Poll: What Clinical Drug Development Processes Should Be Opened Up? 3

Open Innovation can be applied in many ways.   And Open Innovation in drug development is rare and unfamiliar.  So, in an attempt to help clarify what we mean by Clinical Open Innovation, we’ll get down to some examples.

We believe there are many clinical development processes that should not be considered competitive and do not directly impact the pharma intellectual property model. By opening them up it can help patients and drug developers.  Our approach is to leverage open and free knowledge generation to do so.

You may ask, what are some processes to think about? Here are a few:

  1. Protocol Design. What if protocols where designed with a patient perspective, such that inclusion/exclusion criteria and scientific end points are understandable and aligned to both research and patient objectives? Might physicians, researchers and patients in the crowd weigh in to assure the very best clinical trial designs?
  2. Monitoring Plans. How could the crowd shape and provide feedback on monitoring plans and oversight, so that data and safety monitoring is clear, transparent and patient focused?
  3. Site Selection. Could the crowd have insight into facility and staff characteristics to help make site selection and trial execution more efficient?
  4. Recruitment. What if clinical trial information could be matched up with patient needs to drive recruitment? What if patients were automatically notified if they met trial inclusion criteria?
  5. Clinical Trial Training. What if clinical trial training credentials where published in public, so that costly redundancy in training for clinical trials were eliminated?

We’re interested to know which of these processes is most valuable to open up.  Please vote for one of the above processes or add one of your own.

Finally, your thoughts and reasons for your votes are valuable to share  –  comments are welcome!

3 comments

  1. ALS is a classic example. WE are either slow progressors, or dead pretty quickly. There is no biomaker. Changes are hard to measure , and it is a darn good probability that study participants will die. The gopod news it is a rare disease. The bad news is that it is a rare disease. Almost impossible get valid statistical data when people drop dead on you

  2. Thanks for sharing – exactly why clinical trials need to be focused on the patient. The traditional notion of large scale patient populations to gather summary statistics in rare disease areas doesn’t work so well…change is required to be more targeted to reduce the time it takes to conduct clinical research. Your last sentence brings it home…

  3. Lots of good ideas here — hard to vote for just one. It would seem like training and recruitment are the most within reach for finding novel external solutions (we’re doing some of that already). But Id love to see some unexpected creativity in the other areas — especially site selection, where we’re in serious need of fresh approaches.

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