The official, Wang Chen, said at a news conference that registration trials in five major eastern Chinese cities would continue until wrinkles were worked out.
Currently in NSCLC, 3 phase III registration trials have completed accrual, and 1 remains in progress.
Recently, two registration trials − one with anamorelin and another with enobosarm − failed to reach their primary endpoints, thus raising questions.
There is an unmet need for a quantitative and a reproducible assessment of bone scan that generate reliable data in multi-institutional registration trials.
Currently, 4 phase III registration trials are being conducted with vandetanib alone or in combination with chemotherapy in patients with pretreated advanced NSCLC.
As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA).
Distinctive features of registration trials in oncology need to be considered when these studies form basis for EBA, especially in cancer-indications with long post-progression survival; and with several consecutive therapeutic options available post-progression.
TARGET-NASH is a 5-year, longitudinal, observational study of patients with NAFLD designed to evaluate the effectiveness of clinical practice interventions and provide practical information unobtainable in registration trials.
RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment.
Clinical trials designed to show robust data on efficacy and tolerability particularly during registration trials must be complemented by robust observational research to confirm and better describe clinical effectiveness in the target population.
The most common causes for failure in the registration trials could be preempted by testing novel agents in milder forms of the disorder, such as schizotypy and assessing the effect with validated biomarkers.
