SBIR-STTR Award

The use of computers and Internet has greatly improved the capacity of medical data solutions, but there still exist problems when conducting drug abuse research. One major concern regards the capacity to collect data in real-time and within natural contexts, since drug use and health issues are sensitive topics. Another concern regards traditional data and project management that lacks enough options for interactive communications between people. It often takes time before information or data summaries are accessible to make decisions on safety or efficacy. As a solution based on wireless technologies, this SBIR Phase-I application aims to develop a prototype of iPhone-based Real-time Data Solution (iRDS) and study the feasibility of using mobile-phones for data collection, management, and analysis in medical research related to drug abuse and other behavioral problems. Taking up to 6 months, the following applications will be created using iPhone, Web, and database development tools. 1. Develop prototype applications for real-time data collection: (i) iCollect provides an iPhone interface for behavioral/psychological data-entry; (ii) uDesign running on the web server offers a tool for designing questionnaire with electronic forms; (c) vData manages medical data on the data server. 2. Develop prototype applications to dynamically mange and analyze data: (i) iAnalyze provides an iPhone interface for exploring, processing, and analyzing data; (ii) uAnalyze is the web app that conducts data analysis requiring heavy computations. 3. Develop prototype applications for project management: (i) iCom provides interactive communication tools between researchers and study participants via text message, email, and web-page; (ii) iAdm offers reminder and progress monitoring services over iPhone to help researchers exchange information and coordinate tasks quickly. Accomplishment of the above miniature iRDS system would (i) enable data collection in real-time within natural contexts, (ii) manage and analyze data quickly, and (iii) improve the efficiency of study administration. Ten smokers will be used to assess the reliability, validity, and other features of the iRDS system using standard behavior and quality of life questionnaires. Complete development of iRDS and related methodologies will be conducted in Phase-II, and the system will then be extended to accommodate other mobile-phones (e.g., RIM, Windows Mobiles, and Symbian cellular phones) for business purposes.

Public Health Relevance:
Quality of data is crucial for the success of all kinds of biomedical research. The proposed methods based on mobile-phones and wireless technologies would greatly improve the quality of data by enabling data collection, management and analysis conducted in real-time and within natural contexts. The proposed iPhone-based system will also provide useful tools for interactive communications and efficient project management.

Public Health Relevance:
Project Narrative Quality of data is crucial for the success of all kinds of biomedical research. The proposed methods based on mobile-phones and wireless technologies would greatly improve the quality of data by enabling data collection, management and analysis conducted in real-time and within natural contexts. The proposed iPhone-based system will also provide useful tools for interactive communications and efficient project management.

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The success of drug development and clinical research is heavily dependent on the quality of data, patience compliance, and statistical analysis. Traditional data collection via paper-pencil is labor- intensive and inconvenient, often leading to missing, noisy or invalid entries. There is always a challenge to monitor patients'medication compliance. When conducting analyses, traditional statistical methods lack of flexibility to make faster decisions. Seeing the ubiquitous application of wireless technologies and the quick emergence of Cloud Computing and Bayesian adaptive statistics in the pharmaceutical industry, we propose to develop a system called 'portable-devices based Data Solutions over the Cloud'(pDSC) for real-time data collection, scalable data storage, remote patient monitoring, and Bayesian adaptive clinical trial design. pDSC enables faster, cheaper, and effective clinical studies. Phase I of this project was highly successful. A prototype system was developed and tested by potential users. The business concept was highly acceptable for personalized data collection and analysis using the web-phone architecture. The feasibility of combing body area sensor networks with 3G wireless networks for collecting behavioral, psychosocial, geo-spatial and physiological data was fully verified. The protocols between iPhone and the web applications were developed and the method of high-performance Bayesian computation in the cloud was investigated. This Phase II proposal aims to fully develop the pDSC system to use smart phones and other portable devices for real-time data collection and patient monitoring. pDSC will be developed over the Windows Azure cloud platform with secure and scalable data storage mechanisms and interfaces to access other software tools for Bayesian adaptive design and interim analysis. The technical development will enable us to form a contracted research organization (CRO). It will offer cost-effective data services, fully complying with FDA guidelines, to help academic and pharmaceutical industry clients develop medicines to meet the goal of personalized treatment and patient-centered care.

Public Health Relevance:
Quality of data and analysis is crucial for the success of any clinical research. The proposed solution based on wireless and Internet technologies and Bayesian adaptive methods will greatly enlarge the capacity and cost-effectiveness of data solutions in developing pharmaceutical products. It has great potential to meet the needs of next generation clinical research and healthcare delivery featured by personalized medicine, patient-centered service, and prevention-oriented care.