Medrio, a leading EDC company for clinical research, announces his...

San Francisco, CA (press BOX) 10 July 2013

The user experience of technical software is often disappointing, often reflect more as he has made as its use. The Medrio 8.1 presents a new user interface, the workflow-controlled and faster for the user is. "By observing how for new as well as for experienced researchers do their work, it became clear that there were separate data collection and monitoring of workflows that are rarely done at the same time", said Jeff Johnson, Medrios Director of customer experience.

Data entry user must to register patients, see to what data entered at this stage, and respond to requests. Observers, on the other hand need data to see which data needs cleaning, to monitor close queries and forms. Each workflow can be streamlined. The new user interface by 8.1 Medrio is faster and requires less clicks of common tasks is more aesthetically pleasing.

"In addition the Medrio 8.1 fully validated and 21 CFR part 11 compliant data input via iPad leads," said Michael Farr, Medrios Manager of the Medrio scholars. "Although the Medrio not free for commercial trials require 21 CFR part 11 compliance is available, we have found that many do both academics our University customers and commercially sponsored studies and can operate as an EDC for both." Always a student database is as easy as visit enter scholars.medrio.com and an email address. "

"Our research program has the Medrio for less than a year, but has come, depending on the system for a legion of functionality, that we can get uneasy in REDCap. From the forms can easily created or by our other studies on monitoring, reporting and approval processes copied; a very comprehensive solution is all accessible from any computer with a standard Web browser, Medrio. Moreover, thanks to their support and responsiveness it amazingly is free they are, "said Troy Hamilton, clinical research manager Division of Nephrology at the University of Calgary.

About the Medrio, Inc.
Medrio offers an integrated eClinical software as a service (SaaS) platform with a fully hosted electronic data capture (EDC) system, the dramatic study of timelines and costs reduced, by it project managers control over their studies. Enable you studies entirely online will be built without the need for any custom development, Medrio eClinical trials can be ready in days instead of weeks. Medrio was successfully deployed Enterprise studies, registrations and other clinical studies by a number of leading research institutions on contract (CRO), as well as biopharmaceutical and device in phase I-IV. Medrio is free available for investigator-initiated studies that are funded University or Government. Founded in 2005, is headquartered Medrio in the San Francisco Bay area. For more information, visit scholars.medrio.com for more info on Medrios scholars program.

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Analysis Shows Cancer Biorepository Speeds Clinical Trials, Drug Development

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;??Pharma Industry / Biotech Industry
Article Date: 10 May 2013 - 1:00 PDT Current ratings for:
Analysis Shows Cancer Biorepository Speeds Clinical Trials, Drug Development

Researchers at Moffitt Cancer Center say identifying and selecting participants for phase II cancer clinical trials from a centralized warehouse of patient-donated biological data expedites participant accrual, reduces trial size, saves money, and may speed test drugs through the drug development pipeline.

Their study, which analyzed datasets from recent clinical trials conducted at Moffitt, was published online recently in Statistical Methods in Medical Research.

Launched at Moffitt in 2005, Total Cancer CareR is a comprehensive approach to cancer that enables physicians, researchers and caregivers to identify and meet all the needs of a patient and their family during the patient's lifetime and for future generations. At the heart of this approach is the Total Cancer CareR Protocol, which allows patients at Moffitt and its partner institutions to donate excess tumor tissue and biological samples for research. The samples are analyzed for biomarkers and other unique qualities and stored in a biorepository for study. Researchers can also use the information to quickly identify potential candidates for clinical trials based on a patient's biological and molecular profiles.

Total Cancer CareR enables evidence-based cancer care and helps usher in an era of personalized medicine, a concept the National Institutes of Health has invested in heavily. The authors also note that the National Cancer Institute has funded efforts to develop information and biospecimen infrastructure projects.

Efforts to discover biomarkers for disease and the identification of genetic signatures that can guide treatment selection are driving efforts to create patient biorepositiories. And the future of molecular-based, personalized medicine will uncover new innovations, adding to the body of information available for designing clinical trials, the authors said.

Unlike Moffitt, few institutions have established the infrastructure necessary for the systematic collection and maintenance of biosamples, related molecular analysis, electronic medical records and other data from their patient populations, said study co-author Benjamin M. Craig, Ph.D., associate member of Moffitt's Health Outcomes and Behavior Program.

"By taking a systems approach, biomarker and genetic profile information not only enables personalized medicine, but also promotes comparative effectiveness research," Craig said. "The contribution of a data warehouse that integrates clinical, biospecimen and molecular data for conducting clinical trials is essential for making good decisions about resource allocation."

By conducting a "value of information" study on the effectiveness of data warehousing in conducting phase II clinical trials, the authors found that patient accrual for trials was quicker when using data from the Moffitt biorepository. They also found that fewer patients needed to be enrolled in a study and that the amount of information recovered was equal to the amount of information gleaned from trials with greater numbers of participants.

"Our study provides evidence that programs, such as the Total Cancer CareR Protocol, that follow patients and collect clinical data for storage in a common warehouse can reduce the number of patients needed for a clinical trial without compromising the results of the study," said study lead author David Fenstermacher, Ph.D., chair of the Biomedical Informatics Department at Moffitt. "Another positive impact of using the biorepository for clinical trial participation is that phase II trials that test new cancer treatments being developed by the pharmaceutical industry move more quickly and cost less."

According to the authors, the effective assessment of new molecular-targeted therapies for tumors will be an essential part of stratified clinical trials design as trials become smaller, shorter, cheaper and more individualized. They also suggested that the development of new, molecular-targeted treatments will require the use of clinical, molecular and biospecimen data generated from the point of care.

