By: Paul Howard
The answer, of course, is learning how to share. In medicine, the question is when, and how, to share data. The hope (and hype) of Big Data is that massive datasets can help researchers and companies slice and dice cancer into smaller, more manageable patient populations where companies can rapidly develop, test, and launch new cancer targeted drugs and diagnostics. The goal, of course, is to generate much better patient outcomes, at much lower cost, than the status quo.
There’s also an increasing demand for companies to develop better metrics for demonstrating their products’ value to patients and the overall health care system. Sharing data (with appropriate protections for intellectual property) can help companies, researchers, and oncologists refine their understanding of cancer’s many molecular pathways—and fine-tune the algorithms needed identify key vulnerabilities, while matching drugs to the patients most likely to respond (essential to improving the “value proposition” for patients, payers, and innovators).
It’s hard to overstate how devious and unpredictable cancer can be. Cancer cells have much in common with viruses and bacteria, at least in terms of their ability to evolve to adapt to drug treatment. Like HIV/AIDS, successful cancer therapies that cure or keep the disease in check indefinitely are likely to require precise cocktail therapies that overwhelm cancer’s ability to mutate and survive.
Researchers know this. The problem is that no single institution, or company, has all the pieces required to build the “knowledge network” needed to defeat cancer in real time. Winning the war on cancer will take unprecedented collaboration: across hospitals, drug companies, regulators and insurers, all of whom possess key parts of the data puzzle.
This is where projects like ASCO’s CancerLinq, NIH’s Biomarker Consortium, and Project Data Sphere come in. Project Data Sphere is the most recent, and in some ways, most interesting of the collaborations because it’s leveraging clinical trial data from some of the industry’s leading companies—normally fierce competitors—to build a research platform that will be, for most intents and purposes, open to all comers (anyone with a plausible research question which might lead to a better understanding of cancer).
A Golden Era Of Cancer Drug Development—But Too Many Opportunities and Lives Are Still Lost
Wait, you might ask, aren’t we already in the midst of a golden era of cancer drug development? It certainly looks like it.
Every week seems to bring announcements of promising new oncology targets, better drugs in the pipeline, and better patient outcomes (including less toxicity). The FDA’s Oncology Division, inside the Center for Drug Evaluation and Research (CDER), has a good reputation among sponsors as being more flexible and innovative than some other divisions. Pricing for oncology products is at a premium, and new drugs routinely command six figures—attracting yet more investment and research.
All this is reflected in drug companies’ pipelines. PhRMA estimates that out of the more than 900 biologic medicines in development in 2013, a staggering 37 percent (the largest category by far) were for cancer or related conditions. And about 30% of all drugs in development and projects in 2011 were focused on oncology. From 2005-2012, close to 20% of all FDA approved drugs were for oncology indications. Today, cancer patients have greater hope than ever of living longer, better lives after a cancer diagnosis—and even, in a few cases, finding an outright cure.
But don’t crack the champagne quite yet. Oncology drug development remains plagued by lower success rates than other indications (although that seems to be changing, thanks to biomarker targeted trials). Meanwhile, those vaunted new technologies (genomics, proteomics, etc.) being brought to bear on oncology come with their own added costs. Only a sliver (3-5%), moreover, of all U.S. patients participate in clinical trials, with far too many oncology trials (about 20%) failing to accrue enough patients to reach completion—for reasons that have nothing to do with efficacy or adverse events. That’s a lot of valuable time and resources wasted.
In short, oncology drug development is, in many ways, getting more expensive and challenging, even as the underlying technology gets better.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.