For Clinical Trials, Digital is the Way to Go

March 25th, 2013
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Review any drug’s development history: Clearly, the execution of clinical trials makes up the lion’s share of the timeline. To further complicate matters and extend development timelines, as more drugs are being developed on a global basis, it’s more difficult to keep a clinical trial on target with multiple sites around the world, site qualification visits, and record keeping. In fact, 80% of today’s clinical trials fail to meet one or more milestones. Fortunately, digital technologies – increasingly being adopted by contract research organizations (CROs) and larger biopharmaceutical companies – may offer a way around the limitations of today’s paper-based practices.
 
Recently, Johnson & Johnson, Merck & Co. and Eli Lilly & Co. announced their plans to create a database of global clinical trial sites, which would streamline any participating trial’s significant paperwork requirements. The database would contain site and experimental infrastructure details, and good clinical practice GCP records. The partners will be presenting their progress at the Partnerships in Clinical Trials meeting in April.
 
 
In addition, Acurian, the patient recruitment company, is starting to use social media networks like Facebook to find patients for its trials. For this purpose, social media seems to be catching on, at least in trials that impact a wide range of people. For a recent Phase III study for diabetes, for example, Acurian said that nearly half of its patients were recruited from a digital source, while 39% came from direct mail solicitations and 15% from television advertising. For its part, Lilly has integrated social media into pilot trials for diabetes and head and neck cancer; it claims a cost savings of more than 10% over traditional recruitment methods.
 
Better decision-making; streamlining processes

Sharing information on a real-time basis and making data more easily available allows for better decision-making, streamlining processes from early-stage planning and protocol development through regulatory submission to publication of clinical results. And initial resistance due to fears of violating HIPAA (the Health Insurance Portability and Accountability Act) is starting to weaken, as more companies involved in remote monitoring are using cloud computing, know that they have to be HIPAA compliant to be successful, and add safety and security features to their software services.
 
Digital trials’ increased efficiency doesn’t stop with databases and recruiting, however. For example, at Popper and Co., we have discussed the idea of adding more digital technology to mobile medical carts. The carts can be equipped with cameras, point of care testing kits for glucose, respiratory infections, or other lab tests. With an internet connection, a nurse can see a rash, infection, or adverse effect of a trial drug, image it, and send it to the physician. Imagine the possibilities of sending any kind of trial data from hundreds of these carts at a multisite trial.
 
Is your company seeking to develop a strategy to fill this critical digital gap and to develop more ways to bring drugs and devices to patients faster? We can help you create new strategies, ideas, and inventions to address true unmet needs, and give your company (and its products) a sustainable market advantage. To learn more, please subscribe to our newsletter, follow us on Twitter, or send me an email.


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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.