Data Security in Clinical Trials Using Blockchain Technology

Author(s):  
Marta de-Melo-Diogo ◽  
Jorge Tavares ◽  
Ângelo Nunes Luís

Blockchain technology in a clinical trial setting is a valuable asset due to decentralization, immutability, transparency, and traceability features. For this chapter, a literature review was conducted to map the current utilization of blockchain systems in clinical trials, particularly data security managing systems and their characteristics, such as applicability, interests of use, limitations, and issues. The advantages of data security are producing a more transparent and tamper-proof clinical trial by providing accurate, validated data, therefore producing a more reliable and credible clinical trial. On the other hand, data integrity is a critical issue since data obtained from trials are not instantly made public to all participants. Work needs to be done to establish the significant implications in security data when applying blockchain technology in a real-world clinical trial setting and generalized conditions of use to establish its security.

Author(s):  
Shaveta Malik ◽  
Archana Mire ◽  
Amit Kumar Tyagi ◽  
Arathi Boyanapalli

Clinical research comprises participation from patients. Often there are concerns of enrolment from patients. Hence, it has to face various challenges related to personal data, such as data sharing, privacy and reproducibility, etc. Patients and researchers need to track a set plan called study protocol. This protocol spans through various stages such as registration, collection and analysis of data, report generation, and finally, results in publication of findings. The Blockchain technology has emerged as one of the possible solutions to these challenges. It has a potential to address all the problem associated with clinical research. It provides the comfort for building transparent, secure services relying on trusted third party. This technology enables one to share the control of the data, security, and the parameters with a single patient or a group of patients or any other stakeholders of clinical trial. This chapter addresses the use of blockchain in execution of secure and trusted clinical trials.


2011 ◽  
Vol 7 ◽  
pp. S713-S713
Author(s):  
Luc Bracoud ◽  
Angelika Caputo ◽  
Chahin Pachai ◽  
Boubakeur Belaroussi ◽  
Ana Graf ◽  
...  

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Alina Danet ◽  
Joan Carles March Cerdá ◽  
Manuel Romero Vallecillos

Objetivo. Los ensayos clínicos con heroína (diacetilmorfina-DAM) han aportado al arsenal terapeútico disponible una alternativa en la atención a drogodependientes. El objetivo del presente artículo es conocer las experiencias y resultados clínicos de los estudios sobre el uso terapéutico de la heroina.Metodo. Revisión bibliográfica de los diferentes estudios y ensayos clínicos realizados hasta el presente a nivel mundial, sobre la intervención con pacientes dependientes de opioides. Se han consultado las bases de datos: EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid, y los descriptores «heroin», «diacetylmorphine», «clinical trial», «survey».Resultados. Se detectan 42 referencias, 16 presentan los resultados de ensayos clínicos de Suiza, Holanda, Alemania, Canadá, España y Reino Unido, comenzando con 1994. El resto de estudios se refieren a: captación y participación de los drogodependientes, mortalidad, calidad de vida, efectos secundarios y necesidad de nuevas investigaciones y ensayos clínicos.Conclusiones. Los estudios clínicos llevados a cabo hasta la actualidad muestran heterogeneidad en los métodos y variables empleadas, pero los objetivos son comunes (parten de evaluar los efectos del uso terapéutico de la heroina) y los resultados constatan la seguridad y efectividad de la prescripción médica de la diacetilmorfina. AbstractObjective. Clinical trials with heroin (diacetylmorphine) bring an alternative to the available therapeutic possibilities for addict people. The purpose of this article is to describe the experiences and results of clinical studies centered on the therapeutic use of heroin.Method. Literature review of studies and clinical trials, centered on the intervention with opiois- dependent patients. The databases consulted were : EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid. The descriptors : «heroin», «diacetylmorphine», «clinical trial», «survey».Results. The literature review revealed the existence of 42 references, of which 16 presented the results of clinical trials in Switzerland, Holland, Germany, Canada, Spain and United Kingdom, starting with 1994. Other references are centered on uptake and involvement of the drug, mortality quality of life/ side effects and need for further research and clinical trials.Conclusions. Clinical studies carried out until the present show heterogeneity in the methods and variables used, but the objectives are the same (based on assessing the effects of the therapeutic use of heroin) and the results confirm the safety and effectiveness of medical prescription of diacetylmorphine.