Their analysis of the effectiveness of the Total Cancer CareR Protocol, through which more than 96,000 patients have consented to donate tissue samples and clinical data for biowarehousing and analysis has shown the benefit to those conducting clinical trials and the patients participating.

"The knowledge gained from our study and other studies under way at Moffitt are providing the foundation for creating the next generation of data management infrastructure to support personalized medicine," Fenstermacher said. "As these resources mature, data assessment strategies, such as 'value of information' studies, will be imperative to understand how data can be used to enhance patient care and improve treatment outcomes through evidence-based guidelines."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject. The study was funded by National Cancer Institute grants 5K25CA122176 and 5UC2CA148332.
H. Lee Moffitt Cancer Center & Research Institute Please use one of the following formats to cite this article in your essay, paper or report:

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Data Addressing Patient And Physician Barriers To Clinical Trials To Be Presented By Experts

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 17 May 2013 - 1:00 PDT Current ratings for:
Data Addressing Patient And Physician Barriers To Clinical Trials To Be Presented By Experts

Researchers from University Hospitals Case Medical Center's (UHCMC) Seidman Cancer Center in Cleveland, OH, will present findings from two studies evaluating new technologies designed to address common barriers to patient enrollment in clinical trials. Results from a large-scale, randomized trial demonstrated that the use of tailored, web-based videos delivering educational information to patients before an oncologist visit can significantly improve knowledge and reduce attitudinal barriers that impact enrollment in clinical trials. A second, preliminary study showed that a new automated technology created by UHCMC researchers helped oncologists identify clinical trials for individual patients in a busy outpatient oncology clinic.

"Although clinical trials are the key to developing new, better cancer treatments, less than 10 percent of cancer patients participate in them," says Neal J. Meropol, MD, study author, Chief of the Division of Hematology and Oncology at UHCMC and Case Western Reserve University School of Medicine and member-elect of the ASCO Board of Directors. "We know there are multiple barriers to clinical trials for both patients and oncologists, and the new technologies being evaluated at University Hospitals Case Medical Center Seidman Cancer Center are designed to break down those obstacles by providing individualized education for patients and new technology to help oncologists efficiently identify appropriate trials for their patients."

Common barriers to patient enrollment in clinical trials include fear of side effects, receiving placebo instead of treatment, financial concerns and the misperception that clinical trials should only be considered as a "last resort" option. For oncologists, a common obstacle is the time needed to help identify appropriate clinical trials - thousands of which are currently in progress across the country - for their patients. At the UHCMC Seidman Cancer Center, there are currently more than 300 ongoing clinical trials focused on cancer.

About the Studies

Oral Abstract Session: Health Services Research
Randomized Trial of a Web-based Intervention to Address Barriers to Clinical Trials
Abstract #6500: June 3, 8:00 - 8:15 a.m.

Dr. Meropol will present findings from a trial examining the use of PRE-ACT - Preparatory Education About Clinical Trials - a tailored, interactive, web-based intervention to address patient barriers and improve preparation for consideration of clinical trials as a treatment option. The prospective, randomized, multicenter, Phase 3 clinical trial evaluated 1,255 patients and utilized baseline assessments to determine their top clinical trial barriers. Patients in the PRE-ACT group were presented with a video library of 30-90 second clips that addressed their individual barriers, as indicated by their assessment results. Patients in the control group received online, text-based information that wasn't tailored to their individual barriers. A follow-up survey was conducted to reassess patient knowledge and attitudes.

Results showed that PRE-ACT significantly improved patient understanding and attitudes towards clinical trials when viewed before a visit to an oncologist. The control group also had improved knowledge, reduced attitudinal barriers and improved preparation, but the PRE-ACT group was more satisfied with the amount and format of information presented to them and felt more prepared to consider enrollment in clinical trials when compared to patients who received written information.

Funding for this study was provided by a National Cancer Institute (NCI) grant (R01CA127655) to Case Western Reserve University School of Medicine.

General Poster Session: Health Services Research
Trial Prospector: An Automated Clinical Trials Eligibility Matching Program
Abstract #111482: June 3, 1:15 - 5:00 p.m.

Co-authors Andrew Parchman, MD, Hematology and Oncology Fellow at UHCMC, and Dr. Meropol will present findings examining the use of Trial Prospector - an automated, HIPAA-compliant program pioneered by UHCMC that matches patients to clinical trials based on information extracted from their electronic medical records. Its user-friendly interface allows for physician perusal of relevant clinical trials and eligibility checklists at the point of care without requiring manual data entry. For this study, pilot testing was performed in a GI oncology subspecialty clinic. Eleven oncologists completed surveys after each patient visit to assess the usability and impact of Trial Prospector.

Results showed that the Trial Prospector matching algorithm was 100 percent accurate and saved time identifying potential clinical trials. Physicians generally found it to be easy to use, and 90.9 percent said they would recommend its use for clinical trial eligibility screening. Based on these preliminary findings, Dr. Parchman and team intend to expand data elements to increase the precision of trial matching and expand to other disease specialties and practice locations.

Funding for this study was provided by the Clinical and Translational Science Collaborative of Cleveland, UL1TR000439 from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH roadmap for Medical Research to Case Western Reserve University School of Medicine.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject. ASCO Annual Meeting: May 31-June 4, 2013 | McCormick Place | Chicago, Illinois
University Hospitals Case Medical Center Please use one of the following formats to cite this article in your essay, paper or report:

MLA

University Hospitals Case Medical Center. "Data Addressing Patient And Physician Barriers To Clinical Trials To Be Presented By Experts." Medical News Today. MediLexicon, Intl., 17 May. 2013. Web.
20 May. 2013. APA

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'Data Addressing Patient And Physician Barriers To Clinical Trials To Be Presented By Experts'

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If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

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Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

View the original article here