More Carrot, Less Stick: How to Effectively Drive Adoption of ‘eResearch’ Methods

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Lenis Sosa, MSN, RN, CCRC, Houston Methodist Research Institute

Even the most change averse clinical trial practitioners can warm up to managing clinical trials in new electronic environments if the benefits are demonstrated early and often, says Lenis Sosa, MSN, RN, CCRC with the Houston Methodist Research Institute in Texas. It’s a big challenge because transitioning from paper to electronic files in clinical research not only causes concerns related to subject information and trial data confidentiality, it also creates new challenges related to managing a multitude of systems, Sosa says.

At Houston, Sosa and team have implemented an electronic health records system, EPIC, that has streamlined communications with the clinical side of the operation so his team can readily see which patients are enrolled in research, and efficiently flag what patients invoices are research or clinical in nature.

Nurses, researchers and others conducting the trial in a new electronic environment will be less resistant to change if you can give them a clear visualization of the project’s goal and what that change will ultimately mean for them on a day-to-day basis, he adds. He advocates training sessions planned well in advance. It’s also important to adjust training to different audiences. “I’m a nurse, and we’re taught to do assessments with open-ended questions,” Sosa says. He uses some of that same skillset as he designs educational presentations for his own staff and more broadly across the entire hospital system.

In addition to navigating the all-important human factor, it’s also critical to be well-versed in the latest developments in US and EU regulations and guidance documents covering the management and use of electronic tools in clinical research, experts say.

Ultimately, training should be scheduled well in advance of any implementation, strive to be entertaining, and make it clear to wary users how it will make their job easier and more efficient, Sosa says. “You don’t want to surprise anyone,” he adds.

Learn More

For more tips on managing the transition from paper to electronic files in clinical research, check out eResearch: Managing Clinical Trials in an Electronic Environment.

Clinical Research Training Programs Must be Brought into 21st Century

Clinical trial training programs require a significant overhaul to keep pace with the growing demands of the job, say several members of the Joint Task Force for Clinical Trial Competency (JTF).

“Clinical research has become a profession,” says Stephen Sonstein, PhD, Director of Clinical Research Administration at Eastern Michigan University. “It’s no longer just a task,” he adds. Sonstein is lead author on a paper outlining JTF industry survey results scheduled to be published in the December issue of Clinical Researcher.

Given the increased size, complexity, and demands of trials, “the generally accepted on-the-job training model is not acceptable anymore,” Sonstein says. Bottom-line: Clinical Research Coordinator’s (CRCs) and others in the trial chain must be trained to get a better understanding of their roles in the development of medicines and medical devices.

The limits of current training and competency programs are crystal clear, in part because “so many CRCs don’t have a general grasp of how medicines are developed” or the broader role of study coordinators in the process, says Carolynn Jones, Assistant Professor of clinical nursing at The Ohio State University’s Masters of Applied Clinical and Preclinical Research and an active member of the task force.

Example: While the vast majority of CRCs in today’s workforce are strong in their niche area (e.g., data management, patient recruitment), they often have not gotten adequate training to have at least a cursory understanding of scientific concepts and how protocols are designed, Sonstein says.  This has a potential impact on the collection of endpoints and study outcomes, Jones points out.

In the past, competency-based education and training generally focused on specific roles (e.g., investigator, pharmaceutical physician, or clinical research nurse). The JTF aligned and harmonized competency requirements, as identified by surveys and other industry input, into a single framework of eight domains and 51 associated core competencies. These are designed to define professional competence throughout the clinical research roles, as represented by the JTF Core Competency Framework (CCF).

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Core Competency Framework Domains

The JTF CCF’s eight domains are:

  • Scientific Concepts and Research Design
  • Ethical and Participant Safety Considerations
  • Medicines Development and Regulation
  • Clinical Trial Operations (Good Clinical Practices)
  • Study and Site Management
  • Data Management and Informatics
  • Leadership and Professionalism
  • Communication and Teamwork

One organization that has already adopted the CCF is the Consortium of Academic Programs in Clinical Research (CoAPCR) by using the CCF as the curriculum foundation for their academic programs. The JTF members hope to help others recognize the need for prior academic education followed by continuing specialized training Jones says.

Editor’s Note: This is the first blog in a series examining new training concepts proposed by the Joint Task Force for Clinical Trial Competency based on its core competencies.

