Navigating the Perils and Promise of Centralized Clinical Management

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Nirmala Thevathasan, Huron Consulting Group

The leaders of institutions involved in the conduct of clinical research have the option of various models for managing their clinical research personnel. When considering a centralized or hybrid model for management of such professionals, experts advise that the organizational leaders must engage stakeholders early and often in the process, and build in flexibility to acknowledge there is never a one-size-fits-all approach.

According to Mindy Muenich and Nirmala Thevathasan from Huron Consulting Group, external economic and regulatory pressures continue to create challenges in the field of clinical research, including:

  • Changes to the research funding landscape
  • Increasing regulatory and reporting requirements

Elements of the internal dynamics of a research enterprise such as calls to centralize administrative service operations for research and to improve workflow, time to enrollment, and cost recovery are all challenging institutions to think strategically about how to manage their clinical research personnel and operations in an efficient and cost-effective manner.

Muenich, a director with Huron Consulting Group’s research services practice area who previously served as the director of Clinical and Translational Research Office at the Cincinnati Children’s Hospital Medical Center and UC Health, has first-hand experience with these challenges.

While flexibility is the key when considering a centralized approach, Thevathasan stressed a few bedrock ideas. “Regardless of your staffing model, standardized processes are critical to successfully conducting research,” she says. Thevathasan is a manager with Huron Consulting Group and was previously the associate director of the Clinical Trials Office at The Children’s Hospital of Philadelphia.

Muenich and Thevathasan advocate for institutional leaders taking an in-depth look at the strategic and financial goals for engaging in research, and aligning their staffing models accordingly.

Learn More

To learn more about ideal staffing models for management of clinical research personnel, as well as considerations for determining and implementing the appropriate model(s) at your institution, sign up for this August 3 ACRP Webinar, Clinical Research Professionals Resource Management: To Centralize or Not? Just $25 for ACRP Members! Sign Up>>

Can Facebook-Fueled Trials Lessen Recruitment Burden on CRCs?

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Kai Langel, director of patient research and cofounder of eClinicalHealth Limited

A Phase IV clinical trial deemed “successful” by the firm that provided patient outreach technology for it is the type of new trial that will make the job of a clinical researcher coordinator (CRC) more “meaningful,” according to Kai Langel, director of patient research and cofounder of eClinicalHealth Limited. The diabetes trial recruited all of its patients using only Facebook.

Far from being any kind of threat to CRCs, who often are tasked with patient recruitment, this kind of technology will spare them from some of the tedious administrative work that takes away time more productively spent looking at patient data and helping keep trials on-track, Langel says. “CRCs shouldn’t go looking for a new career,” he stresses. “Their jobs won’t go away no matter how good the tool.”

Patients self-registered their interest in the study using the Clinpal system, eClinicalHealth’s online recruitment tool. The coordinating study site then reviewed applications. Selected patients were sent electronic information before electronically signing the informed consent form. Study materials were delivered directly to patients who used a smart, wireless glucose meter as part of the study. Glucose measurements were automatically sent from the device into the Clinpal system, and were then available for real-time review by patients and study site staff.

The study’s lead investigator and CRC “kept an eye” on the trial, Langel says. Patients also had a number to call the CRC with questions. The patient population skewed relatively elderly, Langel says, and most questions had to do with technology issues, such as when a participant didn’t access his or her initial link within the 24-hour key lock period. The CRC had to help guide them to setting up a new link to retrieve that information.

Seventy-four individuals registered interest in the study through Facebook, and 60 were ultimately enrolled, for an 81 percent conversion ratio. That’s a much better result than what is seen in typical online patient recruitment studies, according to eClinicalHealth. In addition, the study site estimated spending about two-thirds less of the investigator and study nurse’s time on recruitment versus the usual situation in a trial that did not use online recruitment.

Sanofi R&D is contributing to the study as part of a program to develop patient-centric clinical trials, according to eClinical Health.

Langel allows that this type of patient recruitment is best suited for trials seeking the most general of populations, such as asthma or diabetes, where the exclusionary criteria do not need to be particularly odious.

