Welcome to the April issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
- SCRSCurrent: News and Information about SCRS.
- SCRSConnects: Exclusive interviews with industry leaders. This month: Jeff Kasher
- MetricsThatMatter: Unique and current metrics supporting your success.
- SiteSpotlight: Site stories of innovation and success. This month: MedPharmics
Let us know what topics you would like SCRS to address in upcoming issues.
SCRS’ “summit season” has officially begun with the European Site Solutions Summit held in London in March! A record-breaking number of sites, sponsors, CROs, and service providers came together to learn, network, and share innovative solutions to some of the major pain points in clinical research.
If you missed the EU Summit, consider joining us for July’s Asia-Pac Site Solutions Summit in Melbourne, Australia July 17-18, 2018! The Site Patient Recruitment Innovation Award (SPRIA) comes to the Asia-Pac Summit for the first time this year. If you are an Asia-Pac site, submit your innovative recruitment plan for SPRIA Asia-Pac consideration today!
SCRS is also holding the very first Oncology Site Solutions Summit in Austin, Texas, February 2-3, 2019. More information on this incredible and important event is forthcoming.
As always, SCRS spends the entire year planning for October’s Global Site Solutions Summit. Registration is open and the agenda is almost finalized – register early to save!
Jeff Kasher has always been one to follow his professional passion. Trained as a scientist, he began his clinical research career at Eli Lilly and Company, and in his 28 years there, he gained a reputation for speaking his mind and supporting what is right over what is easy. As a result, Lilly’s president called Jeff into his office one day and asked him to recommend changes that were needed within the organization. Jeff candidly shared what he felt could be improved, and as a result Lilly began implementing a major global overhaul. Jeff’s leadership was recognized, and he was asked to head global clinical development for the company. “Drug developers are trying to bring forward medicines that will help people live longer and better lives,” Jeff said. “The need of the patient is always at the head of our industry. If we ask ourselves What’s the right thing to do for the patient? we will always come up with the right answer to the question we’re facing.”
As he grew in his career, Jeff became increasingly well-versed and interested in helping people live longer and better lives, and he understood intimately that this effort needed to start within the clinical research industry. He decided to step outside of big pharma to continue this effort. In 2015, Jeff moved on from Lilly to start Patients Can’t Wait, LLC, a consulting company that works with companies involved in industry-changing technology and processes for clinical development. Through Patients Can’t Wait, he utilizes his industry experience to help smaller companies navigate the complexities of big pharma. Among the most prevailing of these complexities is the industry’s aversion to change. “One of big pharma’s most significant challenges continues to be the slowness at which change takes place,” Jeff said. “For example, new skills for employees need to be identified and developed. The trending skill used to be IT, but now IT is part of the fiber of what every employee brings to the table. We need to tailor employees’ skills in order to broaden our reach.” It seems that though the industry understands that there is a need for less talk and more action, this need has not become actionable yet.
Speaking further on these challenges, Jeff pointed out the biggest surprise he has observed: “There is a level of disrespect that flows from the biggest of the big down to the smallest of the small,” he said. Whether it is a sponsor talking to a CRO, or a CRO talking to a small site, this trickle-down effect is felt industry-wide. “Normal protocol should be to really listen to the vendors you interact with and to follow up with them whether you’re interested or not,” Jeff said. “What I’ve seen in working with various-sized companies is that there’s a dialogue, and all of a sudden it just ends. They’re never told why communication ended.” This impacts smaller companies the most, as they don’t have the luxury of time and money to figure out why communication ended abruptly. “They’re trying to bring something new to the surface and instead end up spending valuable resources on solving the why, when a simple phone call would have eliminated the problem,” Jeff said. While this has created an inefficiency in the industry, it also means that there is potential for fast improvement as the bigger players change their business practices. As Jeff put it, “Many companies are trying to maintain the status quo, when really we need to be going in there and shaking it up.”
While making such big changes could have a large and positive impact on the industry, change doesn’t come easy. “People want security. It’s challenging to disrupt the status quo and try something different, so we fight the change even if it’s what’s best for us in the long-term. This,” Jeff shared, “is why organizations like SCRS are so important. SCRS has been incredibly helpful in bringing together sites and other industry executives to create change that we really need.” He spoke to Lilly’s use of SCRS’ Site Advocacy Groups (SAGs), which provide targeted site opinions to the organizing company, and how important the site perspectives gained from SAGs were in creating the change that led Lilly to win the Eagle Award at SCRS’ 2017 Global Site Solutions Summit. “It helped Lilly utilize the value of the sites’ perspective to innovate change.”
When asked what one piece of advice he would give to help sites achieve or maintain sustainability, Jeff was clear on the top priority: “Deliver,” he said. “There is nothing that will ensure additional work from sponsors more than delivering.”
Who Thinks What Is Critical?
Given the frequency with which sponsor/CRO and site opinions do not align completely throughout the clinical trial process, it may be reasonably assumed that there is equal disparity in the factors both groups consider to be most important. SCRS’s 2017 Site Landscape survey data indicate that although this is true in some cases, in others it simply isn’t.
