clinical trials

  1. S

    reports for TSCs and unblinded and blinded sections of DMC meetings (clinical trials)

    Dear All, I wonder if you can please advise me what the conventions are for reports for Trial Steering Committee/TSCs and unblinded and blinded sections of Data Monitoring Committees/DMC meetings during clinical trials. I am particularly interested in what tables are produced and are they split...
  2. S

    Correlation and ROC analysis with repeated measures data

    Hi all, I have a hypothetical study where participants are taking drug X per standard of care. I have 3 different timepoints (baseline, therapy, post-therapy follow-ups) at which participants have biomarker sampling and echocardiograms performed. Exploratory objective: efficacy; Exploratory...
  3. M

    Arthritis trial data: Advanced multivariate stats problem.

    I am a doctor planning a post-hoc exploratory analysis of some clinical trial data and would like some suggestions as to the best approach. Patients with arthritis have many inflamed joints; in clinical trials, doctors test 66 of these for tenderness and swelling. The result is trinary: 0; no...
  4. P

    The Future of Clinical Trials Biostatistics - Bayesian?

    I have noticed a trend with hiring managers to vault candidates that are well versed in Bayesian analysis to the top. This is not necessarily because someone will sink or swim based on their allegiance to Bayes, these managers may not even have implemented any of the methodology at all yet...
  5. klapacius

    Wich margin of non-inferiority to pick?

    Hi everyone, I have been thinking about this quite long: Event rate of death in particular sick population is 22% Treatment A has a relative risk to placebo at 0,4 (95% CI 0,18-0,9) If I want to perform a non-inferiority trial what margin of non-inferiority should I use?
  6. T

    Covariate imbalance and restricted randomization

    Dear all, I'm involved in a cluster-randomized clinical trial with 20 clusters and 2 treatment arms, intervention and control. We would like to perform restricted randomization on the 20 clusters eliminating all randomization schemes that do not have exactly 10 clusters each assigned to either...
  7. D

    Missing data in clinical trials - HELP! Differential drop out plus ignoring questions

    Hi, I have a long format, repeated measures dataset. I have 19 variables (columns) - all representing individual questions on a 19 item scale. For my main analysis, I use the sum total of these 19 items across each row in the dataset (and a GEE analysis, with the sum total of the 19 items as...