This concept is now validated following FDA approval of Kadcycla™ and Adcetris™, for the treatment of HER2-positive breast cancer and Hodgkin Lymphoma respectively.
The bacterial ATP synthase is now considered a validated antibiotic target following the recent approval of the antituberculosis agent bedaquiline (29, 30).
Inclusion criteria comprised: interventional articles relating to the concomitant use of corticosteroids and antibiotics in the treatment of septic arthritis; presence of a control group or cohort; clearly stated inclusion and outcome criteria; assessment of results using a validated appropriate statistical test and ethical approval.
To measure QoL and functional status the validated questionnaire EQ-5D was used after approval of the EuroQol group.
This questionnaire will be translated to Norwegian and validated according to standard scientific procedures with approval from Kujala et al. [ 46].
A well-established (validated) surrogate would be able to support regular approval, whereas a surrogate " reasonably likely to predict clinical benefit" might only support accelerated/conditional approvals [ 23, 24].
Following approval from the University Human Research ethics committee, a validated questionnaire was distributed electronically to physician members of various medical databases in South Africa as South Africa does not have a formal registry of critical care practitioners.
Urgent solutions to contain those costs are necessary and range from re-engineering the macroeconomic basis of cancer spending (e.g. value-based approaches to bend the cost curve and allow cost saving technologies), educating policy makers, introducing transparent and equitable regulatory systems, and adopting validated outcomes in both clinical trials and processes of drug approval [ 1, 2].
Hence, although the use of surrogate endpoints and non-validated CBM measures may even be considered a worse option, in palliative settings quality of life data is usually collected but approval is still based on surrogate and non-validated measures [ 15].
If you've thrown a bunch of your self-worth eggs into the Male Approval basket like Lewak has, this might make you feel validated -- for a second, until it's over.
Therefore, methods that can expand the limited supply of validated clinical samples would have major impacts on both the test and device performance evaluation and approval process, and the on-going proficiency assessment of the test providers.
