Increasing the efficiency of study selection for systematic reviews using prioritization tools and a single-screening approach.

Background: Systematic literature screening is a key component in systematic reviews. However, this approach is resource intensive as generally two persons independently of each other (double screening) screen a vast number of search results. To develop approaches for increasing efficiency, we tested the use of text mining to prioritize search results as well as the involvement of only one person (single screening) in the study selection process.

Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA.

The history of European health technology assessment (HTA) goes back more than 30 years. Almost as old as HTA agencies themselves is the desire to achieve European collaboration. This gained further impetus with the establishment of the European Network of Health Technology Assessment (EUnetHTA) in 2006.

Development and validation of study filters for identifying controlled non-randomized studies in PubMed and Ovid MEDLINE.

A retrospective analysis published by the German Institute for Quality and Efficiency in Health Care (IQWiG) in 2018 concluded that no filter for non-randomized studies (NRS) achieved sufficient sensitivity (≥92%), a precondition for comprehensive information retrieval. New NRS filters are therefore required, taking into account the challenges related to this study type. Our evaluation focused on the development of study filters for NRS with a control group ("controlled NRS"), as this study type allows the calculation of an effect size.

Echocardiography in nonclinical studies: Where are we?

Echocardiography is a powerful, noninvasive tool used both in clinical and nonclinical settings, including in drug development. When used appropriately, it can provide valuable translational information about pharmacodynamics, safety pharmacology, or toxicology, helping to define no-observed-adverse-effect levels and providing guidance for clinical monitoring and dose selection. Echocardiography is advantageous in conducting longitudinal studies and reducing the number of animals used in safety assessments.

Overview of the Components of Cardiac Metabolism.

Metabolism in organs other than the liver and kidneys may play a significant role in how a specific organ responds to chemicals. The heart has metabolic capability for energy production and homeostasis. This homeostatic machinery can also process xenobiotics.

Study filters for non-randomized studies of interventions consistently lacked sensitivity upon external validation.

Background: Little evidence is available on searches for non-randomized studies (NRS) in bibliographic databases within the framework of systematic reviews. For instance, it is currently unclear whether, when searching for NRS, effective restriction of the search strategy to certain study types is possible. The following challenges need to be considered: 1) For non-randomized controlled trials (NRCTs): whether they can be identified by established filters for randomized controlled trials (RCTs).

Effective study selection using text mining or a single-screening approach: a study protocol.

Background: Systematic information retrieval generally requires a two-step selection process for studies, which is conducted by two persons independently of one another (double-screening approach). To increase efficiency, two methods seem promising, which will be tested in the planned study: the use of text mining to prioritize search results as well as the involvement of only one person in the study selection process (single-screening approach). The aim of the present study is to examine the following questions related to the process of study selection: Can the use of the Rayyan or EPPI Reviewer tools to prioritize the results of study selection increase efficiency? How accurately does a single-screening approach identify relevant studies? Which advantages or disadvantages (e.

Biomarkers of drug-induced acute kidney injury: a regulatory perspective.

Biomarkers are one of the drug development tools that are being developed through collaborative efforts among multiple stakeholder communities to enhance the drug development process. Biomarkers of acute drug-induced renal injury as used in drug development are more commonly referred to as renal safety biomarkers, the focus of this manuscript. Areas covered: This manuscript provides an overview of the history and evolution of the United States Food and Drug Administration's Center for Drug Evaluation and Research's Biomarker Qualification Program.

Trial registry searches for randomized controlled trials of new drugs required registry-specific adaptation to achieve adequate sensitivity.

Objectives: To analyze the availability of randomized controlled trials (RCTs) of new drugs in trial registries and to develop and test different search strategies in ClinicalTrials.gov (CT.gov), the EU Clinical Trials Register (EU-CTR), and the International Clinical Trials Registry Platform (ICTRP).

Evaluating the Renal Safety of Investigational New Drugs: Where Should We Be Going?

We the authors work in the US Food and Drug Administration (FDA) review division responsible for the therapeutic agents for primary renal disease. We also field consultative inquiries regarding off-target adverse renal effects of drugs intended to treat other diseases. We do neither basic science research on renal diseases nor clinical studies of new drugs, but we are professional spectators of both.

Prospective comparison of search strategies for systematic reviews: an objective approach yielded higher sensitivity than a conceptual one.

