Change is in the air – Part 9

November 1, 2016November 1, 2016 / John Neal / Leave a comment

This is the ninth installment in the series on changes coming to the Clinical Research John Neal - Head shot Casual - Oct 2015 enterprise that John Neal, CEO of PCRS Network, 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 first presented that prediction, and those that have followed, at the ACRP 2016 Meeting & Expo in Atlanta in April 2016 in a presentation on the “Future of Clinical Research” during the ACRP Executive Summit on Site Strategies.

For background information as to what is driving the changes John predict’s are coming, please see the first article in this series titled “Change is in the air.”

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, in the ACRP Online Community Open Forum. We will make each post here, with the details posted in the ACRP Online Community Open Forum . The ACRP Online Community Open Forum is available to all ACRP Members in good standing.

John’s first eight posts predicted that . . .

Major changes are coming that will be disruptive, displacing many people currently working in the industry
There will be a decrease in the number of single drug studies in the future;
The process by which Sites are selected to conduct studies will be radically transformed, and
- fewer sites will be needed in the future
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
Attention will turn more toward prevention, rather than cures
There will be fewer studies involving large numbers of subjects as attention turns toward rarer diseases
The drug development pipeline will change dramatically, and we will see an increase in Investigator Initiated Studies (IIS)
Fewer study visits will be conducted at research Sites

Crystal Ball With Number 2016

In this ninth post, John predicts . . .

Mobile devices will become a standard means of collecting many study data points.

Visit the ACRP Online Community Open Forum to read the details behind this and my previous predictions in this series.

Change is in the air – Part 7

July 25, 2016July 25, 2016 / John Neal / Leave a comment

This is the seventh 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.”

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.”

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. The ACRP Online Forum is available to all ACRP Members in good standing.

In his first six posts, John predicted that . . .

Major changes are coming that will be disruptive, displacing many people currently working in the industry
There will be a decrease in the number of single drug studies in the future;
The process by which Sites are selected to conduct studies will be radically transformed, and
- fewer sites will be needed in the future
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
Attention will turn more toward prevention, rather than cures
There will be fewer studies involving large numbers of subjects as attention turns toward rarer diseases

Crystal Ball With Number 2016

John’s seventh prediction, which is two-fold, is. . .

The drug development pipeline will change dramatically, and we will see an increase in Investigator Initiated Studies (IIS)

Visit the ACRP Online Community Open Forum to read the details behind John’s predictions in this series.

Change is in the air – Part 6

June 30, 2016 / John Neal / Leave a comment

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.”

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.”

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 at http://community.acrpnet.org/home. The ACRP Online Forum is available to all ACRP Members in good standing.

In his first five posts, John predicted that . . .

Major changes are coming that will be disruptive, displacing many people currently working in the industry
There will be a decrease in the number of single drug studies in the future;
The process by which Sites are selected to conduct studies will be radically transformed, and
- fewer sites will be needed in the future
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
Attention will turn more toward prevention, rather than cures

Crystal Ball With Number 2016

John’s sixth prediction is. . .

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

Visit the ACRP Online Community Open Forum at http://community.acrpnet.org/home to read the details behind John’s predictions in this series.

Change is in the air – Part 5

June 15, 2016August 20, 2016 / John Neal / Leave a comment

This is the fifth 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.”

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.”

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 Community Online Forum. You can find each post here, with the details posted in the ACRP Online Community Open Forum at http://community.acrpnet.org/home. The ACRP Online Forum is available to all ACRP Members in good standing.

Crystal Ball With Number 2016

John’s fifth prediction is. . .

Attention will turn more toward prevention, rather than cures

Visit the ACRP Online Community Open Forum at http://community.acrpnet.org/home to read the details behind these and John’s previous predictions in this series.

Change is in the air – Part 4

June 7, 2016June 7, 2016 / John Neal / Leave a comment

This is the fourth installment in the series on changes coming to the Clinical Research enterprise that John Neal began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.”

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.”

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 Community Online Forum. You can find each post here, with the details posted in the ACRP Online Community Open Forum at http://community.acrpnet.org/home. The ACRP Online Forum is available to all ACRP Members in good standing.

Crystal Ball With Number 2016

John’s fourth prediction is. . .

Fewer Principal Investigators will be needed in the future

Visit the ACRP Online Community Open Forum at http://community.acrpnet.org/home to read the details behind these and John’s previous predictions in this series.

