Welcome to the November issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
Sites NOW Highlights Issues Impacting Site Operations in September Launch
“Our main goal here is collaboration towards information.” With these impactful words, the first-ever SCRS Sites NOW session was launched. In a dynamic session that attracted more than 80 clinical executives, unreleased data and industry perspectives were shared freely in a virtual environment that emulated the face-to-face energy of past Site Solutions Summits.
Sites NOW is a virtual discussion and content project created in response to the COVID-19 pandemic and focused on the changing landscape clinical research sites and industry partners face in 2020. Over the next 12 months, Sites NOW will provide a forum for content-sharing, open discussion, and networking among industry stakeholders, to include sites, sponsors, CROs, and solution providers. At each session, subject matter experts provide a 30-minute presentation focused on providing meaningful metrics and invaluable insight into one central theme impacting research today. Following the presentation, attendees participate in team breakout sessions to discuss industry standards, best practices, and pressing questions related to the presentation with the overall objective of providing information for site success.
While advancing site sustainability is the underlying mission of SCRS, Sites NOW delivers a platform to meet, share, and explore solutions that advance thoughts, best practices, and – most importantly – relationships.
The initial session tracked different industry perspectives on one central theme: why sites matter. Industry leader David Vulcano, vice president of clinical research at HCA Healthcare, kicked off the meeting by presenting new data from a recent SCRS Site Survey to convey the rich and varied perspectives on why sites matter in 2020. Mr. Vulcano provided a comprehensive overview of the evolution of the site and how its function has changed congruently with clinical trial format.
WHO OWNS A STUDY?
With the evolution of research, particularly in 2020, the answer could be “everyone involved.” While the pharmaceutical sponsor is arguably the owner, the site provides certain elements that the sponsor does not: the physical location of the study, the coordination of the study itself, the interface with patients. And those elements, Mr. Vulcano acknowledged, are more important than ever. According to Mr. Vulcano, the value of the interface opportunity provided by the site is at an all-time high. With patients at home in quarantine, face-to-face interactions are welcome – even when the average patient has to travel more than 25 miles to get to the trial site.
For patients and subjects, the site is indisputably essential; it is the central source to which the personal relationship is tethered. It is a trove of answers, help, and knowledge.
Mr. Vulcano averred that with different stakeholders funding and managing the study, responsibilities become fragmented such that the concept of ownership is challenging. Who owns the patient experience when the patient experience is so incredibly multifaceted that patients have their EKGs taken at home? And in such a situation, should the sponsor or the site be responsible for oversight?
The concept of a virtual and/or decentralized trial amplifies the challenging question of “who owns a study”? Mr. Vulcano disclosed that the primary concerns sites expressed were related to the unknowns associated with a study, such as patient safety and the lack of comfort level at the site. Another pressing concern is a straightforward one: the budget for this type of trial is simply too low.
While the complexities of study ownership are vast, the importance of the site remains paramount. Mr. Vulcano explored the unparalleled importance of sites to sponsors, CROs, communities, and patients/subjects. For sponsors and CROs, Mr. Vulcano reported that protocol feasibility and “hands-on” assessments available to the site are vital. Having hands-on assessments available at the site eliminates the guesswork inherent in telemedicine and reduces the likelihood of adverse events. Sites also have exclusive access to volunteers and unique understanding of local diversity and inclusion.
As for the importance of the site within the community, Mr. Vulcano revealed that sites are a rich resource of knowledge for experimental care options and regulations. Further, what the population considers to be a “new” therapeutic is something with which the site already has considerable experience. Clinical research sites also exert a positive local economic impact.
Prior to the meeting, SCRS queried its membership on the level of importance of site functions in clinical trial progression and completion. In order of “extremely” to “very” important, members identified:
(1) Subject recruitment and retention;
(2) Access to targeted subject populations;
(3) Promoting clinical trial awareness; and
(4) Providing feedback on study design
These metrics were discussed by Sites NOW breakout teams, who reached the consensus that these four items are preeminent among important site activities.
The site and its important functions have become the focus of global attention. Clinical research has taken center stage this year in a way that the industry could not have foreseen. While the fruits of clinical research dictate, prolong, and save our lives, the focus is not on the process itself but on the product. For those who are not a part of the clinical research world, access to the drugs and devices that treat and cure is simply an expectation, and they have minimal interest in their development. This year, that completely changed as clinical research was thrust into the spotlight. News articles, tweets, and press conferences are all focused on tracking the answer to the most important question: “When?”
Sites NOW discussions reflected and embraced this new normal. Attendees agreed that the site workforce has the potential to improve study outcomes when there is collaboration among stakeholders and when training is developed by sites and sponsors working in concert. “Collaboration is key.”
