3 years ago

Clinical Research Experience

Clinical Research Experience

Review underlying

Review underlying assumptions for statistical power during the trial • Assess overall rates of the main clinical outcomes (blinded to allocated treatment) • Assess impact of compliance to allocated treatment on risk factor levels (for example unblinded differences in lipids or BP) • Modify study duration, number of events and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes)

FDA draft guidance: Adaptive design clinical trials for drugs and biologics “Statistical bias can be introduced into adaptive design studies that make modifications based on interim analyses of a biomarker or an intermediate clinical endpoint thought to be related to the study final endpoint even though the final study analysis uses a clinical efficacy endpoint. This is because of the correlation between the biomarker and final study endpoint.” Not true: assessing the effect on a biomarker (such as blood lipids or pressure) does NOT introduce bias (ie, does not inflate type 1 error)

Clinical Research Experience
Clinical outcomes assessments to revive feasibility of trials in CV
Protection of persons in clinical research - FDIME
Using computerised clinical data for epidemiological research
Examples of ethnicity and geography issues in global clinical trials ...
Clinical research participation and adoption of clinical innovations:
Lecture 12: Randomized Clinical Trials - jhsph ocw
CLINICAL STUDIES - PharmXpert Academy
Outcomes Research and Clinical Research Networks
Innovative design of trials
Clinical Experience with the Xience V stent ... -
Clinical Research In Central Oregon -
Understanding Clinical Trial Design - Research Advocacy Network
Research Design Considerations for Clinical Trials of ... - immpact
Implementation of Medical Research in Clinical Practice - European ...
PrEP Clinical Trials Results and Future Directions for a ... - amfAR
Community Participation In HIV Clinical Research In Thailand
QPS Late Stage Clinical Research Overview -
CoreValve Clinical Experience
Clinical Research Today - Winter (RBCH Research Newsletter)
Managing the Anticoagulation Clinic IJN Experience
Adverse Events in Clinical Research
3 Pharmaceutical Research and Clinical Trials - The Canadian ...
M S Ramaiah Clinical Research Centre coordinates all Clinical trials ...
Integrating Wound Care Research into Clinical Practice
Clinical Practice Improvement - Primary Health Care Research and ...