 |
Sales Contacts
|
|
Reprints & ePrints
Interested in reprints of articles published in Bio-IT World magazine or one of our electronic newsletters? Contact:
Becky Mullaney
Reprint Management Services
717-399-1900 ext.166
|
|
|
|
| IN THIS ISSUE |
 |
Agrawal: New Directions in Drug Safety |
|
Using eMedia to Support Clinical Studies |
|
Agrawal: New Directions in Drug Safety
By Deborah Borfitz
The drug safety departments of most pharmaceutical companies have become too burdened with operations to effectively manage risk. A new approach is needed to detect problems earlier, communicate clear benefits, and prevent a risk-averse public from potentially blocking important advances.
So says Sanket Agrawal, chief strategy officer of Irvine, CA-based Relsys International. At the moment, safety departments end up placing 80 percent of their focus on single adverse event (AE) management and aggregate reporting, and the remainder on risk and signal management. For instance, over one-third of many companies' core safety staff currently supports the "non-value-added function" of AE intake. "It could be the other way around, as intended, through a sustained drive to simplify processes, integrate underlying systems, and perhaps even some regulatory assistance."
Passive monitoring of products is an outdated notion, given the complexity of today's medical products, says Agrawal. "Some studies show that as few as 1 percent of AEs even get reported by physicians." Beyond "being a good citizen," they have no incentive to do so.
By contrast, doctors in the U.K. are required by regulation to report any AE on the first 10,000 prescriptions of a newly released drug, says Agrawal. In Japan, pharmaceutical companies voluntarily pay physicians to track every patient prescribed a new drug for up to a year after its release. New product distribution is also limited to specific providers. The Japanese approach "seems to be more effective than passive reporting in surfacing abnormalities."
A few years ago, a pharmaceutical company launching a product in Europe limited distribution to providers willing to actively collect patient safety information, says Agrawal. "The company got three times as many quality reports than they would have otherwise."
Were physicians in the U.S. to become more conscientious about reporting AEs, "the industry would collapse" in a deluge of data. The public needs constant education about the realities of drug development, says Agrawal. Consumers want risk-free products, unrestricted access, and a speedier drug approval process. But they will also litigate if approvals come too fast or products are abused or misused.
Relsys uses the image of an iceberg in its educational efforts with lay people. "No matter how good the science is," Agrawal says, "when a drug is released we can see only a percentage of the risks. If we want to know everything, it means we would never release a drug." The message should be that "all drugs are chemicals and come with side effects, known and unknown. Pharmaceutical companies need to communicate the benefits [correlated to price] versus the risks...and let people make informed decisions."
The focus has been disproportionately on risk, says Agrawal, "which is understandable given the human propensity to weigh risks higher than rewards. For example, direct-to-consumer ads read through a list of risks, leaving consumers confused about the benefits of a product. Clearly, there's a lot of room for improvement in the educational aspect."
Companies could also more actively communicate to the public all they do to monitor known and unknown drug risks, says Agrawal. "If you go back any more than five years, you will see that companies are doing much more now, but are not getting credit for their efforts."
Proactive Surveillance
On the other side, "clinical trials will never expose risks the way real-world usage does," says Agrawal. More proactive post-marketing surveillance is required. At the moment, communications between product manufacturers and health care providers is "almost a one-way dialogue, focused on getting drugs on a formulary or approved list."
Growing acceptance of active surveillance is behind the exponential growth in Phase IV clinical studies and the desire to tightly integrate eClinical and safety tools, says Agrawal. Seamless electronic integration has yet to happen, in part because drug development is a multi-departmental, multi-IT-system process at most companies. "Vendors are just starting to offer that capability." Some vendors are acquiring complementary technology and integrating in-house, while others like Relsys are pushing for a standards-based open integration through "best-of-breed" alliances.
Risk management, from pre-clinical to post-marketing, needs to be a "holistic discipline," Agrawal says. Technology is needed in such areas as signal management, regulatory communications, and label update tracking. The U.S., which has separate guidances for risk assessment and risk minimization, is philosophically a bit behind Europe.
The FDA is taking steps in the right direction, including its recently announced plans to do a comprehensive assessment of the safety of drugs 18 months after introduction and to collaborate with the Veterans Health Administration to track how real patients fare after taking drugs, says Agrawal. The FDA has also announced its intentions to "take into account some of the recommendations of the IOM [Institute of Medicine]. There are now budget requests for this, to hire additional people at CDER [Center for Drug Evaluation and Research] and acquire new electronic tools [to facilitate reporting and analysis of AEs]."
