We sat down with panelist Lawrence Florin, Consulting Partnerships at Medidata Solutions to discuss risk-based monitoring and managing, industry trends, and the upcoming 2014 Partnerships in Clinical Trials Conference. Check out the interview below.
Given that you’ve worked both on the sponsor and vendor side, what are some things you learned and now apply in your day-to-day business operations?
The most important insight I have gained is the importance of understanding and appreciating the needs and concerns of all parties at the table. That said, ultimately everyone is focused on driving improvements in the lives of patients and everyone has a role to play to achieve that objective. Further, mid-sized and larger sponsor organizations continue to build deeper relationships with their vendors. As a result, a sponsor’s expectation of the value each vendor has to offer increases. Vendors are convinced that their ability to continually deliver higher value is through longer-term, more strategic relationships. Regardless of the many ways that these relationships can be defined, the value is delivered in the form of people, process, technology and data. Lastly, the most compelling observation I have made is how the level of engagement has evolved. Sponsors do not only desire high quality, cost-effective services and technology; they now are inclined to sit down and listen to the vendor’s value proposition—even if it encroaches on their own core competencies—and find ways to incorporate the offerings to complement their own agendas. Similarly, vendors appreciate that as the stakes become higher, they must continually improve, innovate and find ways to share their expertise to address the breadth of their clients’ clinical development (and potentially commercialization) challenges.
What trends are you seeing within the Pharma Industry and why are they developing that way?
As everyone recognizes, for the past several years, pharma has struggled to address a perfect storm of industry-wide challenges that first surfaced due to patent expiries of a series of blockbuster drugs and their associated diminishing revenue streams. The impact of this first challenge has been magnified by the demands presented by healthcare reform and an increasingly complex regulatory environment, coupled with the escalating influence and pressures from payer organizations globally. That said, the industry has grappled with these issues and is now turning the ship into the headwind. Organizations are compelled to operate in a leaner, more collaborative manner—more work is being outsourced and more assertive business development (licensing, M&A), co-development and co-marketing activities are being undertaken. The realization of the need for more collaboration has inspired the creation of government, industry and academic consortia to tackle everything from disease area research to establishing clinical development execution standards to coordinating reimbursement criteria, even to conducting comparative effectiveness programs. Companies have rationalized their portfolios and concentrated efforts in carefully selected therapeutic areas and indications to deliver more targeted therapies. More attention is directed towards patient outcomes, starting in clinical development and continuing throughout the life cycle management of the product. All of these efforts are geared toward ensuring that the industry thrives, and the successes are beginning to slowly, but surely, coalesce. A new norm is emerging, with the only certainty being that the industry will continue to confront and need to address more rapid disruptive and transformational changes.
What do you see as the top three challenges in risk-based monitoring and/or risk-based study management? How is Medidata addressing these challenges?
While there are a number of challenges, one can argue that in order to implement a risk-based study management and monitoring program, three key factors that need to be considered include: (1) Addressing the resistance to change that is typical of our conservative industry (often due to patient safety and regulatory concerns); (2) Leveraging technology to enable effective central and remote monitoring of site quality; and (3) Establishing processes, roles and responsibilities that ensure clarity and alignment across the organization through every phase of risk planning and remediation. On this final factor, what is most critical is to institute a thorough risk-assessment process during the protocol development stage and carry it through the entirety of the program. Medidata has been at the forefront of helping the industry move towards adopting a risk-based study management and monitoring paradigm. Within our clinical cloud platform are technological solutions that serve as the foundation of any risk-based program. For example, our targeted source data verification (TSDV) solution is directly linked to our Rave EDC/CDM system; it helps study teams configure (and adjust) the amount of critical and non-critical data to be source verified based on compound, study and site level quality metrics. These quality metrics are accessed in our platform through our Site Quality Management (SQM) tool. To develop these metrics, our team has analyzed industry performance data from over 6,000 clinical trials and derived a set of metrics that provide study teams with a visual snapshot of site quality to help them identify areas of high or low risk. With that information, study teams can help sites improve data quality by taking corrective actions and save time and money by targeting their resources more efficiently. It is noteworthy to point out that our approach is distinctive from the rest of the industry. While many companies are racing to implement large volumes of metrics and risk indicators, we believe that a select set of well-conceived indicators can be more sensitive and can avoid sometimes confounding, albeit unintended, noise from a larger battery of performance metrics and risk indicators, collectively. A third piece of the puzzle is our large (and growing) Insights data trove. Insights can be mined to provide benchmarking and other performance comparisons and risk profile assessments. In fact, sponsor and CRO study teams report that one of the biggest challenges to implementing a risk-based study management and monitoring program is establishing the expected benchmarking and tolerance ranges at the outset of a study. Finally, complementing these technology solutions are our consulting and professional services practices that can provide a range of qualitative support services (best practices, operating procedures, governance, change management, etc.) that need to be in place in order to successfully and expeditiously bring risk-based study management and monitoring from the pilot stage into the business-as-usual future state.
What are you most looking forward to at the 2014 Partnerships in Clinical Trials conference?
I always look forward to Partnerships; I find that there are always new things to learn and it is, of course, a great networking venue. This year I look forward to learning more about a number of topics such as cross-industry collaboration models, how the industry is promoting the concept of patient-centric trials, what is new in the mHealth and eHealth arenas as well as the how the proper use of data and technology can markedly improve the clinical development process.
Join Lawrence and Medidata March 30-April 2nd in Las Vegas at IIR's 23rd Annual Partnerships in Clinical Trials. Don't miss his panel - Risk Based Study Management for Small to Midsized Companies, on 3/31. We hope to see you in a few weeks!
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