Welcome to the October issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
Articles in this issue include:
- SCRS Current: Site Tank and SPRIA finalists wow at the Global Site Solutions Summit.
- SCRS Connects: Chris Trizna, president and founder of CCSi, found purpose in clinical research.
- Listen Up: “Patient-centricity” is not a term commonly used by site leaders.
- Metrics that Matter: We asked what “patient-centricity” means to you.
- Site Focus: Clinical research sites in Puerto Rico help others as they rebuild.
We always love to hear from you, please let us know what you think or would like to hear profiled next month.
More than 900 site and industry leaders gathered in Boca Raton, FL at the largest Global Site Solutions Summit ever. The exhibitor hall featured our first pharmaceutical company exhibitor, Pfizer, demonstrating the importance industry sees in connecting with sites.
Congratulations to SCRS Eagle Award winners Eli Lilly and Company and INC Research/inVentiv Health! After initial nominations, these winners were selected by a vote of all clinical research sites globally, regardless of SCRS membership. Christine Pierre, present of SCRS, said, “The Eagle Award reflects an eagerness to honor and appreciate the sponsor and CRO who have demonstrated outstanding working relationships with sites. SCRS congratulates Eli Lilly and Company and INC Research/inVentiv Health for their efforts in raising industry standards in establishing strong partnerships with clinical trials sites.”
The presentations for Site Tank and Site Patient Enrollment Innovation Achievement (SPRIA) provided inspiration for patient outreach around the globe. Georgina Sposetti, MD, representing Instituto de Investigaciones Clinicas, won the Site Tank competition with “Un Ensayo para Mí,”(A Study for Me) a website where patients in Argentina can search for clinical trial opportunities.
Nazneen Qureshi, representing LMC | Manna Research, Inc., won SPRIA with a Type 1 diabetes trial that was their first entry into pediatric trials. The team utilized a combination of internet and activity engagement providing educational opportunities in partnership with patient organizations to reach diabetic teens and their parents.
Last year’s Site Tank winner, Gregory Folz, Administrative Director of the Research Institute of Deaconess Clinic, presented an update on the development of kits4life, an app connecting sites with unused laboratory supplies with communities in need. The app was demonstrated by Q2 Lab Solutions, which provided technical development support. Using the app and template contract language to release the supplies, sites can connect with 530 aid organizations in 87 countries.
With all of this support, Kits4life was still in need of $20,000 to continue operations through another year. SCRS, representing the support of more than 9,000 member sites and sponsors, has stepped up to provide this support.
Join us at the 2018 Global Site Solutions submit to hear from next year’s finalists. This is the only global conference dedicated to sites. Register now for the 2018 Global Site Solutions Summit to be held October 12-14, 2018 in Boca Raton, FL.
As a young man, Chris Trizna had a job but was still seeking a purpose. Then he discovered clinical research. He has successfully applied his skills to building the clinical recruitment company CSSi and in 2014 was named to the PharmaVOICE 100.
In college, Mr. Trizna played soccer and got a general business degree along the way. “I just went into sales like a lot of my friends in sports,” he remembers. “I went into financial planning products, but it was a recession. So then I went into selling paper. Carbonless copy forms were the height of efficiency back then.”
Eventually, he landed in management at a call center and did well. “Running operations based on metrics and leading a team is really my sweet spot,” he explained. The call center had a contract to answer calls about an over-the-counter medication. That led to a contract for one clinical trial, but it wasn’t his project.
The person who was in charge of that trial opened another company to focus just on clinical research, and Mr. Trizna moved to that company. As he worked to manage contract terms and develop metrics, he was learning more of the skills necessary to run his own company.
“I love metrics. I love technology,” he said. “You have to think about what call volume your ads are going to generate and be strategic about placing ads at a rate that your call center can support.”
When that company sold and changed focus, he was ready to start Clinical Site Services, which eventually became CSSi. He knew that he wanted to stay in clinical research. “When I first started it was a job. Then you learn about these conditions, you meet people who are sick, and it gets personal.” Mr. Trizna’s sister-in-law died as a result of breast cancer, and he still uses images of her family in messaging about breast cancer studies. “There’s more of a personal drive to make the study successful and find cures,” he explains. “It becomes less about the business.”
Working in patient recruitment is just one part of a big puzzle that brings new medications to market, but it has one of the biggest effects on study timelines. “Even though we’re a small part of a study, we make a big impact. There’s no better job than realizing you’re affecting lives now and in the future.”
Mr. Trizna builds this personal approach into CSSi’s culture. “When we interview people, I tell them that if it’s just a job, this might not be the right fit for you,” he said. He explained that some of his employees specifically ask to work on conditions that affect their families.
Mr. Trizna reports that technology has changed clinical trial recruitment. “We still advertise, but not like we used to. Technology has allowed you to hone in on specific people and educate more. What we do now is education. And then the site presents the study to the patient, and they educate more.”
