scholarly journals Design and virtual implementation of a biomedical registry framework for the enhancement of clinical trials: colorectal cancer example

2019 ◽  
Vol 26 (1) ◽  
pp. e100008 ◽  
Author(s):  
Athanasios Kotoulas ◽  
George Lambrou ◽  
Dimitrios-Dionysios Koutsouris

IntroductionClinical trials generate a large volume of literature and a vast amount of data. Following the 'open science' model, data sharing has enormous potential to strengthen scientific research. Currently, to the best of our knowledge, there is no existing web based Hellenic biomedical registry that displays available patients for clinical trials, providing direct access to registered physicians to all data, assisting them in finding eligible patients in the initial clinical trial recruitment process.MethodsThis paper describes the design and virtual implementation of a web based prototype biomedical registry in Greece. The system represents an eGovernment framework proposal for the central storage of patients' biomedical information and the operations associated with this process. The increasing tendency to include molecular data as prerequisite elements in clinical trials is adopted in the registry philosophy. The designed system is based on free, open source software and it is implemented virtually on a local host environment.ResultsUsing colorectal cancer as an example, valid data from patients increases the reliability index, demonstrating the functionality of the web application.ConclusionIn conclusion, the combination of biomedical data and information technology in order to display potential participants per health unit, facilitates recruitment for clinical trials.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3624-3624
Author(s):  
C. Bui ◽  
M. Hampshire ◽  
C. Vachani ◽  
J. Metz

3624 Background: Colorectal cancer patients are increasingly looking to the Internet for information on clinical trials; however, services offering clinical trials recruitment have not been well defined. This study describes one of the first web-based cancer clinical trials matching resources and the demographics of the colorectal cancer patient user base. Methods: Oncolink ( http://www.oncolink.org ) is the web-based educational resource at the University of Pennsylvania and serves between 1.5–2 million pages per month to over 385,000 unique IP addresses. Oncolink, in conjunction with EmergingMed (New York, NY), launched one of the first clinical trials matching resources on the Internet. Patients input demographic and tumor-specific information via secure Internet-only registration or via the Internet with assistance from a call center, to match to trials. As of 12/2005, there were 112 total colorectal trials in the database. Results: Between 12/2000 and 9/2005 a total of 41,970 individual profiles were created, with 3289 (7.8%) by colorectal cancer patients. Other GI tumors accounted for 15% of profiles. Of the 3289 patients, 54% were male and 46% were female, and the median age was 55 (range 19–96). Most patients reported their disease as having spread to another organ (62%) or to lymph nodes (15.4%). Most patients were previously treated with surgery (81%), radiation (26%), chemotherapy (74%), and/or biological therapies (21%) (bevacizumab, cetuximab, interferon or interleukin). Patients who used the call center with the Internet were more likely to apply for enrollment in a clinical trial after review of the matches (77% vs. 10%, p<0.001). The median number of trial matches in the system was 7 per patient. Of the 3289 colorectal patients, 681 patients (21%) went on to apply for enrollment to trials based on their matches. Conclusions: This report demonstrates that a significant percentage of colorectal cancer patients are willing to use the Internet to match to clinical trials. Contact with a call center greatly increases the likelihood of application to trials. Internet based clinical trials resources should maintain options for personal communication to increase the likelihood of enrollment to clinical trials. No significant financial relationships to disclose.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3561-3561
Author(s):  
Reese Garcia ◽  
Andrea Dwyer ◽  
Sharyn Worrall ◽  
Christopher Ryan Heery ◽  
Dustin A. Deming ◽  
...  

