16. How will the patient community be informed about the results of each trial?
In line with GSK’s policy regarding transparency around GSK-sponsored research, the results of these studies will be submitted for presentation at appropriate scientific meeting(s) and submitted for publication, in searchable, peer reviewed, scientific journals.
17. Who is responsible for deciding whether the study drug works and whether or not it will be further developed?
Each of the ongoing studies have pre-determined endpoints to investigate the effect of GSK’968. These study results (including any interim analysis) will be examined by GSK’s cross-functional project team to determine if the benefit: risk profile merits further development. If necessary, they will seek expert opinion to analyse and review the data. In addition, an independent data monitoring committee (IDMC) monitors the safety of the drug during clinical studies.
18. If I am taking part in a GSK trial in which the study drug seems to work, and GSK applies for marketing authorization, will I be allowed to continue to take the drug at the end of the trial, even before it becomes generally available in my country?
Where there is a compelling medical rationale for patients who have derived measurable medical benefit from an investigational medicine during a clinical study to continue to receive that compound after the study, GSK endeavours to provide that treatment either though additional clinical studies or though expanded access programmes.
Study participants who complete the Phase II & III studies and meet extension study entry criteria may be eligible to participate in an extension study. Open-label extension studies are planned for patients who complete randomised, placebo-controlled trials. Extension studies are planned to be a minimum of two years in duration or until GSK2402968 becomes commercially available, whichever is longer. Participation of particular sites/countries is subject to local regulatory and ethics committee approvals.
19. If I am taking part in a GSK trial in which the study drug seems to work, but I was taking placebo, will I be allowed to transfer to the study drug?
Open-label (active treatment) extension studies are planned for the PII and PIII studies. Patients who complete randomised, placebo-controlled trials and meet the extension study criteria may be eligible to participate, regardless of what treatment arm they were on in the original study. Participation of particular sites/countries is subject to local regulatory and ethics committee approvals.
20. If the study drug seems to work and GSK applies for marketing authorization, what are the next steps and how soon will it become available to patients who weren’t in the trial?
The results of ongoing clinical studies will support GSK’s submissions for marketing authorisation approval by regulatory agencies. We cannot speculate on when, if approved by regulators, the study drug might be available. However, it is GSK’s policy to ensure that its resources are applied to the efficient and expeditious conduct of clinical trials that will enable investigational compounds to gain earliest appropriate marketing authorisation.
21. Does GSK involve patient views in clinical trial design?
Clinical trial design must be agreed with regulatory agencies, such as EMA and FDA. In addition, GSK seeks input on the clinical development plan from a variety of sources including physicians, patients and patient advocacy groups, as needed when appropriate.
More broadly, as well as informing clinical study design, patient insight into a disease and its impact on patients and carers, improves GSK’s understanding and enables us advance development of medicines that best meet the needs of patients.
These questions have been translated into Japanese and are available from the Japan’s Registries website – Remudy.