Welcome to the June issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
- SCRSConnects: Exclusive interviews with industry leaders. This month: Carol Zhu
- MetricsThatMatter: Unique and current metrics supporting your success.
- ACROUpdate: Insights from influential industry stakeholders.
- SiteSpotlight: Site stories of innovation and success. This month: Centennial Medical Group
As one of the first people to bring clinical research to China, Carol Zhu is passionate about improving the quality of communication and training in the field. She began working as a pharmaceutical researcher in China after graduating from Peking University in 1990, but the job didn’t fulfill her desire to work with people so her time in the position was short-lived. “I wanted to interact with people, not mice and rats, so I took a position in marketing and sales with Merck & Co.,” Carol said. Though her passion was more on the research side of the industry than the marketing, she felt that this opportunity was more likely to point her in her desired direction. Not long after, Merck hired Carol as their first clinical research associate (CRA) in China, where she spearheaded the creation of training programs to inform local professionals about clinical research.
“People in China were not aware of clinical research or what it was twenty-five years ago,” she shared. “There was no ICH or GCP, and no one knew what a clinical research associate was.” Carol decided to change this and created training on GCP, operations and other topics important to the efficacy and awareness of clinical research in China. She worked for Merck for 12 years to advance training in clinical research in China and progressed to senior management roles before moving on to other initiatives including managing GSK’s Shanghai R&D center; partnering with the Fudan University Shanghai Cancer Center to found START Shanghai, a Phase I oncology research center; and supporting the development of the Bill & Melinda Gates Foundation’s China-based R&D center. Carol is currently the managing director of Drug Information Association (DIA) China, where she leads the development and implementation of the organization’s strategies to increase membership, knowledge and impact for all organizations working in clinical research.
While Carol’s breadth of experience is impressive, her passion has not changed. Working with others is what keeps her excited about her work. When offering trainings, she often shares with young professionals new to the industry the importance of understanding their passion. “Your passion is what drives your level of commitment to the work you do. This is important when working in a field that so deeply impacts people’s lives.”
Equally as important as a person’s dedication to their work in clinical research is the quality of their communication. Often the focus is on improving communication between sponsors/CROs and sites. This is integral to improving the industry as a whole, but we can’t overlook the importance of communication within each sponsor, CRO and site organization. “Ultimately we all work for the patient,” Carol said. “In order to bring the highest benefit to patients, we have to create teams that work well together.” Carol works diligently to not only increase the knowledge base of clinical research professionals, but also to improve their connection to their passion and quality of communication.
Her work has paid off in dividends: China has seen great breakthroughs and reforms in the last two years, and the DIA and Carol have played important roles in some of them. China became an ICH member last year, and the DIA helped facilitate many conversations and related training and workshops. The DIA is currently developing a training program for oncology research sites that will offer a research training curriculum to assist industry leaders who are trying to get into the field.
When asked what advice she would pass on to clinical research sites to help them increase their sustainability, Carol mentioned two things: “Train your staff, then train them some more. And don’t overlook the spirit of your team – how can you motivate them to work together? Empowering your team to bring new ideas and projects that people can learn from will line you up for success.”
The Budgeting Dinosaur Age: Modernizing Site Payment Frequency
The frequency with which sites receive payments from their funders is a topic of frequent discussion in the clinical research community and ties directly to the history of data entry. Twenty or more years ago, sites recorded study data on paper and had to enter it using a manual process, which meant that they were often behind on data entry. Funding partners understandably adopted quarterly payment terms which reflected this lag time. Twenty years ago, this made sense and resulted in sites receiving payment around the same time that funding partners received the data.
Along came technology, which revolutionized the way sites enter and submit data to sponsors and CROs. With the manual processes sites used to have to complete removed, they are now able to enter and deliver data to their funders with significantly less lag time. There is room for sites to improve here, as data are not regularly entered in real time even when the sites have the capability to do so, which contributes to perpetuating payment delays. Dramatic improvements have been made, however, and despite the improvements to site delivery processes and timelines, sponsors and CROs haven’t matched this with an improved payment timeline.
When it comes down to it, sites are hired to perform clinical trials and provide quality, reproduceable data. The industry has implemented some improvements that have made payment for these activities more efficient. However, payment processes continue to be tied to the legacy of data transfer, with many sponsors/CROs still utilizing quarterly payment terms. As shown in Figure 1, 50% of sites were still being paid quarterly in 2017. Sponsors and CROs are making changes, as reflected in the ~20% decrease in quarterly payments to sites compared to 2015. At the 2017 SCRS Global Site Solutions Summit, many sponsors and CROs publicly shared the changes they have implemented to improve site payment terms, with Eli Lilly and Company and Syneos Health recognized as the winning sponsor and CRO of the 2017 Eagle Award.
