明研究的充分方案以及一个对于回答问题可行的设计。许多人主张将历史对照作为临床试验的一种有效方法。除非历史对照中的病例数很多且预后变量匹配良好，否则执业医师应谨慎看待这种方法。
