SCRS InFocus Archive – May 2021

On May 20, we’re enthusiastically celebrating Clinical Trials Day and what it means for all of us in clinical research. Last year, the SCRS team created the #SCRSRiseUpTogether video to encourage the clinical research industry to stay strong and rise up stronger and better than ever through COVID-19. A year later, we have remained resilient and found ways to continue to connect to one another through online communities, webinars, virtual summits, and more.

This Clinical Trials Day, we asked our site member community for one word to describe what working in clinical research means to them this year. Some of the answers included perseverance, innovation, growth, dynamic, and faith, among many others that convey our collective hope for how far we’ve come and what the future holds.

What does working in clinical research mean to you right now? 

SCRS members and partners shared their thoughts in a short video.

We also have a special episode of the SCRS Talks podcast featuring Pfizer’s Liz Rogers, Head of Global Study and Site Operations, and Sarah Tweedy, Vaccines Clinical Operations Head, who shared some insights about Pfizer’s journey through COVID-19 and thoughts on what trends and changes are unfolding for the industry.

Right now, the SCRS team is planning for the Global Site Solutions Summit, which will be in person this October in Hollywood, Florida. Whether you’re getting your team together for the first time – or the first time in a long time – the SCRS Global Site Solutions Summit is the best place for you and your team to connect with sites, sponsors, CROs, and solution providers. We will keep all attendees updated with planned safety precautions, including sanitizer stations, temperature checks, reduced capacity throughout the conference and exhibitor areas, and enhanced and more frequent cleaning throughout the hotel and conference areas. Register now to be the first to know which speakers and panelists we have selected for industry-leading and data-driven sessions that will drive the future of the clinical research industry!

Arnaud Dourlens Shares Insights on Clinical Trials Day and the Future of Clinical Trials

As we commemorate Clinical Trials Day on May 20, it’s the perfect time to take a step back and consider how far we have come as an industry – especially in the wake of COVID-19. This year, ACRP’s Clinical Trials Day’s theme is “We Rise”, which could not be more applicable to the innovative collaboration and resilience happening throughout the clinical research community right now.

Arnaud Dourlens, Head of Clinical Supply Chain Operations at Sanofi, shares what Sanofi is doing to support site sustainability and patient-centricity for Clinical Trials Day. “In addition to proudly sponsoring the Association of Clinical Research Professionals ICTD online events, we have several activities planned to highlight the significance of clinical trials through personal testimonials and celebrating the many ways clinical trials have improved quality of life for millions of people around the world,” said Dourlens. “We are also holding our first virtual 5K for employees to show how we Go the Extra Mile for Patients.”

“All of us at Sanofi are extending our appreciation to the many thousands of dedicated clinical research professionals around the world who undertake a career in clinical research to advance medicine and treatments for patients’ needs.”
Ultimately, Dourlens believes that the future of clinical trials will be more patient-centric than ever before. With the increase of technologies such as connected devices, advances in-home delivery, and improved virtual communication, clinic visits can be conducted at a time and location more convenient for the patient. Dourlens expanded, “We are going to empower the patient, giving them a better understanding of steps and interactive access as protocol progresses.”

“We will be able to capture rich data which will reflect a global view of patients and all of the data linked to the health of a larger population – allowing us to gain a deeper understanding on what are the parameters influencing clinical trials on the wider population. This will be helpful to the entire research team to understand the different effects within a trial of the treatment and to adapt and optimize the protocol accordingly,” Dourlens shared. “Clinical trials will become known as the gold standard of care.”

Built-in sensors in clothing, phones, and household devices may be able to collect data from patients, effortlessly and continuously, 24 hours a day, and this data will allow sites to adapt more quickly to protocols and conduct more trials. Providing study coordinators with a real-time, holistic view of a patient’s health, these adaptive trials may have the potential to improve trial success rates and significantly reduce time and resource costs. This data will truly empower decisions for sites, as they will be able to access and understand this data and use it to improve operations and patient engagement.

According to Dourlens, a major challenge in clinical operations is guaranteeing treatment availability at the right time and in the right place across the globe despite huge uncertainty on recruitment location. Sanofi found a way to improve the process to benefit investigators and ultimately patients by employing machine learning for trial supply management.

He added that despite high scarcity of some innovative drugs, utilizing machine learning and AI makes it possible to speed up access to treatment and secure availability for the patient – creating greater efficiencies in clinical trials. It’s imperative that sites have an understanding of this technology so they can utilize it properly and educate study participants on its functionalities as well.

To support its ultimate goal of supporting efficient trials for sites and patients, the SMILE (Sanofi Making Investigators Lives Easier) Program launched three years ago to conduct clinical trials from a site-centric perspective with the goal of improving trial efficiency and helping patients get needed medications faster. Before kicking off the program, Sanofi spent ample time really looking at clinical trial efficiencies with an eye toward reducing the burden on clinical research sites to make it easier for sites and patients to contribute to a greater extent.

