Welcome to the December 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: Debora Araujo
- MetricsThatMatter: Unique and current metrics supporting your success.
- ACROUpdate: Organizations share updates and perspectives on topics that matter most.
A Year in Review
As 2018 comes to an end, the SCRS team extends our sincerest thanks and appreciation to our member sites, leadership council, committee members, global impact partners, and all those who helped us achieve the goal of increasing the sustainability of the global clinical research site community. This is a goal and reality that, simply put, cannot be realized without your support.
SCRS has had quite a year, with many highs and one significant low. We are still feeling the loss of our founder, friend, and leader in the clinical research space, Christine Pierre. Many of you knew her well, and we know you feel this loss, too. We’re appreciative of the condolences, kindness and support you have extended to the SCRS team over the last few months as we regroup to honor Christine by allowing her legacy to not only live on, but thrive, as SCRS grows.
SCRS has advanced several projects which Christine spearheaded throughout 2018. Best Site Practices (BSP) was developed in collaboration with the Association of Clinical Research Organizations (ACRO) and TransCelerate BioPharma. The program provides sites with an outline of the critical elements necessary to start and sustain a clinical research site, and an evaluation which measures site performance against multi-stakeholders’ expectations. Sites have the opportunity to showcase their BSP results to demonstrate their commitment to quality, if they choose to.
Part of what makes SCRS unique is our relationship with Global Impact Partners (GIP), comprised of industry’s top sponsors, CROs and professional solution providers. I’m With SCRS allows sites to view each GIPs progression and current level of involvement in important SCRS initiatives, and GIPs to review their progress toward full-scale implementation of these initiatives.
The Trial Opportunity Platform (TOP) was reignited in an effort to connect member sites with sponsors and CROs seeking sites for study opportunities. Available to SCRS members and Global Impact Partners (GIP), the program provides sites with access to available clinical trials, and GIPs with access to a network of skilled sites for study selection.
If you would like more information about any of the above programs, contact senior project manager, Jimmy Bechtel.
In addition to program updates, SCRS identified key changes within the site community via our annual Site Landscape survey, which is presented at the Global Site Solutions Summit annually. We will continue to report on these data throughout 2019.
Finally, SCRS has many incredible changes and updates planned for 2019. We look forward to sharing more with you as soon as we are able over the coming months.
The SCRS team wishes you a happy holiday season and a prosperous new year!
Debora Araujo found her way into the clinical research industry through the door of budget and finance. A small pharma company recognized her skills in finance and decided to take a chance on her. “Most people think you have to be a science major to get into clinical research, but that isn’t true,” said Debora. The company taught her what she needed to know about the clinical research field, and her temporary position became permanent.
It didn’t take long for Debora to develop a keen interest in the field, and in early 2018 – about twelve years after branching off into clinical research financial operations – she formed a company called ClinBiz whose intention was to connect professionals engaged in the business aspects of managing clinical trials. “As I began to attend industry conferences, I noticed that many of those in clinical outsourcing, contracting and financial management fields weren’t able to attend,” Debora said. “I started to think, wouldn’t it be great to have a way to connect on these topics? I created a YouTube channel and started posting videos, then added a blog and podcast as the videos gained popularity. We are also launching fresh online courses starting in January 2019.” ClinBiz’s first conference for clinical business professionals will be held in New Jersey March 13-14, 2019. There is also an option to attend the conference via livestream – quite the forward-thinking alternative!
Debora also released a book in 2018. The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them uses fictional superheroes such as “The Numeror” and “Mr. Peripheral” to share her experience tackling the issues that cause delays in clinical trial agreement (CTA) execution. “One of the main things our industry suffers from is a lack of standardization,” Debora said. Her book provides tools and insight to help businesses standardize their practices and processes.
The book also highlights Common Language Evaluation and Reconciliation (CLEAR), a project spearheaded by SCRS founder Christine Pierre. CLEAR introduces five common contract clauses with the purpose of streamlining contract negotiations, accelerating site initiations, increasing recruitment timeliness and reducing study start-up costs. “It is a challenge to innovate in the area of CTA negotiations,” shared Debora. “CLEAR simplifies this process.”