‘Ideathon’ Confronts Stubborn Clinical Trial Enrollment Woes

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Clare Grace, vice president for site and patient access with INC Research in the United Kingdom

In support of Clinical Trials Day last May, INC Research and the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP) announced the Inspiring Hope Ideathon, a new “crowdsolving” event coming in late September and designed to promote greater awareness and encourage participation in clinical trials. To get an update, ACRP spoke with Clare Grace, vice president for site and patient access with INC Research in the United Kingdom.

ACRP: Can you briefly describe what the Inspiring Hope Ideathon is?

Clare Grace: The goal is to build a community of problem-solving advocates to present creative ideas that are feasible and sustainable, and that create a long-term impact in the broader clinical research community. Healthcare professionals and leaders from across the industry are encouraged to generate new and unique ways to help raise awareness of clinical trials and study participation.

A key challenge for sites is enrolling patients. The first step toward any enrollment discussion is simply making patients aware of the role that clinical trials play in the development of new medicines. We think honing in on a personal connection to the research is integral for participation to increase.

Together, INC and CISCRP want to build momentum and stimulate more active engagement within the clinical research community.

ACRP: How is this project different from other efforts by sponsors and advocacy groups to promote clinical trial awareness?

CG: The Ideathon is a new style of event that involves rapidly solving a problem with a large group of people in an innovative and competitive style. These types of events are utilized quite extensively in the technology industries and amongst entrepreneurial groups, but they haven’t been used very widely to solve challenges in clinical research.

We believe that by taking a more hands-on approach and inviting everyone to the table, we can develop a more realistic notion for change than other clinical trial awareness campaigns—and hopefully that change will stick. CISCRP’s research has demonstrated that…[helping] the public and patient communities become more aware of their role in the [research] process, combined with making the experience more positive for them, will be a large improvement. I think patients want to feel as though they are active partners in the process.

ACRP: How is the Ideathon being promoted, and who is the main targeted audience for idea submissions? Patients or professionals, or both…?

CG: We’re hoping that a broad pool of stakeholders will participate. The more diverse, the better. The hope is to encourage people who may not necessarily vocalize their ideas regularly, but who have a lot of them, to speak up and to form teams and to mobilize those ideas. The better we are at reaching out to a broader audience, the better we will be at actually having a really accurate, tangible collection of ideas that may move the needle, ultimately improving clinical research literacy overall.

We are promoting the campaign in various ways. We have a short video on our website currently that explains what the Ideathon is, plus other content on the website. We are also promoting the event via social media using the #ideas4patients hashtag and via direct e-mail messages.

ACRP: How active have things been in the idea submission process so far? What comes next?

CG: We’re pleasantly surprised and excited by the diverse range of contributors involved so far. We have submissions coming in from pharmaceutical companies, contract research organizations, communications and technology vendors, sites, patient agencies, and academic institutions. Our hope is that this collection of ideas will inspire all of us to think more openly, more broadly, more creatively about things that we can do to raise awareness for clinical trials.

To research professionals who see this blog, we’d like to encourage your participation in the Ideathon as well by submitting your ideas, signing on to become a mentor, and spreading the word using your networks and expertise to educate those around you about the importance of clinical research. The main reason patients don’t participate is a lack of awareness of what clinical trials are, how they fit into the drug development process, and where they take place. Many physicians are not looped into the research process, so when patients do speak with their physicians (the most likely person in their lives they would speak to regarding these matters), they’re often unaware of trials available to patients in their areas.

Once the Ideathon submission process closes on August 8, entries will be evaluated by a distinguished panel of judges to determine a shortlist of finalists. These finalists will then be invited beginning August 15 to further develop and present their ideas at the Inspiring Hope Ideathon event itself, which takes place September 27–28 at District Hall in Boston, Mass.

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

This is the sevent installment in the series (Change is in the Air) 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.”

Prediction 7: The drug development pipeline will change dramatically, and we will see an increase in Investigator Initiated Studies (IIS).

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John Neal, CEO of PCRS Network, LLC

To some extent, this prediction could be inferred from my fifth and sixth predictions. But I believe the changes will run deeper than simply a shift away from major diseases like diabetes and hepatitis C. With effective treatments available for those diseases, and continuing advances in oncology leading to decreasing mortality rates for many types of cancer, research and development funds will become increasingly available for a broad range of diseases. Additionally, advances in technologies will make it possible to study many diseases in ways that simply were not possible previously.