The FDA stresses that it wants to "use the strength of science" to support its safety monitoring work, says Agrawal. The agency probably doesn't have the infrastructure to independently conduct research, as it once did. More likely, the FDA will be "a more active participant in clinical trials" and "make public all clinical trial results," as is currently being pushed in Congress.
Agrawal's "holy grail" is to find signals, in real time, directly from physicians' medical records. "Healthcare systems have the data in a structured format," he says, but privacy concerns remain a critical barrier.
|
|
| Using eMedia to Support Clinical Studies
By Bill Cooney
COMMENTARY | In recent years eMedia, including Web-based and CD/DVD-based programs, have gained widespread use in the medical community for both initial training and learning reinforcement. But the use of electronic media has lagged in training to support clinical study launches, where the conventional live-meeting approach still prevails.
There is ample evidence that eMedia training is underused in clinical research, especially in training site staff to perform individual studies. Electronic media can yield numerous advantages for clinical research, including faster study start-ups, improved performance by study sites, lower overall costs, and much better documentation of training to protect patient safety.
IT professionals can play an important role by supporting clinical study teams in their adoption of more advanced eMedia-based training methods, by ensuring that study teams make the right choices in new eMedia applications and service providers. IT professionals can also be instrumental in the design of eMedia training strategies that capture and track training data, so that individual training activities can be documented and reported.
Many opportunities exist to make better use of eMedia in clinical studies. Here are a few examples:
Separate training curricula for investigators, coordinators, raters and others. Investigator meetings address several distinct audiences, all with differing study roles. Some training is shared among these audiences, but other topics are role-specific. Curriculum for study launch training should include break-out sessions that are carefully structured to make the most of each audience's time and provide the information they need to succeed in their respective roles. In many cases, eMedia can be used in role-specific formats. For example, study launch meetings can be structured so that coordinators travel to a face-to-face meeting, while investigators participate on the same meeting day, but remotely via a live webconference. This produces a level of convenience and intensity of training that best meets the needs of each audience.
Reinforce training beyond the study launch. Training should not be a one-time data dump! Ongoing training should be planned and not held on an ad-hoc basis in response to problems, as are most mid-study meetings. An ongoing program of training reinforcement can anticipate challenges, such as patient recruitment, and address them before they can elevate into problems. Various eMedia formats are well suited to reach target audiences, while periodically reinforcing their experiences. For example, email and eNewsletters can cost-effectively reach study sites, and refer participants to a study-specific website that offers multimedia training resources. For live moderated training, mid-study webconferences can also be scheduled to provide study updates, reinforce key messages, and allow study sites to share feedback and best practices in the conduct of the study.
Provide a Web-based learning management system (LMS). An online LMS is a sensible way to centralize training resources for convenient and cost-effective use. This allows authorized users to access online training courses, register for training events, and test-out where required. Importantly, an LMS provides learners with a "scoreboard" that shows various training and study components, while indicating the completion status of each component. An LMS can also automatically generate website pop-up boxes or reminder emails to target learners, driving completion rates. In addition, it can enable study sponsors and clinical research associates to view the activity and completion status by individual, site and study. Another advantage is that an LMS can serve as a critical resource to extend training to additional target learners.
Typically, standard launch meetings attracts two staff members (one investigator and one coordinator) from each study site, but it's well established that each site uses four to six staff members to conduct a typical study. For those additional two to four target staff members per site, a study-specific LMS is a cost-effective way to deliver the training needed for safe, accurate execution of the study protocol.
Track and document the training completed by each individual by study site. A comprehensive training/tracking program enables study sponsors to ensure that each study site member has completed various activities and, where needed, tested out. In addition to training modules, study sponsors can track that individuals attended mid-study updates, reviewed protocol amendments, responded to polling questions, registered for up-coming programs and participated in various other activities.
Such tracking and documenting can also make sure that individuals complete mandatory activities, and direct the efforts of CRAs supporting study sites. Regulatory authorities require that study sites be adequately trained in the conduct of each clinical trial, so that patient safety is protected. This regulatory need can be met by an LMS that produces a superior level of performance and documentation of training.