Mr. Trizna has been a part of the Global Site Solutions Summit from the second year, which the first-year vendors were invited to attend. At the recent Global Site Solutions Summit, CSSi launched a query tool to allow sites to look for potential study patients in their electronic medical record (EMR). The product, MyClinicalTrial ID (MCT-ID), helps validate a site’s database against the inclusion criteria of a study. This helps sites select studies in which they can be successful and helps Sponsors select sites for their studies. “Our focus is on helping sites apply their data to helping the patients they already have.”
Mr. Trizna points out that this data allows a site to validate the recruitment goals in the site selection process, ensuring that research programs can match up with patients. Sites will still have challenges reaching out to their database so CSSi has hired former study coordinators to work as local enrollment specialists helping client sites pre-screen their patients.
“I could never find what was right for me until I found this industry. But all the roles I had made me ready to run this business,” he says.
Upon reviewing the SCRS discussion forums, “Patient-centric” or variations of the term were not found. This is important to consider as site leaders have communicated on these forums for years.
For sponsors and CROs, “patient centricity” is a term coined as a reminder about the most important aspect of clinical research, the patient, who is not immediately visible. In between the enormous amount of decisions to be made to meet regulatory requirements, meet the needs of clients, and perform tasks in the most efficient manner possible, that thread of connection to the patient can become lost. When sponsors and CROs communicate about patient centricity, they are often attempting to reconnect that thread in order to make sure their processes make sense when viewed through that core mission.
What a review of patient-centricity topics on the discussion forum reveals is that sites are operating with different language and preoccupations about serving the patient than CROs and sponsors are. Though all the parties are trying to meet the same goals, these language and location differences need to be taken into consideration for effective communication.
For more on what site leaders have to say about topics around patient centricity, Global Impact Partners can join mySCRSsolutions online community and members can join the online community created for them – mySCRScommunity for investigators, owners, directors, and managers or mySCRShuddle for site staff.
Readers were asked to define “patient-centricity” in their own words. Answers emphasized keeping the patient in mind from the first steps of developing the protocol for the study. Answers also emphasized keeping the patient at the center of clinical research with all other stakeholders relating to the patient first. As one respondent put it, “What [patient-centricity] is not is keeping sponsors, sites and IRB’s as three separate pillars holding up research.”
With the patient at the center, respondents emphasized treatments for symptoms that patients notice. These treatments not only require new products, they also require new procedures and approaches that make providing the treatment the center of care. An example from a respondent was making skin care treatment for diabetics a specific treatment area.
Respondents also emphasized making clinical research and healthcare access easy for patients. In the above example, a skin care clinic that is responsive to patient needs may be a patient-centric response to diabetes. Other examples provided included making informed consent documents easier to read, and making it easier for patients to access clinical research opportunities.
These responses indicated a similar philosophy, but also indicated that in practice “patient-centricity” covers a wide range of practices.
The discussion continues on the SCRS LinkedIn Group: What does “patient-centricity” mean to you?
As Puerto Rico suffers under the devastating impact of Hurricane Maria, the clinical research community is coming together to recover and to help others. Kosmas Kretsos, Executive Director of the Puerto Rico Consortium for Clinical Investigation (PRCCI) reports that a site in Añasco, DMRA, lost its roof but is still seeing patients during the daylight. The only family practice in the town, their continued operation is vital to the community.
PRCCI is supporting this site and others by renting and deploying satellite phones to remote hospitals and clinics and obtaining and delivering supplies. They are also working to facilitate reliable diesel delivery and mobile hotspots.
A few sites have full power service and communications and others are fully operational with generators. PRCCI is working with its member sites to carry out ongoing studies with the least amount of disruption. PRCCI is also continuing startup on new studies where facilities are operational and the team has determined the site can reliably execute the study and patients are ready to become involved in clinical research.
To support sites in Puerto Rico, make a tax-deductible contribution to PRCCI at https://www.gofundme.com/57f9d-puerto-rico-hurricane-relief-fund or contact Kosmas Krestsos at firstname.lastname@example.org.
Photo of DMRA in Añasco, Puerto Rico provided by Kosmas Kretsos.
Site Focus is a new section in the SCRS InFocus Newsletter. You are invited to send your site news to Mary D’Rozario at email@example.com.
Don’t Miss SCRS at these Upcoming Events
2018 SCOPE Summit – February 12-15, 2018
2018 EU Site Solutions Summit – March 26-27, 2018
2018 Asia-Pac Site Solutions Summit – July 17-18, 2018
2018 Global Site Solutions Summit – October 12-14, 2018
Boca Raton, FL
SCRS is a global trade organization founded in 2012 which represents almost 9,000 research sites in over 45 countries. SCRS’ mission is to unify the voice of the global clinical research site community for greater site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites, as well as companies that sponsor or support clinical research sites, benefit from membership and partnership. Our Voice. Our Community. Your Success. Join the community and collaborate with the Global Experts in Site sustainability.