Welcome to the November issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
- SCRSCurrent: News and information about SCRS. This month: Remembering Christine Pierre
- SCRSConnects: Exclusive interviews with industry leaders. This month: Kelly Wiggins
- MetricsThatMatter: Unique and current metrics supporting your success.
- CTTIUpdate: Organizations share updates and perspectives on topics that matter most.
CKP – In Memoriam
On October 23rd, we mourned the loss of SCRS founder, Christine Pierre to ocular melanoma with metastasis to the liver. A dedicated advocate for the site community, Christine was a dynamic leader who devoted nearly three decades of her life’s work to strengthening and unifying the voice of the global clinical research site community.
While many know of Christine’s unmatched professional aptitude, not all had the opportunity to meet CKP – the woman who almost always wore red, regularly had two pairs of glasses on at once, and who notoriously wrote entire emails in the subject line.
To read more about Christine’s career and life, view the news release.
Fun CKP Facts
All that and a bag of chips – Christine loved to use this describe something important.
When Christine first started giving the Hidden Costs of Conducting Clinical Research course (which led to the creation of the Site Solutions Summit) she picked locations based on hotels she wanted to stay in. “How classic Christine is that?” said Mike Jay, who often gave the presentation with her. “We stayed at some nice places!”
At one conference at which SCRS exhibited, Christine didn’t like the plants she’d ordered. So, she piled the entire SCRS staff into a minivan and went to a landscaping store. They bought new decorations and drove back to the conference with their heads hanging out of the windows because the car was full of giant plants!
Christine had a post-it note taped to her phone that said You can’t listen when you’re working, to remind her that when SCRS staff called her and could hear her typing, they knew she wasn’t fully engaged.
Some of her last words to SCRS’ VP of operations, Allyson Small, were Make sure you have our to-do list. “She was famous for her to-do lists and stopped by my office frequently hoping to cross things off of hers,” Allyson said. “She couldn’t imagine how people remembered or accomplished things without one!”
Whether she was gift-giving, delivering praise or providing constructive feedback, Christine always saw the potential in people even when they didn’t see it…yet.
Kelly Wiggins began her medical career as an open-heart surgery nurse. She loved it, but after seven years the schedule became too taxing. A colleague suggested she apply for a clinical research coordinator role; she applied, got the job, and just like that the direction of her career changed. Little did she know at the time that the schedule of a clinical research professional is often just as grueling as that of a nurse! But what her clinical research career lacks in free time it makes up for in the dividends Kelly prizes most: the abilities to connect to her patients and to make real and lasting change in people’s lives.
“I’m a connecting kind of person,” Kelly said during our interview. “Often, visits with my patients take a long time because I take the time to get to know them. I find that doing so helps me treat them more effectively.” Helping to bring new products to market is a part of this connection for Kelly: “Most everyone dreams of improving lives through innovative technology and devices, but I actually get to do it,” she said.
I asked Kelly what kept her at the same site for more than eleven years and in the role of clinical research coordinator for more than sixteen. She laughed, realizing I’d done a little LinkedIn research prior to our talk. “I’m the director of research at Optim Healthcare,” she said. “But I’m also the clinical research coordinator – it’s a one-man show over here. I like the challenge of working with contracts and budgets, and I enjoy the coordinator roles because I love the patient interaction.” Kelly has a very low loss of follow-up with the patients she works with, which demonstrates the value of the personal connection she develops with her patients.
Despite enjoying her job, Kelly noted that it is a considerable challenge to juggle many things at a time and switch gears at a moment’s notice. Continuing on this topic, I asked Kelly what she sees as one of the site industry’s more significant challenges. She called out remote monitoring. “It can be a good thing – a great thing – but my observation is that it requires a lot of work on the site side, and often it feels like the work we put in isn’t equally met by the sponsor.” While remote monitoring has many benefits, Kelly finds on-site monitoring to be more efficient in one key area: communication. “When the monitor is onsite, their job can be done then and there without back-and forth emailing and phone calls,” Kelly said. “There is nothing intrinsically wrong with remote monitoring. I just don’t believe that we’re effective enough communicators to let it do its job and truly simplify the monitoring process. To many sites, it feels like it adds steps instead of creating ease in process.”
To alleviate some of these burdens, Kelly’s site incorporates remote monitoring costs into their budgets so that the time spent on the activity is captured and compensated. Optim Healthcare focuses on orthopedic trials, which are very specialized – “Studies don’t just come knocking on our door,” Kelly said. As a result, she picks and chooses what she fights for in their CTAs and has found a way to embrace remote monitoring without sacrificing quality communication.
Speaking of what she fights hard for, Kelly has taken her love of helping others to the very highest level. She went on her first mission to Africa in 2004 to aid those in need in Zambia, and was forever changed by the experience. She returned the very next year to work with the children in Zambia. “After the trip in 2005, my husband and I didn’t return for a long time because we wanted to start our family, but the pull to go back to Africa never left me. Once our children, whom we adopted, were a little older, I felt it was time to go back,” she shared. In 2017, Kelly went on her third mission with a team of eleven, providing medical services to 1,300 people in four days in a remote village in Zimbabwe. This past year, she co-led her fourth mission, guiding a group of five.
