Change is in the Air: Part VI

This is the sixth installment in the series on changes coming to the clinical research enterprise that John Neal, CEO of PCRS Network, LLC,  began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.”

John_Neal

John Neal, CEO of PCRS Network

Prediction 6: There will be fewer studies involving large numbers of subjects as attention turns toward rarer diseases

As I noted in the fifth post of this series, there are now effective treatments for many of the diseases that historically plagued large numbers of people. But there remain many diseases, including genetic disorders and orphan indications, for which there are no effective treatments. Even oncology studies will be focused on more specialized cancers.

When I asked Dr. John Hubbard, President and CEO of BioClinica, what the focus will be for studies in the future he stated “Certainly there will be a focus on oncology, but companies are looking at other therapeutic areas like neuro science and Alzheimer’s diseases, and diseases where there may be a strong genetic link.”

So, why now?

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About this Series

John presented 18 predictions about the future of clinical research in a presentation at the ACRP Executive Summit on Site Strategies during the ACRP 2016 Meeting & Expo in Atlanta.

For background information as to what is driving the changes John predicts are coming, please see the first article in this series titled “Change is in the Air: 18 Predictions about the Future of Clinical Trials.”

Based on his research, John made eighteen primary predictions at the Summit. Because he based each prediction on numerous interviews, significant background data compiled in researching the topic, and other relevant information, we are presenting them in a series, with one or more predictions incorporated into each post, presented approximately weekly in the ACRP Online Community Open Forum.  You can find each post here, with the details posted in the ACRP Online Community Open Forum.  The ACRP Online Forum is available to all ACRP Members.

In his first five posts, John predicted that:

  1. Major changes are coming that will be disruptive, displacing many people currently working in the industry (read);
  2. There will be a decrease in the number of single drug studies in the future (read);
  3. The process by which Sites are selected to conduct studies will be radically transformed, and
    • fewer sites will be needed in the future (read);
  4. Fewer Principal Investigators will be needed in the future, and
    • Sponsors will slowly begin increasing the number of subjects each site is allowed to enroll (read);
  5. Attention will turn more toward prevention, rather than cures (read).

2 thoughts on “Change is in the Air: Part VI

  1. Pingback: Prediction: Investigator-Initiated Studies (IIS) to Increase as Drug Development Pipeline Dramatically Changes - ACRP

  2. Pingback: Prediction: Investigator-Initiated Studies (IIS) to Increase as Drug Development Pipeline Dramatically Changes | ACRP Blog

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