Published online Sep 15, 2018. doi: 10.4251/wjgo.v10.i9.228
Peer-review started: June 12, 2018
First decision: July 9, 2018
Revised: July 12, 2018
Accepted: August 4, 2018
Article in press: August 4, 2018
Published online: September 15, 2018
Processing time: 96 Days and 0 Hours
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.
Core tip: Oncologic patients enrolled in phase III pivotal trials are usually selected on the basis of specific characteristics and they are quite different from the real practice populations: this could account for low reproducibility of results in the clinics real world. In this Editorial, differences between prospective clinical trials and real practice studies are discussed giving a critical and positive perspective on the results of real practice studies also through specific examples. The correct and balanced interaction between clinical trials and real practice results can help the scientific community to improve the knowledge on anti-cancer drug therapies.