First, let’s look at who thinks what is important. Figure 1 illustrates the top 5 out of 9 given factors that sites and sponsors/CROs listed as critical to successful clinical trial execution. While sponsors/CROs listed lacking or inadequate PI oversight as most critical, sites ranked it 6 out of 9, indicating that they do not feel PI oversight is lacking. Sites placed communication between the site and sponsor/CRO as most critical, while sponsors rated it 6 out of 9 and CROs 4 out of 9, indicating that communication quality and quantity are sufficient. In recent years, the industry has seen a much-needed shift in which sponsors prioritize communication with sites. That sponsors place more emphasis on communication than CROs is telling of the shift in industry and shows that sponsors are recognizing the importance of communication in a way they historically haven’t.
Both sponsors/CROs and sites more or less agreed on the importance of recruitment, with sponsors/CROs placing it at 2/9 and sites at 3/9. The same was true for budgets and contracts, with sponsors/CROs placing it at 3/9 and sites at 2/9.
Figure 2 demonstrates where expectations are aligned, while Figure 3 outlines all 9 factors. As indicated above, both sites and sponsors/CROs agree on the importance of recruitment. Further, both believe that meeting recruitment goals 100% of the time should be prioritized. Regarding the importance of budgets and contracts, sites felt these documents should be returned and executed within 7 days, while sponsors/CROs have a slightly more aggressive timeline at 5 days for execution. Though both agree that it is reasonable to expect that budgets and contracts will be returned and executed within a week, metrics like those shared in this Clinical Leader article show that this process usually takes upwards of 2-3 months. The desire to improve these numbers is there, but desire isn’t enough to change the reality. Sponsors often believe that sites hold up contract execution, while sites say that they turn around contracts within a reasonable timeframe, but the contracts then sit on the sponsor’s desk. Currently, we only track the timeline to execution and not the back and forth that occurs, so we have no solid answers about where the bottlenecks are. This brings us back to the importance of communication, as indicated by the sites – if we can improve our communication, we will also improve our turnaround time.
Finally, even though both groups did not agree on the importance of PI oversight, both did indicate the importance of the site’s having an SOP in place and consistently adhering to PI oversight expectations.
These data suggest that our problem isn’t so much that we disagree on what’s important as it is our ability to effect change that will improve our turnaround times. In partnership with many sponsors and CROs, SCRS developed Common Language Evaluation and Reconciliation (CLEAR) to address this issue. You can view the white paper to read more about how CLEAR addresses the challenges and bottlenecks encountered in contract language and negotiation here. SCRS challenges sites and sponsors/CROs alike to take a look at their contract language and determine whether the negotiations change the material outcome of the contract so much that the time lost is truly worth it.
Though industry ranks some of these elements differently, these data clearly demonstrate that we agree more than we disagree. Now it’s time to stop talking and start taking action to improve in the areas that both sides identify as important.
“Integrated” MedPharmics Sites
What sets MedPharmics apart from other clinical research sites is the fundamental realization that the attainment of health must encompass mind, body, and spirit. This belief stands as one of the core tenets of integrative medicine, which integrates the best of traditional Western medicine with the best of alternative medicine. MedPharmics’ interest in integrative medicine took root in 2015 when our CEO, Andrea Jeanfreau, RN, completed a one-year program in integrative medicine with Dr. Andrew Weil, widely acknowledged as the founder of integrative medicine in the US. What started out as an administrator’s personal interest has evolved into a passionate commitment that permeates the entire company.
Our dedication to the advancement of integrative medicine extends beyond performing studies in this arena, and we incorporate these principles into the very fabric of our work environment.
Each member of our conscientious team is exposed to enormous pressure in the race to develop new medications for the treatment of human disease. Integrative medicine guides us in off-setting these negative effects.
A healthy workplace literally begins with a healthy environment. We strive to limit as many potential toxins as possible by utilizing “green” products. The list of these items is extensive and includes cleaning products, paper goods, and office supplies. The surroundings are further enhanced through the judicious use and diffusion of essential oils and colors that have been proven to promote feelings of ease and comfort. MedPharmics’ commitment to a healthy atmosphere extends to the environment-at-large and is reflected in its recycling and re-using campaigns. Clinical research generates a significant amount of recyclable material, including paper, cardboard boxes, and packing material. Unused lab supplies are donated to local charitable health care facilities. Foamed polystyrene, which is produced in great abundance for insulation, is re-used whenever possible.
Juicing is encouraged with equipment available in our kitchenettes. Lectures on Dr. Weil’s non-inflammatory diet are offered on a regular basis.
MedPharmics contracts with HealthArt, an organization that offers a variety of clinically proven holistic treatment modalities to aid patients on their journey to integrative health, to provide each staff member with a free 30-minute restorative wellness session per week in a quiet, dedicated area conducive to stress reduction. These sessions include formal therapies in energy medicine, acupuncture, hypnosis, aromatherapy, and geometric spacing with certified practitioners. The sessions can also include regular, informal therapies consisting of time in a massage chair, music therapy, and relaxing on an infrared biomat.
MedPharmics has embraced integrative medicine not only because it yields more creative and productive employees, but because it promotes the health and happiness of others.
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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.