Dr. Michael Rosenberg dissects the efficiency problems in clinical trials, and some possible solutions for the future of drug research. Check out his video discussing the Crisis of Efficiency.
For more information on Health Decisions and adaptive clinical development, visit our website at http://www.healthdec.com.
By Michael Rosenberg, MD, MPH, Health Decisions President and CEO
In a recent ClinPage newsletter, “7 Reasons for Big CROs to Worry,” Mark Uehling discusses the real challenges ahead for large CROs like Kendle, whose revenue dropped 19% from 2008 to 2009. The article brings up a few key issues that the largest CROs need to address if they want to stay competitive as the industry changes. These issues also serve as compelling reasons to partner with a CRO that has seen this coming and adapted to shifting market conditions and sponsor needs to avoid these pitfalls.
People
Many sponsors get frustrated when they are introduced to one team before they sign a contract, and then end up working with a completely different, lower-level team when the trial begins. Uehling says, “…large CROs bring the equivalent of Leonardo DiCaprio to a bid defense. Mr. DiCaprio amazes everyone. He is dazzling. But when the trial actually begins, Mr. DiCaprio is … um … unavailable.” All CROs should give sponsors the opportunity to meet and get fully comfortable with the team that will actually be managing their investment, and are responsible for the success of their programs.
Also, it’s no secret that large CROs have high employee turnover. As Uehling says, “One of the reasons that sponsors are frustrated with CROs is that they never encounter the same person. Small CROs can nurture employees and retain them.”
Sponsors deserve consistency of personnel, and small to mid-size CROs can provide it when large CROs cannot. In addition, CROs that employ more advanced techniques, like adaptive monitoring, can dramatically reduce “arduous travel” without reducing overall data quality, keeping CRAs happy and keeping them on the study for the long haul.
Technology
Most large CROs have not fully invested in technology, and therefore must partner with technology vendors, giving away a lot of their control of the study. Sponsors should partner with a CRO with an integrated, proprietary technology platform that integrates clinical trial and data management with a range of data collection options — from paper to Web EDC to digital pen — depending on sponsor needs. As many large CROs struggle to support a large number of sponsor-selected technology systems, the CROs that can seamlessly adapt to sponsor technology and processes and integrate their own systems, while maximizing operational efficiency, will be the most successful.
Big CROs operate like big pharma — dinosaurs who seem unable to change with the times. And sponsors who want inconsistent project teams and outdated processes and technology can continue to work with them.
But sponsors who want a true partner that can maximize the value of their investment should look to the CROs that are actually moving the industry forward.
Recently, Health Decisions CEO Michael Rosenberg had an opportunity to sit down with Dr. Adam Goldstein and Dr. Adam Zolotor on Here’s to Your Health, UNC Family Medicine’s radio talk show. The discussion that ensued is an eye-opening overview of pharma’s potential to produce quality treatments faster and more efficiently. To realize this potential, explained Rosenberg, all the industry has to do is disrupt the inertia that’s driven the market in years past, but which is now hindering its ability to evolve.
The solution seems obvious, but is in many ways profound: “a systematic way of figuring out what’s working and what’s not” in clinical programs. Dr. Rosenberg explains how this approach can apply not only to the much-talked-about topic of adaptive design, but also to the basic management operations that are universal to every trial.
For example, the ability to measure the performance of every investigator site and determine whether its over- or underachievement is a result of recruitment sources, staff skills, training issues, or one of any number of variables, makes optimization a simple matter. If you can see what’s happening and why–as it’s taking place–you can eliminate the maladaptive qualities of “bad sites” and replace them with the habits of more functional ones.
You can hear more about how this approach applies to enrollment and other bottlenecks by listening to the interview here.
The whole country has its ear turned toward Washington, eagerly listening for how we’ll be affected by the myriad proposed disruptions to healthcare policy. Notwithstanding the legitimate concerns of patients for access to affordable drugs, of taxpayers for funding big government-managed programs, and of employers for balancing the added costs of insuring staff, life science companies will face a whole different set of challenges, regardless of how the cards fall in the Senate and House.
Inevitably, the industry as a whole – from pharma to biotech to device – will be even more hamstrung than in months prior by pressure to perform at lower costs while still making medical breakthroughs. It’s the age-old battle between innovation vs. efficiency, fought by nearly every company in every industry in the history of business. But never on such a grand scale with such heavy-hitting global repercussions at stake.
