scholarly journals CART-WHEEL.org: An Ethically Approved Online Database for Patient-Entered Data to Facilitate Rare Cancer Research

2020 ◽  
pp. 136-146
Author(s):  
Damien Kee ◽  
Clare Parker ◽  
Susie Bae ◽  
Katherine M. Tucker ◽  
Michelle Harrison ◽  
...  
Keyword(s):  
Cancer Research ◽  
Clinical Trials ◽  
Clinical Information ◽  
Research Process ◽  
Evidence Base ◽  
Future Research ◽  
Specific Information ◽  
Rare Cancer ◽  
Cancer Data ◽  
Power Studies

PURPOSE Rare cancers are challenging for researchers, as clinicians and scientists have difficulty recruiting sufficient patient cases to power studies appropriately. Likewise, patients often are frustrated by a lack of specific information or evidence base for their cancer and, although eager to participate in research, have limited opportunities. We established CART-WHEEL.org, an online patient-entered database, to directly engage patients in the research process, collect rare cancer data, and facilitate their entry into additional research. PATIENTS AND METHODS Patients access CART-WHEEL.org directly online. Clinical information is collected from users via a streamlined questionnaire developed collaboratively with consumer groups to ensure accessibility and relevance. Data collected include the following: patient demographics, comorbidities, and risk factors and tumor diagnostic, biomarker, and treatment history. Patients can download a medical summary for personal use; consent for research use of data; and indicate willingness to be contacted about other research or clinical trials. We describe data collected to date and its validation, and we provide examples of how CART-WHEEL.org can facilitate rare cancer research. RESULTS From January 2010 to March 2018, 558 patients provided consent and entered their rare cancer data. One hundred distinct rare tumor types and patients from 22 countries were included. Validation of data entered by 21 patients with sarcoma against a hospital database demonstrated accuracy sufficient to facilitate future research in key fields, such as tumor site (95%) and histopathologic diagnosis (90%). Examples of CART-WHEEL–based disease-specific projects, subsequent recruitment to other rare cancer projects, and rare cancer patient cases of interest are described. CONCLUSIONS Online platforms like CART-WHEEL.org can engage consumers directly, facilitating collection of patient-entered rare cancer data for hypothesis generation, and connect patients with researchers to enable specific rare cancer research and clinical trials.

scholarly journals Qualitative features in clinical trials: coordinates for prevention of passive and active misconduct

2018 ◽  
Vol 5 (1) ◽  
pp. 5 ◽  
Author(s):  
José Roberto Wajman ◽  
Sheilla de Medeiros Correia Marin ◽  
Paulo Henrique Ferreira Bertolucci ◽  
Marcia Lorena Fagundes Chaves ◽  
Theresa Bromley
Keyword(s):  
Clinical Trials ◽  
Public Involvement ◽  
Scientific Misconduct ◽  
Clinical Information ◽  
Good Clinical Practice ◽  
Research Process ◽  
Research Field ◽  
Financial Interests ◽  
Trial Monitoring ◽  
Information Recognition

<p class="abstract"><span lang="EN-IN">For many years, the quality concept in clinical trials has been discussed and recommended by Good Clinical Practice (GCP) guidelines. Regulatory Authorities and also the Public Involvement anticipate that the pharmaceutical industry will concentrate on creating quality frameworks amid the arranging and leading of conventions of controlled protocols. Nevertheless, many factors have been suggested as contributing to the occurrence of scientific misconduct within the research field, such as: personal and financial interests, site monitoring, available resources, workload, competition among investigators, and the implicit </span><span lang="EN">consent of sponsors. The negligence on data fraud represents not only omission but misconduct as well, in this case, a passive attitude intrinsically related to the act of transgression. A properly culture of research must be based on a fundamental ethos of integrity, openness and honest work of high quality in all parts of the research process. </span><span lang="EN-IN">There is a need to change the focus from inspection-based quality improvement to planned systematic quality management within clinical trials. In search for a monitoring improvement, a full statistical  way to deal with information recognition comprises of executing however many measurable tests as could be allowed on whatever number clinical information factors as could be expected under varied circumstances. Adoption of specific and preventive clinical trial monitoring procedures can identify potential misconduct and data fraud leading to improvement in overall data quality and scientific reports</span><span lang="EN-AU">. </span></p>