Background: In the development of search strategies for systematic reviews, "conceptual approaches" are generally recommended to identify appropriate search terms for those parts of the strategies for which no validated search filters exist. However, "objective approaches" based on search terms identified by text analysis are increasingly being applied.

Objectives: To prospectively compare an objective with a conceptual approach for the development of search strategies.

The Role of End-of-Life Issues in the Design and Reporting of Cancer Clinical Trials: A Structured Literature Review.

Background: Randomized controlled trials (RCTs) are important sources of information on the benefits and harms patients may expect from treatment options. The aim of this structured literature review by the German Institute for Quality and Efficiency in Health Care was to explore whether and how the end-of-life (EoL) situation of patients with advanced cancer is considered in RCTs investigating anti-cancer treatments.

Methods: Our journal pool comprised 19 medical journals, namely five preselected key general medical journals as well as 14 specialist journals (mainly cancer) identified via a scoping search.

Development of search strategies for systematic reviews: validation showed the noninferiority of the objective approach.

Background: Different approaches can be adopted for the development of search strategies of systematic reviews. The objective approach draws on already established text analysis methods for developing search filters. Our aim was to determine whether the objective approach for the development of search strategies was noninferior to the conceptual approach commonly used in Cochrane reviews (CRs).

Appraisal tools for clinical practice guidelines: a systematic review.

Introduction: Clinical practice guidelines can improve healthcare processes and patient outcomes, but are often of low quality. Guideline appraisal tools aim to help potential guideline users in assessing guideline quality. We conducted a systematic review of publications describing guideline appraisal tools in order to identify and compare existing tools.

Qualification of cardiac troponins for nonclinical use: a regulatory perspective.

The US Food and Drug Administration (FDA) Biomarker Qualification Review Team presents its perspective on the recent qualification of cardiac troponins for use in nonclinical safety assessment studies. The goal of this manuscript is to provide greater transparency into the qualification process and factors that were considered in reaching a regulatory decision. This manuscript includes an overview of the data that were submitted and a discussion of the strengths and shortcomings of these data supporting the qualification decision.

Simple search techniques in PubMed are potentially suitable for evaluating the completeness of systematic reviews.

Objective: The Institute for Quality and Efficiency in Health Care (IQWiG) assesses the added benefit of new drugs by means of company dossiers. The pharmaceutical company performs the information retrieval, which is then assessed by IQWiG. Our aim was to determine whether PubMed's Related Citations (RelCits) and/or a simple-structured Boolean search (SSBS) are efficient and reliable search techniques to assess the completeness of an evidence base consisting of published randomized controlled trials (RCTs).

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development.

Randomized controlled trials on PET: a systematic review of topics, design, and quality.

Unlabelled: Randomized controlled trials (RCTs) add important information to diagnostic accuracy studies in the evaluation of PET and PET/CT. We evaluated how many RCTs on PET existed, which clinical topics they addressed, and what their design and quality were.

Methods: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (Clinical Trials) up to August 2010.

Routine development of objectively derived search strategies.

Background: Over the past few years, information retrieval has become more and more professionalized, and information specialists are considered full members of a research team conducting systematic reviews. Research groups preparing systematic reviews and clinical practice guidelines have been the driving force in the development of search strategies, but open questions remain regarding the transparency of the development process and the available resources. An empirically guided approach to the development of a search strategy provides a way to increase transparency and efficiency.

Troponin measurements during drug development--considerations for monitoring and management of potential cardiotoxicity: an educational collaboration among the Cardiac Safety Research Consortium, the Duke Clinical Research Institute, and the US Food and Drug Administration.

Drug-induced cardiac toxicity is a recognized challenge in development and implementation of pharmacotherapy. Appropriate biomarkers are needed to detect these abnormalities early in development and to manage the risk of potentially cardiotoxic drugs or biologic agents. Circulating cardiac troponin (cTn) is the most widely used biomarker for detection of myocardial injury.

An evaluation of searching the German CCMed database for the production of systematic reviews.

Objectives: National databases may be useful sources in the production of a systematic review (SR). The aim of this study was to assess the potential benefit of a systematic search in the German database 'Current Contents Medizin' (CCMed).

Methods: The study was conducted on the basis of published SRs that included CCMed as a literature source.