Additional Resources

Want to learn more about volunteer recruitment and social media? Check out these sessions from the ACRP Online Conference Library:

NIH Expects Multisite Research Trials to Stick with Single IRB

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Carrie Wolinertz, PhD, NIH Associate Director for Science Policy

The National Institutes of Health (NIH) just issued a policy statement to the effect that it expects all sites participating in multisite studies funded by NIH and involving non-exempt human subjects research to use a single institutional review board (IRB) to conduct the ethics review to ensure the protection of participants.

The stated policy, years in the making and consistent with long-time NIH thinking, is designed to enhance and streamline the process of IRB review and reduce inefficiencies, the agency says. “We’ve been hearing for years, and the scientific evidence bears this out, that the use of [multiple] IRBs can slow research without a consummate increase in protection,” says Carrie Wolinetz, PhD, NIH’s associate director for science policy.

If anything, there are sometimes so many chefs in the kitchen that no one notices when the pan’s on fire.

While patient groups have broadly cheered the measure, others, including some research institutions, have expressed wariness, Wolinetz admits. “They know they have a lot of work to do to get their [information technology] systems in order,” she notes. NIH will offer ideas, FAQs, and other tools to help research institutions meet these and other new challenges associated with the new policy edict, she adds.

The new policy applies to the domestic sites of NIH-funded multisite studies where each site will conduct the same protocol involving non-emempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. However, it does not apply to career development, research training, or fellowship awards.

More Information

Check out our White Paper, Considerations for AMCs When Debating the Use of a Central IRB, to learn more about the main points of maintaining local IRB review and oversight of multisite trials versus outsourcing to a commercial IRB as the IRB of record.

Diagnostics Key to Effective Alzheimer’s Clinical Trials

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Dave Ricks, senior vice president and president with Lilly Bio-Medicines at Eli Lilly and Company

Nearly one-third of all subjects enrolled in Alzheimer’s trials don’t match the protocol because they don’t actually have the disease, according to Dave Ricks, senior vice president and president with Lilly Bio-Medicines at Eli Lilly and Company. Weak diagnostics is one of the biggest problems, he added. “We need diagnostics before the symptoms appear,” he told attendees of the Pathways to Prevention policy discussion event on research and treatment for Alzheimer’s held in Washington, D.C., on June 23.

Clinical researchers and others recognize the need for advanced diagnostics, says Laurie Ryan, PhD, chief of the Dementias of Aging Branch and program director for Alzheimer’s disease clinical trials with the National Institute on Aging, National Institutes of Health (NIH). Calling it an “exciting time,” Ryan noted that NIH researchers are actively engaged in a number of trials to improve diagnostic capabilities, including brain scans to detect plaque build-up, blood tests to identity early signs of Alzheimer’s, and ways to identify other biomarkers that can serve as early warning systems and guide preventive treatment.

In comparison to other diseases, Alzheimer’s research is made even more difficult because it requires identifying tools in a number of areas to produce combination therapies, says Ronald Petersen, PhD, MD, director of the Mayo Clinic Alzheimer’s Disease Research Center.

The event was held in part to announce Lilly’s Alzheimer’s Readiness Project, an initiative designed to combine efforts to advocate on behalf of those with the disease, encourage effective and efficient research, and ensure a regulatory system that reflects the latest in scientific theories and conclusions.

For more details on the Readiness Project and Pathways to Prevention, visit:

Pharmacist Involvement Key to Improving Clinical Trial Recruitment, Retention

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Gerald Finken, R.Ph., M.S.

More than 95% of respondents in a recent survey said they were more comfortable participating in a clinical trial knowing that a pharmacist was on call to answer questions, says Gerald Finken, a registered pharmacist since 1982. “A majority of patients have significant questions which, if not addressed in a timely manner, can adversely impact the clinical efficacy and health outcomes of a study,” Finken adds.

The survey analyzed 17 clinical trials with a focus on observing high-, medium-, and low-impact interventions by pharmacists. Key findings include:

  • More than 27,000 pharmacist calls were made to 3,874 trial participants.
  • In four trials for one chronic disease medication, more than 92% of patients had at least one intervention.
  • Nearly half of clinical patient calls to the pharmacist had at least one intervention.
  • The majority of interventions involved concurrent medications, side effects, and interactive voice response systems used by trial managers for communication with patients.