So is there a way for drug and device makers to come out on top? To squeeze efficiency from every single minute and every single dime while still innovating the next big life-saving breakthrough? If want to keep the industry from crumbling—and dragging worldwide health standards down with it—we have no choice but to find a way.
Luckily, advancements in clinical research are charging ahead at a mile a minute—becoming more available and more widely accepted every day. Considering the proportionally massive amount of R&D resources swallowed by clinical trials, this could be the ticket to pharma’s survival. After twenty years of designing and conducting trials, nothing is more clear to us than the necessity of efficiently fostering innovation WHILE innovating new ways to operate more efficiently. This means that, for a drug developer to successfully compete in this tumultuous market, it’s got to break up with the old ways of managing clinical trials. Replace rigid, pre-determined protocols with flexible yet bullet-proof processes that allow for constant gains in efficiency. With this mantra, our sponsors finish trials faster and enter the market sooner – freeing up amazing amounts of resources for hunting that next breakthrough product.
With an eye-catching exhibit, powerful technology demos, a high-profile speaking opportunity, and memorable marketing outside the convention center, Health Decisions made a big impact at DIA 1010 in Washington, DC
The Washington D.C. Convention Center Exhibition Hall was buzzing as the doors opened Monday morning for the Drug Information Association’s 46th Annual Meeting. Although attendance was down a bit (as with most trade shows in the past few years), a wide range of sponsors, CROs, software suppliers, and other vendors set up shop to show off their latest tools and technologies for running clinical programs.
As show attendees walked up to the convention center, they couldn’t miss the mock protestors stationed at the crosswalks with large picket signs reading “Demand More” and “CROs Must Do Better,” outraged at the fact that clinical trials only enroll on schedule 10% of the time (based on 2009 CenterWatch surveys). The protesters handed out flyers and stickers, letting attendees know that they should visit Health Decisions’ Booth (#929) if they want to talk to a CRO that meets or exceeds enrollment goals for 83% of studies.
Inside the Exhibition Hall, the Health Decisions red stood out in a sea of blues, greens, and purples, and large “10%” banners tied in the booth with the protest attendees just saw outside. Representatives from the company’s Clinical Affairs and Business Development teams were on hand to talk to potential sponsors about issues they were facing while running their clinical trials, using a demo of the Health Decisions technology platform and reporting tools to show them how the company can impact their bottom line through time and cost savings.
Health Decisions’ new demo revealed a comprehensive dashboard that reports key site management metrics in real time. This capability enables personnel to focus on proactive management, anticipating and avoiding site errors that range from queries to patients lost to follow up. Included are detailed metrics on enrollment strategies, error rates, sharing of best and worst practices, and other key performance indicators.
On Monday afternoon, more than 100 people gathered to hear Health Decisions CEO Michael Rosenberg, MD, MPH, present a panel session entitled “Centralized Monitoring: When Does It Make Sense?” Dr. Rosenberg described how fast access to metrics, flexible processes, and automated technology enable study monitors to increase efficiency by making mid-course adjustments to study operations based on current information. This enables decision-makers to optimize site activity on a rolling and continuous basis for dramatic aggregate time and cost savings. For more information about the session, read the press release. Throughout the week, Dr. Rosenberg also held meetings with representatives from industry journals and the trade press, and promoted his new book, The Agile Approach to Adaptive Research, released by Wiley & Sons in January.
Health Decisions recently signed an agreement to utilize OmniComm’s TrialMaster eClinical products platform to drive operational efficiences and provide a wider range of EDC options to sponsors.
OmniComm’s EDC platform helps us continue to raise standards of efficiency, quality, and success in the development of pharmaceutical products and medical devices. Combined with our Agile Clinical Development methodology, the new system will help us continue to significantly accelerate timelines, optimize resource allocation, improve data quality, and maximize both the return on investment and net present value of our sponsors’ clinical projects.
We chose OmniComm for its advanced technology, ability to deliver cost-effective operational efficiencies, and its interoperability with our proprietary processes and software including Adaptive Monitoring, Adaptive Randomization, and our comprehensive CTMS. Flexible data collection and workflow capabilities and total cost of ownership were also key considerations in our decision to deploy the TrialMaster solution.
For more information, read the press release on Yahoo! Finance.
This month the FDA released a new draft guidance on adaptive designs in clinical trials. The document provides advice on best practices for planning and conducting these studies, and outlines ways to facilitate an efficient FDA review.
Until now, many sponsors have been wary of adaptive designs because of a lack of FDA guidelines, and concerns about regulatory approval. But this positive step by the FDA should hopefully begin to change that, showing that the agency recognizes adaptive designs as a viable option, and is beginning to encourage them.
