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[FG] Briel Matthias

Projects & Collaborations

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Systematic Review of Palliative Care research performed and published: Exploring the meta-research landscape and areas of improvement

Research Project  | 5 Project Members

Abstract

Background:

Palliative care aims to alleviate suffering, improve quality of life, and address distressing symptoms in people with advanced disease. Despite its clinical importance, many interventions—particularly pharmacological approaches—are supported by limited high-quality evidence, with recommendations often relying on expert consensus or long-standing routine. Clinical trials are essential to strengthen the evidence base, yet research in palliative care faces well-described barriers such as recruitment challenges, underpowered studies, and premature termination. To our knowledge, no meta-research study has systematically mapped the clinical-trial landscape in palliative care. This review intends to establish a benchmark for research activity, identify under-represented areas, and outline priorities for future investigation, including recruitment expectations and attrition estimates.


Objectives:

This systematic review provides a comprehensive overview of clinical trials conducted in palliative care over the past two decades. We aim to (1) quantify the number, scope, and characteristics of registered and published trials; (2) identify which symptoms and interventions are studied more intensively, and compare this with the known prevalence of symptoms in advanced disease; and (3) document rates and reasons for non-completion or non-publication of registered studies.


Methods:

We will search major trial registries (ClinicalTrials.gov, WHO ICTRP, EudraCT) and bibliographic databases for interventional studies in adult palliative-care populations registered between 2000 and 2020. Eligible studies include prospective interventional designs; pediatric studies and disease-modifying cancer therapies will be excluded. Two reviewers will independently screen records and extract data using piloted forms. Discrepancies between registered and published outcomes will be assessed, and reasons for non-publication will be sought by contacting investigators. Descriptive statistics will summarize study characteristics, with subgroup analyses by symptom category, intervention type, sponsor, and region. Meta-analysis of publication rates will be conducted if appropriate.

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Pharmacological antiemetic prophylaxis and treatment for opioid induced nausea and vomiting (OINV) in patients treated for cancer pain: Cochrane systematic review

Research Project  | 6 Project Members

Background:

In cancer patients with incurable disease pain is one of the most debilitating symptoms with a prevalence of about 70% (1). Many of these patients need opioids, which are the mainstay in managing cancer pain. Initiation of opioid therapy is frequently hindered by opioid induced nausea and vomiting (OINV) in up to 40% of patients (2). Nausea is highly distressing symptom that may occur with or without vomiting and can affect overall outcome and quality of life (3). To avoid discontinuation of the opioid therapy 50-80% of doctors prescribe prophylactic or on-demand antiemetics to reduce OINV (4), although evidence for this practice is scarce or not supported by randomised controlled trials (RCTs) (5). However, the medications used to prevent OINV, e.g. dopamine antagonists can trigger adverse events in the central nervous system (headaches, drowsiness) or even parkinsonism-like symptoms.

 Aims / Methods:

To better inform physicians, guidelines and patients, we propose a Cochrane systematic review and meta-analysis of RCTs concerning the benefits and harms of antiemetic drug therapy for the prevention and treatment of OINV in patients treated with opioids for cancer pain therapy.

Benefit for patients and / or public

The numbers of affected patients are expected to increase during the decades to come due to the medical progress in oncology and the demographic change (9,10).


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RETUNE

Research Project  | 7 Project Members

Tobacco smoking represents a leading health burden in the aging population of people living with HIV in Switzerland. New tools for smoking cessation like electronic cigarettes or nicotine pouches are promising to reduce the harm caused by tobacco smoking. However, high quality evidence of their effectiveness among people living with HIV and outside of explanatory randomized trials is missing. 


RETUNE is a highly pragmatic randomized trial, fully embedded in the Swiss HIV Cohort Study (SHCS), using the “Trials within Cohorts” (TwiCs) design. 

In the TwiCs design, participants are recruited within a prospective cohort study and can consent not only to regular data collection at cohort visits, but also to be randomized in future low-risk pragmatic trials (“randomization consent”). Participants are informed that only participants randomized to the intervention arm are approached and may then accept or decline the offered intervention. Participants in the intervention who accept the intervention, are asked to sign an “intervention consent”, that only covers additional data collection in this group and the safety/side-effects of the intervention – similar to a routine clinical consent (e.g. consent for a lumbar puncture in clinical care). 


RETUNE aims to assess the effectiveness of the offer of a menu including different tobacco cigarettes substitutional products (e-cigarettes, nicotine pouches, nicotine patches) to quit smoking. People with HIV in the SHCS who smoke tobacco cigarettes and who signed the randomization consent will be randomized in a 1:1 ratio to the offer of the menu or to usual care. People are included regardless of their willingness to quit smoking. The primary endpoint is tobacco abstinence after 6 months. RETUNE is a multicenter trial which will include centers in Basel, Bern, Geneva, Lausanne, St. Gallen, and Zurich. 


RETUNE is funded by the Tobacco Prevention Fund, the Novartis foundation for medical-biological research, and the Swiss National Science Foundation.



Involved partner:

Swiss HIV Cohort Study

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MARTA: Making clinical trials more affordable - systematic investigation of trial costs and tool development

Research Project  | 1 Project Members

Randomized clinical trials (RCTs) are an essential method of evaluating health care interventions and a cornerstone for evidence-based health care. Their conduct, in particular for investigator-initiated RCTs, has long involved many practical challenges, challenges that have become increasingly complex and costly. Efforts to render RCTs more cost-effective are, therefore, urgently needed. Identifying lever-points for cost reductions requires knowledge of cost structures and cost drivers (e.g. recruitment duration, sample size, therapeutic area, number of trial sites). The medical literature, however, currently lacks detailed empirical data addressing costs and resource use of investigator-initiated RCTs as well as information about current practices of budget planning and cost monitoring, attitudes, needs, and preferences of trial investigators, trial support organizations (e.g. Clinical Trial Units), and funding agencies. Academic investigators usually depend on scarce financial resources; user-friendly and reliable tools to effectively limit costs of RCTs through optimized budget planning and cost monitoring during the conduct of an RCT are currently unavailable and sorely needed. We therefore propose three complementary projects using mixed-methods to render investigator-initiated RCTs more affordable and efficient through evidence-based budget planning, stakeholder consensus regarding relevant budget items, and the development of suitable tools. In Project A we will gather empirical resource use and cost data from 180 investigator-initiated RCTs in Switzerland, Germany, Canada, and the United Kingdom to investigate cost patterns, empirically identify major cost drivers and lever-points for cost savings, examine planned versus actual RCT costs, and explore heterogeneity of costs across medical fields and countries. Project B will consist of semi-structured interviews to explore current practices, attitudes, needs, and preferences of trial investigators, trial funders, and trial support organizations with respect to budget planning, funding acquisition for RCTs, managing costs during RCT conduct, and supporting tools in Switzerland. In Project C we will develop reliable and user-friendly budget calculation and cost monitoring tools for RCTs with stakeholder consensus based on systematically collected evidence from the literature/internet and informed by user needs and preferences (as elicited in Project B). We will formally user-test and evaluate the reliability and accuracy of developed tools using the generated database of empirical RCT cost data from Project A. The results of the proposed mixed-methods work will have immediate impact on the research practice of trial investigators, trial support organizations, and funders of RCTs in Switzerland and abroad. Given the increasing costs and complexity of RCTs, our project is timely and should shift the discussion from "rough guesses" to "analysing transparent and valid data" so that costs of clinical trials can be assessed, cost drivers identified, and costs effectively limited so that RCTs, critical to advancing clinical science, become more affordable.