Bill Cooney is the founder, president and CEO of MedPoint Communications, Inc. Email: Bill.Cooney@medpt.com.
|
| |
| |
2007 Bio-IT World Conference & Expo
|
April 30 � May 2, 2007 in Boston TRACK 5: e-Clinical Research & Translational Medicine program includes: Emerging Genomic Data Standards in Clinical and Clinical Trials Environment
Mollie Ullman-Cullere, MS, MSE, Senior Information Architect, Harvard � Partners Center for Genetics and Genomics Implementing Pharmaceutical Modeling and Simulation for Designing Arrogant BA/BE Clinical Studies
Dongzhou Liu, MSc, Ph.D., PDF, Principal Investigator, Forest Research Institute Crossing the Chasm, From Research to Clinical and Back
Diane Keogh, Corporate Director Research Computing, Partners HealthCare Clinical Trial Transparency
Dan McDonald, VP, Strategic and Product Development, D.L. Anderson International, Inc.; former VP and General Manager, Thomson CenterWatch
David Heck, Senior Director, Thomson CenterWatch Medical Informatics Perspectives on Pharma e-Clinical: Leveraging EMR Expertise
Scot Silverstein, MD, Director, Institute for Healthcare Informatics, College of Information Science and Technology, Drexel University, Philadelphia; former Director, Published Information Resources and The Merck Index, Merck Research Labs
|
|
| |
FEATURED EVENTS
MIT PROFESSIONAL INSTITUTE � SUMMER SESSION 2007
The Massachusetts Institute of Technology is currently accepting registrations for 36 intensive programs designed especially for professionals. Courses are from 1 to 5 days long and are taught on campus by MIT faculty from June through August. Earn a certificate and CEUs. Offerings include biotechnology, chemical engineering, energy, data modeling and analysis, IT, lean fundamentals, mechanical engineering, nanotechnology, nuclear systems, lasers & optics, technology policy,system architecture and other topics of vital interest to today�s engineers and scientists. Visit our website to register and view course descriptions. http://web.mit.edu/mitpep/go/pi07-bioit.html
IT Infrastructure Qualification and Application Conference - March 19 - 22, San Diego, CA
The newly refreshed 9th IT Infrastructure Qualification & Application Validation Conference bridges the gap between the IT, QA and software development departments. This program was developed in response to research with your industry peers regarding the greatest challenges facing pharmaceutical professionals involved in IT Infrastructure qualification and application validation. Join Us March 19-22, 2007 in San Diego to learn more at
http://www.iqpc.com/NA-10517-002/1010
Post Approval Summit - April 30 - May 1, Boston, MA
Don�t miss the industry�s premier conference on post-approval research. The Post-Approval Summit at Harvard is a two day conference mapping strategies for demonstrating science, safety, and value through patient registries, phase IV studies, risk management programs, and quality initiatives.
For more information, or to register, go to www.postapproval.org
SBS Annual Meeting - April 15 - 19, Montreal, Canada
This inaugural spring meeting will highlight the significant and exciting recent advances in the cutting-edge science that underpins the discovery and development of new therapeutics. We invite you to join us at the Palais Des Congr�s de Montr�al in April to actively participate in what will surely be one of the most enlightening and memorable SBS conferences to date! www.sbsonline.org
BIO International Convention - May 6 - 9, Boston, MA
Tap into the biotechnology innovations that will benefit all aspects of life on earth at the BIO International Convention at the Boston Convention and Exhibition Center May 6 9, 2007. Join 19,000 global professionals and 1,700 exhibiting companies as they converge for the most important scientific breakthroughs, trends, business opportunities, energy, agriculture, and more. http://www.bio2007.org
|
|
| |
|
|
| FEATURED CONTENT |
HP revitalizes multi-specialty clinic�s IT environment - whitepaper
Physicians� Clinic of Iowa P.C. (PCI) is a multi-site, physician - owned medical group and needed to function as though they were in the same  building. Today � after an infusion of specialized expertise, products and services from HP and HP Partner EnCompass � the group�s technology environment is stronger, faster and more stable than ever. Download Now.
Baptist Healthcare improves security, manageability, with Consolidated Client infrastructure - whitepaper
When Baptist Healthcare System decided to consolidate five business offices across the state into one, the IT department needed to provide a secure, easily manageable fix and chose HP�s Consolidated Client Infrastructure (CCI) solution. Download Now.
How Beverly Enterprises realized a $6 million dollar ROI with new technology including HP Thin Clients.
Beverly Enterprises, Inc�s success is due in part to a focus on continual process improvement � always looking at ways of optimizing  operations and making administrative functions more efficient. With that goal in mind Beverly Enterprises set out to streamline their technology platform. The result is a return-on-investment exceeding six million dollars while creating new technology efficiencies in relationship stability, customer service and reliability through the effective replacement of client and server equipment with solutions that included HP Thin Client. Download Now.
|
|
| Contact the Editors |
We invite your comments and feedback for this edition of eCliniqua. We also welcome proposals from all readers for guest commentaries on topics of broad interest to the e-clinical trials industry to appear in eCliniqua.
|
|
|
