By eCliniqua Staff
Last week saw the annual gathering of the Drug Information Association (DIA) in Philadelphia. What follows is a selection of news and product releases that coincided with the event.
Medidata Solutions released results of new study it sponsored from the Tufts University Center for the Study of Drug Development (CSDD) assessing the design of current clinical trials. The study revealed that up to 25 percent of the procedures administered to patients (as required by clinical protocol) may be unnecessary, costing the industry $3-5 billion annually in clinical trial costs.
The results, presented by Tufts CSDD principal investigator Ken Getz, were compiled over eight months based on data from 15 international sponsor companies. Getz and colleagues used a customized version of Medidata Designer to analyze more than 115 trial protocols and categorize more than 22,000 medical procedures. The costs of both “core” and “non-core” procedures were measured using Medidata’s benchmarked clinical trial database.
“This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity,” said Getz. “The results have been eye-opening for participating companies and will no doubt serve as a jumping off point for pharmaceutical and biotechnology companies to examine ways to reduce the number of non-core procedures to improve clinical trial efficiency and substantially reduce study budgets.”
Key study findings include:
- About 25% all clinical trial procedures are considered non-core – they are not directly tied to the trial end-points
- These non-core procedures represent about 20% of a clinical trial’s budget – an estimated $1 million in non-core procedure costs per study
- Physician-related costs associated with non-core procedures total $2-4 billion a year across the industry
- When including other trial costs -- data management, monitoring, statistical analysis etc. -- non-core procedures represent an estimated $3-5 billion each year
“This study emphasizes the increasing role technology, and the expertise around it, will continue to play in helping drug developers design, conduct and manage efficient and effective clinical trials,” said Medidata president Glen de Vries.
BBK Worldwide says it is revolutionizing global patient recruitment with the launch of shop.BBKWorldwide.com, a new online resource for clinical research professionals where they can learn about, and purchase, a full range of patient recruitment products and services. The website fosters more informed decisions and redefines the audience of purchasers to include those looking for quick, stand-alone solutions, says the company.
“Traditional strategies have focused on accelerating the enrollment of patients,” said Bonnie. Brescia, founding principal, BBK Worldwide. “We’re looking to influence timelines even sooner – during the purchasing phase, when valuable time can be lost identifying and learning about the latest solutions.”
As clinical trial sponsors get more savvy about their purchasing options, BBK Worldwide believes its new online resource will help them find accessible recruitment solutions, which will only become more critical as trials get more complex. The site features innovations that include:
- Ready. Set. Go. Card – a quick and convenient way to provide global study reimbursements.
- Clinical Study Notifier – a notification service that alerts patients to clinical trials.
- eBinder: Study iPads – a communication platform to help manage documents, data, and study personnel across multiple sites and teams.
ArisGlobal announced the release of Register 5.3, featuring enhanced XEVMPD compliant regulatory tracking and e-submissions management. This is the latest version of ArisGlobal’s regulatory e-submissions management and tracking solution, used by more than one third of the top 25 biopharma companies worldwide.
The new release features enhancements to Register allowing improved tracking of efficiently and the capability to better manage regulatory intelligence. There is also a user friendly help feature that enables quick searching with each field in the application.
“In a time in which all focus had to be on XEVMPD compliance… we have been able to introduce two new modules in our Total Regulatory solution. We believe that Register 5.3 will be a timely addition to the arsenal of companies looking to gear up for the big imminent change – ISO-IDMP,” said Wim Cypers, VP regulatory affairs at ArisGlobal.
iGATE, an integrated technology and operations company providing Business Outcomes-based solutions, released the iGATE Research Accelerator (RA) platform for life sciences -- a streamlined program designed to reduce the cycle times and costs of bringing a new drug to market.
The RA empowers pharmaceutical developers and CROs with fully integrated clinical information management technology and iGATE’s business outcomes-based methodology, enabling them to make faster, more informed decisions. Drug developers that engage in this approach pay only for performance, leading to increased project hours and ultimately, higher billing.
“The slightest inefficiencies can put millions of dollars at risk,” said David Kruzner, iGATE executive VP, iTOPS Solutions and Consulting. “Utilizing the RA platform, organizations can do a far better job of capturing critical data across multiple systems and verifying, analyzing, reporting and reusing it through multiple phases, supporting their short-term and long- term objectives.”
iGATE’s management solution links the systems and data-related procedures throughout the clinical process – from data capture to clinical data management, product registrations, document and submission management, pharmacovigilence risk management, reporting and analytics, and clinical operations R&D portfolio management.
Blue Chip Prospect
In other survey news, Blue Chip Patient Recruitment recently conducted a survey on mHealth and its implications for patient recruitment, revealing some interesting facts about how patients, site coordinators and physicians are using mobile technology to manage healthcare.
“mHealth is in its early adoption phase, but there are some exciting opportunities that clinical trial sponsors can leverage now,” said Neil Weisman, executive VP/General Manager of Blue Chip Patient Recruitment. “Our findings show that 92 percent of site coordinators are eager for tools to help them do their jobs more efficiently and are open to receiving mobile devices from trial sponsors, so there is great opportunity to engage with trial participants early.” Among the key findings:
- More than 75 percent surveyed patients prefer to use smartphones and tablets for communication, whereas less than 50 percent use their phones for computing
- Among the most active mobile users, two thirds are receptive to receiving clinical trial information via email
- The waiting room is an ideal opportunity to engage patients with clinical trial messaging. On average, more than half of patients use mobile devices in waiting rooms.