scholarly journals An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study

2015 ◽  
Vol 3 (39) ◽  
pp. 1-142 ◽  
Author(s):  
Carrol Gamble ◽  
Louise Dudley ◽  
Alison Allam ◽  
Philip Bell ◽  
Deborah Buck ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mixed Methods ◽  
Public Involvement ◽  
Research Collaboration ◽  
Research Programme ◽  
Evidence Base ◽  
Research Community ◽  
Future Research ◽  
Randomised Trials ◽  
Managerial Roles

BackgroundIn comparison with other study designs, randomised trials are regarded as particularly likely to benefit from patient and public involvement (PPI). Using mixed-methods research we investigated PPI from the perspectives of researchers and PPI contributors.MethodsRandomised trials in receipt of funding from the Health Technology Assessment (HTA) programme between 2006 and 2010 were identified. Funding applications and board and referee comments were obtained and data relevant to PPI extracted. Chief investigators (CIs), PPI contributors and UK Clinical Research Collaboration Registered Clinical Trials Units (RCTUs) were surveyed. Interviews were conducted with researchers and PPI contributors.ResultsA total of 111 trials were included. Text relevant to PPI was identified in half of the trials for which the first-stage applications were available, but only one-quarter described PPI within their development. In the second stage of the application, the majority provided some text relevant to PPI, with over half having PPI in their development. Fewer than half of referees commented on PPI, and funding boards rarely provided comments in relation to PPI. Seventy-three per cent (81 of 111) of CIs responded to the survey and 98% (79 of 81) included PPI at some stage in their trial. CIs considered high impact from PPI contributors to occur more frequently in trial setup, with low or no impact being more common during trial conduct, analysis and dissemination. Only one-third of CIs provided PPI contributor contact details but all contributors contacted completed the survey. The majority of contributors felt engaged and valued by the research team. Interviews were conducted with researchers and/or PPI contributors for 28 trials identifying two main influences on perception of PPI impact: whether or not CIs expressed personal goals and plans for PPI; and the quality of their relationship with the PPI contributors. The importance of early engagement was identified, with opportunity for input thereafter limited. Three PPI roles were identified: oversight, managerial and responsive. Oversight roles, as required by funders, were associated with low impact in comparison with responsive or managerial roles. Most researchers could see some value in PPI training for researchers, although those that had received such training themselves expressed concerns about its purpose and evidence base. Training for PPI contributors was considered unnecessary, with conversational approaches preferred, although this did not appear to provide an opportunity for role negotiation. The RCTU survey response rate was 85% (39 of 46). The majority (37 of 39) reported PPI within trials co-ordinated by their unit. Trial characteristics were used by half to determine the approach to PPI. Two-thirds reported recent developments or changes in implementing plans for PPI (21 of 33). Support to PPI contributors was commonly offered through members of staff at the unit.ConclusionsPPI is occurring in the majority of trials funded by the HTA programme, but uncertainty remains about how it is assessed and valued. Early involvement, building a relationship between researchers and contributors, responsive or managerial roles, and having defined goals for PPI were associated with impact. Efficiency could be gained by utilising the RCTU network to identify and tackle challenges, and develop a risk-based approach utilising trial characteristics. Recommendations are made to trial funders and the research community. Given the difficulties for some informants in recalling PPI contributions, future research using a prospective approach would be valuable. Ethnographic research that combines observation and multi-informant interviews is likely to be informative in identifying impact. The research community needs to give further consideration to processes for selecting PPI contributors and models of implementing PPI.FundingThe National Institute for Health Research Health Services and Delivery Research programme and INVOLVE.

scholarly journals Repurposing Infectious Diseases Vaccines Against Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Liese Vandeborne ◽  
Pan Pantziarka ◽  
An M. T. Van Nuffel ◽  
Gauthier Bouche
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Infectious Diseases ◽  
Killer Cell ◽  
Future Research ◽  
Measles Vaccine ◽  
Cancer Data ◽  
Research Activities ◽  
Immunological Mechanisms