I asked Kelly what she would do at her site if she had no limits. She said she would build a center to accommodate pain studies where patients can stay overnight to be monitored, giving them a particular drug to see if it was more or less beneficial than another. “But you can’t bite off more than you can chew!” Kelly said. “That’s an important part of site sustainability: measure your dreams against reality so that you don’t diminish your ability to change patients’ lives by doing too much, too fast.”
So, what is important to focus on? “Sometimes coordinators forget the human element,” she said. “It’s important that we remember that patients are gifting us their time to be a part of the study. Patients need to be seen as people – first impressions are important and can make or break whether a patient wants to be in a study. How we communicate with the patient is so important.”
Site sustainability and site quality have never been more important, or more directly linked, than they are today. As reported in the 2018 SCRS Site Landscape survey, 64% of sites report having less than 3 months of operating cash on hand – up from 60% in 2017 (Figure 1) – and the majority of sites report having less than 15% gross revenue (Figure 2). In an environment where sites are paid on a quarterly vs. monthly basis nearly 50% of the time and where it takes an average of 10.3 weeks to execute a clinical trial agreement (Figure 3), it is critical that the practices the clinical research industry identifies as critical to site sustainability and quality are prioritized and employed by sites.
In February 2015, SCRS released a white paper outlining the critical elements of responsible site management and identified six domains of Best Site Practices (BSP). These domains were reviewed and weighted in collaboration with ACRO and TransCelerate Biopharma and their member companies. 4-5 qualifications within each domain were compiled to provide clarity and guidance to sites to support them in achieving a compliant, efficient, and sustainable business model. The domains identify policies and areas of practice that all sites should have in place to increase efficiency and ensure patients are treated safely in order to be recognized as a site committed to quality.
The six domains are:
- Principal Investigator: Qualifications & Oversight
- Staff: Qualifications & Experience
- Site Performance: Study Start-up, Recruitment & Retention
- Site Performance: Data Management & Data Quality
- Site Infrastructure: Facility & Process
- Compliance & Regulatory/Human Subject Protection
A key component of building a strong site is having evidence and knowledge about how the site measures up against critical industry-determined metrics and practices. SCRS developed the Best Site Practices (BSP) Program and related questionnaire in 2018 to give sites a means to evaluate their quality and success by utilizing the domains identified in the 2015 white paper.
Created with multi-stakeholder input, the SCRS BSP questionnaire enables sites to evaluate their achievement status under each domain. SCRS member sites can log into their MySCRS account to complete the questionnaire. Afterward, the site will receive a certificate with a score for that particular best site practice as well as an overall score weighted upon total completion. Sites can share their exemplary scores with sponsors and CROs as a demonstration of their commitment to quality. A site that receives a lower score than expected will have the opportunity to utilize SCRS resources to improve their BSP domain and overall scores over the course of the next 12 months, at which point the site can complete the questionnaire again.
The Best Site Practices Program is a positive step toward quantifying the quality and performance of SCRS member sites. They can use this certification along with other existing qualifications and feasibility materials to prove that they are most qualified to participate in a particular study. In addition, SCRS is helping sponsors and CROs recognize the importance and weight of SCRS BSP during their site selection process.
The Best Site Practices Program is live now for SCRS members and will be available for non-members in early 2019.
The Right Training at the Right Time: CTTI Releases Recommendations for Investigator Qualification
A one-size-fits-all approach to investigator qualification does not work. It leads to unnecessary repetition, creating burdens for site teams and limiting the opportunity for more relevant and specific training. Fortunately, new recommendations and resources from the Clinical Trials Transformation Initiative (CTTI) propose a new evidence-based approach that streamlines processes and targets training to exactly what is needed, when it is needed.
Developed by a team of experts and leaders across the clinical trials enterprise, the new recommendations aim to help investigators and their delegates better prepare to conduct high-quality clinical trials. They also help sponsors and contract research organizations (CROs) implement a more efficient and effective means of qualification to determine whether a site team is a good fit for a particular protocol.
Currently, Good Clinical Practice (GCP) training is widely used as the industry standard to ensure investigators are qualified, but there is little evidence that simply completing GCP training is sufficient. CTTI’s recommendations provide a new approach that recognizes previous training and experience, identifies gaps in knowledge and skills, and addresses qualification aspects that go beyond applying GCP principles to the conduct of clinical trials. Implementation of these recommendations could also help to create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.
Taking on this new approach to qualification will require a leap of faith from all sides of the clinical research industry—investigators and sites will need to take greater control of their own qualification process, while sponsors and CROs will need to be more willing to accept documentation of relevant education and experience as evidence of qualification. Nevertheless, site teams that take the initiative have the potential to enhance the quality and efficiency of their clinical trials.
|Cultural Competency Training: Explaining the Meaning and What You Need to Know
December 20, 2018
12:00 PM EDT
|The Impacts of Culture on Clinical Research
December 21, 2018
12:00 PM EDT
|New Approaches to Preparing and Qualifying Site Teams for Clinical Trials
January 17, 2019
12:00 PM EDT
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.