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A Look at the Future of Decentralized Trials: Predictions from Anju Software's EVP of Operations, Mike Keens

Predictions can bring excitement, make you more aware, or produce a sense of call to action. Attendees at Outsourcing Clinical Trials West Coast 2022 in Burlingame, CA had the opportunity to experience one or more of those feelings while hearing from Anju Software’s EVP of Operations, Mike Keens, as he gave an update on his 2021 decentralized trials predictions and looked to the next 24-months of what he believes the DCT landscape will hold.

Speaking to a packed room full of clinical trial leaders, Mike presented a thorough, thought-provoking session titled “DCT Trials: What do we have and where are we going? Structuring your current options for success and predicting the next 24 months”.

Let’s look at a few of his past and current predictions.

Mike’s 2021 Predictions

In June 2021, Mike made four predictions, two of which materialized and two that are still likely, but it’s too early to tell. His spot-on predictions include:

  • Industry interest will result in advancing DCT offerings in China
    • Proof: Increase of home health and CRO providers now working in China to support DCT
  • DCT will almost completely replace patient centricity as an industry focus
    • Proof: Currently, zero references to “patient centricity” in the DIA 2022 Program

Looks like his 2021 predictions are headed in the right direction. We’ll have to keep waiting to see where his ‘too early to tell’ predictions will land.

Mike’s 2022-2023 Predictions

As US COVID infection rates and deaths decrease, the decentralized trials landscape will continue to evolve and be shaped. Looking to the next 24-months, Mike gave his thoughts on what he sees in four key areas: Sponsors & Dollars, Regulatory, Landscape, and Watchful Waiting (longer-term predictions).

Some of his 24-month predictions include:

  • Sponsors & Dollars
    • CRA monitoring budgets will be shifted to off-set the use & cost of technology and home health in DCT Sponsor impatience with overpromise of ROI in technology (and expense) may slow down rate of tech deployment
  • Regulatory
    • Acceleration of DCT adoption based on increased comfort post pandemic, FDA guidance’s, and EMA Comment
    • Telemedicine will be the slowest growing DCT component due to ongoing issues with state laws governing telemedicine (limiting physician comfort with overall adoption)

  • Landscape
    • Pharmacy chain involvement in COVID vaccine efforts will increase competition with “traditional” sites
    • CROs will not acquire any well-known DCT providers, but well-known DCT providers will make acquisitions to shore up existing service gaps

  • Watchful Waiting
    • Inundation of multiple technology platforms will create site friction - adding to site “pain”
    • Expanding adoption of DCT into more infirmed/higher morbidity patients and therapeutic areas will result in a high-profile negative patient outcome/press event and may temporarily slow DCT adoption

I’m sure we will all be watching over the next 24-months to find out if what Mike sees in his crystal ball comes true.

To view Mikes full presentation including his complete list of 2021 and 2022-2023 predictions from OCT West 2022, click here.

Also, stay tuned to hear directly from Mike as he gives further insight into his predictions in a three-part video series.

Anju Software's TrialMaster EDC enables you to manage and scale even the most complex decentralized trials in record time. Contact us today to learn more.

 

 

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