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Author

Dan McDonald

Dan McDonald

Dan is vice president, business development, Imperial Clinical Research Services. Dan is a seasoned executive who specializes in identifying income opportunities, building strategic partnerships, and managing contract negotiations. A prolific and popular thought leader, Dan has presented at numerous industry conferences and events, has conducted workshops and sessions on patient engagement, and has been published numerous times in industry books, trade magazines, and journals.

    Ancillary Trial Supplies and EquipmentBusiness InsightsLife-Science EventsPatient Recruitment and Retention

    Bridging Research and Health Care: If We Don’t Do it, Someone Else Will

    by Dan McDonald May 21, 2018
    written by Dan McDonald

    I recently had the honor and privilege of representing Imperial at the inaugural Bridging Clinical Research and Clinical Health Care conference in National Harbor, Maryland. It was interesting and worthwhile.

    The conference brought together heavy hitters and important voices, including the FDA and advocates from the patient community. Participants took on a challenging subject: How do we create a bridge between the incredibly important work that goes on in clinical research and the commercial health care world?

    How do we create a bridge between the incredibly important work that goes on in clinical research and the commercial health care world?”

    Everyone knows where to get over-the-counter or prescription drugs, but very few people know where they come from. Everyone knows a physician, but few know a researcher or a clinical investigator. What if we could find a way to increase the three percent of patients and three percent of physicians who participate in clinical research annually to five percent or even 15 percent? What kind of impact would that have on improvements in health globally?

    It’s not a new question, and for those of us who have been in the industry for 20+ years, it can be a worn-out one. Not because there isn’t passion to improve, but because the task seems so large, and individual and corporate interests are much too diverse. As such, the cycle continues and it never seems to improve.

    Progress often happens incrementally, especially in research. We have been making progress and word is getting out with such important efforts as:

    • The “Bridging” conference mentioned above
    • The launch of the GoBoldy campaign by the American biopharmaceutical industry and their compelling and widely advertised PSAs
    • ACRP’s efforts to raise awareness about the upcoming International Clinical Trials Day
    • Groups like CISCRP and their Aware for All initiative

    There is arguably more effort behind this cause today, more than any time in the history of the industry, and that is to be applauded. Whether this will push the three percent up to five percent or beyond is hard to tell, but it is refreshing to see this focus after so long.

    However, risks remain. For every good story brought forward by the industry, there is a negative one that surfaces in the news. 60 Minutes just ran a story about price gouging and the impact it’s having on towns across the U.S. I have not included the link here. Not because the story isn’t true, but frankly, there are already enough vehicles out there for spreading such messages. Unfortunately, the daily good news about advancements in research is harder to find.

    There are other risks, too. Kent Thoelke, EVP and CSO at PRA Health Sciences, was part of a fascinating CRO panel at the bridging conference which talked about some of the challenges we face in bringing the benefits of clinical research to the consumer. Thoelke sounded a stark warning regarding the ever-growing presence of technology and retail companies in health care. He contrasted those organizations with the notoriously slow and stodgy way that clinical research embraces technology. His warning, if I can accurately paraphrase, was this: less than 30 percent of millennials have a primary care physician. Most attend minute clinics when they have a health issue, or use telehealth and internet-based options. They don’t fit our brick-and-mortar-based system.

    Thoelke went on to say that technology companies increasingly own the relationship with the consumer. They are finding new and efficient ways of driving change and the consumer is getting accustomed to that. Will these organizations and the environments they’ve created bypass us as we continue our slow and steady path?

    One way we can create a bridge between clinical research and clinical health care is to harness the tremendous wealth, intellect, and science war chest that our industry currently possesses. We can drive that into creating technologies and efficiencies to cut through the bureaucratic red-tape and regulation-laden landscape to affect real change. If we can’t figure out how to build it, we have to buy it while we still can. Often the most successful companies mix strong business philosophies and operating acumen with purchased ideas, solutions, and market share in order to advance the business.

    We need to start modeling the greater industry this way or run the risk of being left behind. If Amazon and Tesla can build rocket ships to carry us into space, I’m pretty sure they can tackle the issue of drug development.

    We all have a part to play in driving us forward.

