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Change is Coming to Clinical Trials


  • November 7, 2013

  • Jerry Matczak, Community Manager for the Lilly Clinical Open Innovation team provides us with a few key takeaways from this year’s conference:

    1. Pharma’s commitment to collaboration is real.  As evidence, look to TransCelerate BioPharma, Inc.,  a non-profit consortium of 17 pharmaceutical companies who are working together to solve common problems in drug research and development. After only one year of operation, the consortium has set a number of actionable deliverables, and is poised to make a real difference in clinical trial efficiency. The intent of the consortium is to allow the industry to collaborate in common areas like site qualification and training, risk-based monitoring, coordination with regulators and leveraging data standards.  TransCelerate is all about making clinical research more efficient, and improved efficiency means valuable treatments can be delivered to patients more quickly and at a lower cost.

     

    Similarly, the Investigator Databank, sponsored by JannsenMerck and Lilly, has also progressed in its objective to share investigator site data. By pooling important data from investigator sites like training records and site qualification data into a single source, it’s easier to identify the appropriate sites to conduct clinical trials. I was impressed to hear that more than 80 percent of study  sites who have been approached have been willing to opt-in to sharing their information in the data bank.

    2. Steps are being taken to provide patients access to their clinical trial data. Pfizer‘s announcement of its upcoming launch of their Blue Button pilot caused quite a bit of excitement among the conference attendees. The first-of-its-kind initiative will enable patients who have participated in clinical trials to download their individual clinical trial data using the Blue Button standard. Clinical trial participants will be able to  download and use their data as they wish – with caregivers and providers, to add to their personal health records, or in any way of their choosing. Craig Lipset, Pfizer’s Head of Clinical Innovation explained the company’s reason for launching this project by saying, “Sometimes, it’s just the right thing to do.”

    Photo by @medidata

    Photo by @medidata

    3. Clinical trials are being integrated into day-to-day living. Walgreens and Novartis have continued with the pilot program they announced last year in which they integrate certain aspects of clinical research into patients’ regular pharmacy visits. Also, Medidata and Spaulding Clinical have partnered for their first clinical trial, which will use mhealth devices to “evaluate the impact of mobile and cloud-based technology on patient engagement for improved health outcomes in the diabetes community.”  The trial will serve to demonstrate how tracking devices like Fitbit can be combined with Withings health-tracking scale to collect data in any clinical trial setting.

    4. eConsent is happening.  Joe Kim of Shire has shared how the patient experience can be better, audit-ability can be improved and overall efficiency can be gained by capturing clinical trial eConsent on an iPad.  It became evident during the conference that most pharma companies are either piloting an eConsent program or are planning to pilot one.

    One Thing I Wish There Was More of…

    I am struck by the potential value of these efforts and inspired by the industry’s alignment on them.  However, if there’s one thing I would like to see more of at DPharm, it would be a bit more spirited discussion on how the implementation of these efforts lands on stakeholders.  I would have liked to have heard more direct engagement  with those who will be most affected by the changes, like site investigators and, most importantly, patients.

    We did hear a bit of that kind of feedback during the “The Investigator POV: What Disruption is Needed to Achieve Better Relationships” panel discussion.  When the panel of site investigators was asked about what they wish sponsors would change in clinical trials they mentioned streamlined payment, more input into trial design, a better compensation model for screening failures and, overall, a bit of a behavior change between trial sponsor and site investigator.  It was great to hear a number of diverse perspectives and see opportunities there for alignment.  I just wish there was a few more opportunities to hear those perspectives in other sessions.

    Looking Forward

    There is no doubt that the industry is aware of the need for change.  It’s extremely encouraging to see year-to-year progress being made in driving efficiency and improving the patient experience in clinical trials.  DPharm is THE place for the pharma industry to come together to share ideas in clinical trial innovation and forge collaborations.  It’s an unmatched opportunity to build individual relationships and to network.  It’s also  a place to catch a glimpse of the future of clinical trials, and a place where you can see the hope for better treatments turned into actionable ideas to disrupt and innovate in clinical trials.