RESEARCH AND DEVELOPMENT PAYMENTS IN THE US

Despite advances in healthcare, there are still many diseases that have no cure or for which new treatments are needed to prevent transmission or help patients better control their symptoms. Working with healthcare professionals to conduct research is vital to ViiV Healthcare's (VHC) vision, which is to deliver significant improvements in the treatment of people living with HIV.


At the same time, VHC remains firmly committed to its core values of integrity and trust and, as such, is disclosing research payments for research studies led by US healthcare professionals that began on or after January 1, 2010. The information on this page pertains to all phases of medicine and product discovery and development, including nonclinical research studies and Phase I-IV clinical trials. This report will be updated annually.

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.

Using the Report

The disclosure report contains a number of different attributes or fields. These are study number, payee, PI or lead researcher, city, state and amount.

  • The study identification number reflects VHC's internal number that is used by VHC (and its parent companies, GSK and Pfizer) for tracking purposes. This identification number is also used for the clinical studies that are made publicly available on clinical study registers such as ClinicalTrials.gov.
  • Payee refers to the institutions, entity or individual initially receiving the payment (e.g., to whom the check is made out).
  • The city/state fields correspond to the location of the PI or lead researcher and not necessarily to the payee.
  • Payment amounts are recorded in US dollars.

In the case of large, multi-center clinical trials, it is not unusual for a single study number to be associated with a number of different payees (also called investigational sites), or for large payees (e.g., large academic medical centers) to be involved with a number of different VHC research studies.