Identical chemotherapy schedules given on and off trial protocol in small cell lung cancer response and survival results

Abstract

Patients who are treated within clinical trials may have a survival benefit dependent on being a trial participant. A number of factors may produce such beneficial outcome including more rigorous adherence to a peer reviewed trial protocol, management by an experienced treatment team, being treated in a specialist centre etc. The current investigation compared patients treated on and off trial with the same standard arm treatment regimen. The results could then be interpreted without the confounding factors of differing treatment regimens, treatment teams or treatment hospitals. The results demonstrated given these circumstances that survival was no different for patients participating in a randomised trial compared with a group of patients similarly treated who were not eligible for trial entry or who declined randomisation. These results were obtained by the rigorous adherence to a defined protocol with the invaluable assistance of designated lung cancer staff.

Implementation of Electronic Checklists in an Oncology Medical Record: Initial Clinical Experience

“…This approach in clinical trials provides greater uniformity and quality of treatment compared with treatment of the general patient population and is known to enhance outcomes. [10][11][12][13] In the book, "Checklist Manifesto," Gawande 14 describes how faulty memory and distraction can lead to errors in achieving complex tasks for all-or-none processes: preparing an airplane for takeoff, or evaluating a sick person in the emergency room. Checklists provide protection against such failures by providing process verification and instilling discipline to improve performance.…”

Survival of stage IIIB/IV non-small cell lung cancer patients who received chemotherapy but did not participate in clinical trials

“…Few clinical trials have included such patients. In contrast to previous findings, a recent study demonstrated that the survival of small cell lung cancer patients receiving the same chemotherapy regimen, centralized treatment, and rigorous adherence to a defined protocol was not different from the survivals of patients treated in a clinical trial [24]. Recently, a retrospective assessment of data from the SEER tumor registry clearly showed that chemotherapy for 6232 elderly metastatic NSCLC patients was as effective as that in randomized trials with mostly younger, highly selected patients [25].…”

Why Institutions Do not Participate in Ovarian Cancer Trials – Results from a Survey in Germany

“…Its appointed members must have a particular interest in research, be willing to work extra hours to run the trial, and be prepared to attend study meetings within the team and other institutions. Thus, trial centers develop distinct expertise and high standards of care which nontrial patients at the same institution can profit from [14]. Until more convincing evidence is available for trial effects, we will suggest the quality of care even for patients outside a study protocol is better in trial centers than in nontrial centers.…”