POST SUMMIT GLOW
Year after year, SCRS scrutinizes each post-Summit survey carefully and sees the same sentiment expressed by attendees: “I wish I could go to the Summit every month.” The “post-Summit glow” is a phenomenon known to all Global Site Solutions Summit attendees. After days spent absorbed in content-rich sessions and forging invaluable relationships, attendees leave with renewed energy and passion for clinical research. There is a burst of momentum that follows the Summit as participants leave with refreshed commitment to their work and to each other. It is a reminder that the clinical research community is vast and useful in its vastness for the ideas, research, and best practices that abound, yet also close-knit. After all, the research community is comprised of individuals who care: care about the survival and advancement of humanity, care about science, and care about each other.
The Sites NOW format was carefully crafted to capture the substance and energy of the Summit and share it each month. Clinical research has taken the global spotlight this year in a way that none of us could have planned for, and opportunities to engage with one another are imperative.
SCRS Sites NOW will be convening each month. For details, visit https://myscrs.org/scrs-sites-now/.
Sites NOW Supporters
Sites NOW Participating Organizations
AbbVie | Accel | Accellacare (ICON Plc) | Advarra | AstraZeneca | Bio-Optronics | BRANY | Bristol Myers Squibb | BTC/ClinEdge Site Networks | Clearwater Cardiovascular Consultants | ClinEdge | Clinical Site Partners, LLC | Clinical Trials of Texas, Inc.(CTT) | Clinical.ly | Clinvest Research | Complion | Covance | CTMD Clinical Research | DM Clinical Research | East Coast Institute for Research | Elite Research Network | Evolution Research Group | GlaxoSmithKline | Greenphire | HCA Healthcare | ICON, plc | Janssen R&D | LMC Manna | Research Medical deScriptions | Medix | Medpace | Meridian Clinical Research | Northwell Health | OrthoIllinois | Oviedo Medical | Research | Parexel | Pfizer | PharmaSeek | PMG Research | Prime Site Research Solutions | RealTime Software Solutions | Ripple | Science Corporation | Roche | RX Trials | Sanofi | Sentral Clinical Research Services | South Broward Research | StudyKIK | SubjectWell | Suncoast Clinical Research | Syneos Health | Synergy Clinical Research | Total Clinical Trial Management | Trifecta Clinical | Veeva | Veterans Research Foundation of Pittsburgh | VirTrial | WCG
SCRS Eagle Award
A Letter from the 2020 SCRS Eagle Award Recipients
To our Site Partners,
We can think of no greater honor than to have earned your vote for the 2020 Global SCRS Eagle Award, for the second year in a row. This award is recognition of the clinical trial excellence that we are achieving together.
This year has been truly unprecedented, one which has impacted many of us both personally and professionally as we face this devastating pandemic. Recognizing that many of the steps we had to take in the past nine months created additional burdens for our sites, we want to thank you for your patience, commitment to your study participants, and continued support of our shared clinical work. We are deeply grateful not only for your partnership in our clinical trials, but also for all the work you have been doing in your local communities through this global health crisis.
We would also like to say thank you for the incredible support and flexibility we’ve received from our CRO partners. While this year has certainly not been easy, it has taught us what is possible when we come together and truly work as one team.
The honor of this award isn’t just given to Pfizer – it’s shared with all of you.
On behalf of everyone at Pfizer, thank you for your votes, for your essential partnership, and for the important work you do on behalf of your study participants.
Head of Global Study and Site Operations
Site Colleagues –
Strong relationships between sponsors and investigators, site staff and patients are the centerpieces of any clinical trial. In a year when those relationships became even more critical to moving medicines forward, we were so honored to be recognized by sites with the Eagle award for the fourth year in a row.
I’ve never been prouder to work in the industry. All of you – site colleagues around the world – have inspired me and my colleagues at Syneos Health as we’ve watched you accelerated patient-centric of working to navigate the challenges of COVID-19. Our shared purpose of bringing important therapies to patients has never been stronger, and we look forward to continuing to learn from you and collaborating with all of you as we move through the pandemic and beyond. To all sites, thank you for what you do, every day, especially during these unsettled times. We simply could not do what we do without you. A heartfelt thank you and sincere appreciation to clinical trial volunteers for making clinical development possible.We also want to call out the ongoing leadership from everyone at SCRS, THE organization that provides a voice for sites – we know the industry is in a better place because of it. The team are all simply amazing and proudly nurturing an incredible legacy left by their inspirational founder, Christine Pierre.
