Change is in the Air: 18 Predictions about the Future of Clinical Trials

This is the first of an ongoing series offering predictions of future changes to the clinical research landscape by John Neal, CPA, BS, CRCP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees.

John Neal, CPA, BS, CRSP, founder and CEO of PCRS Network, LLC

You can almost smell it; Change is coming to the clinical research enterprise!

At the ACRP 2016 Meeting & Expo in Atlanta last month, I presented my predictions of the “Future of Clinical Research” during the ACRP Executive Summit on Site Strategies. Some of my predictions came as a surprise to many in the audience.

I based my predictions on information I gathered during numerous interviews with leaders in the industry, as well as through in depth research into the topic over several months.  Of course, not everyone agreed on every point, but I discovered many common themes, shared views, and information pointing to significant trends.

While major changes will occur, changes will not happen quickly. However, when they do occur, they will be disruptive and many people working in the industry will be displaced.

To understand what changes are likely to occur, it was necessary to delve into what factors are converging that are likely to drive the changes.  The primary drivers I discovered include:

• Pushback from payers. The cost of drugs continues to increase, without commensurate improvements in outcomes.
• From protocol design, to selection of sites, the current system is broken and unsustainable. The cost and time to develop new drugs continues to increase at an alarming rate
• Too much non-core data is being collected (Tufts Center, 2012), with the cost burden shouldered by sites. Protocols have become increasingly more complex.
• New technologies will facilitate better, lower cost data collection.
• Patients are becoming better advocates for themselves. They are demanding better outcomes for their healthcare expenditures.

Based on my research, I made eighteen primary predictions. Because each prediction was based on numerous interviews, significant background data, and other relevant information, I am going to break them down into a series, with one or more predictions, and the relevant support, presented each week.

The first prediction: While major changes will occur, changes will not happen quickly. However, when they do occur, they will be disruptive and many people working in the industry will be displaced.

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