    Here at Imperial, we are embracing bridging, but in a slightly different context. We have deliberately and methodically built our business to support areas that are critical to the success of a study. These areas, which fall outside the core expertise of sponsors and CROs, can be the most disruptive to studies. These examples come to mind: filling challenging supply chain gaps. Identifying, engaging, enrolling, and retaining study subjects. Translating information to make sure that it is accurate, compelling, and useful to end-users across the globe. Lastly, we care about the customers we service and the study subjects we all serve. If we all do our part, we can create a strong bridge between clinical research and clinical health care. If we don’t, someone else surely will.

    May 21, 2018 0 comment
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  • Business InsightsLife-Science Events

    3 Ways to Outsmart the Big Dogs as You Move into the Clinic

    by Dan McDonald February 23, 2018
    by Dan McDonald February 23, 2018

    You’ve done all the background work. You’ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You’ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company – entering the clinic.…

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  • Life-Science EventsPatient Recruitment and Retention

    The Role of Patient Engagement in the Transition from Lab to Clinic

    by Dan McDonald January 17, 2018
    by Dan McDonald January 17, 2018

    The drug discovery and development process is a complex and challenging landscape, especially for the majority of small biopharmaceutical and medical device companies. It’s truly a survival of the fittest environment, fraught with potential pitfalls and company killers. For every Kite Pharma (acquired by Gilead…

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  • Patient Recruitment and Retention

    Do We Have a Performance Measurement Problem in Clinical Trial Patient Recruitment?

    by Dan McDonald March 17, 2017
    by Dan McDonald March 17, 2017

    It’s fairly well accepted in today’s clinical research environment that proactive strategies for driving enrollment in clinical trials are part of the complicated equation of success. According to a 2016 survey of study sponsors conducted by Imperial, nearly 55 percent of sponsors develop formal recruitment…

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  • Patient Recruitment and Retention

    The Facts on Patient Enrollment Delays

    by Dan McDonald March 2, 2017
    by Dan McDonald March 2, 2017

    The Undeniable Truth Everyone is aware that patient enrollment is an issue. In a recent report from Tufts Center for the Study of Drug Development on 150 global trials, it was discovered that 9 out of 10 studies eventually achieved enrollment goals, but that it…

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  • Business InsightsPatient Recruitment and Retention

    Behind the Scenes at Trial Sponsor Companies Part 2: Enrollment Plans, Strategies, and Metrics

    by Dan McDonald October 19, 2016
    by Dan McDonald October 19, 2016

    In my last blog post, I wrote about findings from a first-of-its kind survey conducted by Imperial. We surveyed managers and directors of clinical operations, project managers, lead/senior CRAs, and patient recruitment specialists from sponsor companies, and ended up with a behind the scenes look…

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  • Business InsightsPatient Recruitment and Retention

    Behind the Scenes at Trial Sponsor Companies Part 1: The Atmosphere in Clinical Operations

    by Dan McDonald October 19, 2016
    by Dan McDonald October 19, 2016

    Patient recruitment and enrollment are key contributors to delays in completion of clinical research trials. How do sponsors tackle their patient recruitment challenges? What priority are these challenges given internally? Imperial wanted to find out. We surveyed 160 line managers in clinical operations at sponsor…

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  • Patient Recruitment and Retention

    Getting Patient Recruitment Right from the Start: Planning Your Protocol

    by Dan McDonald September 9, 2016
    by Dan McDonald September 9, 2016

    This is the first of two posts containing excerpts from our forthcoming ebook on proactive recruitment planning.  CenterWatch data tells us that in clinical trials, too many patients who volunteer don’t qualify, or they leave the study after they are enrolled. 69% fail prescreening 58% decline…

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  • Patient Recruitment and Retention

    7 Reasons for Patient Enrollment Challenges

    by Dan McDonald November 24, 2015
    by Dan McDonald November 24, 2015

    In my last post I covered facts on enrollment delays from my latest ebook.  In this post I’m going to cover the seven most common reasons for these enrollment challenges. There are a number of reasons that sites may struggle or fail to enroll patients –…

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  • Life-Science EventsPatient Recruitment and Retention

    Talking Recruitment with Small/Mid BioPharm CMOs at CMO Summit – West

    by Dan McDonald November 12, 2015
    by Dan McDonald November 12, 2015

    I had the honor of attending and presenting at the CMO Summit – West earlier this week in Burlingame, CA. Attended by 75-80 industry executives – primarily consisting of Chief Medical Officers, heads of clinical development and leaders from the financial community – the CMO…

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