At GSK, we are dedicated to improving the quality of human life by enabling people to do more, feel better and live longer. As part of this commitment, we recognise the valuable role that Supported Studies (Investigator-Sponsored Studies (ISS) and Supported Collaborative Studies (SCS)) play in fulfilling this mission.

Supported Studies are research conducted by an external Sponsor with GSK's support. There are two different ways GSK can provide support:

• Investigator Sponsored Studies are entirely designed and managed by an external Sponsor. GSK can support in the form of funding and/or product (including GSK products, adjuvant for vaccines, placebo, or other medicinal products necessary for the research). These studies are also known as Investigator-Initiated Studies, Investigator-Initiated-Trials, Investigator Initiated Research or Investigator Sponsored Research.
• Supported Collaborative Studies are conducted by an external Sponsor, with GSK contributing to study design and deliverables, in addition to the provision of funds and/or products.

In both circumstances the Sponsor of the research is accountable for all aspects of the study as well as for complying with all applicable ethical, regulatory and legal requirements.

GSK reviews proposals received at set points throughout the year. GSK is committed to responding to your proposal within eight weeks from the closing date of the relevant submission period. For ViiV Healthcare, there is a slightly different process. For more information, please click the buttons below.

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Supported Studies: A case study

Landmark GEMINI studies meet primary endpoint

Today, we announced positive headline results from ViiV Healthcare's landmark phase III GEMINI study programme. This continues our game-changing efforts to provide patients with HIV with the option to take two medicines instead of three, while still controlling the virus.

The 48-week primary endpoint results from the GEMINI studies, which used a two-drug regimen of dolutegravir and lamivudine, show that adults who had never received treatment for HIV could get a similar level of efficacy from taking the 2DR as they could from taking a three-drug regimen.

"The Gemini studies show that 2DRs could be an option for treatment naïve patients and can support a broad range of patients living with HIV around the world." said John Pottage MD, Chief Scientific and Medical Officer of ViiV Healthcare.

"The timely delivery of these important outcomes is the result of tremendous hard work and collaboration between ViiV and the GSK Team," said Kathy Rouan, SVP and Head of Projects, Clinical Platforms and Sciences (PCPS). "I want to extend my personal thanks to all of you who have contributed to this outcome; for your focus on these patients and the impact that your diligence and high performance will achieve."

"We believe these data represent an important step in the journey to redefine HIV treatment, confirming the fundamental principle that no one should have to take more medicines than they need." added Deborah Waterhouse, CEO, ViiV Healthcare.

Full results from the GEMINI studies will be presented at upcoming scientific conference. ViiV Healthcare will now plan for regulatory submissions for the two-drug regimen of dolutegravir and lamivudine later this year.

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