lmr schreef op 18 maart 2019 21:59:
[...]
Ik ben geen expert, maar in mijn interpretatie geeft dit aan dat ze nog niet alle informatie hoeven te publiceren omdat ze de resultaten insturen voor FDA approval. Zover ik kan lezen kan dit enkel bereikt worden d.m.v. een gesprek met de FDA.
Dit is wat Clinicaltrials erover schrijft:
clinicaltrials.gov/ct2/about-studies/...Certification
A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner. See Delay Results Type in the Results Data Element definitions for more information about this certification.
Extension request
In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information.