When I spoke recently with Jamie Macdonald, CEO of INC Research on the topic, he stated, “You are going to see ongoing research in oncology, and some of the areas where there has not been enough progress like urology, Parkinson’s, Alzheimer’s, and some of the motor neuron diseases as well. The science will lead us to continue that work.”

“KOL input is important, because they are leading the academic science, but operation input from Investigators that are very hands on from a clinical standpoint is necessary.” Jamie Macdonald, CEO of INC Research

With increased emphasis on more specialized and rarer diseases, I believe we will begin to see an increase in IIS, as individual doctors or groups identify opportunities to make progress in areas that, to date, may not have been economically desirable or feasible for pharmaceutical companies to pursue. The opportunities to study diseases that impact smaller populations, but that could provide major benefit to those populations are nearly endless.

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Patient-Centric Approach Helps Cut Costs and Speed Clinical Trials, Sanofi Exec Reports

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Victoria DiBiaso, Sanofi’s global head of clinical operations strategy and collaboration

Working up front with patients—starting in the research space to identify unmet medical opportunities according to patient need—and then extending patient interactions into the construction of clinical trials and patient-engagement approaches has  helped Sanofi  optimize the way they approach clinical trials. Patient input has aided the company in terms of reducing the number of subject visits, increasing overall patient satisfaction levels, and generally improving its clinical trial research programs, says Victoria DiBiaso, Sanofi’s global head of clinical operations strategy and collaboration.

“We’ve seen a dramatic reduction in amendments along with other significant improvements,” DiBiaso says. While these positive results aren’t all due to adopting the patient-centric approach, it’s clear it is a big factor, she adds.

Perhaps most importantly, the patient-centric approach, if more widely adopted in the industry, can improve the perception of clinical trials, DiBiaso says. “It will help people understand that research is good, and that patient collaboration is needed in order to provide new medical options to patients faster and more efficiently,” she explains.

Sanofi works closely with patient groups to identify patient advisors, and engages with them from the early research stages into when the investigational medicines advance into human studies. In the clinical space, this means working with patient groups and members of their patient communities before trials are designed.

The interactions are not intended to be about recruitment; instead, Sanofi views the patient advisors as subject matter experts. In turn, the company uses input from patients to inform the early design of a trial and its subsequent patient outreach based on that input, so the studies are designed around the day-to-day lives of patients and the information and support associated with the trial meets their needs.

For a recent trial in a young population, Sanofi’s early patient engagement quickly told trial managers that the best way to interact with subjects was via social media.

“One participant told us ‘I spend 95% of my time on social media and the other 5% charging my phone so I can get back on social media,’”DiBiaso says. “That tells us that electronic collection of patient-reported data and activities to support adolescents for retention is appropriate for this patient population.”

In another study, Sanofi was looking at how best to allow patients to reduce their overall site visit burden, which would require more study medication to be managed at home in a refrigerated setting. The patient advisors worked with Sanofi on the solution of providing participants with refrigerated cooler bags so that the medication could be removed from the large packaging and fit into their fridges, and letting them bring materials back to the site on a less burdensome schedule. “It was such an easy solution that we might not have thought of it ourselves,” DiBiaso notes. Sanofi reduced the cost of the study and the site visit burden, and maintained high levels of patient retention by providing that kind of flexibility, she reports.

There are other intangible benefits, DiBiaso says, noting that members of a patient group took the microphone at a recent DIA show to say how much they enjoyed working with Sanofi and its patient-centric approach to designing trials. “That felt pretty good,” she says.

Related Resources

Learn more about implementation of patient centricity, social media, and mobile technology in clinical trials from these recorded ACRP 2016 Meeting & Expo sessions:

CRCs ‘Absolutely Critical’ to Success of Precision Clinical Trials

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Christopher R. Cogle, MD

New technologies and concepts are all well and good. However, they won’t advance precision clinical trials alone. The key to success? Clinical researcher coordinators (CRCs). That’s the verdict of one of the winners of a recent clinical trial challenge affiliated with the Harvard Business School (HBS).

“Without fantastic CRCs, we wouldn’t be as successful,” says Christopher R. Cogle, MD, a professor of medicine at the University of Florida and scholar in clinical research with the Leukemia & Lymphoma Society. The work of CRCs to recruit patients and capture clinical outcomes is “absolutely critical” to the entire process, he stresses.

