Background
To help you understand the information we are disclosing, the payments listed here were provided to:
- US research entities and institutions associated with principal investigators (PI) or lead researchers when the PI (or lead researcher) is a US healthcare professional; and/or to
- US healthcare professionals who provide services to VHC when they are a PI or lead researcher in a VHC sponsored or supported study.
In most cases, VHC does not know the amount of compensation the PI or lead researcher receives from his or her institution. In the VHC business model, GSK and Pfizer operationalize VHC's HIV clinical trials through service level agreements. 2010-2013 reports include payments made directly by GSK or Pfizer to HCPs or indirectly by GSK or Pfizer through a third party such as a Contract Research Organization (CRO). For purposes of research payments, VHC defines a US healthcare professional as an individual who can prescribe or dispense a prescription medicine to a US patient. In order to be eligible to conduct VHC research, a US healthcare professional also must be qualified to undertake and be responsible for the research study. Since 2014, ViiV decided that payment made directly by Pfizer will be reported by Pfizer to CMS directly. Thus, ViiV Healthcare report submissions will only include payments made by GSK.
Payments for research do not just constitute compensation for the PI or lead researcher. Research costs also include payments for any study visits and any other costs to conduct the research study at the site, such as:
- Procedures (diagnostic tests, laboratory services and patient assessments);
- Detailed monitoring of clinical outcomes and drug safety; and
- Institutional overhead.
Finally, VHC is committed to providing as complete and accurate a disclosure as possible. However, despite our best efforts, from time to time errors can occur (e.g., when a PI or lead researcher moves to a different institution). As a result, we have established internal processes to continually review and validate our disclosures and to correct the records when errors are identified.