Vaccines used to prevent infections have long been known to stimulate immune responses to cancer as illustrated by the approval of the Bacillus Calmette–Guérin (BCG) vaccine to treat bladder cancer since the 1970s. The recent approval of immunotherapies has rejuvenated this research area with reports of anti-tumor responses with existing infectious diseases vaccines used as such, either alone or in combination with immune checkpoint inhibitors. Here, we have reviewed and summarized research activities using approved vaccines to treat cancer. Data supporting a cancer therapeutic use was found for 16 vaccines. For 10 (BCG, diphtheria, tetanus, human papillomavirus, influenza, measles, pneumococcus, smallpox, typhoid and varicella-zoster), clinical trials have been conducted or are ongoing. Within the remaining 6, preclinical evidence supports further evaluation of the rotavirus, yellow fever and pertussis vaccine in carefully designed clinical trials. The mechanistic evidence for the cholera vaccine, combined with the observational data in colorectal cancer, is also supportive of clinical translation. There is limited data for the hepatitis B and mumps vaccine (without measles vaccine). Four findings are worth highlighting: the superiority of intravesical typhoid vaccine instillations over BCG in a preclinical bladder cancer model, which is now the subject of a phase I trial; the perioperative use of the influenza vaccine to limit and prevent the natural killer cell dysfunction induced by cancer surgery; objective responses following intratumoral injections of measles vaccine in cutaneous T-cell lymphoma; objective responses induced by human papillomavirus vaccine in cutaneous squamous cell carcinoma. All vaccines are intended to induce or improve an anti-tumor (immune) response. In addition to the biological and immunological mechanisms that vary between vaccines, the mode of administration and sequence with other (immuno-)therapies warrant more attention in future research.

Projecting a European Diploma in Psychology

2002 ◽  
Vol 7 (3) ◽  
pp. 221-224 ◽  
Author(s):  
Bernhard Wilpert
Keyword(s):  
Research Process ◽  
Project Team ◽  
Future Research ◽  
Research Results ◽  
External Constraints ◽  
Internal Procedures ◽  
The Eu

The paper presents an inside evaluation of the EuroPsyT project, funded by the EU Leonardo Program in 1999-2001. While standard research usually neglects to reflect on the internal and external constraints and opportunities under which research results are achieved, the paper stresses exactly those aspects: starting from a brief description of the overall objectives of the 11 countries project, the paper proceeds to describe the macro-context and the internal strengths and weaknesses of the project team, the internal procedures of cooperation,. and obstacles encountered during the research process. It winds up in noting some of the project's achievements and with a look towards future research.

Using corpora in depth psychology: a trigram-based analysis of a corpus of fetish fantasies

Corpora ◽  
2012 ◽  
Vol 7 (1) ◽  
pp. 69-90 ◽  
Author(s):  
Andrew Wilson
Keyword(s):  
Depth Psychology ◽  
Constant Pressure ◽  
Psychological Theory ◽  
Evidence Base ◽  
Future Research ◽  
German Language ◽  
Alternative Theory ◽  
Depth Psychological ◽  
Psychological Constructs ◽  
Quantitative Linguistics

Contemporary depth psychology is under constant pressure to demonstrate and strengthen its evidence base. In this paper, I show how the analysis of large corpora can contribute to this goal of developing and testing depth-psychological theory. To provide a basis for evaluating statements about foot and shoe fetishism, I analyse the thirty-six most frequent three-word phrases (or trigrams) in a corpus of about 1.6 million words of amateur fetish stories written in the German language. Zipfian methods from quantitative linguistics are used to specify the number of phrases for analysis and I argue that these reflect the core themes of the corpus. The analysis reveals three main dimensions. First, it corroborates the observations of the early sexologists that foot and shoe fetishism is very closely intertwined with sadomasochism. Secondly, it shows that genitalia-related phrases are also common, but an examination of their contexts questions Freud's theory that fetishism results from an assumption of female castration. Thirdly, it reveals that the mouth also plays a key role; however, the frequent co-presence of genitalia references in the same texts does not seem to support straightforwardly the most common alternative theory of fetishism based on object relations. Future research could valuably extend this approach to other fetishes and, in due course, to other depth-psychological constructs.