3561 Background: Colorectal cancer (CRC) remains one of the most lethal cancer killers worldwide. Recently, research has shown great strides in the treatment of MSI-H mCRC using immunotherapy, however, these treatments have not been effective in MSS patients, who make up a majority of CRC cases. Due to numerous barriers, clinical trial enrollment numbers remain as low as 9% of the eligible populations, despite the reliance of many late stage CRC patients on clinical trials for treatment. Perhaps greatest of these barriers is the lack of meaningful patient-facing clinical trial matching, making advances in MSS mCRC IO clinical research extremely slow. Methods: In May 2017, Fight Colorectal Cancer (FightCRC) launched its web-based trial finder, The Late Stage MSS Trial Finder (TF) with the late Dr. Tom Marsilije, a stage IV CRC patient and researcher, and Flatiron Health. The TF is a publicly available immunotherapy-based repository of clinical trials. An algorithm automatically codes for a subset of trials from ClinicalTrials.gov to be uploaded into the tool, and trained FightCRC advocates follow a strategic logic flow to prioritize trials of highest potential benefit and lowest risk for patients. Results: Between 30 and 100 trials are uploaded into the TF for curation each week. A total of 378 trials have been indexed in the TF to date. In February 2019, a mobile application was introduced. From May 2017 to January 2019, the tool has seen > 15,000 users, yielding 26,000 searches in 105 countries; primarily from the United States, China, the United Kingdom, Canada, and France. On average, users navigate to 2.5 pages and spend > 2.5 minutes per use. Providers are using this as a tool to find clinical trials and to discuss these options in real time. CRC patient feedback confirmed the platform functionality. Conclusions: The Trial Finder is a unique tool for MSS mCRC patients pursuing clinical trials. The success of the tool may be attributed to patient focused selection of therapies that show promise. The FightCRC late stage MSS CRC trial finder is being widely utilized, in diverse settings. With our patient curators and Medical Advisory Board, FightCRC will improve the search features and outcome tracking with user feedback. The goal for the TF is to address key barriers to patient entry into clinical trials and promote patient-provider discussions to inform decision making.


2019 ◽  
Vol 16 (6) ◽  
pp. 657-664 ◽  
Author(s):  
Junhao Liu ◽  
Jo A Wick ◽  
Dinesh Pal Mudaranthakam ◽  
Yu Jiang ◽  
Matthew S Mayo ◽  
...  

Background Monitoring subject recruitment is key to the success of a clinical trial. Accordingly, researchers have developed accrual-monitoring tools to support the design and conduct of trials. At an institutional level, delays in identifying studies with high risk of accrual failure can lead to inefficient and costly trials with little chances of meeting study objectives. Comprehensive accrual monitoring is necessary to the success of the research enterprise. Methods This article describes the design and implementation of the University of Kansas Cancer Center Accrual Prediction Program, a web-based platform was developed to support comprehensive accrual monitoring and prediction for all active clinical trials. The Accrual Prediction Program provides information on accrual, including the predicted completion date, predicted number of accrued subjects during the pre-specified accrual period, and the probability of achieving accrual targets. It relies on a Bayesian accrual prediction model to combine protocol information with real-time trial enrollment data and disseminates results via web application. Results First released in 2016, the Accrual Prediction Program summarizes enrollment information for active studies categorized by various trial attributes. The web application supports real-time evidence-based decision making for strategic resource allocation and study management of over 120 ongoing clinical trials at the University of Kansas Cancer Center. Conclusion The Accrual Prediction Program makes accessing comprehensive accrual information manageable at an institutional level. Cancer centers or even entire institutions can reproduce the Accrual Prediction Program to achieve real-time comprehensive monitoring and prediction of subject accrual to aid investigators and administrators in the design, conduct, and management of clinical trials.


2010 ◽  
Vol 39 ◽  
pp. 19-24 ◽  
Author(s):  
Ling Li Fu ◽  
Tao Chen

With more clinical trials using electronic way, new drugs electronic application has becoming an inevitable trend in near future. A well-designed case report form (CRF) is the premise of high quality clinical trials which facilitates data collection and entry, and directly benefits other facets of clinical data management. Firstly, paper introduces the CRF design modes and design principles. Then paper describes the CRF design process, and based on this, paper constructs the data structure with CDISC ODM concept. Lastly, paper explores how to convert the paper CRF to electronic format in web application with SAS statistic requirements in detail.