HBS was recently part of a project that awarded $100,000 in prizes to the winner and two runners-up in its HBS/Kraft Precision Trials Challenge (PTC). “The objective of the challenge is to highlight innovations or ideas that show promise in either reducing costs or increasing the speed in which these go through the trial process,” says Robert S. Huckman, faculty chair for the Health Care Initiative with HBS. The PTC was the first research pilot for new HBS/Kraft Precision Medicine Accelerator, propelled by a $20 million gift from the Kraft Family Foundation.

“A CRC has to be well versed in this technology and its ramifications,” Cogle says. He works closely with his CRCs to help modify protocols as needed and educate them on the most appropriate way to collect specimens. “The gung ho CRCs get it,” Cogle says. They relish learning something new, they are excited by new technology, and appreciate that this can offer some new opportunity for a patient stricken with, for example, certain blood-related or pancreatic cancers. “CRCs want to help to offer patients a new opportunity to fight back,” Cogle concludes.

While the stereotype is that older employees tend resist change—especially new technologies—more than millennials, that’s not been Cogle’s experience. “Maybe I’ve been lucky, but the CRCs I’ve worked with embrace new ideas and new technologies,” he says. “That’s why they are CRCs. It’s the ‘R’ in the job.”

For more on this topic, check out the article on “Industry Embraces Precision Clinical Trials” in the forthcoming August 2016 issue of ACRP’s Clinical Researcher journal.

Learn More

Winners of the HBS Precision Trials Challenge were announced during a free ACRP Webinar on Clinical Trials Day (May 20). This free session explores new ideas in precision medicine and clinical trials.

Watch It Now>>

FDA Calls for Increased Clinical Trial Diversity

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Jonca Bull, MD, Assistant Commissioner for Minority Health with the Office of Minority Health

It’s time for the clinical trials industry to step up to the plate and do everything it can to champion diversity in clinical trial participants, says Jonca Bull, MD, Assistant Commissioner for Minority Health with the Office of Minority Health in the U.S. Food and Drug Administration (FDA). “Participants need to more closely mirror the patients who will ultimately use the medicine.”

A number of diseases impact some populations in different manners than others. For example, sickle cell disease primarily affects people of African and Hispanic descent, and Asian American communities report more hepatitis B. Currently, however, the majority of clinical trial participants are white and male.

Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials, says FDA Commissioner Robert Califf, MD. He cites a wide range of literature that has recorded this under-representation in recent years, particularly for women in some cardiovascular trials and general inclusion of black/African-American and minority participants in clinical trials.

The result? “We may miss vital data that could be used to…make better evidence-based, regulatory decisions,” suggests Bull.

Last month, the FDA launched a new diversity awareness program to coincide with World Sickle Cell Day (June 19), observed annually to help increase public knowledge and raise awareness of sickle cell disease.

For more on FDA’s “The Year of Clinical Trial Diversity” initiative, visit FDA’s Blog.

National Academies Report Calls for Withdrawal of Common Rule

Congress and the Obama Administration still have time for a critical “course correction” by withdrawing the Notice of Proposed Rulemaking for the “Common Rule,” according to the final portion of a report issued by the National Academies of Sciences, Engineering, and Medicine on June 29. The chair of the committee that wrote the report, Larry Faulkner, president emeritus at the University of Texas, Austin, hopes the recommendations will inspire changes that will lead to “significantly greater value to the public from the nation’s investment in research.”

The dust is still settling on the announcement, and that makes it difficult to discern the impact of the new report at this stage, says David Borasky, MPH, CIP, vice president of quality management at Copernicus Group IRB. “The call for the establishment of a national commission” could be significant, he suggests.

In several places, the report focuses squarely on clinical trials, including tasking a proposed national, independent commission with addressing how the basic ethical principles governing human subjects research should be applied to unresolved questions and contexts. For example, when the unit of intervention is a cluster or group, or when comparing the effectiveness of clinical studies of different experimental interventions for a disorder to determine whether one approach may be preferable.

Part one of the National Academies study was released last September. The full study was sponsored by the U.S. Department of Education and the National Institutes of Health.

With an election looming and control of the U.S. Senate and House of Representatives seemingly up for grabs, it’s unclear how quickly these recommendations might or might not move forward.

To read a recent article on the Common Rule coauthored by Borasky for ACRP’s Clinical Researcher journal, please visit http://clinicalresearcher.acrpnet.org/content/30/1/14.

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.”

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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).