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.

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.

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.

A recent article (originally appearing in Oncology NEWS International Vol. 18 No. 12) discusses traditional Phase II trials for oncology and whether or not they should be phased out. The author writes that “shortages in funding, manpower, and willing patients have created the proverbial perfect storm in the current clinical trial system” – which puts even more pressure on drug developers to reevaluate traditional Phase II studies.

The article provides two opposing viewpoints: Dr. Richard S. Kaplan, an associate director of the National Cancer Research Network in the UK, argues that Phase II studies have not reliably met the challenges in oncology trials, while Dr. Alberto Sobrero, director of medical oncology at Ospedale San Martino in Genoa, Italy, points out that traditional Phase II trials have led to the development of useful drugs, and are worth keeping as long as certain caveats are taken into consideration.

Regardless of which side you are on, it is clear that steps need to be taken to improve the way Phase II oncology trials are designed and run. Sponsors just can’t afford traditional trials designed in the formative years of oncology, based on needs and assumptions that are no longer relevant.

Trial designs must be evaluated based on current best practices that take into account all available processes and technologies. It’s increasingly important for sponsors and CROs to take a hard look at adaptive design methodologies, randomization, response rate endpoints, trial size, and other factors to help eliminate waste and cut timelines while ensuring the highest level of patient safety.

The Triangle Business Journal reported yesterday that scientists from the BC Cancer Agency have decoded the DNA of metastatic lobular breast cancer, which accounts for about 10 percent of all breast cancer. The exciting breakthrough could lead to the development of new treatments that could help thousands of women who suffer from the disease

According to the director of the agency’s Genome Sciences Centre Marco Marra, advances in DNA sequencing technology are what made the new discovery possible. This study was conducted in just a few weeks, compared to the years it took to decode the first human genome, which clearly shows the rapid progress that is being made in technology and in overall efficiency.

As new breast cancer treatments enter clinical trials, it is absolutely paramount that drug developers make the same commitment to efficiency to get these new treatments to the patients who need them as quickly as possible. The key lies in improving upon currently industry processes and taking advantage of the new technologies that are available to cut timelines and reduce wasted resources.

For example, Health Decisions helped a sponsor get a metastatic breast cancer drug to market nine months early, saving the sponsor $2 million in a study involving 460 patients at 95 sites around the globe. Using the latest trial management technologies and making information available to key stakeholders in real time, the drug got to patients who needed it almost a year early, and at the same time the sponsor saw a $366 million increase in product sales, according to the New York Times.

The New York Times’ recent article on Boeing’s delays getting its new 787 Dreamliner off the ground should hit close to home for many of us in the drug development industry. The Dreamliner (which might be more aptly named the Nightmareliner for Boeing at this point) is more than two years behind schedule and still awaiting its first flight tests, “sorely testing the patience of suppliers and customers and damaging Boeing’s credibility.”

It’s easy to connect Boeing’s situation to one of the largest issues facing drug development organizations – outsourcing.  The Times reports that Boeing “lost control by farming out more work than ever and not keeping close tabs on suppliers.” This lack of coordination and communication with vendors who should be trusted partners is also the fastest way to irreparably damage a drug development program. While outsourcing clinical research can save extensive time and money compared to managing these functions in-house, pharma companies absolutely must have transparency and control of their trial in order to ensure the appropriate progress at each step.  The ability to achieve this simple task is a major shortcoming of our industry.

Transparency and control are the keys to effective trial management, especially when outsourced. Choosing a partner with the capability to provide fast, accurate information is the only way to ensure a trial’s efficient, risk-free progress. In light of current market obstacles, drug developers simply cannot afford the luxury of doing things the “old way” by ignoring advanced tools and processes that enable the delivery of this information. Efficiency is everything, and recognizing outsourced partners that understand this is a requisite stepping stone to achieving that goal.

This week’s New York Times article “For Profit, Industry Seeks Cancer Drugs” is a good reminder of just how complex oncology drug development has become. Cancer drugs are so lucrative that the industry continues to pour billions of dollars into research, but only one new cancer drug has made it to the market this year.

Because of the wide range of diseases and the high risk of cancer clinical trials, it is extremely important that studies are run as efficiently as possible – minimizing risk to patients while cutting costs. More than ever before, drug developers need to be able to adapt to unforeseen changes in their study progress by receiving the relevant information they need to make crucial decisions about their studies on a real-time basis.

Traditional paper-based methods and outdated processes that were “good enough” for other drugs in the past just won’t cut it in such a competitive market. To bring successful cancer drugs to market and take advantage of the tremendous financial opportunity that has presented itself, the industry needs to adapt its thinking and implement the latest tools and technologies.

Shirly S. Wang writes for the WSJ Health Blog: “It’s no secret that the biotech industry has been hurting during the economic downturn as investor dollars slowed to a trickle. As of March, 120 out of 360 publicly traded biotechs had less than six months of cash left, and 10 had filed for bankruptcy since November. The Boston Globe reports this morning that in the past week, two more folded in Massachusetts – one of the hubs of biotech activity.”

To ensure survival in this economy, biotechs need to focus on running their clinical trials more efficiently by making continuous adjustments to studies based on timely, accurate information. You’ve got to be able to adjust on the fly. While traditional drug development processes do not allow for this, it is easily accomplished through a combination of adaptive design and adaptive day-to-day operations. By applying adaptive programs, milestones are met more quickly and the waste of time and expensive resources is dramatically reduced.

Biotechs can empower themselves to accomplish more with limited funds. The technology and processes are available; it’s time to adapt or be left behind.