I was diagnosed with invasive ductal carcinoma in May of 2014. Fortunately, my cancer was early stage, I didn’t require aggressive chemo, and I’m nearing my five-year remission milestone.
Despite having worked at the National Institutes of Health (NIH) on clinical trials and in pharma for much of my career, I didn’t appreciate all sides of the drug development process until I was a patient relying on it for my life. Several things became decidedly uncomfortable as I approached the process from a new perspective.
Our cultural tendency of making pharma the boogieman obscures the reality of the 15.5 million cancer survivors in the US (2016 data) whose lives were saved, like mine, by the half a million Americans who make up the U.S. pharmaceutical industry, along with members of the U.S. healthcare community at large. But even with great success, the battle is not over.
While I’m grateful for thousands of unnamed professionals who moved innovations forward to save people like me, the experience made me acutely aware of the estimated 26,000 annually who died waiting for a drug that was in the pipeline to treat their specific form of cancer. With cancer being only one such devastating disease, that means hundreds of thousands or more will die waiting for the drug they desperately need.
I developed a sense of outrage at the convoluted, friction-filled, multi-year drug development process. Frankly we all should. It costs U.S. $ 2.6 billion to bring a drug to market and between 10 years to as many as 30 years—while patients are dying. Scientific rigor is critical in drug development, yet why a decade to apply said rigor so that it can help?
Removing the friction: the I-word we forget
We’ve got to get beyond the talk and the Tweets and get moving with real and lasting change that gets drugs to market faster. As a tech company leader who counsels life science firms, I often see disparate workstreams require better handling, processing, and sharing of data to optimize process, quality, and time—and resistance to change in teams that ostensibly advocate for innovation.
The drug development process is missing the iterative development that tech leaders have adopted years ago. By tackling small changes quickly, and often in parallel, reams can react and process through unexpected surprises in an agile manner.
We need to stop looking for sources of massive transformation, and apply innovation from tech companies at focused, incremental points that don’t reinvent the wheel—just offer a better, faster, and in most cases, cheaper approach to traditional methods with very few, if any, tradeoffs. Here’s are four examples.
- Protocol development—Agile process changes in drug development, such as adaptive trials used in the development of blockbuster treatments like pembrolizumab (Keytruda®; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co) have helped bring medications to market faster by building iterative learning and planned course corrections into the process.
- Digital monitoring, especially remotely—The U.S. Food and Drug Administration (FDA) is providing guidance to manufacturers with the Digital Health Innovation Action Plan (DHIAP). The plan offers direction on the medical software requirements of the 21st Century Cures legislation. Its recent grant awards demonstrate the FDA’s commitment to harnessing the power of digital solutions to improve the patient experience in health monitoring and the quality of data being captured on patients.
- Direct-to-Patient (DTP), virtual clinical Trials, and cyber studies—Traditional clinical trials are fraught with friction, patient inconvenience, discomfort, and frustration. Smart phones, mobile nurses, telemedicine, e-consent, and apps are simplifying onerous process for patients, making it easy for the 80% of ill patients who wish to participate in clinical trials—70% of whom live over two hours away from a site—to do so. Companies like Science 37 have harnessed remote tools to bring these patients into the process, making participation easier while enlarging the sample size by removing barriers to a fixed-site trials. The trials for Sanofi’s 3-G capable, wireless glucose meter demonstrates the possibilities for virtual clinical trials.
- Solutions SupportiBg DTP clinical trials—For example, QuickSTAT allows DTPs to safely transport patient samples to investigators when patients participate remotely. Telehealth options support similar efforts by removing barriers to patient participation from electronic informed consent to eVisits. Companies like AMC Health are offering platforms designed to integrate bi-directional video, biometric sensors, subjective data capture, and text capabilities that offer a rich clinical trial experience and data set, while making it easier for all stakeholders to participate. 
These new offerings don’t reinvent the wheel—each offers a better, faster, and in most cases, cheaper approach to traditional methods with very few, if any, tradeoffs.
Beyond FDA compassionate use exemptions and related programs, physicians and technologists alike need to develop a collective sense of outrage at the length of the US drug development process so that we fix it – soon – now. It’s the least we can do so that those awaiting drugs in the pipeline to treat their cancer don’t wait as long – and so everyone can deliver upon the higher purpose of their professions.
 Hirsch IB, Martinez J, Dorsey ER, Finken G, Fleming A, Gropp C, Home P, Kaufer DI, Papapetropoulos S. Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action. Clin Ther. 2017 May;39(5):1064-1076. doi: 10.1016/j.clinthera.2017.03.018. Epub 2017 Apr 14.
Last Editorial Review: November 20, 2018
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