2003 ◽  
Vol 30 (3 Suppl 6) ◽  
pp. 56-67 ◽  
Author(s):  
W. Gillies McKenna ◽  
Ruth J. Muschel ◽  
Anjali Gupta ◽  
Stephen Hahn ◽  
Eric J. Bernhard

2012 ◽  
Vol 2 (2) ◽  
pp. 112-116
Author(s):  
Shikha Bhatia ◽  
Mr. Harshpreet Singh

With the mounting demand of web applications, a number of issues allied to its quality have came in existence. In the meadow of web applications, it is very thorny to develop high quality web applications. A design pattern is a general repeatable solution to a generally stirring problem in software design. It should be noted that design pattern is not a finished product that can be directly transformed into source code. Rather design pattern is a depiction or template that describes how to find solution of a problem that can be used in many different situations. Past research has shown that design patterns greatly improved the execution speed of a software application. Design pattern are classified as creational design patterns, structural design pattern, behavioral design pattern, etc. MVC design pattern is very productive for architecting interactive software systems and web applications. This design pattern is partition-independent, because it is expressed in terms of an interactive application running in a single address space. We will design and analyze an algorithm by using MVC approach to improve the performance of web based application. The objective of our study will be to reduce one of the major object oriented features i.e. coupling between model and view segments of web based application. The implementation for the same will be done in by using .NET framework.


2019 ◽  
Author(s):  
Ruslan N. Tazhigulov ◽  
James R. Gayvert ◽  
Melissa Wei ◽  
Ksenia B. Bravaya

<p>eMap is a web-based platform for identifying and visualizing electron or hole transfer pathways in proteins based on their crystal structures. The underlying model can be viewed as a coarse-grained version of the Pathways model, where each tunneling step between hopping sites represented by electron transfer active (ETA) moieties is described with one effective decay parameter that describes protein-mediated tunneling. ETA moieties include aromatic amino acid residue side chains and aromatic fragments of cofactors that are automatically detected, and, in addition, electron/hole residing sites that can be specified by the users. The software searches for the shortest paths connecting the user-specified electron/hole source to either all surface-exposed ETA residues or to the user-specified target. The identified pathways are ranked based on their length. The pathways are visualized in 2D as a graph, in which each node represents an ETA site, and in 3D using available protein visualization tools. Here, we present the capability and user interface of eMap 1.0, which is available at https://emap.bu.edu.</p>


2020 ◽  
Vol 21 ◽  
Author(s):  
Daniel Sur ◽  
Andrei Havasi ◽  
Alecsandra Gorzo ◽  
Claudia Burz

Background: Anti-EGFR monoclonal antibodies (mAbs) have become a relevant solution for the treatment of patients with metastatic colorectal cancer. Current anti-EGFR monoclonal antibodies face a series of problems, including resistance and non-durable response, and RAS and BRAF mutations serve as exclusion criteria for treatment with anti-EGFR mAbs. Advances in molecular tumor profiling and information on subsequent pathways responsible for disease progression and drug resistance helped develop a new generation of anti-EGFR mAbs. These second-generation mAbs have been developed to overcome existing resistance mechanisms and to limit common side effects. For the moment, existing literature suggests that these novel anti-EGFR mAbs are far from finding their way to clinical practice soon. Objective: In this review, we summarize and evaluate current data regarding ongoing research and completed clinical trials for different second-generation anti-EGFR monoclonal antibodies. Conclusion: Anti-EGFR mAbs exhibit efficacy in advanced colorectal cancer, but second-generation mAbs failed to prove their benefit in the treatment of metastatic colorectal cancer. Understanding the biological basis of primary and acquired drug resistance could allow scientists to design better clinical trials and develop improved second-generation mAbs.


2021 ◽  
Vol 10 (3) ◽  
pp. 470
Author(s):  
Marta Martín-Richard ◽  
Maria Tobeña

Different strategies of maintenance therapy (sequential CT, intermittent CT, intermittent CT and MAbs, or de-escalation MAbs monotherapy) after first-line treatment are undertaken. Many randomized clinical trials (RCT), which evaluated these approaches, suffer from incorrect design, heterogenous primary endpoints, inadequate size, and other methodology flaws. Drawing any conclusions becomes challenging and recommendations are mainly vague. We evaluated those studies from another perspective, focusing on the design quality and the clinical benefit measure with a more objective and accurate methodology. These data allowed a clearer and more exact overview of the statement in maintenance treatment.


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