As we all continue to look for ways to support site sustainability, patient-centricity, and optimize processes in clinical trials, it’s more important than ever for sites, sponsors, and patients to be able to collaborate and communicate efficiently and effectively. And, Sanofi agrees that the importance of the site voice in this unified vision cannot be understated. SCRS and its network of sites and partners are encouraging dialogue and working to find solutions through collaboration so that together, we can rise to embrace the future of clinical research.

Clinical Tech: The Good, the Bad, and the In-between of the Site Experience

Wayne Baker
Chief Commercial Officer
Greenphire

The March meeting for the SCRS Sites NOW program talked about Clinical Tech: The Good, the Bad, and the In-between of the Site Experience to discuss when clinical tech toes the fine line between beneficial and burdensome. Industry leaders Wayne Baker, Chief Commercial Officer of Greenphire, Bill Dirkes, M.D., M.B.A., Founder and President of DocuTrial, and Taryn Collett, CCRC, Regional Director of Clinical Operations at Meridian Clinical Research spearheaded a compelling panel discussion of the opportunity of clinical tech in 2021.

Panelists acknowledged that clinical tech had garnered a spotlight in the decentralization driving pandemic-era clinical research, as it was essential in the facilitation of remote data collection. They contemplated three central questions: How can service providers optimize products? How can sites facilitate smooth implementation? And how can sponsors help?

The responses to these queries tackled each pivotal point in the sequence of inception of the service to its actual deployment in a study. First, in the design phase, communication is key. Service providers need to listen to sites to understand precisely what their needs are. In breakout discussions, site executives stressed that their highest priorities for product investment were those centered on integration, compatibility, single sign-on capability, and study dashboards. It was suggested by panelists that service providers survey customers regularly on their evolving needs so that the product devised will meet them.

Interspersed in the discussion were various interactive polls. When asked as to the number of systems used by site staff, 35% said more than 15 – while not surprising, that is a staggering number. The learning curve, plus maintenance of so many clinical trial technology platforms can be more than some clinical research sites can support, leading to the dreaded “one and done syndrome.”

Technology can certainly provide solutions to many site challenges, but at the same time, can add complexity and be a drain on resources if not implemented well. The panel tackled these issues head-on, with the following taking center stage:

• Purpose-built technology: In order for technology to truly solve the workflow challenges often experienced by sites, it’s essential for systems to be specific to clinical research and understand the day-to-day experiences of researchers. Rather than just any telemedicine program, it is crucial to have platforms that embed clinical visit data in one integrated view. Furthermore, instead of using traditional accounts payable methods or basic gift cards for patient payments, it is much more efficient for site staff to use an integrated payment platform for patient reimbursements with patient visit schedules and other control mechanisms built into the system.
• Platform Integration: Simply put, sites don’t want to use disparate systems. They’re looking for an integrated experience. Creating synergies through systems such as the Shared Investigator Platform (SIP), which can bring together many solutions into one interface to simplify site staff user experience.
• Feedback loop: When creating technology tools or enhancing existing software solutions, it is essential that this isn’t done in a vacuum. Involving sites in roadmap planning can help ensure that the tools developed will work as needed and thereby adopted. Examples can include regular satisfaction surveys, user forums, and more. Another quick tip on how to ensure that new innovations will be embraced by sites is to inquire about other applications currently a part of their environment. What CTMS is being used and why? What patient survey tools are becoming preferred? Look for leading solutions that have gained market traction and endorsement by sites and participants. Sponsors are wise to assess and consider software solutions that can be used on a broad scale and become a standard part of their toolkit.
• Technology Training: In addition to developing software solutions with the site experience in mind, it is crucial that site users are properly trained on how to use the tool effectively and also what’s in it for them. Once implemented, there is a greater chance for success when staff are properly trained but are also motivated to use the tool because they recognize the value it provides to them and their organization.

The Future of Technology

Technology is leading the transformation of daily activities in both our personal and professional lives. For clinical research sites, technology can automate labor-intensive processes, mitigate errors thereby improving the overall quality of their work and ultimately help sites achieve desired outcomes more quickly and with less cost.

Yet any change can often bring fear or even resistance. The session further explored ways to overcome these hurdles, specifically by channeling the emotions that employees have and reminding them about the value that an effective technology solution can provide. So, we should listen intently and tackle trepidation and resistance head-on. Oftentimes, early resistors can be converted into your best champions of technology and innovation.

One sponsor in the breakout talked about the importance of communication when driving adoption of technology. Specifically, she conveyed that ROI must always be communicated to sites upfront and throughout – why the technology will make processes easier and replace the pain points of the past.

It is vital that sponsors, CROs, and clinical research sites fuel the innovation path with solution providers.  It is of equal importance that those solution providers actively listen to the needs of their customers and use it to prioritize their innovation roadmap. It was enforced that the service provider’s job is not done when the product is up and running at the site. Instead, there should be a continuing relationship with open communication that solicits feedback from users constantly. It was proposed in the breakout discussion that a chat feature be part of each product so that users can receive on-the-spot assistance when faced with a problem.

A theme that emerged in the discussion of the sequence of service selection and implementation is the need for collaboration. One clinical executive provided a succinct summary of this sentiment: “We need more synergy. Synergy between the creators of clinical tech, the sponsors who select them, and the sites who are using them.” Once this is attained, the frontier of clinical tech in 2021 and beyond will be boundless.

