Partnerships In Clinical Trials 2012 Media Partner
goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.
52 Perspectives: “Addressing Study Startup Challenges from Root Causes”
This contribution to ’52 Perspectives’ is a joint effort between
Ann Neuer, President of Medical deScriptions, and
Beth Harper, Chief Clinical Officer of
CenterPhase Solutions.
When it comes to meaningful ways to improve study start up (SSU), Beth Harper, Chief Clinical Officer of CenterPhase Solutions, says her company is onto something pretty hot. “Taking the root causes of slow study start-up and facilitating each aspect until it is completed seems to be an effective method of accelerating the process and dramatically improving results,” she comments.
Harper, an industry veteran and tireless advocate of improving site efficiency, knows what she’s talking about. In its first case study at the Mayo Clinic, CenterPhase’s flagship collaborative site, Harper explains that the techniques employed by her company have resulted in achieving the First Patient Enrolled benchmark in 155 days versus the industry average of 210 days, and a patient enrollment rate 50% higher than other investigative sites. Moreover, patient enrollment figures were within 10% of predictions based on a careful analysis of de-identified patients existing in Mayo’s electronic medical records database as well as pre-screen, consent loss, and screen fail estimates.
According to Harper, the root causes of slow SSU fall into four buckets:
- - Collection of regulatory documents
- - Budget negotiations
- - Contract negotiations
- - Site training
Collection of Regulatory Documents
The preliminary step of collecting regulatory documents can take months of back and forth between the sponsor and investigative sites before they are accurately completed. “The root cause of this slowdown is that sites sometimes do not receive the materials in a timely manner or do not understand what’s expected of them, especially if they are new or haven’t been trained,” Harper explains.
And there can be more complications. Institutional review boards (IRBs) and other scientific review committees at large academic medical centers may have specific regulatory requirements that are not part of any standard packet they might receive from a sponsor. If the sponsor does not know what those requirements are or from whom to request this information, the process can drag on or eventually stall. “In this instance, our job is to be a communications facilitator to ensure all parties have a clear understanding of what is needed to move forward. This can avoid weeks or months or fruitless back and forth,” Harper comments.
Budget Negotiations
The key issue credited with causing delays in budget negotiations is the huge disconnect between how sponsors and sites value the effort sites put into starting and conducting clinical trials. The challenge reflects sponsors’ growing concern with Fair Market Value (FMV), a concept gaining traction since the Office of the Inspector General (OIG) in the US Department of Health and Human Services put forth a guidance in 2003 entitled Compliance Program Guidance for Pharmaceutical Manufacturers. Since then, OIG has assessed several multi-million dollar fines on big pharma for violating FMV, although the term is rather vaguely defined in the guidance. As a result, some sponsors are taking a non-negotiable position that, in the interest of fairness, all investigative sites must be paid the same per patient, regardless of varying costs among sites.
“Sites don’t understand FMV and its ramifications. In order to comply with FMV, sponsors may have to ask sites to justify why they are asking for certain start-up payments, and either sites don’t have this information or don’t want to produce it. Then, both parties are going around and around, and increasingly, some sites are walking away because they can’t achieve budget negotiations,” Harper points out.
Contract Negotiations
Contract negotiations can be particularly contentious when sponsors comment that language is non-negotiable, or if there are issues that become deal breakers. For example, some institutions have very strict policies that any samples collected during a clinical trial can only be stored for limited time periods, such as no longer than two years after the study is completed. But increasingly, sponsors are requesting long-term storage of biologic specimens, possibly for unspecified future use, as long as the patient gives consent. “For some sites, this subject is non-negotiable. It’s a deal breaker. Even if the sponsor eventually gives in, it can take four to six months for this negotiation,” she says.
Harper explains that for contract negotiations, the role of her company is to communicate clearly to both parties what the true deal breakers are upfront so they can either be negotiated in a reasonable length of time or the opportunity is turned down from the get go.
Site training
For the most part, the industry has replaced investigator meetings with Webinars and series of e-training modules. Oftentimes, there is additional training provided by the sponsor during the onsite initiation visit. “The problem is that sites have to bear the burden of going through all of the training modules for all of the studies they conduct. This obligatory box checking exercise for modules that discuss GCP, adverse event reporting, or completion of the electronic case report form can take 45 minutes apiece or longer. It’s frustrating and wastes lots of time because experienced sites have been through this process dozens of times, but they have to go through it whenever it’s part of the sponsor’s SOPs. What they really need is information about substantive issues related specifically to the study at hand,” Harper remarks.
About
Ann Neuer:
Ann Neuer, MBA is President of Medical deScriptions, a provider of writing solutions and qualitative market research services to the biopharmaceutical and clinical trials industries. She has written white papers as well as numerous articles for peer-reviewed industry publications, including ways to improve study start-up, patient recruitment, and clinical trial efficiency. Ann can be contacted at aneuer@cinci.rr.com or 513-984-4990.
About
Beth Harper:
Beth is the Chief Clinical Officer of
Centerphase Solutions, Inc. a new company dedicated to delivering timely and predictable study execution. Beth’s biopharmaceutical and device industry association experience is varied and includes serving in various capacities for forums, committees, chapter and national president, and the board of trustees for the Association of Clinical Research Professionals (ACRP). She is a widely published author of articles on site selection, study feasibilty assessment, recruitment planning and site performance enhancement, and is a frequent speaker at industry conferences. Beth is also an Adjunct Assistant Professor, School of Medicine and Health Care Sciences, Clinical Research Administration Programs with the George Washington University.
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