Clinical trial data: ethical considerations in the face of technological advances

2014 ◽  
pp. 54-65
Author(s):  
Blair Henry
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Ethical Considerations ◽  
Technological Advances ◽  
The Face

scholarly journals Clinical data monitoring during COVID-19 pandemic: an experience from a regulatory trial in India

2021 ◽  
Vol 8 (2) ◽  
pp. 163
Author(s):  
Divya Pillai ◽  
Monika Bahl ◽  
Padmapriyadarsini C ◽  
Ranjan Kumar ◽  
Supriya Semwal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cost Effectiveness ◽  
Clinical Data ◽  
Patient Management ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Monitoring ◽  
Ethical Considerations ◽  
Routine Monitoring

<p>The essence of any clinical or healthcare related discovery is its methodologically sound clinical research and clinical data monitoring. This eventually helps the clinicians to understand the best possible clinical management pathways or patient management at all the levels of healthcare system. The pandemic has had an impact on clinical trial data monitoring as well. New or mixed approaches to routine monitoring have been introduced to ensure the quality of the overall research in these challenging times and are being tested for efficacy, cost-effectiveness while keeping ethical considerations as the main priority. This write up intends to highlight a few steps taken to ensure data integrity and participants’ safety and rights.</p>

VP23 The New Cancer Drugs Fund: The Future Model Of Oncology Reimbursement

2018 ◽  
Vol 34 (S1) ◽  
pp. 165-165
Author(s):  
Sean Walsh ◽  
Richard Macaulay ◽  
Erika Turkstra ◽  
Ricky Tsang
Keyword(s):  
Clinical Trial ◽  
Observational Data ◽  
Clinical Trial Data ◽  
Brentuximab Vedotin ◽  
Trial Data ◽  
Phase Iii ◽  
Cancer Drugs ◽  
Cell Transplants ◽  
The Face ◽  
Set Up

Introduction:The Cancer Drugs Fund (CDF) was set up in 2011 in England to enable patients to access oncology therapies that are not routinely publicly funded. In April 2016, the CDF became a temporary reimbursement fund under the remit of the National Institute for Health and Care Excellence (NICE) with the aim of collecting observational data to inform subsequent technology appraisals. This study aims to evaluate how the reformed CDF has been utilized in the 18 months since this reform.Methods:NICE Final Appraisal Determinations for Single Technology Appraisals of oncology drugs from (29 July 2016 to 24 November 2017) were identified and key data extracted.Results:Seventy-four oncology drug:indication appraisals were identified, 54 (73 percent) were recommended/optimized, 10 (14 percent) were not recommended and 10 drug:indication pairings (14 percent: osimertinib, brentuximab vedotin, pembrolizumab, olaratumab, obinutuzumab, venetoclax, nivolumab [3 indications], and ibrutinib) were referred to the CDF. For most, the greatest uncertainty in their cost-effectiveness analyses related to their survival benefits, intended to primarily be resolved through subsequent clinical trial readouts. However, for venetoclax, ibrutinib and brentuximab, the main areas of uncertainty (relating to comparative survival benefit, pre-progression mortality, and rate of subsequent stem cell transplants, respectively) are expected to be resolved primarily through observational data collected under the CDF.Conclusions:The newly reformed CDF has been utilized in a minority of cases. Typically, the CDF acts as a temporary access mechanism for treatments that receive market authorization based on early/single-arm trial data until longer-term and/or Phase III data are available. However, venetoclax, brentuximab, and ibrutinib demonstrate how the CDF may address significant areas of uncertainty through the collection of uncontrolled observational data. For venetoclax, with only single-arm supportive clinical trial data, observational data of this intervention and appropriate comparator are to be collected, providing a potential case study of how to appropriately manage reimbursement in the face of significant clinical uncertainty.

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

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