The Shifting Burden of Technology

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David Morin, MD, RPh, FACP, CPI, director of research for Holston Medical Group

The phrase “technology solution” begs the question: A solution for whom?

A 2016 global survey of 252 sites by CenterWatch and ACRP explored the impact of technology and advanced the discussion in the May issue of CenterWatch Monthly. The response from a majority of sites discussing their experiences with technology was not flattering. Site concerns ranged from requirements for additional training, poor reliability of systems, use of outdated hardware and software, and time spent managing more devices. Though the goal is to improve efficiency, these processes sometimes add more work and challenges in a field increasingly burdened by complexity.

Technology concerns aren’t limited to investigative sites. As reported in the HealthIT.gov Dashboard, as of March 2015 there were 779 information technology (IT) vendors supplying electronic health record (EHR) products to nearly 500,000 healthcare professionals in the U.S. Of these, five companies comprise more than 50% of the market share. Communication between these systems remains a major challenge.

…Sites now have to spend significant time storing devices, training, trouble-shooting, and uploading information.

Also, the May 2016 issue of Internal Medicine News discusses 10 ways EHRs lead to physician burnout. Major complaints include too many clicks, poor workflow, bloated notes, and long sign-in processes.

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Study Questions Efficacy of Wearable Health Monitoring Devices

FitBit’s heart monitor wearable device miscalculated heart rates by nearly 20 beats per minute during strenuous workouts, says a new study by researchers at California State Polytechnic University, Pomona. The study was commissioned by Lieff Cabraser, a law firm behind a class action suit alleging that FitBit products using the PurePulse heart monitor do not accurately track wearers’ true results.

FitBit fired back that the study was skewed because it was funded by the plaintiffs, who are presumably biased to find data that support their case. FitBit also defended its own research and development of the PurePulse technology.

However, a separate study conducted earlier by researchers at Ball State University and a local TV station in Indiana reported that the FitBut HR, which uses the PurePulse technology, showed an average heart rate error of nearly 15 percent.

The outcome of the court case and the dissection of the various studies come as more and more people are wearing FitBits for a variety of health-related reasons. Questions remain, experts note. For example, Lancaster General Hospital is currently recruiting patients for a clinical trial study to examine the efficacy of FitBits and other wearables in encouraging better diet and health results. Positive or negative data about FitBits in a broader sense could have an impact on their value, real or perceived.

Change is in the Air: Part III

This is the third installment in a series on changes coming to the clinical research enterprise from John Neal, CPA, BS, CRSP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees.

Previous Predictions: I & II

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

Prediction 3: My 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

Based on my research, there is compelling evidence pointing to the movement toward replacing the existing site selection process with one that begins with identifying individual patients that will qualify for a study. After those patients are identified and geographic concentrations are determined, networks of sites that provide coverage for the areas of concentration, and which can deliver additional efficiencies by centralizing many of the non-clinical functions required to conduct studies, will be selected. Individual sites not affiliated with a network affording those benefits to the sponsor will only be selected if they have access to high concentrations of the target study population.

If you look at how I/E has continued to expand to specify much more individualistic or personal criteria, it is going to be harder for individual sites to find study subjects within their normal coverage domain. It is going to require much more collaboration to find patients that qualify for studies.

You may ask why such a radical transformation is needed. The answer lies in the fact that the system of site selection commonly used in the industry today is simply broken.

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CTTI: Chronic Clinical Trial Recruitment Issues Crush Recruitment Results

Failure to address clinical trial recruitment issues at the outset continues to plague sites, according to the findings of a new task force. Result? Nearly 40% of clinical trials fail to meet recruitment goals, says Elizabeth Mahon, JD, associate director of Global Clinical Operations – U.S., Janssen R&D.

“Recruitment planning too often is an afterthought,” Mahon says. She’s part of a Clinical Trials Transformation Initiative (CTTI) Recruitment Project team that drew upon representatives covering the entire gamut of trials, including Food and Drug Administration officials, patient advocates, investigators, study coordinators, and others to get a full picture of the state of the clinical trial industry. It’s not always a pretty picture.

For example, there are no consistent recommendations or frameworks for conducting recruitment planning across disciplines, Mahon says. That’s a significant problem for those in academia and other sectors who essentially have to start over again each time they focus on recruitment planning, she adds. Providing a framework will help make certain key considerations such as patient rights are front-of-mind from the earliest stages of planning, Mahon says.