At Syneos Health, establishing and maintaining strong relationships with sites is embedded in our business model, and we could not be prouder. As we close out the year, our commitment to you is that we will continue to harness site feedback and insights to drive continuous improvement and proactively seek to address site challenges. This includes accelerating site holdback payments, incorporating new technologies to improve enrollment, streamlining investigator site payments, and providing practical and operational approaches to bringing patient-centricity and engagement into trial design.
On behalf of every-one at Syneos Health, a sincere and heartfelt thank you. Stay safe.
Executive Director, Site & Patient Services
SCRS CKP Award
Christine K. Pierre Site Impact Award Recipient Kay Scroggins
Kay Scroggins has been recognized with this year’s SCRS Christine K. Pierre Site Impact Award after being involved with SCRS from its earliest years. This year, Ms. Scroggins was chair of the SCRS Global Site Solutions Summit, work that started in January and went through the challenge of transferring the conference to a virtual experience.
When asked about the challenges of transferring to a virtual format, Ms. Scroggins credited the SCRS staff for the work they put into organizing the event. Her job was to lead the planning committee. “The purpose of the planning committee is to come up with the content and focus of the conference,” Ms. Scroggins explained. “What are we hearing, what are people struggling with, what do they need information about.” The committee was able to meet face-to-face in January, in a structure organized and supported by SCRS staff. It turned out to be the only time the committee was able to meet in person.
Remembering the first Site Solutions Summit, Ms. Scroggins said, “The first summit was the first time sites came together to discuss how they do business. In the years since, the presentations have gotten more sophisticated and topics have gotten more complex.” Those first years started the conversation.
“Now the sites have a voice, that’s something that has been built out of the Summit and it’s a story we need to tell and re-tell,” said Ms. Scroggins. “This is the story of a visionary. Christine Pierre brought the sites together, and she didn’t just bring the sites together she also brought in the CROs and the sponsors.”
Unlike some conferences where attendees may attend every few years to catch up, the SCRS Site Solutions Summit is based on repeat attendees and multi-year ongoing conversations. Every year, these conversations are able to go deeper and deeper into specific elements of site management because of the community that has developed.
The conversations have built into benchmarking projects, with the Site Landscape Survey at the forefront. “We developed business standards and expectations. How much revenue should be associated with a study coordinator? What are the standards for productivity? That’s what Christine gave us: she gave us information,” said Ms. Scroggins.
It was important that the SCRS Site Solutions Summit have system support and people support that allowed both the information and the community aspects to thrive. The organization of the Summit ended up being a mix of information sessions with speakers and panels along with therapeutic area sessions that were less structured and just gave attendees an opportunity to talk among themselves.
“Christine always talked about how important the people ‘off the stage’ were – they’re the people that make the Summit,” said Ms. Scroggins. “So in continuing her vision, the Summit was designed to bring in everyone’s voices. And SCRS has Sites NOW, which is continuing that format throughout the year.”
As the sites continue to use their voices, individuals like Kay Scroggins will be here to tell the story of how that vision came together.
SPRIA Recipient: COVID Heroes
Cindi Nellis knew Clinical Trials of Texas had created something remarkable. “We had never seen such an enormous response from so little spent,” she remembers. “5,000 new people!” In a pandemic and not certain whether the SCRS Global Site Solutions Summit would even be able to be held, she submitted the story for the Site Patient Recruitment Award (SPRIA). After it was presented at what turned out to be a virtual Summit, their recruitment program, “COVID Heroes,” won.
The project started with a meeting with the staff. The team had always looked beyond clinical research for more effective marketing. “We look outside the clinical research industry,” explained Ms. Nellis. “What are the big brands doing? We go to conferences in marketing that are mainly not medical businesses.”
“We were thinking, how can we help our patients now? So we did a poll and found out a lot of them had lost their jobs because of COVID. Well, we have an HR department, we have people who can provide information about how to manage that situation.” By the time the project had finished its major push, the team had created more than 200 pieces of content about dealing with situations created by COVID.
“Patients responded to what we were doing,” said Ms. Nellis. “They said, ‘You really understand us.’” Ms. Nellis credits the workforce at Clinical Trials of Texas as well as the polling of patients. Building a diverse workforce has meant they already have connections across the community and people who can both listen to their neighbors and speak to them effectively.
So what happens next? “We’re definitely not going to stop, the community needs us. They need to understand what clinical research is doing,” said Ms. Nellis. However, the strong response has presented some challenges. It’s not just that the pace of content creation wasn’t sustainable: “The rest of our organization has had to answer all these calls. We had to hire more people for the phones. As an organization, Clinical Trials of Texas is catching up to what they created. Looking at the long-term plans, Ms. Nellis said, “It needs to be more of a movement than a campaign.”