Change is in the air – Part 3

May 20, 2016 / John Neal / Leave a comment

This is the third installment in the series on changes coming to the Clinical Research enterprise that John Neal 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’s second prediction was that “there will be a decrease in the number of single drug studies in the future.” He first presented these predictions, and the others that will follow, at the ACRP 2016 Meeting & Expo in Atlanta in April 2016 in a presentation on the “Future of Clinical Research” during the ACRP Executive Summit on Site Strategies.

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.”

Based on his research, John made eighteen primary predictions at the Summit. Because he based each prediction on numerous interviews, significant background data, and other relevant information, we are presenting them in a series, with one or more predictions, and the relevant support, presented each week in the ACRP Community Online Forum. Each week John will make another post here, with the details posted in the ACRP Online Community Open Forum at http://community.acrpnet.org/home. The ACRP Online Forum is available to all ACRP Members in good standing.

Crystal Ball With Number 2016

John’s third prediction is made up of two parts, which are . . .

The process by which Sites are selected to conduct studies will be radically transformed, and fewer sites will be needed in the future

Visit the ACRP Online Community Open Forum at http://community.acrpnet.org/home to read the details behind these and John’s previous predictions in this series.

Change is in the air – Part 2

May 13, 2016November 1, 2016 / John Neal / Leave a comment

This is the second installment in the series on changes coming to the Clinical Research enterprise that John Neal began in the first article of this series, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.”

This prediction, and the others that will follow, were first presented by John Neal, CEO of PCRS Network, at the ACRP 2016 Meeting & Expo in Atlanta in April 2016 in a presentation on the “Future of Clinical Research” during the ACRP Executive Summit on Site Strategies.

For background information as to what is driving the changes John predicts, please see the first article in this series titled “Change is in the air.”

Based on his research, John made eighteen primary predictions. Because he based each prediction on numerous interviews, significant background data, and other relevant information, we are presenting them in a series, with one or more predictions, and the relevant support, presented each week in the ACRP Community Online Forum. Each week John will make another post here, with the details posted in the ACRP Online Forum at http://community.acrpnet.org/home. The ACRP Online Forum is available to all ACRP Members in good standing.

Crystal Ball With Number 2016

John’s second prediction is . . .

Because sponsors are increasingly seeking efficiencies, and all stakeholders have an interest in minimizing the time required of, and the potential risk to, volunteers who participate in studies, there will be a decrease in the number of single drug studies in the future.

Visit the ACRP Online Community Open Forum at http://community.acrpnet.org/home to read the details behind John’s predictions.

Change is in the Air – Part 1

May 5, 2016November 15, 2016 / John Neal / Leave a comment

Originally published on May 5, 2016. Updated on November 15, 2016 to include details behind the prediction.

You can almost smell it; Change is coming to the Clinical Research enterprise! John Neal - Head shot Casual - Oct 2015

At the ACRP 2016 Meeting & Expo in Atlanta in April 2016, John Neal, CEO of PCRS Network, presented his predictions of the “Future of Clinical Research” during the ACRP Executive Summit on Site
Strategies. Some of his predictions came as a surprise to many in the audience.

John based his predictions on information he 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 he discovered many common themes, shared views, and information pointing to significant trends.

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 he 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 his research, John made eighteen primary predictions. Because each prediction was based on numerous interviews, significant background data, and other relevant information, we are going to break them down into a series.
Crystal Ball With Number 2016

John’s first prediction is that, while major change will occur, changes will not happen quickly. However, when changes do occur, they will be disruptive and many people working in the industry will be displaced.

“There are going to be major changes. The system we have right now is not sustainable.”

Janet Woodcock, MD, Director of CDER

Based on his research, John does not believe there are any revolutionary changes in sight in the near term. However, the changes that occur will upset the status quo as Pharma companies search for ways to stretch their R&D dollars. We are already seeing pressure from payers of all sorts (including Medicare, Medicaid, and other public and private insurers) to reduce the cost of the drugs and devices they cover within their plans.

At some point, pressure from payers will begin to reduce pharma top line growth. When that begins to occur, because R&D spending generally trends at approximately 18% of top line revenues, R&D spending growth will slow. At that point, Pharma will begin in earnest to seek innovative ways to keep the pace of discovery and approvals, but at lower cost on average per approved drug.

Unfortunately for many currently employed in the industry, the changes needed are very likely to be disruptive. According to Jeffrey Kasher, Chairman of the Advisory Board of DrugDev and President of Patients Can’t Wait, LLC, “One of the biggest problems that the industry will face is that the changes that are needed will displace a lot of people. People will hold onto their processes as long as they can.”