Finken, who has worked in the clinical supply chain for 34 years with chain and community pharmacies, independent hospital pharmacies, and a VA hospital pharmacy, suggests usage of apps and wearable devices in trials has supplanted pharmacist involvement in too many cases. “Have we lost focus on ‘human connections’ by the great marketing campaigns of technology?” Finken asks. Perhaps, but it doesn’t appear that interest in that kind of technology is going to wane anytime soon. For example, global shipments of wearable medical devices will surpass 106 million in 2016, according to a study by Future Market Insights. That’s up nearly 5% from 2015.

Finken suggests that data from a Tufts Center for the Study of Drug Development report show there is a problem:

  • In 1980, approximately 10% of New Molecular Entities (NMEs) made it the whole way from Phase I trials to New Drug Application (NDA) approval on the first try by the U.S. Food and Drug Administration at a cost of some $500 million.
  • In 2015 under the same scenario, it was again approximately 10% of NMEs reaching NDA approval by the agency. The cost this time? Approximately $2.5 billion.

If this isn’t addressed, Finken predicts it will cost $3 billion to approve 10% of NDAs in 2020.

Learn more about the importance of improving the connection between pharmacists and trial subjects – and ways to achieve that – Wednesday, June 22, when Finken delivers a live Webinar, Incorporating the Practice of Pharmacy into Clinical Research. Just $25 for ACRP Members. Sign Up>>

Change is in the Air: Part V

This is the fifth installment in the 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

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

Prediction 5: Attention will turn more toward prevention, rather than cures.

To be fair, rarely is there truly a cure found for any disease. Some of the most deadly diseases once prevalent around the globe considered to be “cured” (e.g. Polio, Tetanus, and Yellow Fever) are simply well controlled via vaccines that act to either prevent the infection altogether, or to kill the virus in those already infected. However, the viruses responsible for these diseases have not been eradicated. In fact, Smallpox is the only disease to date that appears to have been completely eradicated, with routine vaccination discontinued in the United States in 1972, and the last known natural case occurring in Somalia in 1977.

“The hierarchy of therapies will be, initially, preventative.  Next, ideally, curative.  Then, there will be a lot of demand in areas of genetic disorders and orphan indications.”

Jamie Macdonald, CEO of INC Research

When I spoke recently with Jamie Macdonald, CEO of INC Research on the topic, he stated, “The hierarchy of therapies will be, initially preventative. Next, ideally, curative. Then, there will be a lot of demand in areas of genetic disorders and orphan indications.” Mr. Macdonald emphasized that this focus will we be led “…in part by the science, looking at those areas that clearly have the biggest impact, not just on healthcare costs, but more from the societal costs as well.”

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Change is in the Air: Part IV

This is the fourth 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.

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

Prediction 4: Fewer Principal Investigators will be needed in the future.

Following my first three posts predicting that:

  • major changes are coming that will be disruptive, displacing many people currently working in the industry (read more);
  • there will be a decrease in the number of single drug studies in the future (read more);
  • the process by which Sites are selected to conduct studies will be radically transformed, and fewer sites will be needed in the future (read more)

it may seem that it would follow logically that fewer PIs will be needed. I do not believe it is those factors that will have the greatest impact on how many PIs will be needed. Instead, it is another factor (actually interconnected factors) that will drive the reduction in the number of PIs.

As more PIs have become available, the number of studies available per PI has decreased significantly over the last decade.

First, although there has been a push for many years to create a larger pool of investigators, that need has been based almost entirely on the turnover caused by PIs choosing not to continue to conduct research. One of the primary reasons given by PIs who have made that decision is the financial burden placed on the site/PI. Part of that burden has come from declining budgets and untimely payment terms, but as more PIs have become available, the number of studies available per PI has decreased significantly over the last decade.

