4. Does GSK provide “family-friendly” information or overviews about its trials online?
On a global level, GSK provides information regarding its ongoing studies via registries like www.clinicaltrials.gov. These registries provide core scientific information regarding study objectives and endpoints, as well as inclusion and exclusion criteria. As each family will have different information needs, it is best if families speak to their physician and/or local study investigator for more details regarding the studies.
5. Where can I reliably find out which study sites or clinics are involved in the GSK trials?
In the interests of making up to date information regarding clinical studies available to the DMD community, GSK also provides study information to DMD support and advocacy communities and other study registries, by request.
6. I heard that the clinic I go to is going to be involved in a GSK trial but it is not listed on the GSK study register or clinicaltrials.gov. How can I be sure I am getting the correct information?
A clinical study cannot progress in any centre until all relevant local regulatory and ethics committee approvals have been granted. As such, GSK does not post details of study sites on www.clinicaltrials.gov or www.gsk-clinicalstudyregister.com until it has been confirmed that all the necessary approvals have been granted and the centre can begin recruiting. This can lead to a small time lag, but it does ensure that the information posted is accurate.
7. Why is the information on clinicaltrials.gov not identical to the information on the GSK clinical study register?
Information regarding clinical studies goes into single system, which then feeds into both these sites. The core study information should be identical, but often www.gsk-clinicalstudyregister.com contains more detailed contact information for investigator sites. In addition, www.clinicaltrials.gov reviews all new data prior to publishing, which can result in a time lag in information posting on this website.
8. At what stage does GSK update the information about the trial on both clinicaltrials.gov and the GSK clinical study register?
The database that feeds www.clinicaltrials.gov and www.gsk-clinicalstudyregister.com is updated on ongoing basis and data is transferred on weekly basis. Any updates to www.clinicaltrials.gov information has be reviewed before publishing, but this typically happens quickly.
9. When does GSK reveal which countries will be participating in a clinical trial and identify the individual investigator sites?
For a clinical study to be conducted in any country, the company conducting the study has to obtain approval from the national regulatory agency to progress the study. Once national approval has been granted, or in parallel with regulatory submissions, each proposed local investigator site has to obtain all relevant local regulatory and ethics committee approvals before it can participate in the study. GSK posts details regarding participating countries and study sites on www.clinicaltrials.gov or www.gsk-clinicalstudyregister.com when all the necessary approvals have been granted.
10. Why doesn’t GSK provide information regarding study investigator sites early in the process?
GSK does not post details of study sites until it has been confirmed that all the necessary approvals have been granted and the centre can begin recruiting. Communicating information regarding potential study sites earlier in the process could lead to disappointment as all the projected study sites may not proceed due to regulatory and/or ethics committee issues.
These questions have been translated into Japanese and are available from the Japan’s Registries website – Remudy.