Nearly everyone seems to acknowledge that many of the current processes that contribute to study delays and increased costs are antiquated, inefficient, and ineffective, but the will doesn’t exist currently to take dramatic steps to make significant change.

The question is not whether significant changes will occur; but only when, what, and who will be effected?

For a PDF version of this article visit the PCRS Network Newsroom.

On December 7, 2016 John will present “The Future of Clinical Research” again in a webinar offered by ACRP. Visit ACRPnet.org for more information.

The Value of Getting a New Drug to Market Quicker

October 30, 2015November 1, 2016 / John Neal / Leave a comment

As the time and cost to bring a new drug to market continues to increase, pharmaceutical companies, search for new and innovative ways to accelerate the process. In addition to efforts to streamline internal processes at both pharmaceutical companies and CRO’s, some trial Sponsors have turned to the FDA’s Priority Review Voucher (PRV) program to trim months off of the FDA approval timeline.

Established in 2007 by the FDA Amendment Act of 2007, and revised in 2012, under the FDA’s PRV program, the FDA may issue a limited number of vouchers to Sponsors in exchange for the Sponsor dedicating resources to develop drugs for specific indications. Once issued, the vouchers can be resold and used by the acquirer, with some limitations, to accelerate the review of a drug of their choice. The priority review cuts a minimum of four months from the total time the FDA takes to complete their review.

The cost to develop a new drug and get it through FDA approval averages $2.6 billion and takes over a decade.[i]

Using ten years as the average time to market, the cost per day to a Sponsor on a single drug averages over $712,000. Accelerating the time from discovery to approval by four months reduces the cost by over $85 million. However, that does not take into account the opportunity cost of lost revenue for every day a drug is not on the market.

To understand the value to a Sponsor of getting their new drug on the market quicker, consider what companies have recently paid to acquire PRV’s. The purchase of vouchers by Sanofi (May, 2015 for $245 million) and AbbVie (August, 2015 for $350 million)[ii] place a value for each day reduced from the time to market of $2.041 million and $2.97 million, respectively. Having invested in the PRV, one might assume that the potential revenue relative to the investment is expected to exceed the cost of the PRV, further enhancing the value of each day in the market.

Every day spent from discovery through market launch is costly, so time saved throughout that period delivers a significant return to the Sponsor, and helps to save and improve lives by bringing better drugs to market sooner.

[i] “The Biopharmaceutical Research and Development Process”, Pharmaceutical Research and Manufacturers of America®, http://www.phrma.org/graphic/the-biopharmaceutical-research-and-development-process

[ii] Lorenzetti, Laura, “Drug companies are paying huge sums to fast-track FDA approval”, Fortune, October 20, 2015, http://fortune.com/2015/10/20/pharma-fda-vouchers-resale

PCRS Network’s proprietary processes reduce the time required from site identification through to site initiation to less than thirty days. Our mission is to Save and Improve Lives by Accelerating Clinical Research.

Are We There Yet?

May 22, 2015 / John Neal / Leave a comment

While returning home from the MAGI East 2015 Conference, I happened upon an article about time management. The article offered the observation by psychologist Guy Winch that people who are chronically late for meetings typically suffer from “. . . blind spots in the calculation of time. They’ll figure out how long it takes to drive from point A to point B, but they won’t account for the time needed to leave their apartment, get to the parking lot, and get in their call. Small-ticket items add up, causing them to be late.”[i] The article seemed particularly timely.

In more than one session at the conference, either in those I presented or attended, there was discussion about the disparity between how much time is budgeted by a sponsor to complete various protocol required procedures versus the actual time required.

Discussions like those above are necessary and beneficial for maintaining a healthy relationship between Sponsors, CROs, and Investigative Sites. However, talking simply is not enough. So let me offer a solution.

The solution is to conduct a time study. Developed by Frederick Winslow Taylor, the principals and processes for performing a time study are detailed in his book The Principles of Scientific Management.[ii] Applying this to clinical research, a study is done in which those responsible for performing the individual procedures and tasks required by the protocol (including other study documentation such as the lab manual, eCRFs, training materials, Informed Consent Form (ICF), and monitoring plan) perform “mock” procedures, capturing the actual time required under real-world conditions to conduct the series of tasks required to complete the procedures. When done properly, a time study provides a realistic view of the time and effort required to conduct the procedures as they would be performed in an actual clinical research site setting.

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