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Clinical Trials and the Wisdom of Crowds

Monday, December 22, 2014

The Pulse on Global Trials by Matthew Howes

I am writing this column from Basel, Switzerland, where I have been asked to share my experiences in leading innovation with an audience of 300 Roche employees.

While many thought leaders on innovation point to examples outside of healthcare as sources of inspiration (Apple, Google, Uber), my perspective is that coveting the latest consumer inventions will not make healthcare companies innovative. Innovation is a mindset, and we have to look within our industry, our organizations, our teams and, most importantly, within ourselves to find new sources of value.

Core principles for innovation

Johnson & Johnson underscores the need for research organizations to align dollars to deeds and articulates three core principles for making innovation a success:
1. Innovation requires a discreet investment.
2. Innovation must be tied to specific strategic objectives.
3. Innovators cannot be the same people who are charged with inline business operations.

As 2014 comes to a close, I find myself reflecting on my January 2014 column, in which I called for this to be the year of humanizing clinical trials. The need for collaboration among multiple stakeholders, across multiple regions, continues to grow. There is mounting evidence innovation is happening in the industry. Here are a few examples, along with the lessons each of them brings.

The first example comes from the folks here in Basel. Most R&D functions follow a well-established process for crafting clinical studies, but researchers at Roche are questioning convention and embracing new information in the hopes of improving clinical trial design. For a recent study, trial authors decided to do something quite different. They invited patients into the organization to see if there was anything they could learn from them that would affect the way they designed the study. It turned out there was. Roche authors were so enlightened from their interactions with patients that they actually redesigned the study.

What Roche has done is make a very self-aware decision to move away from “group think” mentality. Rather than relying on the same sources of data, the same assumptions and the same processes, it has taught us that listening to a broader set of stakeholders provides us with valuable information to make better decisions. Rather than piling on ideas and requirements, such as inclusion and exclusion criteria, in trial protocols, Roche has highlighted an opportunity for research organizations to innovate through the process of subtraction: instead of the kitchen sink approach, carefully prioritize and select based on what makes sense in the real world. 

The second example comes from the nonprofit Cancer Research Institute, a leader in the field of immune-oncology whose primary mission has been the funding of basic science to discover new treatments. Earlier this year, CRI launched TheAnswerToCancer.org, a web site for cancer patients and caregivers providing information on cancer immunotherapy. 

The web site—which explains cancer immunotherapy to the lay audience, aggregates stories from the patient community and helps patients find clinical trials—represents a significant expansion into education, an area in which this research organization historically has participated in limited scope. 

“As major advances in cancer immunotherapy begin to alter the landscape of cancer treatment, patients facing a cancer diagnosis need to be aware of immunotherapy as a potential treatment option for them,” said Jill O’Donnell-Tormey, Cancer Research Institute’s CEO. 

The lesson here is that digital interventions can be deployed to expand access to important research studies, and the role of research can be extended to educate the public at large about important initiatives happening in the scientific arena. Clinical research is still behind the curve when it comes to “digitizing” the full clinical experience, from trial recruitment to informed consent to patient retention and, finally, communicated study outcomes. In my January column, I referenced a research project I conducted of investigators around the world on the topic of digital interventions. Most of the respondents indicated they saw the value digital interactions bring to their research, but almost none reported actually using them.  

The third example comes from Johnson & Johnson. With over a dozen new drugs approved in the last 10 years, J&J ranks at the top of the most productive pharma companies and, arguably, is one of the most disruptive. In an effort to remain at the forefront of discovering and developing medicines for unmet medical needs, J&J has created an internal group called Clinical Trial Innovation to develop healthcare solutions to modernize clinical trials, improve data quality and enhance the clinical trial process for both patients and investigators. 

There is a great deal of case evidence supporting the transformation from convention to innovation, beyond these examples. As we move into 2015, let’s hope we see more action and more results in the innovation of clinical trials.  

 

Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health. A leader in digital strategy, Matthew has provided the fuel for digital businesses visited by over 100 million people every month. Email matthew.howes@inventivhealth.com.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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