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Flawed Communication Between Researchers and Nurses Can Spell Trouble

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Shannon Huffaker, RN, MSN, CCRC

Imagine you are a research nurse/clinical research coordinator (CRC) for an in-patient randomized, double-blind study that aims to lower “bad” cholesterol. One of your subjects is seen by a resident who is not on the study team, and who orders a lipid panel, the positive results of which are then shared with your subject by a non-team nurse before you realize what’s going on. Whoops. So much for blinding the patient from knowing if she was receiving the active treatment or a placebo.

Shannon Huffaker, RN, MSN, CCRC, doesn’t have to imagine this frustrating scenario. As a clinical research supervisor at Lehigh Valley Health Network in Allentown, Pa., she has witnessed this and similar circumstances, and now uses the anecdote as an example of the importance of effective communication between researchers and the nurses who are providing the standard care for trial participants who are also hospitalized patients.

“Communication is frequently discussed in healthcare in general, but infrequently discussed regarding its role in the conduct of research trials,” Huffaker noted in a session she presented at the recent ACRP 2016 Meeting & Expo in Atlanta, Ga. “The complexity of studies that makes communication so challenging in hospital settings includes such factors as study procedures that may seem ‘tacked on’ to standard of care to staff who are not directly involved in the study; the fact that several medical disciplines are often involved in any given study; and the likelihood that there are differences in local nursing practices from one hospital to another in multisite studies.”

In addition to the accidental unblinding of a study patient, the potential consequences of poor communication between CRCs and other nurses can include:

  • missed/incorrectly timed study labs or assessments
  • missed/incorrectly timed study medications
  • administration of medications prohibited by the study protocol
  • inadequate data collection

“All of these can have dire consequences for the patient, institution, and nursing staff,” Huffaker warns.

Although there is a need for research staff to communicate with providers and other members of the healthcare team, nurses spend the most time with the patients, and are central to coordinating their care in the hospital. Saying that “a one-time study in-service or education session for the nursing staff is not the end of communication,” Huffaker also addressed several strategies for increasing communication levels for the benefit of hospital-based clinical trials.

Access Huffaker’s full presentation through ACRP’s Online Conference Library at http://bit.ly/1UhAiQu.

Chronic Over-Reporting of Clinical Trial Results Wastes Time and Money

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Lynn Meyer, CCRP, President, IntegReview IRB

When it comes to reporting ongoing data updates in clinical trials, less is sometimes more, according to Lynn Meyer, CCRP, president of IntegReview IRB in Austin, Texas. “There’s a lot of wasted energy spent on over-reporting ongoing trial results,” she says. Unnecessary reporting to institutional review boards (IRBs) can cost an extra $5,000 per site, she adds.

Here is some case study math showing how the situation can get out of hand:

  • Coordinator spends 5 minutes submitting the Investigational New Drug (IND) safety report to an IRB and 5 minutes to get the principal investigator’s signature and file everything in the Site File
  • 10 minutes x 10 reports/month = 100 minutes, or about 1.5 hours per month
  • One protocol = 2 IND safety reports per month
  • 2 x $25 (report) = $50 per site
  • If 100 sites: $5,000 per month

It’s a common and costly problem, Meyer says.

For example, some researchers automatically report a serious adverse event to their IRB. That’s the correct action to take if it is part of the trial protocol. However, there are no regulations actually requiring that information be sent to the IRB, Meyer says. “In many cases, the IRB will send back an acknowledgement of receipt and never look at it again,” she notes. Researchers can become prisoners, she says, of old standard operating procedures that fail to reflect new realities or what is actually required in a given situation.

It takes an experienced investigator to understand the nuances of the situation, Meyer says. While it is mandatory to report an unanticipated problem in a trial, inexperienced investigators sometimes feel that they are “safer” if they report on every little thing. “It’s a lack of confidence” as much as it is a true understanding of what’s required and what isn’t, Meyer explains.

There are tools out there to help. Meyer cites two Office for Human Research Protections (OHRP) guidances that offer checklists for how to determine if an event should be reported or not (see OHRP Guidance Decision Tree). It’s not always as simple as printing the OHRP checklist out and taping it over your computer screen, though.

Learn More

Meyer will present a webinar June 15 titled How to Streamline Over-Reporting; click here to sign up.

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