And with the Society for Clinical Research Sites doing the great work that they do and creating forums such as the Sites NOW program, we will be firmly on a path to ensure the site experience is properly represented in the advancement of all clinical technology solutions.

About the Author:

As Greenphire’s Chief Commercial Officer, Wayne is responsible for the global commercial strategy of the rapidly growing organization, including the execution of sales and marketing programs. Wayne is a proven strategic sales executive with more than 25 years of commercial experience in technology and life science industries.

Prior to joining Greenphire in 2016, Wayne served in numerous senior leadership roles at Advanced Health Media (AHM), a leading global provider of SaaS-based solutions designed to manage compliant interactions with healthcare professionals and organizations for the highly regulated life sciences industry. During his tenure, Wayne helped establish AHM as the market leader, playing an integral role in the organization’s 1500 percent revenue growth during a four-year period, with continued global expansion thereafter. Earlier in his career, Wayne gained sales leadership and industry experience at Parametric Technology Corporation (PTC) and Brent International. He earned his bachelor’s degree in Chemical Engineering from Drexel University.

Wayne resides in the Philadelphia area with his wife and four children. When not tending to business matters, Wayne is a dedicated coach and active spectator of his children’s sporting events, and also enjoys playing golf and entertaining friends.

Patient Engagement: What Matters Most

Ken Getz
Founder and Chairman, CISCRP
Director, Research Professor, Tufts University

April’s Sites NOW meeting with Ken Getz of CISCRP and Tufts Center for the Study of Drug Development and Casey Orvin of StudyKIK explored what successful patient engagement looks like, and how we can strengthen it throughout the pre-study, post-study, and touchpoints in between. Now more than ever, successful patient engagement practices include convenience, connection, trustworthiness, and truthfulness.

From the April Sites NOW discussion, it was clear there is a prominent opportunity to develop a content marketing strategy that can be shared from site to site to help them get started building awareness and engaging with their local and target communities through social media, video discussions, text messaging and more. It was clear that activating a “one size fits all” approach to recruitment and patient engagement will not be successful if we want to reach and establish trust within diverse patient communities. Multiple forums for disseminating messages are needed as well as empathetic, personalized and strategic messaging to develop meaningful and beneficial relationships with patients. By finding ways to foster relationships within communities, we can better understand the patient profile and create an experience to keep them informed and engaged about clinical research.

A compelling challenge the industry is working to address is increasing awareness and literacy surrounding clinical research as a whole. A 2017 CISCRP Perceptions & Insights Study showed that a majority of the general public doesn’t know where clinical research is conducted, can’t name an agency that oversees safety, are not aware of how much time it takes to develop a new medical therapy, and can’t name a living scientist in clinical research. During the pandemic, the number of people who perceived clinical trials as unsafe and who were unwilling to participate in a study increased substantially.  When patients have a better understanding of what clinical trials are, how they work, and their impact on society, the industry can establish and maintain trust with the public that will shift towards easier recruitment and engagement.

Social media use has soared during the pandemic, and our industry has a unique opportunity to connect with patients like never before. Within online communities, communication should be focused on more than posting and discussing trials. Sharing entertaining content that is relatable to patients is a simple way to keep patient communities interactive in meaningful ways. Engaging with these communities will also allow us to offer greater transparency and disclosure about clinical research processes. To strengthen patient engagement post-study, it’s critical to convey appreciation and value and establish ongoing connection and support. Post-trial, CROs can share results of studies so study participants can better understand the value of their participation.  Then, patients may be will be more willing to share their trial experience with others.

Continuing to minimize the complexity of patient experiences and creating convenient procedures and protocols is another top priority to facilitate better patient engagement. Patient Advisory Boards and Professional Advisory Panels are some of the top patient-centric activities currently being implemented and piloted among clinical research organizations. Utilizing emerging strategies and technologies that were deployed in recent years or due to the pandemic can continue to help increase patient engagement in trials as well, including telemedicine, remote monitoring, eConsent, home visits, wearable devices, direct-to-patient drug delivery, and other modalities. By increasing convenience of participating in trials, we can increase willingness to participate and keep patients engaged throughout the trial and beyond.

April’s Sites NOW meeting also discussed the importance of engaging with healthcare providers and keeping them informed of study opportunities so that patients will be much more likely to participate in a trial. According to a 2019 survey by CISRP, 83% of patients consider their physician’s recommendation a top factor influencing their decision to participate. Additionally, 68% of patients rate their HCP as the top preferred source for information about clinical research and 71% of patients say that they would speak with their physician or nurse prior to deciding to participate.

Building a relationship of trust through consistent and predictable interaction over time (BRT) should be the focus for stronger patient engagement strategies. It’s imperative for sites to be committed, dedicated, and engaged with patients and HCPs. Once we have established trust, we can facilitate discussions, garner feedback, and hear insights and concerns directly from patients.

Join the next SCRS Sites NOW meeting, convening every month. For details, visit https://myscrs.wpenginepowered.com/scrs-sites-now/.