This is welcome news to drug developers who have spent years fine-tuning adaptive techniques and designing and running adaptive studies. These methods can provide a large number of benefits to sponsors and study subjects by increasing the speed, accuracy, and safety of clinical trials.
The FDA writes that compared to non-adaptive studies, adaptive design approaches may lead to a study that:
The 50-page document gives advice on topics such as:
Partner with a CRO with adaptive experience from day one
Regulators are beginning to get their heads wrapped around adaptive research, but will continue to look to the drug developers to prove their case for using novel approaches. Even though the FDA has finally put forth draft guidance, it is still necessary to partner with a CRO that has experience working with the agency from the earliest stages of protocol design to ensure a high level of comfort with the adaptive techniques being recommended.
You can download the full PDF version of the Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics at this link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf
We’d like to extend our congratulations to Dr. Michael Rosenberg, our CEO and resident author, on the release of his new book: The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development. Released last Friday under John Wiley & Sons Publishers, the book is being hailed as the drug development industry’s first complete guide to adaptive clinical research and “an essential evolutionary step toward improving drug research and development.”
As a company devoted to raising the standards of efficiency and quality in clinical trials, we’re proud that the innovations we’ve developed over the last twenty years have formed the basis for this important new resource. The Agile Approach presents a complete exploration of the tenets behind our Agile Clinical Development platform (You can find out more about Agile here). It expands the application of adaptive methodology beyond trial design to include operational components, supporting infrastructure, and the ways in which these elements interact to diffuse the most costly trouble areas.
We also invite you to read more about The Agile Approach on the publisher’s website, and as always, your thoughts and feedback are welcome.
In a recent Wall Street Journal column, Thomas Friedman presents an interesting take on the Chinese economy, which brings to mind an interesting parallel with the drug development industry. He describes two counterparts: “Command China,” which consists of the Communist Party and traditional, state-owned enterprises, and “Network China,” which is a highly entrepreneurial sector that participates in diverse, high-value flows of business knowledge.
Friedman argues that these economies are at odds, quoting noted business writer John Hagle, who writes, “we are shifting from a world where the key source of strategic advantage was in protecting and extracting value from a given set of knowledge stocks…into a world in which the focus of value creation is effective participation in knowledge flows, which are constantly being renewed.”
While a purely free-flowing exchange of information in our industry would probably not be feasible due to regulatory restrictions, the knowledge flow concept can still be applied to how information is exchanged within a specific study or program, and where pharma, biotech, and device companies look for innovation.
At the study level, a continuous flow of dynamic information made possible by advanced research methods and new technologies gives sponsors the ability to receive real-time information and act on it as quickly as possible. This is contrary to the traditional research model, where information is collected and analyzed periodically, or at the end of the study, and then decisions are made.
At the organizational level, many large companies don’t methodically search for innovation outside their own walls. To be successful, they need to look to specialized consultants and service providers who have the experience and expertise implementing new processes and technologies.
As Friedman points out: “The future belongs to those who promote richer and ever more diverse knowledge flows and develop the institutions and practices required to harness them.” As we continue to see skyrocketing costs, drug developers that embrace new ways of running trials and sharing information have the greatest chance of success.
After a year of legislation and congressional speculation insulating medical device makers from lawsuits and economic penalties, it looks as though the FDA will replace its favor with the same scrutinizing eye it keeps on drug developers.
JAMA wound down 2009 with a fairly excoriating report on the FDA’s premarket approval criteria for high-risk cardio devices, concluding that these devices are often approved despite their basis “on studies that lack adequate strength and may be prone to bias.” Though the FDA insists that JAMA’s report doesn’t depict the whole picture, its own report concedes weakness in several aspects of its approval standards for devices. The New York Times reports that the FDA is developing guidelines to toughen these standards, requiring more thorough data on goals, subjects, and outcomes.
For many device makers, this new layer of complex FDA regulations could cause major problems. The learning curve for designing a trial protocol, managing data, and submitting findings that meet these more rigid standards can be steep. Engaging the right CRO should be at the top of the to-do list for these device developers.
But identifying the right research partner will require device makers to look beyond the FDA’s new standards for data quality. As a side effect, more complex regulations will inevitably result in intensified competition. Just like in the market for highly regulated drugs, success for device makers will be driven by the race for faster, more efficient development solutions that are bulletproof enough to meet premarket approval requirements.