Contemporary clinical trials communications
-
Contemp Clin Trials Commun · Dec 2020
Effectiveness of a brief manualized intervention, Managing Cancer and Living Meaningfully (CALM), adapted to the Italian cancer care setting: Study protocol for a single-blinded randomized controlled trial.
Patients with advanced cancer suffer from psychosocial distress that may impair quality of life and that may be ameliorated by psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial (RCT) to assess the effectiveness of a novel, brief, semi-structured psychotherapeutic intervention to reduce distress and increase well-being in patients with advanced or metastatic cancer. The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT). ⋯ The primary outcome is difference in severity of depressive symptoms between treatment arm and the primary endpoint is 6 months. The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care. If shown to be effective, CALM-IT can be implemented nationally to relieve distress and to promote psychological well-being in patients with advanced cancer.
-
Contemp Clin Trials Commun · Dec 2020
Remdesivir for coronavirus 2019 (COVID-19): More promising but still unproven.
From December 2019 to May 22, 2020 the emerging and ever-increasing pandemic of coronavirus 19 (COVID-19) had no effective and safe treatment. Not surprisingly, remdesivir attracted worldwide attention. In a trial published online ahead of print, of 1063 patients, 541 were assigned at random to remdesivir and 522 to placebo. ⋯ With respect to mortality there was no suggestion of any benefit. In fact, the mortality rate in those receiving remdesivir was 15% (22/150) compared with 13% (10/77) for those assigned to placebo. Ongoing randomized trials should be designed, conducted and analyzed to provide the necessary reliable data on mortality to resolve the remaining clinical uncertainties.
-
Contemp Clin Trials Commun · Dec 2020
Risk and mitigation actions for clinical trials during COVID-19 pandemic (RiMiCOPa).
The COVID-19 virus diffusion is, nowadays, global and any clinical trial is potentially affected by the direct and indirect consequences of the COVID-19 during the pandemic. Any step, from protocol design to result's disclosure, needs to be revised to assess the impact of the COVID-19 on the study, evaluate the potential risks, and establish a mitigation plan. We have developed a series of recommendations, belonging to our experience in any aspect of clinical trials. We hope that the Risk and Mitigation actions for clinical trials during COVID-19 Pandemic (RiMiCOPa) will help all clinical trial professionals, patients, auditors, and assessors to ensure effective data management, statistics, and medical writing standards while conducting clinical trials in the pandemic.
-
Contemp Clin Trials Commun · Dec 2020
Health Outcome Predictive Evaluation for COVID 19 international registry (HOPE COVID-19), rationale and design.
The disease produced by the new coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), named COVID-19 (Coronavirus Disease-2019) has recently been classified as a pandemic by the World Health Organization (WHO). However, scarce clinical data is available and generally limited to the Chinese population due to the first cases were identified in Wuhan (Hubei, China). This article describes the rationale and design of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) registry (ClinicalTrials.gov Identifier: NCT04334291). ⋯ As secondary objectives, the analysis of other clinical events, the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed. The results of HOPE COVID-19 will contribute to a better understanding of this condition. We aim to describe the management of this condition as well as the outcomes in relation to the therapy chosen, in order to gain insight into improving patient care in the coming months.