ABSTRACT
Background: In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods: We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012-2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results: Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary: Most clinical trials registered during 2012-2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.
Subject(s)
Neoplasms/therapy , Clinical Trials as Topic , Humans , RegistriesABSTRACT
"Syndrome of recommended patient" is manifested as the presence of numerous unexpected and unusual complications in patients that the treating physician is trying to give a better assistance. Even assuming that a few complications may appear by chance, there are several factors from daily clinical practice that facilitate the presence of such a syndrome, and some of them can be corrected in order to reduce its incidence. All of them come from the change on daily clinical practice on these patients, as if they do not fit for the attention provided for other people. These factors favouring the presence of this syndrome come from: patients' attitude, inefficient use of health resources, absence of an adequate register of clinical data and change in usual clinical practice on interpretation of diagnostic tests as well as in the indication of treatment of these patients. The best way to prevent this "syndrome of recommended patient" is to maintain, even within these patients, an attitude based on solid clinical knowledge and to follow up the same clinical rules accepted for other patients.
