Thursday, October 27, 2016

Exciting Innovation at the Heart of Clinical Trials

On the heels of an exciting Partnerships in Clinical Trials US earlier this month, Lisa Henderson, Editorial Director of Applied Clinical Trials sat down to discuss the current state of the clinical trials industry, the role that innovation will play in the coming years, patient centricity, and strategic partnerships. Take a look at this exclusive interview below.  

How would you rate and/or describe the state of innovation, generally, in clinical today? Where has the industry made progress and where have we fallen short?

Overall, innovation is good. If you keep in mind that the pharma industry in general is viewed as very conservative and risk-averse, then major strides have been made on the clinical trials/clinical operations side. Just in the past four years, the progresses include:

• - Including patients in the paradigm
• - Changing actual clinical trial processes (RBM)
• - Colleagues sharing more at conferences and in articles/blogs on what works and what doesn’t.
• - TransCelerate, pre-competitive alliances

Most change is slow and incremental, and in many cases, is a people issue…a change management issue. And that requires educating employees, engaging them in the change, getting them comfortable with the change and leading them to another vision.
What are you seeing in the way of innovation that excites or inspires? Can you provide some best-in-class examples?

I am a true believer that clinical trials need to be automatically integrated into the potential treatment pathways for an individual…that although they are experimental drugs, they should be a choice that is offered in the doctor’s office or hospital. Some call it Clinical Research as a Care Option, and I think it needs to be more mainstreamed into healthcare.

With that being said, anything that matches patients with trials or changes the integrated healthcare delivery system is exciting. Patient eFinder utilizes the doctor to match potential patients; Molecular Match uses lab data to match the biomarker data to a trial; and many more personalized or targeted technology uses to match patients more quickly and efficiently to trials .

We had a peer-review article on integrated clinical research systems, which could take many forms, but are essentially research arms of large integrated medical systems, run by an experienced Investigator, that has access to the larger Institutions EMR and clinical resources. So again, having clinical trials easily available to an integrated health system would help patients transfer into research more seamlessly. And then big data. For example, IBM Watson to aggregate and analyze data quickly and meaningfully to find patterns in either diagnosing diseases more quickly, predicting safety issues, and getting people in and out of treatment pathways for efficiently.

What’s next? Where do you see the opportunity for greatest advancement in the next few years? What should our audience be paying attention to looking forward?

Biomarkers, genomic information, gene testing…anything leading to personalized / targeted medicine is exciting. But there is an underlying issue that clinical trials will be changing quickly because of these advances in medicine and technology. Then tackling the regulation vs. innovation problem. Are regulations protecting people or making it harder to streamline and innovate? Are companies too slow to change in a world that is changing quickly around them?

Is patient centricity truly at the core of clinical trials?

Not yet. It depends on what you think patient-centricity means. Unless the definition of research and healthcare become more fundamentally entwined in both approach and regulation, it would be impossible to have a completely patient-centric clinical trial.

Are strategic partnerships in clinical trials living up to what they promised?

I believe no. There is little transparency on what has been gained or lost by sponsors or CROs on the road to strategic partnerships. By some measures, the outsourced landscape will need to evolve if the 70% outsourced R&D prediction for 2020 is true. I haven’t got a handle on what the penetration rates will mean, but scaling up and down is difficult. Oversight and management is still difficult and ultimately, the sponsor is still the responsible party for drug development.

But I would really like to some hard statistics on monetary improvement in clinical trials partnerships; or speed to market, or just more metrics in general on the status of partnerships in our industry.

Join the conversation with over 1000 industry leaders at Partnerships in Clinical Trials Europe in Vienna on 16-17 November 2016. Plus get an exclusive 10% off ticket prices by entering the code CQ3011BLOG at the checkout (T&Cs apply). Find out more here.

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