Debora’s purpose in starting a company, publishing a book and developing a conference for clinical business professionals all within a 12-month period was to address the challenges impacting clinical trial efficiency with solutions that she is uniquely qualified to address. “It is true that knowledge is power,” she said. The clinical research industry is always seeking methods to streamline processes. In her work, Debora has introduced innovative ways to implement change. “It isn’t so hard to decrease the combative nature of negotiations when you understand why the other side is asking for something.”
Administrative roles receive less attention in almost any work space, and Debora believes that this needs to change: “Administrative work sounds so simple in comparison to something like risk-based monitoring, but this work can really impede forward movement when it isn’t done efficiently.” Simplifying and standardizing approaches to administrative tasks will go a long way toward increasing clinical trial efficiency.
By the same token, none of this work can have a significant impact if sponsors don’t join the implementation train. Debora believes that one of the best things a sponsor can do to guarantee clinical trial success is to prioritize the quality of their relationship with sites by having candid and transparent discussions and implementing strategies that streamline administrative tasks impacting research sites.
When asked what one piece of advice she would give to sites to maintain or achieve sustainability, Debora said, “Understand exactly what you need during negotiations, why you require it, and be prepared to back up your need with appropriate rationale and documentation. This will increase the chances of your sponsor covering your needs.” Like sites, sponsors are trying to conduct research as effectively as possible without getting into trouble. If both sites and sponsors are committed to contributing to each other’s effectiveness, the potential for success increases greatly.
A longtime focus of SCRS is the problem of cash flow to clinical research sites, largely resulting from sites needing to wait three or more months for payment. In an environment where employees are standardly paid bi-weekly, vendor payments, utilities and rent are paid monthly, and study patients are paid at the time of visit, quarterly payment terms create a barrier to success for sites.
Sites may find it necessary to focus enrollment efforts on studies with more frequent payment terms than to those that pay infrequently, because this model provides the capital needed to sustain and grow their research operations. The quarterly payment model forces many sites to cover the costs not provided by sponsors and CROs through unsustainable measures such as utilizing lines of credit, charge cards or personal loans. There are, of course, exceptions to this reality. Larger organizations such as clinical practice communities, hospitals, and academic centers may have enough fluid cash to temporarily cover the day-to-day operating needs of their clinical research departments, but even large organizations feel the pinch. All sites need regular payments that cover reimbursement of their incurred expenses at a minimum. As was recently stated by an SCRS site in our online community, “Anything other than monthly payments has a negative effect on cash flow and does not allow us to operate efficiently.”
Figure 1 illustrates that the number of sites reporting having less than 3 months of operating cash in the bank has increased from 60% in 2017, to 64% in 2018. We can only speculate why this number has increased in the last year. While this figure is high and the increase unfortunate, in 2016, 66% of sites reported having 3 months or less of operating cash. Improvement is slowly being realized as sponsors and CROs heed the sites’ voice and begin allowing monthly payments.
Another issue that negatively impacts a site’s cash flow is the practice of withholding. As is documented in SCRS’ Site Payment white paper, holdback payments evolved as a way for industry to ensure that sites complete various study-related activities – specifically data management. When studies were conducted and documented almost entirely on paper, sponsors and CROs didn’t have a real-time window into the sites’ study activities. Much has changed and today over 90% of studies use EDC, which provides sponsors and CROs full transparency into sites’ study progress specifically to study data.
Withholding trends are reflecting change and an increase in transparency from sponsors and CROs. While Figure 2 shows that overall withholding trends remain around the 12% mark, 2018 saw this number drop to a 10-year low of 11%.
Also contributing to the cash flow dilemma are decreasing profit margins. As shown in Figures 3 and 4, sites reported a 20% profit margin in 2011. This number decreased to 13% in 2016, which reflects a 35% erosion of profit margin in the last 5 years. In 2017, more than 20% of sites report a profit margin under 5%, while the average retained earnings for 2017 is 16-20%. This profit margin is used to support activities like additional professional development, building more robust compliance programs, and expanding therapeutic bandwidth to offer greater services to the industry.