It’s all part of building a bigger tent when first considering a patient recruitment strategy and subsequent tactical plan. One key is to identify and engage all stakeholders from the very beginning, Mahon says. “Too often it is just sponsors and some key opinion leaders” sitting at the table, she notes. Instead, she advises including others—such as clinical researchers—to make planning more holistic.

Mahon and the CTTI group will present more of their findings and some recommended solutions during a webinar today at 12:00-1:00pm EST. Learn More

Change is in the Air: Part II

This is the second installment in a series on changes coming to the clinical research enterprise from John Neal, CPA, BS, CRCP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees. Read the first prediction here, or continue reading…

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Prediction 2: 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.

In place of single drug studies, collaborative, multi-sponsor studies will become more common. Multi-sponsor collaboration on studies is not a new concept. Going back as far as 1986 with theCardia Arrhythmia Suppression Trial (1), multiple drugs have been tested within the same study.

A more recent example is the Lung-MAP study, “a multi-drug, multi-sub-study, biomarker-driven squamous cell lung cancer clinical trial that uses state-of-the-art genomic profiling to match patients to sub-studies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.” (2)

“You are going to see more collaborative trials occurring when multiple sponsors studying the same disease will work together to create one protocol.”

Jeffrey Kasher
Chairman of the Advisory Board of DrugDev
President of Patients Can’t Wait, LLC

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Flexible Biomarkers Critical to Improving Rare Disease Clinical Research, Biogen CEO Says

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Martine Rothblatt, ACRP 2016 Meeting & Expo keynote speaker, who has both personal and professional ties to rare disease trials

While there are some 566 potential drugs targeting rare diseases in the pipeline, various regulatory, financial, and scientific hurdles continue to slow other important advances.

“We need better and more predictive biomarkers and surrogate endpoints,” Biogen CEO Dr. George A. Scangos told attendees at “Targeted Cures: A Policy Discussion on Treating Patients with Rare Diseases” in Washington, D.C. today. The event was sponsored by Pharmaceutical Research and Manufacturers of America (PhRMA).

While it is critical to maintain a balance between speed and efficacy, Scangos said clinical researchers and the broader industry need a new breed of biomarkers as required by the Food and Drug Administration (FDA) and other regulators. For example, Scangos asked if a drug in the research phase needs to show a survival benefit when it can take years to determine it. Conceding that the FDA is probably in a no-win situation, he nevertheless advocated for a new regulatory scheme that keeps pace with advances in the healthcare landscape. “Industry and FDA are not at odds” in terms of finding that balance, he added.

Sponsors, researchers, and the full range of healthcare professionals need a more transparent regulatory policy, echoed PhRMA President and CEO Stephen J. Ubl. Research into rare diseases is challenging enough as it is. “It’s tough to conduct clinical trials,” in part because the science for researching rare diseases presents such a “tangled puzzle,” Ubl told attendees. That’s just another reason that a comprehensive attack is so critical to advancing new drugs and devices targeting rare diseases, or those defined as impacting fewer than 200,000 patients.

“These are emotional diseases,” Scangos said. Noting that everyone in the audience probably knew someone impacted directly or indirectly from a serious medical condition, he singled out spinal muscular atrophy as a particularly horrific disease because it impacts infants at three or four months, and usually kills them before they are 18 months old. It is also the most common genetic cause of death for babies, he said.

At times, the impact of defeating a rare disease can be put in viscerally individual terms.

“The people in this room saved my daughter’s life,” Martine Rothblatt told attendees at ACRP’s 2016 Meeting and Expo in Atlanta, Ga. last month. At age five, her daughter was diagnosed with what was later called pulmonary arterial hypertension, an incurable lung disease. By 12, the condition had become debilitating for her daughter. Rothblatt, an early pioneer of satellite radio, was frustrated by the expensive and very limited medication options available at the time. She founded United Technolgies to help find better treatments. The effort succeeded.  Today, her daughter is healthy woman in her mid-30s who has an active leadership role at United.

Clinical research played a key role in that happy ending, Rothblatt said. “Thank you,” she told her ACRP audience.

Lack of Standardized Competence Putting Clinical Trials at Risk

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Jim Kremidas, ACRP Executive Director

Clinical trials will remain at risk of continued variance in research conduct quality if workforce development and standardization of competence and career paths are not prioritized, warns Jim Kremidas, Executive Director of the Association of Clinical Research Professionals (ACRP).

