Ethical Conflict in Providing Informed Consent for Clinical Trials: A Problematic Example from the Gynecologic Cancer Research Community

2004 ◽  
Vol 9 (1) ◽  
pp. 3-7 ◽  
Author(s):  
Maurie Markman
Keyword(s):  
Cancer Research ◽  
Clinical Trials ◽  
Informed Consent ◽  
Gynecologic Cancer ◽  
Research Community ◽  
Ethical Conflict

Cervical cancer in Eastern Europe: review and proceedings from the Cervical Cancer Research Conference

2020 ◽  
pp. ijgc-2020-001652
Author(s):  
William Small Jr ◽  
Gheorghe Peltecu ◽  
Anastasia Puiu ◽  
Andrei Corha ◽  
Elena Cocîrṭă ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Research ◽  
Clinical Trials ◽  
Gynecologic Cancer ◽  
Cervix Cancer ◽  
Research Network ◽  
Cancer Research Network ◽  
Common Cancer ◽  
Educational Symposium ◽  
The Subject

Cervical cancer is the third most common cancer among women worldwide, with a disproportionately high burden of disease in less-developed regions of the world. The Cervix Cancer Research Network was founded by the Gynecologic Cancer InterGroup with a mission to improve outcomes in cervical cancer by enhancing international access to clinical trials, specifically in under-represented, underdeveloped areas. The Cervix Cancer Research Network held its third international educational symposium in Bucharest in 2018 and is the subject of this report. The purpose of this symposium was to advance the international understanding of cervical cancer treatment patterns, to foster recruitment to Cervix Cancer Research Network clinical trials, and identify key Cervix Cancer Research Network clinical trial concepts to improve cervical cancer care worldwide.

scholarly journals From biobank and data silos into a data commons: convergence to support translational medicine

2021 ◽  
Author(s):  
Rebecca Asiimwe ◽  
Stephanie Lam ◽  
Samuel Leung ◽  
Shanzhao Wang ◽  
Rachel Wan ◽  
...  
Keyword(s):  
British Columbia ◽  
Cancer Research ◽  
Clinical Data ◽  
Translational Medicine ◽  
Gynecologic Cancer ◽  
Data Access ◽  
Collaborative Governance ◽  
Research Community ◽  
Data Intensive ◽  
Data Commons

Abstract Background To drive translational medicine, modern day biobanks need to integrate with other sources of data (clinical, genomics) to support novel data-intensive research. Currently, vast amounts of research and clinical data remain in silos, held and managed by individual researchers, operating under different standards and governance structures; a framework that impedes sharing and use of data. In this article, we describe the journey of British Columbia’s Gynecological Cancer Research Program (OVCARE) in moving a traditional tumour biobank, outcome unit, and a collection of data silos, into an integrated data commons to support data standardization, data, and resources sharing under collaborative governance, as a means of providing the gynecologic cancer research community in British Columbia access to tissue samples and associated clinical and molecular data from thousands of patients. Results Through several engagements with stakeholders from various research institutions within our research community, we identified priorities and assessed infrastructure needs required to optimize and support data collections, storage and sharing, under three main research domains: 1) biospecimen collections, 2) molecular and genomics data, and 3) clinical data. We further built a governance model and a resource portal to implement protocols and standard operating procedures for seamless collections, management and governance of interoperable data, making genomic, and clinical data available to the broader research community. Conclusions Proper infrastructures for data collection, sharing and governance is a translational research imperative. We have consolidated our data holdings into a data commons, along with standardized operating procedures to meet research and ethics requirements of the gynecologic cancer community in British Columbia. The developed infrastructure brings together, diverse data, computing framework, as well as tools and applications for managing, analyzing, and sharing data. Our data commons bridges data access gaps and barriers to precision medicine and approaches for diagnostics, treatment and prevention of gynecological cancers, by providing access to large datasets required for data-intensive science.

scholarly journals From biobank and data silos into a data commons: convergence to support translational medicine

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Rebecca Asiimwe ◽  
Stephanie Lam ◽  
Samuel Leung ◽  
Shanzhao Wang ◽  
Rachel Wan ◽  
...  
Keyword(s):  
British Columbia ◽  
Cancer Research ◽  
Clinical Data ◽  
Translational Medicine ◽  
Gynecologic Cancer ◽  
Data Access ◽  
Collaborative Governance ◽  
Research Community ◽  
Data Intensive ◽  
Data Commons