The matter of cash flow is one of great importance and magnitude, and SCRS will continue to illuminate these conversations and drive forward real change. While sponsors and CROs need to realize that cash is king, and that sites cannot successfully enroll and treat patients without being able to at least meet monthly expenses, sites also must understand the importance of collecting and supplying quality data to their funders. If both ends of industry engage in these important conversations and drive forward change in response, we will be more successful in meeting our primary goal: to bring affordable, life-changing drugs to patients as quickly as possible.
ACRO Makes Policy Recommendations to Strengthen UK Clinical Research Amidst Unique Challenges of Brexit
After three successful events with UK government officials, ACRO concluded its 2018 Clinical Research Roundtable series having brought attention to the vital role of clinical research. To highlight the impact of the industry and the need for continued success of clinical research in the UK, ACRO collaborated with its member companies to conduct a series of discussions with government officials. The events culminated with specific policy recommendations to improve competitiveness amidst the challenges of withdrawing from the European Union. These policy recommendations have already gained traction with the UK government.
At the first event, representatives from the UK’s major clinical research organizations (CROs) met with the Rt Hon Hilary Benn (Labour – Leeds Central), Chair of the Exiting the European Union select committee, to discuss the implications of separating from the European Union. Hosted by ACRO member Covance, the April meeting included a tour of clinical research facilities that are a source of hundreds of highly skilled jobs.
Focused on strengthening UK leadership in clinical research and public-private partnerships, the second Roundtable was hosted by Syneos Health at their new headquarters in Farnborough. ACRO members were joined by senior officials from the National Institute for Health Research and the Department of International Trade.
The third Clinical Research Roundtable event, an October discussion with Lord O’Shaughnessy, Parliamentary Under-Secretary (Department of Health and Social Care), examined how to advance clinical research in the UK.
“It has been great to support ACRO to develop a strong dialogue between the industry and policymakers in the UK,” said Tim Sheppard, UKI Market Development Director at IQVIA, who hosted the meeting at St Bartholomew’s Hospital in London, a prime site for their UK research. “IQVIA are delighted that we could bring Lord O’Shaughnessy to debate the key issues with our colleagues from across the industry and for him to visit Barts Health NHS Trust and hear about some of the great work done here.”
Meeting participants were encouraged by the Government’s commitment to positioning the UK as an attractive and globally competitive location for clinical research. The conduct of clinical research in the UK builds on the Government’s Life Sciences Industrial Strategy, while also serving NHS patients, who receive care and treatment through their participation in research. ACRO also met with several clinical research patients and providers, who shared direct experiences with clinical trials. Their voices will be part of future efforts to raise the profile of clinical research.
Following the discussion, ACRO proposed six policy changes to address current research challenges, with solutions that position the country for future successes that can be shared by all stakeholders. Those policy recommendations were presented to Lord O’Shaughnessy. The proposals included creating centralized ethics review and centralized contracting mechanisms, the “Right to Write” which states that UK doctors should be able to directly contact patients not registered under them who could benefit from participation in clinical trials, modernizing health data access policies, prioritizing clinical research within hospitals and supporting high-throughput clinical research facilities in NHS hospitals.
“ACRO has been very engaged in representing the clinical research industry’s interests and concerns about Brexit,” said Karen Noonan, ACRO’s vice president, global regulatory policy. “We are pleased that the UK Government is committed to the advancement of clinical research and look forward to identifying policies that advance this work in ways that benefit stakeholders across the UK.”
In late November, the UK government opened a consultation on principles for the management of data throughout the healthcare system, which will likely impact trials and sites. This was followed by the formation of a “Health Data Research Alliance” and release of a second “Life Sciences Sector Deal”. ACRO will be monitoring these achievements and offering input that will help advance the industry and how we collaborate with sites.
Clinical research is vital to healthcare in the UK. Each year, the UK clinical research industry conducts over 1,600 studies that involve more than 35,000 patients. ACRO member companies are also a major source of employment, providing over 13,000 highly skilled jobs. With pan-European health, data, privacy and economic implications, clinical research in the UK has impacts inside the country and beyond its borders.
|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.