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In this article, we explore ethical issues of Deaf people's engagement in research. To focus on the perspectives of Deaf people, we investigated existing qualitative and mixed methods research within a qualitative evidence synthesis. Our synthesis is based on a systematic database search (Scopus, PubMed) and reference check of included papers which resulted in 27 eligible papers. We analyzed the data using thematic synthesis and developed 5 analytical themes. The results present research as a struggle for Deaf people and emphasize the need for changes regarding recognition of Deaf research in a cross-cultural context, maintaining equal and partner relations, and provision of accessible communication. Our research contributes to understanding what the ethical inclusion of Deaf people in research implies. It may also support the development of evidence-based normative recommendations and scientific cooperation between Deaf and hearing people. [ABSTRACT FROM AUTHOR]

Background Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials. Methods and findings Our protocol was prospectively registered in PROSPERO (CRD42015015961). We systematically searched Embase and PubMed for solid and hematological malignancy Phase I pediatric trials published between 1 January 2004 and 1 March 2015. We included pediatric cancer Phase I studies, defined as 'small sample size, non-randomized, dose escalation studies that defined the recommended dose for subsequent study of a new drug in each schedule tested.' We measured risk using grade 3, 4, and 5 (fatal) drug-related adverse events (AEs) and benefit using objective response rates. When possible, data were meta-analyzed. We identified 170 studies meeting our eligibility criteria, accounting for 4,604 patients. The pooled overall objective response rate was 10.29% (95% CI 8.33% to 12.25%), and was lower in solid tumors, 3.17% (95% CI 2.62% to 3.72%), compared with hematological malignancies, 27.90% (95% CI 20.53% to 35.27%); p < 0.001. The overall fatal (grade 5) AE rate was 2.09% (95% CI 1.45% to 2.72%). Across the 4,604 evaluated patients, there were 4,675 grade 3 and 4 drug-related AEs, with an average grade 3/4 AE rate per person equal to 1.32. Our study had the following limitations: trials included in our review were heterogeneous (to minimize heterogeneity, we separated types of therapy and cancer types), and we relied on published data only and encountered challenges with the quality of reporting. Conclusions Our meta-analysis suggests that, on the whole, AE and response rates in pediatric Phase I trials are similar to those in adult Phase I trials. Our findings provide an empirical basis for the refinement and review of pediatric Phase I trials, and for communication about their risk and benefit., Author(s): Marcin Waligora 1, Malgorzata M. Bala 2,*, Magdalena Koperny 1,3, Mateusz T. Wasylewski 1, Karolina Strzebonska 1, Rafal R. Jaeschke 4, Agnieszka Wozniak 5, Jan Piasecki 1, Agnieszka Sliwka [...]

Background: For research with human participants to be ethical, risk must be in a favorable balance with potential benefits. Little is known about the risk/benefit ratio for pediatric cancer phase II trials testing targeted therapies. Objective: Our aim was to conduct a systematic review of preliminary efficacy and safety profiles of phase II targeted therapy clinical trials in pediatric oncology. Methods: Our protocol was prospectively registered in PROSPERO (CRD42020146491). We searched EMBASE and PubMed for phase II pediatric cancer trials testing targeted agents. We included solid and hematological malignancy studies published between 1 January, 2015 and 27 February, 2020. We measured risk using drug-related grade 3 or higher adverse events, and benefit by response rates. When possible, data were meta-analyzed. All statistical tests were two-sided. Results: We identified 34 clinical trials (1202 patients) that met our eligibility criteria. The pooled overall response rate was 24.4% (95% confidence interval [CI] 14.5–34.2) and was lower in solid tumors, 6.4% (95% CI 3.2–9.6), compared with hematological malignancies, 55.1% (95% CI 35.9–74.3); p < 0.001. The overall fatal drug-related (grade 5) adverse event rate was 1.6% (95% CI 0.6–2.5), and the average drug-related grade 3/4 adverse event rate per person was 0.66 (95% CI 0.55–0.78). Conclusions: We provide an estimate for the risks and benefits of participation in pediatric phase II cancer trials. These data may be used as an empirical basis for informed communication about benefits and burdens in pediatric oncology research. [ABSTRACT FROM AUTHOR]

Objectives: Drug development trials must fulfill social value requirement but no estimates of value provided by pediatric Phase 1 trials in oncology exist. These trials involve a particularly vulnerable population. Our objective was to assess of surrogates of social value of Phase 1 trials performed in pediatric oncology: rates of approval of tested interventions, transition to further phases of testing and citation in subsequent primary research reports. Methods: We performed an analysis on a subset of eligible trials included in a previous meta-analysis. That study systematically searched EMBASE and PubMed for small sample size, non-randomized, dose escalation pediatric cancer Phase 1 studies of any malignancy, assessing chemotherapy and/or targeted therapy and looked at risk and benefit. The current analysis assessed all studies in that review published between January 1st 2004 and December 31st 2013 for predictors of social value. This time range allowed for at least five years of subsequent development activity. Sources of data included FDA and EMA medicine databases (for approval), ClinicalTrials.gov and EU Clinical Trials Register (for transition) and Google Scholar (for citation). Results: One hundred thirty-nine trials enrolling 3814 patients met the eligibility criteria. Seven trials (5%) led to drugs being registered for pediatric use in therapy of cancer. Fifty-two (37%) transitioned to later phases of pediatric oncology trials according to ClinicalTrials.gov and/or EU Register. Over 90% of trials were cited by at least one subsequent primary research report or systematic review. Most of the citations were preclinical studies. Conclusions: Our analysis shows that treatments tested in pediatric Phase 1 trials in oncology have low rates of regulatory approval. However, a large proportion of Phase 1 trials inform further testing and development of tested interventions. [ABSTRACT FROM AUTHOR]

Objectives To establish the rates of publication and reporting of results for interventional clinical trials across Polish academic medical centres (AMCs) completed between 2009 and 2013. We aim also to compare the publication and reporting success between adult and paediatric trials. Design Cross-sectional study. Setting AMCs in Poland. Participants AMCs with interventional trials registered on ClinicalTrials. gov. Main outcome measure Results reporting on ClinicalTrials. gov and publishing via journal publication. Results We identified 305 interventional clinical trials registered on ClinicalTrials. gov, completed between 2009 and 2013 and affiliated with at least one AMC. Overall, 243 of the 305 trials (79.7%) had been published as articles or posted their summary results on ClinicalTrials. gov. Results were posted within a year of study completion and/or published within 2 years of study completion for 131 trials (43.0%). Dissemination by both posting and publishing results in a timely manner was achieved by four trials (1.3%). Conclusions Our cross-sectional analysis revealed that Polish AMCs fail to meet the expectation for timely disseminating the findings of all interventional clinical trials. Delayed dissemination and non-dissemination of trial results negatively affects decisions in healthcare. [ABSTRACT FROM AUTHOR]

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The article reports that application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research. It cites example of pediatric phase I trials in oncology which aim to establish safety, the maximum tolerated dose, and preliminary efficacy of tested drugs.