Abstract Background To drive translational medicine, modern day biobanks need to integrate with other sources of data (clinical, genomics) to support novel data-intensive research. Currently, vast amounts of research and clinical data remain in silos, held and managed by individual researchers, operating under different standards and governance structures; a framework that impedes sharing and effective use of data. In this article, we describe the journey of British Columbia’s Gynecological Cancer Research Program (OVCARE) in moving a traditional tumour biobank, outcomes unit, and a collection of data silos, into an integrated data commons to support data standardization and resource sharing under collaborative governance, as a means of providing the gynecologic cancer research community in British Columbia access to tissue samples and associated clinical and molecular data from thousands of patients. Results Through several engagements with stakeholders from various research institutions within our research community, we identified priorities and assessed infrastructure needs required to optimize and support data collections, storage and sharing, under three main research domains: (1) biospecimen collections, (2) molecular and genomics data, and (3) clinical data. We further built a governance model and a resource portal to implement protocols and standard operating procedures for seamless collections, management and governance of interoperable data, making genomic, and clinical data available to the broader research community. Conclusions Proper infrastructures for data collection, sharing and governance is a translational research imperative. We have consolidated our data holdings into a data commons, along with standardized operating procedures to meet research and ethics requirements of the gynecologic cancer community in British Columbia. The developed infrastructure brings together, diverse data, computing frameworks, as well as tools and applications for managing, analyzing, and sharing data. Our data commons bridges data access gaps and barriers to precision medicine and approaches for diagnostics, treatment and prevention of gynecological cancers, by providing access to large datasets required for data-intensive science.

Cervix Cancer Research Network (CCRN): Improving Access to Cervix Cancer Trials on a Global Scale

2016 ◽  
Vol 26 (9) ◽  
pp. 1690-1693 ◽  
Author(s):  
David Gaffney ◽  
Bill Small ◽  
Henry Kitchener ◽  
Sang Young Ryu ◽  
Akila Viswanathan ◽  
...  
Keyword(s):  
Cancer Research ◽  
Clinical Trials ◽  
Gynecologic Cancer ◽  
The United States ◽  
Global Scale ◽  
Cervix Cancer ◽  
Research Network ◽  
Standards Of Care ◽  
Cancer Research Network ◽  
The World

AbstractEighty-seven percent of cervix cancer occurs in less-developed regions of the world, and there is up to an 18-fold difference in mortality rate for cervix cancer depending on the region of the world. The Cervix Cancer Research Network (CCRN) was founded through the Gynecologic Cancer InterGroup with the aim of improving access to clinical trials in cervix cancer worldwide, and in so doing improving standards of care. The CCRN recently held its first international educational symposium in Bangkok. Sixty-two participants attended from 16 different countries including Pakistan, India, Bangladesh, Thailand, Malaysia, Singapore, Philippines, Taiwan, China, Vietnam, Korea, Japan, Columbia, Brazil, Canada, and the United States. The focus of this symposium was to evaluate progress, to promote new clinical trials for the CCRN, and to provide education regarding the role of brachytherapy in the treatment of cervical cancer.

Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

2002 ◽  
Vol 28 (4) ◽  
pp. 361-408
Author(s):  
Lars Noah
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Autonomy ◽  
College Campuses ◽  
Human Experimentation ◽  
Experimental Therapy ◽  
Academic Literature ◽  
Medical Experimentation ◽  
Disclosure Rules ◽  
Near Unanimity

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

scholarly journals GYNOCARE Update: Modern Strategies to Improve Diagnosis and Treatment of Rare Gynecologic Tumors—Current Challenges and Future Directions

Cancers ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 493
Author(s):  
Riccardo Di Fiore ◽  
Sherif Suleiman ◽  
Bridget Ellul ◽  
Sharon A. O’Toole ◽  
Charles Savona-Ventura ◽  
...  
Keyword(s):  
Cancer Research ◽  
Gynecological Cancer ◽  
Gynecologic Cancer ◽  
Delayed Diagnosis ◽  
Research Programme ◽  
Basic Research ◽  
Diagnosis And Treatment ◽  
Rare Cancer ◽  
Cost Action ◽  
Gynecologic Tumors

More than 50% of all gynecologic tumors can be classified as rare (defined as an incidence of ≤6 per 100,000 women) and usually have a poor prognosis owing to delayed diagnosis and treatment. In contrast to almost all other common solid tumors, the treatment of rare gynecologic tumors (RGT) is often based on expert opinion, retrospective studies, or extrapolation from other tumor sites with similar histology, leading to difficulty in developing guidelines for clinical practice. Currently, gynecologic cancer research, due to distinct scientific and technological challenges, is lagging behind. Moreover, the overall efforts for addressing these challenges are fragmented across different European countries and indeed, worldwide. The GYNOCARE, COST Action CA18117 (European Network for Gynecological Rare Cancer Research) programme aims to address these challenges through the creation of a unique network between key stakeholders covering distinct domains from concept to cure: basic research on RGT, biobanking, bridging with industry, and setting up the legal and regulatory requirements for international innovative clinical trials. On this basis, members of this COST Action, (Working Group 1, “Basic and Translational Research on Rare Gynecological Cancer”) have decided to focus their future efforts on the development of new approaches to improve the diagnosis and treatment of RGT. Here, we provide a brief overview of the current state-of-the-art and describe the goals of this COST Action and its future challenges with the aim to stimulate discussion and promote synergy across scientists engaged in the fight against this rare cancer worldwide.

scholarly journals Public Approval of Exception From Informed Consent in Emergency Clinical Trials

2019 ◽  
Vol 2 (7) ◽  
pp. e197591 ◽  
Author(s):  
William B. Feldman ◽  
Spencer P. Hey ◽  
Jessica M. Franklin ◽  
Aaron S. Kesselheim
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Public Approval
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