2014 CBI Investigator-Initiated & Sponsored Research (IISR) Highlights

By Russell Hirschorn

CBI Conference Highlights: Lots of Questions About Research Study Spend Capture & Reporting

CBI Investigator-Initiated
The 2014 CBI Investigator-Initiated and Sponsored Research (IISR) conference held in Philadelphia recently was a great success. Thanks to the CBI team and conference moderator, Alex Kostek, Team Global IIR Group Leader from Pfizer, every session was met with engaged participants and thoughtful questions.

During the sessions, attendees engaged both the speakers and each other with thought-provoking questions, comments, and discussions on areas of concern, which made for a higher level of discourse. The sessions went very smoothly, to some degree due to the fact that Alex kicked the conference off by listing all the acronyms applicable to IISRs (IIT, IIS, IIR, IST, ISS, etc…) to caution attendees that these may be used interchangeably through the sessions. This saved many from confusion later on.

Our session, entitled “Hot Compliance Topics in IISRs” was met with many questions and comments about Medical Science Liaison (MSL) Involvement and Interactions, as well as Corporate Integrity Agreement (CIA) trends and global transparency regulations in the pharmaceutical, life science, medical device, and related industries.

During the first topic of our session, we emphasized that in the implementation of a new process or system to manage IISR studies, the first and most important step is to ensure MSL awareness of management’s desire to do so, and explain the details of how it will be rolled out to acknowledge them as a stakeholder, whether they are involved in the system/process selection or design, or not. We further pointed out that during rollout, the MSL should be designated as an advocate to help investigators adopt the new process/system and explain the benefits they will receive by following it. Furthermore, we encourage ongoing MSL interaction with the investigator as long as it does not impact study design or execution, which could violate compliance or regulatory protocols. At the very least, we feel MSLs should assume an operational role to maintain continuity in their relationship with investigators.

Other areas discussed included IISRs growing prominence in recently disclosed CIAs, which highlight the creation of written policies and procedures governing IISRs, the execution of written agreements with investigators, evidence of research monitoring programs, and adherence to a fair market value (FMV) structure supporting spend decisions related to IISR. We also discussed approaches for successfully addressing these aspects of IISR program compliance. By far the greatest interest among session participants was shown in determining FMV for IISRs. We made the point that there is no magic number for IIT FMV evaluation and that the key is implementing a consistent and repeatable process for all companies, investigators, and studies.

We closed our session with a review of all current regulations requiring the reporting of IITs. This discussion started with an overview of the Federal Sunshine Act distinguishing between aggregate and detailed reporting deadlines, as well as the scope of IISR reporting for Federal Open Payments and the difference between direct and indirect payments.

The majority of questions received focused on what “Delayed Publication” means and how it is applied. We explained CMS’ decision to delay the public display of certain research payments as long as the payment or transfer of value (TOV) is related to research, development, clinical investigations, or a new application of a new drug, device, biologic or medical supply. Delayed Publication is not available for the same activities on existing drugs, devices, biologics, or medical supplies. Any payment or TOV data attached to filings receiving a Delayed Publication indication will be publicly posted on the first reporting date following either the date of approval/licensure or clearance of the Covered Drugs, Devices, Biologicals or Medical supplies (CDDBM) by the FDA or four calendar years after the date the payment/TOV was made, whichever comes first.

Wrapping up the discussion around the Sunshine Act and IISR, we advised participants that IIT spend is reportable in most circumstances, and it was important to note that these payments/TOVs will be attributed to both the organization that receives them, as well as all primary investigators (the CMS Research Template allows for up to 5 primary investigators to be specified for each research payment or TOV). We therefore stressed that it was important to ensure all processes, agreements, and systems were updated to track information that will be integrated with company aggregate spend processes and reporting.

We didn’t focus solely on U.S. compliance laws relating to IISR spend and expanded the discussion into global regulations requiring the disclosure of IISR spend. EFPIA guidelines, for instance, considers an IIT ”Research” if it relates to the planning or execution of “non-clinical studies”, “clinical trials”, or “non-interventional studies.” Study-related payments under EFPIA, are to be reported in aggregate for all research payments per member organization, which is slightly different from Sunshine reporting requirements where each research payment is reported individually under each study executed.

Thanks again to all session participants and attendees for bringing to our attention the key issues and challenges you are facing around IISR program compliance and spend reporting and we look forward to talking more with you about these in 2014!