Unfortunately, though, not all funding partners are on board, and this impacts not only sites’ bottom lines but also their desire to partner with sponsors and CROs who haven’t updated their payment processes. As shown in Figure 2, a Greenphire survey indicated that 60% of sites are dissatisfied with payment frequency, visibility, speed and flexibility; 80% of sites prefer to be paid monthly (contrast that with the 30% of sites who reported receiving monthly payments in 2017); and 59% of sites indicate that quarterly payment terms have a negative impact on the study. While all parties involved in a clinical research study prioritize the patient first, sponsors and CROs should take note that if a site must choose between a study that pays quarterly and a study that pays monthly, the choice is clear. This isn’t something that sponsors/CROs want to hear, but sites often feel forced to make these choices as they simply can’t afford to continue paying for study activities without receiving timely payments. We wouldn’t continue to work if our company took three months to pay us, and sites don’t want to function in that environment either.
The SCRS CALL TO ACTION is twofold:
- Sites need to understand the importance of entering data in real time and implement this practice per SCRS Best Site Practices recommendations.
- Sponsors and CROs need to pay sites in real time.
Although the data entry process has improved dramatically, payment processes are lagging. Implementing real-time practices on both sides of the industry will benefit all involved.
ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers in Inclusion and Exclusion Criteria
Clinical trials have an enormous number of inter-related moving parts, and large global clinical research organizations (CROs) mirror that complexity. When we examine questions of trial participation such as criteria for inclusion and exclusion, CROs approach the issue from a variety of perspectives. There are considerations related to regulatory intelligence and study start-up, feasibility, design, patient recruitment, site management and the sphere of global operations surrounding modern trials.
As mandated by the 21st Century Cures Act, the FDA and the Margolis Center for Health Policy convened a public workshop entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials” on April 16 at Duke University. Joined by stakeholders from the NIH, FDA, patient groups, pharmaceutical and biotech companies, academics and public health practitioners, ACRO’s Executive Director, Doug Peddicord, shared the CRO industry’s unique perspectives. This public event saw discussion on a variety of topics related to eligibility criteria in clinical trials, their potential impact on patient access to investigational drugs, and how they might facilitate the enrollment of a diverse patient population.
The central issue identified by the attendees was designing and executing a clinical trial that accurately differentiates the signal from noise – assessing a candidate drug’s effect – and finds a balance among the variables. Finding that signal also means accounting for probability, effect size, power and sample size. All these have to be considered without breaking the bank.
Increasingly, sponsors and CROs aim to model complex trial variables and their interactions. With the growing use of technology and data sources like electronic health records and real-world evidence, data analytics can be used to predict issues like how “recruitable” a trial will be and the applicability of the results. A foundational issue is the criteria used to determine trial participation. Meeting participants agreed that trial protocols need to be less complex and impose fewer burdens on investigators and patients alike.
Expanding participation will require thinking outside of traditional clinical research models. Successful trials will incorporate patient preferences during the study design phase, gather patient experience data and use virtual trials to help patients participate as part of their normal clinical care.
As the stakeholder meeting demonstrated, there is no shortage of complexity in clinical research. CROs will be at the forefront of innovation to help ideas become medicines. For more details about the topics and presentations or to watch a recording of the entire meeting, visit the Margolis Center.
Centennial Medical Group is a large internal medicine private practice located in Elkridge, MD. Under the leadership of Steven Geller, MD, who serves as medical director and lead principal investigator, the organization has reached a milestone that all research sites strive to achieve: Centennial Medical Group was recently recognized for superior performance and quality in clinical research by IQVIA’s Prime and Partner program and has been identified as a site of choice by many other sponsors and CROs we work with.
For the past 13 years, the research department has consistently met or exceeded enrollment goals on 90% of all trials conducted. According to Dr. Geller, “The key to successful enrollment is carefully choosing studies that fit within your patient population. It is one thing to have patients in your site’s database. The real challenge is how to access those patients and bring them to trials.” Centennial Medical Group has dedicated time and personnel to ensuring that they meet quality and enrollment metrics, and they utilize our EMR system to conduct a thorough feasibility assessment for each trial they conduct. Since 2005, CMG has successfully completed more than 80 trials.
Although CMG mainly focuses on internal medicine, its research department has successfully completed trials in most therapeutic areas including vaccinations, pulmonology, men’s health, pain management, neurology, dermatology, urology and endocrinology. CMG has also had great success conducting studies in the areas of osteoporosis, smoking cessation, obesity, and influenza.
CMG has recently expanded by opening an urgent care center as well as collaborating with a gastroenterology practice and a nearby neurology practice that focuses on movement disorders. These opportunities give the research department the ability to conduct more specialized trials in those therapeutic areas.
Dr. Geller is excited and confident about the future of research at Centennial Medical Group. In 2015, he purchased the Rx Trials site network and continues to expand his contribution to research. Centennial Medical Group is part of the Rx Trials, LLC Network.
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Founded in 2012, SCRS is a global trade organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,000 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, connectivity and mentorship. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community.