2019 ◽  
Vol 188 (3) ◽  
pp. 394-403 ◽  
Author(s):  
Jithma P. Abeykoon ◽  
Saurabh Zanwar ◽  
Stephen M. Ansell ◽  
Morie A. Gertz ◽  
Shaji Kumar ◽  
...  

2017 ◽  
Vol 1 (Suppl) ◽  
pp. 23-25
Author(s):  
Najibah A. Galadanci ◽  
Shehu U. Abdullahi ◽  
Leah D. Vance ◽  
Musa A. Tabari ◽  
Shehi Abubakar ◽  
...  

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 313-313 ◽  
Author(s):  
Jason Edward Faris ◽  
Theodore S. Hong ◽  
Shaunagh McDermott ◽  
Alexander R Guimaraes ◽  
Dushyant Sahani ◽  
...  

313 Background: The recently published Phase III trial of 5-FU, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) demonstrated improved survival compared to gemcitabine in good performance status (PS) patients with metastatic pancreatic cancer (Conroy et al, NEJM 2011). Less is known about the efficacy and tolerability with FOLFIRINOX in the non-clinical trial setting. In this retrospective analysis, we report our institutional experience with FOLFIRINOX. Methods: 29 patients with locally advanced or metastatic pancreatic cancer treated with FOLFIRINOX between July 2010 and April 2011 were used for this analysis. Clinical characteristics, and gradeable toxicities were tabulated, and formal radiographic review performed to determine best overall response rates (ORR). Results: 17 patients received FOLFIRINOX for metastatic disease and 12 patients for locally advanced disease. The median age of patients was 60 (range 39-76). 22/29 patients were men. 18/29 patients had received no prior chemotherapy. There was one patient with PS 2; all others had PS 0 or 1. 8/29 patients had biliary stents. Overall, 11 partial responses (PR) were observed (ORR 38%); 10/11 partial responses were in chemo-naïve patients, who had an ORR of 56%. In the metastatic setting, there were 6 PR, for an ORR of 35%, and 7 patients with stable disease (SD). In the locally advanced setting, there were 5 PR (ORR 42%), and 7 patients with SD. Following treatment with FOLFIRINOX, one patient with locally advanced disease has subsequently undergone R0 resection. The median number of cycles performed was 8 in both the locally advanced and metastatic settings. 12/29 patients required an ED visit or hospitalization during treatment. Grade 3/4 neutropenia was observed in 10 patients; 7/10 had not received prophylactic growth factor treatment from the start of FOLFIRINOX. 4 patients developed febrile neutropenia, 4 patients developed grade 3/4 thrombocytopenia, and 1 patient developed grade 4 anemia. Conclusions: In a non-clinical trial setting, FOLFIRINOX demonstrated activity in both the metastatic and locally-advanced settings. FOLFIRINOX appears to be associated with manageable, but significant toxicities, with over 40% of patients requiring hospitalization.


2009 ◽  
Vol 22 (3) ◽  
pp. 263-266 ◽  
Author(s):  
Yong Ma ◽  
Marinella Temprosa ◽  
Sarah Fowler ◽  
Ronald J. Prineas ◽  
Maria G. Montez ◽  
...  

2004 ◽  
Vol 19 (10) ◽  
pp. 2519-2525 ◽  
Author(s):  
W. Y. S. Leung ◽  
W.-Y. So ◽  
P. C. Y. Tong ◽  
M. K. W. Lo ◽  
K.-F. Lee ◽  
...  

2018 ◽  
Vol 45 (3) ◽  
pp. 192-195 ◽  
Author(s):  
Jennifer E. Fugate ◽  
Waleed Brinjikji ◽  
Harry Cloft ◽  
David F. Kallmes ◽  
Alejandro A. Rabinstein

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