摘要
In the majority of phase Ⅲ clinical trials, patients are generally excluded on the basis of specific comorbidities, performance status Eastern Cooperative Oncology Group ≥ 2, age ≥ 65 years, previous malignancies, brain metastases, active infections, psychiatric disorders, non-measurable disease, number and type of previous lines of chemotherapies or biologic therapies. A question is raised: Can results of phase Ⅲstudies be extended to the general population? There is increasing attention to and a resurgence of some terms as "real world" or "real practice" which are wrongly viewed as contrary to clinical trial protocols. In fact, the general perception is that a contraposition exists between "wrong"(retrospective and biased) and "right"(prospective, randomized, well statistically designed) clinical research. We have to change this perspective. Real practice studies, generally retrospective in their nature, deserve to be reevaluated; biases are physiologically present but their punctual and rigorous description and analysis can help the interpretation of and in some cases reinforce results and their hypothesis-generating power. The correct and balanced interaction between clinical trials and real practice reports can help the scientific community to improve the knowledge on anti-cancer drug efficacy.
In the majority of phase Ⅲ clinical trials, patients are generally excluded on the basis of specific comorbidities, performance status Eastern Cooperative Oncology Group ≥ 2, age ≥ 65 years, previous malignancies, brain metastases, active infections, psychiatric disorders, non-measurable disease, number and type of previous lines of chemotherapies or biologic therapies. A question is raised: Can results of phase Ⅲstudies be extended to the general population? There is increasing attention to and a resurgence of some terms as "real world" or "real practice" which are wrongly viewed as contrary to clinical trial protocols. In fact, the general perception is that a contraposition exists between "wrong"(retrospective and biased) and "right"(prospective, randomized, well statistically designed) clinical research. We have to change this perspective. Real practice studies, generally retrospective in their nature, deserve to be reevaluated; biases are physiologically present but their punctual and rigorous description and analysis can help the interpretation of and in some cases reinforce results and their hypothesis-generating power. The correct and balanced interaction between clinical trials and real practice reports can help the scientific community to improve the knowledge on anti-cancer drug efficacy.