While many initiatives are bringing forth excellent technology solutions to clinical development, ACRP is focused on standardizing and enhancing competencies of the people who ultimately conduct clinical trials at the grassroots level.

“There is no standard path for becoming a clinical researcher. Most people gain knowledge on the job, and organizations utilize disparate onboarding and training programs,” Kremidas notes. “This creates a tremendous amount of variance in research conduct, processes, and workforce competence, which culminates in a detriment to research quality.”

Look no further than the persistence of common U.S. Food and Drug Administration (FDA) inspection findings for proof that the current approach to workforce development is not working.

“ACRP’s mission is to promote excellence in clinical research, so we are leading several initiatives to standardize workforce development and improve clinical trial quality,” Kremidas says.

ACRP is playing a central role in developing clinical research professional competencies through the Joint Task Force (JTF) for Clinical Trial Competency, a multi-stakeholder group seeking to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards. The JTF, which includes representation from the Clinical Trials Transformation Initiative, Multi-Regional Clinical Trials Center, Pfizer, and more, has proposed eight core competency domains for clinical research professionals and is working to fine tune them and begin advocating their industry-wide adoption.

“This is the first step on a long path toward standardizing competence in clinical research and a critical one in eliminating a significant variance in operations,” says Kremidas.

ACRP is also leading an initiative to identify and advocate a set of core competencies required of entry-level clinical research associates (CRAs)/monitors. Convened in December 2015, the multi-stakeholder CRA Workforce Development Task Force includes representation from leading contract research organizations (CROs), sponsors, and more.

“There is a major shortage of CRAs in the workforce,” Kremidas notes. “As a result, sponsors and CROs are battling CRA turnover and substantial compensation increases. At the same time, it’s clear from our own data and continued FDA inspection findings that there is an insufficient level of knowledge, skills, and abilities in the CRA workforce.”

ACRP believes the root cause of the CRA shortage is prioritization of a 2-year experience requirement over validated competence.

“Competency based on tenure discourages a talented pool of potential CRAs who lack an industry-imposed, calendar-based requirement from trying to advance and fill the rising number of open positions,” Kremidas says. “The current system in place to train and mentor new CRAs is demonstrably inadequate to meet a growing demand for new skills and talents.”

Meanwhile, ACRP is providing innovative market solutions, including an 8-week CRA Onboarding program recently delivered to a global pharmaceutical company. A year after the program, the client retained 93% of the CRAs who participated and reported significant improvements in operations.

“By leveraging fresh ideas we have the power to improve clinical trial operations, and it starts with the workforce,” Kremidas says.

How to Help ‘Outsiders’ Appreciate Value of Clinical Research

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Manda Materne, Clinical Trials Pipeline Manager, GuideStar

Site staff and sponsor-based personnel, and even some of the professionals operating in other parts of your hospital or physician practice, don’t always understand how a strong research program can elevate your organization’s public profile, lure the best job candidates, and contribute to the bottom line in a very real way, say two leading experts.

“Too often, leadership doesn’t see the value of research,” says Mary Frances Dobry, marketing manager at GuideStar Clinical Trials Management. “It’s up to your to get the word out.”

Doing it effectively and with finesse requires understanding how to use new tactics when marketing your research services, agrees Manda Materne, a former nurse in a big city emergency room and now Clinical Trials Pipeline Manager at GuideStar. “There is a strategic value to research” that can make a compelling case for appreciating and expanding a shop’s research capabilities. Materne says clinical research coordinators (CRCs) should make the case that research can:

  • Increase ancillary services
  • Minimize patient outmigration and attract new patients
  • Create institutional donor opportunities
  • Bolster the recruitment efforts to lure the right candidates and retain your stars
  • Improve community health

Advocating a proactive approach, both experts say undertaking old-fashioned networking at conferences and smaller local CRC gatherings and getting buy-in from your leadership are keys to success. Consider other even more basic ideas, such as updating your website and making it user-friendly. “Get into a sponsor’s database” by showing them you have the right personnel and infrastructure in place, Dobry said.

According to Materne and Dobry, strong, proven research capabilities can provide a “halo effect” for the entire hospital or physician practice. Done right, a research unit enhances the image and reputation of your organization. However, sometimes it is up to you to make sure others know it.

Learn More

Materne and Dobry will lead a webinar, Marketing Essentials for Clinical Research Professionals, Wednesday, May 18, 12:00-1:00pm. Click Here to Sign Up

ICYMI: ACRP Members now pay just $25 for webinars. All part of the new ACRP! Learn More

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.

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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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