Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials
By Mark P. Mathieu For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore. Read More
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By Ann Neuer
January 20, 2009 | Pfizer recently selected the Exco InTouch text messaging technology to improve the subject recruitment and retention process for its Phase I clinical trials. Exco’s text messaging capability, ATLAS, is a recently launched regulatory-compliant technology that Pfizer can fully integrate with its own database of Phase I volunteers. The integration enables immediate text message-based communication, also known as short message service (SMS) communication, with selected patients, allowing recruitment staff to make a fast assessment of a potential subject’s availability and eligibility.
To start the process, Pfizer can use a range of text message templates to send messages to recipients who can then respond to Pfizer’s system. For example, a recipient could respond to “Text YES to 12345 to participate”. This is a vast improvement over traditional methods such as the mail, which is slow and yields a notoriously low response. “We can reach extremely busy people quickly, wherever they might be, at work, stuck in traffic, on the train, in college. It’s the immediacy that’s the real advantage,” says Exco’s CEO Tim Davis.
In addition to reaching potential volunteers for upcoming studies, Pfizer is mostly using the ATLAS text messaging capability to remind enrolled subjects of upcoming appointments. Adam Linkov, Volunteer Recruitment Manager for Pfizer’s Phase I Clinical Research Unit in New Haven, Connecticut says the largest measure of success will be the increased “show rate,” that is, fewer broken appointments. “We particularly like that the Exco system is automated for us. Once a volunteer says they want to participate in a study and agrees to receive text messages, the system takes over from there. Volunteers automatically get a text reminder of upcoming appointments and are asked to respond as to whether they will be able to keep the appointment,” Linkov explains. He adds that the cost per message is relatively affordable as compared to traditional methods such as television and radio, provided it’s effective.
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| Tim Davis |
Pfizer started testing its text message effort in early summer, and is focusing on Phase I for several reasons. The company’s Phase I units already have a database of people who have previously participated, and the company owns its Phase I units, which, in addition to New Haven, are also located in Brussels, Belgium, and Singapore. Vincent Monsonis, Manager of IT Systems at the New Haven unit explains that Pfizer uses an application called Phase I Management System (PIMS) to manage all aspects of Phase I trials for the locations, including interactions with volunteers and collecting data from volunteers. “The Exco text messaging application resides within the volunteer recruitment area of PIMS,” Monsonis explains.The clinical trials sector is sorely in need of solutions such as these to address the subject recruitment and retention dilemma, one of the industry’s most intractable challenges. In this regard, Exco claims to be making dramatic inroads. The company states that through its SMS service, it is reducing follow-up rates by more than 20%, seeing better results in patient visit attendance, and improving recruitment responses by 500%. “We came up with this figure by knowing how many text messages are sent out and then measuring how many responses come in, either by text response or phone calls. When you send out paper mailers to a known database of volunteers, you typically expect about 5% of people who receive the letter to actually respond. Our current average response rate is 28%,” Davis says.
The ATLAS application is a database integration tool that allows clients to distribute text messages to all countries where volunteers live. Since its recent launch, ATLAS technology has been used in more than 20 clinical trials. Currently, messages can be sent to 220 countries across 650 cellular networks.
eClinical Trial Technologies Revolutionizing Clinical Development Efficiency This Bio-IT World BriefingON report, sponsored by ClearTrial, presents a selection of recent stories from Bio•IT World and sister publication, eCliniqua, that illustrate how new technologies and approaches can have a profound impact on the management and execution of clinical trials.
Remote Data Capture:Acquisition and Analysis See why Electronic Data Capture (EDC) is gaining traction in the pharmaceutical
clinical trials arena. Today approximately half of all clinical trials are conducted
electronically, and the figure is rapidly rising. Report includes contributions from
Oracle Health Sciences, Pfizer, PPD, and C3i.
The Role of Analytics in Transforming Healthcare Sharing many of the data challenges and opportunities faced by Healthcare, the Life Sciences industry remains focused on delivering new, innovative therapies and solutions to patients in a cost effective, timely and safe way. With spiraling R&D costs, new methods such as adaptive trials, and never ending need for deep pharmacovigilance, the Life Sciences companies that effectively use analytics to explore, monitor and optimize their business will rapidly become the new leaders. Oracle’s strategy—built upon Enterprise Health Analytics and Health Data Warehouse Foundation—provides a powerful, practical, and extensible approach to delivering the IT analytics infrastructure required to confront the worldwide healthcare challenge.
Bio-IT World & CHI
Impact of the 1000 Genomes Project on the Next Wave of Pharmacogenomic Discovery
Interview with M. Eileen Dolan, Ph.D., Professor, Medicine, University of Chicago and Speaker at Next-Generation Sequencing Data Management, September 27-29, 2010, Providence, RI
The 1000 Genomes Project aims to provide detailed genetic variation data on >1000 genomes from worldwide populations using the next-generation sequencing technologies. Some of the samples utilized for the 1000 Genomes Project are the International Hap-Map samples that are composed of lymphoblastoid cell lines (LCLs) derived from individuals of different world populations. The detailed map of human genetic variation promised by the 1000 Genomes project will allow a more in-depth analysis of the contribution of genetic variation to drug response. Future studies utilizing this new resource can greatly enhance our understanding of the genetic basis of drug response and other complex traits.
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Software Engineer – Computational Biology Center
Memorial Sloan-Kettering Cancer Center seeks an Engineer to design and develop complex data analysis systems in support of cancer genomics research projects at the Computational Biology Center. Qualified candidate will have a BA, 5+ years of software development experience and expert knowledge of Java, SQL, and HTML.
Apply: www.mskcciscareers.org. Equal opportunity and affirmative action employer.
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