A Literature Review of “ Parenting Styles and Emotional Intelligence of X Class Students”

2017 ◽  
Vol 4 (36) ◽  
Author(s):  
P. Bhavani ◽  
T. G. Amuthavally
Keyword(s):  
Emotional Intelligence ◽  
Literature Review ◽  
Parenting Styles ◽  
Research Programme ◽  
Research Process ◽  
Future Research ◽  
Review Of Literature ◽  
Related Literature

The research for the review of literature is one of the first and foremost important steps in the research process. The search for related literature is a time consuming but fruitful phase of any research programme. In this article, the researcher was made an attempt to present findings from the collected related literature on parenting styles and emotional intelligence of adolescents. The main motto behind this article is to review of related literature from 1990 to till date. The paper also summarizes the findings of the studies on Emotional Intelligence and Parenting Styles giving a direction for future research.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

Sub-Ethnicity and Survivorship Experience: Asian American Breast Cancer Survivors

2021 ◽  
pp. 019394592110319
Author(s):  
Wonshik Chee ◽  
Eun-Ok Im
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Asian American ◽  
Breast Cancer Survivors ◽  
Short Form ◽  
Secondary Analysis ◽  
Future Research ◽  
Japanese American ◽  
Personal Resource ◽  
Cancer Data

The purpose of the study was to explore the associations of sub-ethnicity to the survivorship experience of Asian American breast cancer survivors and identify the multiple factors that influenced their survivorship experience. This was a secondary analysis of the data among 94 Asian American breast cancer survivors from a larger ongoing study. Instruments included: questions on background characteristics, the perceived isolation scale, the Personal Resource Questionnaire, the Memorial Symptom Assessment Scale-Short Form, and the Functional Assessment of Cancer Therapy-Breast Cancer. Data were analyzed using hierarchical logistic and multiple regression analyses. After controlling for other factors, being a Japanese American (ref. = being a Chinese American) was significantly associated with pain scores (odds ratio [OR] = −0.32, p < .01), symptom distress scores ( β = −0.27, p < .01), and the quality of life scores ( β = 0.22, p = .03). Sub-ethnic variations in cultural attitudes, values, and beliefs need to be considered in future research/practice with Asian American breast cancer survivors.

scholarly journals A Detailed Catalogue of Multi-Omics Methodologies for Identification of Putative Biomarkers and Causal Molecular Networks in Translational Cancer Research

2021 ◽  
Vol 22 (6) ◽  
pp. 2822
Author(s):  
Efstathios Iason Vlachavas ◽  
Jonas Bohn ◽  
Frank Ückert ◽  
Sylvia Nürnberg
Keyword(s):  
Cancer Research ◽  
Clinical Information ◽  
Disease Diagnosis ◽  
Molecular Data ◽  
Molecular Networks ◽  
Biological Knowledge ◽  
Omics Data ◽  
Translational Cancer Research ◽  
Using Data ◽  
Biological Entities

Recent advances in sequencing and biotechnological methodologies have led to the generation of large volumes of molecular data of different omics layers, such as genomics, transcriptomics, proteomics and metabolomics. Integration of these data with clinical information provides new opportunities to discover how perturbations in biological processes lead to disease. Using data-driven approaches for the integration and interpretation of multi-omics data could stably identify links between structural and functional information and propose causal molecular networks with potential impact on cancer pathophysiology. This knowledge can then be used to improve disease diagnosis, prognosis, prevention, and therapy. This review will summarize and categorize the most current computational methodologies and tools for integration of distinct molecular layers in the context of translational cancer research and personalized therapy. Additionally, the bioinformatics tools Multi-Omics Factor Analysis (MOFA) and netDX will be tested using omics data from public cancer resources, to assess their overall robustness, provide reproducible workflows for gaining biological knowledge from multi-omics data, and to comprehensively understand the significantly perturbed biological entities in distinct cancer types. We show that the performed supervised and unsupervised analyses result in meaningful and novel findings.

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