Frequently Asked Questions

Q. Why does GSK need to work with U.S. healthcare professionals in the context of research?

Ethical, high quality research is essential in the development of new medicines and treatments. An important step in the research process is the study of a potential new medicine or treatment in human research participants. These outside healthcare professionals, some at academic institutions or others in private practice, have considerable expertise and insight into disease and the ability to translate that experience into valid research questions that help us in developing new medicines.

Q. For disclosure purposes, how does GSK define research?

GSK defines research to include all phases of medicine (pipeline and products) discovery and development, including nonclinical (i.e., nonhuman) research studies and Phase I-IV clinical trials. Our disclosure covers research conducted for all R&D business units, consumer healthcare (over-the-counter medicines), Stiefel, and vaccines.

A research study includes any research-specific protocol or procedure such as clinical, epidemiological, observational or health outcomes research, patient assessments, diagnostic tests, drug safety assessments, in silico modelling, animal research, metadata analysis, proof of mechanism research, diseases understanding etc. These studies also include GSK sponsored or GSK supported studies.

Q. What kind of research work do these U.S. institutions and healthcare professionals listed perform for GSK? What are you paying for?

Payments for research are generally made to institutions that employ healthcare professionals. The payment made to the institution may include compensation for research-specific procedures such as assay development, ex vivo analysis, diagnostic tests, patient assessments, detailed monitoring of clinical outcomes and drug safety, institutional overheads as well as fair market values for the healthcare professional’s time and expertise. In most cases, GSK has no knowledge of the compensation, if any, provided to the PI by the Institution.

Q. How do you select U.S. physicians to work with on research projects? Are there criteria?

We engage researchers based upon our belief that they can conduct high quality, ethical research. That means that we must collect and examine their CV’s. A check is conducted to be sure their medical license is current. We also ensure that researchers have not been declared ineligible to work for the federal government (debarment) or been excluded for past regulatory violations by the FDA (disqualification). We also are implementing a process to exclude anyone who has received a professional sanction and/or disciplinary action from a federal or state government agency or authority.

Q. How do you decide how much to pay a U.S. institution for research?

Study budgets contain a number of components including procedure-related costs (e.g., X-rays) and indirect costs (e.g., administrative fees). In all cases, GSK has established fair market value ranges for what we believe each component should cost. Budgets are built from the ground up (i.e., on a per-patient per-procedure cost). We then factor in other elements such as start-up costs (e.g., site preparation) and indirect costs (e.g., institutional overhead). Once complete, we present the budget to the site and negotiate to reach a final cost acceptable to the institution and to GSK.

Q. Where on the web will this info be displayed and what information do you include?

This is displayed on us.gsk.com in the Responsibility section. Data included will be the study number (which links to details about the trial disclosed on http://www.gsk-clinicalstudyregister.com/ and on www.clinicaltrials.gov), the payee (usually the institution where the principal investigator or lead researcher works), the principal investigator (“PI”) or lead researcher involved, the city and state of the PI or lead researcher and the amount of money they received during the year. We will update the posting once a year.

Q. Can U.S. institutions choose not to have GSK disclose their names and research payment information?

No. If an institution receives payment from GSK for research, that will be disclosed. Likewise we will associate and disclose the names of the lead researcher or Principal Invesigator involved with the research.

Q. Will GSK entertain comments on how to improve the disclosure?

Yes. We are continually reviewing and validating our disclosures, and stakeholder feedback is part of that review process. We do accept and evaluate comments on how to make our disclosure even better in the future. Comments can be shared through the GSK Response Center at 1-888-825-5249 during the hours of 8 a.m.-6 p.m. Eastern Time Monday through Friday.

Q. What other steps have you taken to improve transparency?

• Posting observational studies, meta-analyses and studies of terminated compounds on the GSK Clinical Study Register. Our Clinical Study Register website, launched in 2004, serves as a resource for researchers, medical professionals and the public to access data from GSK-sponsored clinical trials. It supplements locally approved prescribing information and publications in the scientific literature.
• Committing to publish all clinical results in scientific literature (or context and interpretation on the Clinical Study register if the journal refuses to publish the study).
• Reporting clinical trial investigator names and institutions.
• Publishing a quarterly update in the US of grants and sponsorships to US-based health-relations organizations.
• Ensuring that in the US we fund only independent medical education programs that result in improved patient health, run by academic medical centers and affiliated teaching and patient care institutions and national-level professional medical associations. We no longer fund programs run by commercial providers such as medical education communication companies.