SCRS Site Tank
Q & A with Site Tank Recipient Lukasz Wiech, Associate Director, Sites, Accelerated Enrollment Solutions (AES)
Question: How did your response to needing to remotely contact patients start? Did anything change as you developed your remote contact system?
Answer: Accelerated Enrollment Solutions (AES) and the PPD organization as a whole were already making the transition to remote contacts even before the pandemic arrived because we believe it will be an important form of communication in clinical trials in the future. The pandemic has simply accelerated our work on it. We believe it will lead to better understanding of our work among patients and better overall satisfaction with our service. We were pleasantly surprised with our patients’ openness to and understanding of the new approach, proving to us that our fears about our future success were unnecessary.
Question: At first, the system was just to solve the problems created by the pandemic. But you said that then you saw some other benefits. What were they?
Answer: We have fewer patients at our sites, which means our employees and the patients themselves are safer during the pandemic because of the greater physical distancing it affords. For our patients, it also means they don’t have to travel as much. At the same time, we did not experience any drop-off in qualification visit quality or information compared to the traditional model. And we’ve seen more consents compared to “old times.” All of that is thanks to more informed communication and better managing of expectations.
Question: What has it taken to get the most out of your system? What changes to how people act were needed – from staff, patients, industry?
Answer: First of all, we had to convince ourselves that tele- or videoconferencing with patients can be equivalent to live contacts in terms of asking questions and obtaining answers. Our outstanding Virtual Screening Team members were perfectly prepared for this new task as they worked with our patients to help them understand how much easier the remote approach can be. Our professionalism and readiness to assist them definitely helped us to build a solid rapport with our patients.
According to our business contacts, it was appreciated and understood that we want to continue our work even in such demanding circumstances. To date, we have held more than 50,000 virtual visits, saving hundreds of thousands of hours of our patients’ time that otherwise would have been consumed by travel. We’ve also been able to identify thousands of patients who are eligible and eager to consent and participate in clinical trials in our safe site environment.
Question: Now that you have had this success, are there more changes that you want to make?
Answer: We plan to incorporate this methodology at our local offices and sites across the globe. We are discussing opportunities to develop this tool and add new simple and helpful features to enhance its capabilities. It is not easy to develop revolutionary ideas in such a standardized environment as that of clinical trials, but we are still working to remain at the vanguard of positive change.
Question: SCRS is part of #NoGoingBack, a commitment to keep the advances that we have made in clinical research in response to the pandemic. How will you keep the benefits of your system as life returns to something like normal? Or, alternatively, what do you need from industry to be able to keep the benefits of your system
Answer: We absolutely support the #NoGoingBack campaign! No matter what changes the future brings, all of the advances of clinical research have to be preserved and expanded. We owe it to the generations coming after us.
This new solution utilized by AES is now a regular part of our business and will stay with us after COVID-19 has passed. We are routinely looking for new opportunities to change the future for the better, to support clinical trial recruitment and conduct those trials in the best ways we can.
What we need from the industry and regulators is continuous support and openness for new ideas, such as electronic source documentation, e-consent (which is still not used in many parts of the world) and other virtual solutions for the increasingly demanding times ahead of us.
Adapting Clinical Trials During COVID-19: Solutions for Switching to Remote & Virtual Visits
In the clinical trials community, nearly every aspect of research is experiencing unprecedented disruptions due to COVID-19, especially to those trials that were mid-stream when the pandemic hit. The Clinical Trials Transformation Initiative (CTTI), a leading public-private partnership, recently held a webinar to help the clinical trials ecosystem adapt to one of the most common challenges – the swift switch to remote and virtual visits, which has left many sites in uncharted territory.
Even still, stakeholders across the research community are rising to meet these new hurdles by adapting approaches and discovering new best standards for conducting clinical research in today’s new normal. CTTI’s webinar specifically addressed strategies and solutions to help sites with the switch to remote and virtual visits.
The strategies for switching ongoing trials to remote included:
- Virtual (audio/video) or remote visits from alternate sites
- Remote lab collections/assessments at nearby facilities or mobile labs
- Drug shipments directly to patients
- IV drug administration closer to home
- Electronic completion of PRO, QOL, and other questionnaires
- Minimizing unnecessary research and only conducting blood draws or biopsies
The webinar reported on findings from a CTTI survey of stakeholders to identify challenges and solutions for using telehealth for clinical trials, as well as a survey co-hosted with Evidation Health, Inc. to get insights and perspectives from patients. Overall, there was a strong consensus that COVID-19 has changed clinical trials in many ways, for everyone involved, and that we should apply these new virtual and remote approaches to future trials, when appropriate, post-pandemic.
Learnings from this webinar are now captured in CTTI’s new playbook for conducting clinical trials during COVID-19.
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 9,500 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.