Uniting a region's medical centers on clinical projects could create a new model for clinical trials
BY CURT SPROUSE AND DAVID SHIPLEJanuary 15, 2005 | Faster, better, cheaper clinical trials have remained elusive despite years of experience and the growing use of technology such as electronic data capture (EDC). The impact of long, expensive clinical trials has been deliberated in industry conferences, drug company boardrooms, and NIH committees. Now the time appears right for a new type of collaboration that could bring radical change.
This new model for clinical trials could transform every aspect of current practice. The concept is simple: A regional consortium of medical schools adopts a shared clinical trials platform, as well as standardized processes, to achieve economies of scale. The consortium offers one-stop shopping for sponsors and the NIH with a single point of contact. With one legal contract, one trial budget, one institutional review board (IRB), and one IT platform, these features could yield dramatic improvements to the speed, quality, and cost of trials.
This model has many advantages. Instead of a study sponsor negotiating with five trial entities, it would negotiate with one. With a standard contract and budget, negotiations could be done in weeks instead of months. With a single, centralized, focused IRB, the IRB could be held to high standards for quick decision turnaround and competitive fees. With recruiting from deep within the local market's primary-care practices, patient accrual rates could rise from 20 percent to 60 percent. The integration of standard operating procedures (SOPs), processes, and technology could help to ensure an optimized platform that delivers real-time, high-quality data to the study sponsors. Common SOPs would allow schools to focus on science, safety, and quality — not process.
Hail the I-R-N
Projected benefits stem from the fact that each IRN would have a common IT environment and simplified processes for budgets, contracts, and IRB approval.
|Patient feasibility analysis
|Contract turnaround (including budget)
|IRB turnaround (1st review)
|Patient accrual success rate
|Patient retention (improved dropout rate)
|Study initiation phase
|Availability of patient visit data
|LPLV* to DB lock (paper)
||n/a (all EDC)
|LPLV to DB lock (electronic)
|* LPLV=last patient, last visit
Traditional competition and politics within academic health centers (AHCs) would seem to make this model almost impossible. In fact, the model is being brought to fruition. Boston Market Strategies (BMSI) has developed the model — the integrated research network (IRN) — and is supporting the five Philadelphia medical institutions that hope to become the first IRN. The economic context explains some of their readiness. Nationally, the financial outlook for many AHCs and community hospitals is bleak.
The real issue, for industry, is whether AHCs will cling to their traditional approach to research, which has tended to be decentralized, fragmented, and unable to capitalize on economies of scale. In addition to the challenges of conducting large and profitable trials, AHCs face competition from sites in Eastern Europe, Asia, India, and South America.
At the root of the costs and inefficiencies is a tendency for most AHCs and hospitals to take a boutique approach. Physicians have typically built their reputations on individual strengths, with scant institutional support. This has limited every institution's knowledge base and interest in expanding clinical research in a broad, systematic manner.
Surprisingly, given their symbiotic relationship, contract research organizations (CROs) and sponsors have conflicting objectives. Sponsors tend to want a customized approach and the flexibility to change the trial at will, while still expecting the efficiencies of the CRO's experience and technology. CROs tend to protect themselves by engaging in time and materials contracts. CROs often generate additional revenue by correctly anticipating the inefficiencies, lack of standards, and delayed enrollment that invariably afflict trials.
The IRN model, in contrast, aligns the needs of academic sites and sponsors. Pharmaceutical companies have assured us that they are willing to pay more for more efficient trials. IRNs will be uniquely equipped to streamline the process in ways that CROs — with no direct access to patients — cannot.
After years of providing clinical trial consulting and oversight, BMSI believed that a new transformational model was needed to create an efficient, sustainable approach to conducting trials. BMSI began focusing on medical school collaboration while consulting with the University of Medicine and Dentistry of New Jersey. We began by building detailed financial models, feasibility models, and operational plans. The details have been refined while working with the IRN of greater Philadelphia. The projected benefits are indeed compelling (see "Great Expectations").
Planning was divided into several major areas. To recruit patients, for example, a proprietary submodel pioneered by Monarch Clinical Strategies was put in place. This submodel features deep penetration in the greater Philadelphia primary-care practices, and offers the ability to mine insurance claims and provide incentives to identify and recruit eligible trial participants. The Monarch approach can pre-screen and identify potential recruits for the most appropriate trials.
A faster budgeting process was deemed necessary. This will require securing cost information by therapeutic area. BMSI will select the primary cost drivers to establish baselines across all institutions. It will also develop a formula based on published cost figures, plus an appropriate markup.
Having a simpler process to get a signed contract is also important. Many sponsors have quietly said they avoid certain medical centers for certain types of trials simply because of the arduous and lengthy process of contract approval. For now, in Philadelphia, medical schools are working to complete a standard contract template with the goal of completing future study negotiations in a fraction of the time currently needed. The contract template will address study coordination, Stark and anti-kickback laws, contract compliance, and other topics.
Finally, the IT architecture in the IRN must be standardized. (In Philadelphia, Oracle Clinical is a leading candidate, but an open vendor selection exercise is planned.) The IT deliverable will contain an integration plan, an implementation plan, a hosting plan, and a risk assessment. The implementation plan will show IT capabilities at launch, and capabilities at 12-, 18-, and 24-month milestones. The architecture will include clinical data management, EDC, adverse event reporting, site management, integration with financial applications, and an integration engine.
Philadelphia has become a starting point. But BMSI has identified five additional areas where IRNs appear most promising. Each consists of a group of geographically adjacent AHCs near major R&D centers. Besides Philadelphia, these areas include New England, San Francisco, San Diego, and Chicago — where a major sponsor has indicated strong interest in helping catalyze an IRN in the Midwest.
Needed: Your Tax Dollars
While the IRN concept makes sense to a number of thought leaders, the creation of other IRNs is by no means certain. Participating institutions must be aware that they need each other to create the collaborative atmosphere and economies of scale that will return clinical prosperity to the United States. Medical institutions tend to be unnecessarily competitive; they should compete only on scientific terms, not "turf." But a close look at the IRN concept should convince most AHCs that no competitive advantage will be lost, and that the benefits outweigh any concerns of working with a campus across town.
At present, unfortunately, AHCs and hospitals do not have the financial means to build the IT infrastructure for IRNs. Government funding is becoming more available but must be channeled effectively to institutions that have an actionable plan to create an IRN. Federal grants facilitating IRNs could drive U.S. economic development by re-routing more pharmaceutical and biotechnology research dollars back into the country. Many state governments could be convinced that IRN funding would allow them to capitalize on life science resources within their borders.
A classic win-win scenario is in the making. With an IRN, sponsors will get faster trials with real-time, high-quality data. Medical schools will get direct increases to their top-line revenue. The movement of trials from medical schools to offshore and other medical settings will be stalled or reversed. And, everyone involved in the IRN concept will have a simpler clinical trial process.
Curt Sprouse, president of Boston Market Strategies, began his career in auditing and process management at Ernst & Young. David Shiple, formerly an analyst with Forrester Research and SAIC, is managing partner at Sigma2 Consulting.
ILLUSTRATION BY MARK GABRENYA