Independent data monitoring committee

Fundamental healthcare issues may also be involved in the situation of policy-driven therapeutic research. The future investment of society in health may require a large-scale national clinical trial to answer questions relating to the prevention of disease or premature death. This type of clinical trial will not simply relate to one manufacturer s product. As such, it is preferable that the trial is organised on a national level, not necessarily with the exclusion of the company(s) involved. An independent data-monitoring committee (IDMC) should oversee the clinical trial with as much support from the pharmaceutical company(s) as possible. The clinical data collected belongs to the state and should be treated with the same quality standards as any pharmaceutical company sponsored study. 

Trial Management, Data Handling, Record Keeping, and Independent Data Monitoring Committee Investigator Selection... 

Use ofthe Independent Data-Monitoring Committee (IDMC)... 

In order to allow for efficient safety monitoring of the study, an independent data monitoring committee composed of international experts in movement disorder and stereotactic neurosurgery will analyze safety data at predefined intervals during the study. The first safety analysis will be performed when 1-month data from 12 patients is complete, the second will be with 1-month data from 36 patients, and the third and last when all patients have reached the 1-month time point after surgery. 

The following parameters will be listed and analyzed both for the final analysis and for the interim safety evaluations by the independent data monitoring committee ... 

So far, 36 patients have been treated in this trial and their safety assessment by the independent data monitoring committee was favorable. In all, 68 individuals are enrolled into the study, 32 of them are waiting to undergo surgery which restarted in September 2004. Surgeries were finalized in Febmary 2005. Efficacy data from this trial can thus be expected in the first or second quarter 2006. 

Ongoing phase in trials (VITAL-1 and VITAL-2) were comparing GVAX -l-Taxotere with Taxotere -I- Prednisone in randomised, blinded. The primary endpoint was improved overall survival. Both trials have recently been halted. In September 2008 VITAL-2, whieh has emolled 408 patients, has been halted because of the high proportion of deaths in patients receiving the vaccine (67 patients) compared with those in the eontrol arm (47 patients). In October 2008 VITAL-1, whieh has reemited 626 patients has also been terminated on the advise of the study s Independent Data Monitoring Committee which indicated... 

Sartor O, Halabi S (2015) Independent data monitoring committees an update and overview. Urol Oncol 33 143-148... 

After 83 MACE events had accrued, the first interim analysis was performed and the upper bound of the confidence interval placed around the hazard ratio point estimate was 1.51. An independent statistician performed this analysis and communicated the results to the independent data monitoring committee. Having therefore discharged the 1.8 threshold, the sponsor was able to include these interim results in the NDA. To protect trial integrity and statistical validity, the researchers involved with this analysis were not involved in subsequent trial conduct, data reviews, and trial analyses and did not communicate with those still involved in the study. 

Weinstein RS, Lopez AM, Joseph BA et al (2014) Telemedicine, telehealth, and mobile health applications that work opportunities and barriers. Am J Med 127 183-187 Wittes J, Schactman M (2014) On independent data monitoring committees in oncology clinical trials. Chin Clin Oncol 3 40... 

Ellenberg, S.S. and George, S.L. (2004) Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership Stat. Med. 23 1503-1505. 

The code will be broken and data will be analyzed when the 12-mo follow-up has been completed for all patients. At that time, DHA therapy will be offered to all patients who desire to receive it. Clinical and laboratory studies will be monitored by an independent data and safety monitoring committee. This committee will also perform an interim analysis when 30 patients have completed assessment and has permission to terminate the study if there are significant favorable findings or unanticipated adverse outcomes. A determination of statistical power indicates that this sample size is sufficient to detect a major effect (0.862 standard deviations). With a more modest effect of 25%, however, the statistical power diminishes to 60%. The study has been approved by the Institutional Review Board at the Johns Hopkins Medical Institutions and is supported by a research grant from the Office of Orphan Products Development at the Food and Drug Administration. Fifty-two patients are enrolled in the study at this time. The code has not yet been broken. No adverse effects attributable to the medication have been observed. 

Database Manager The database manager functions under the guidance of, but independently from, the Principle Investigator. One model for this function is the data safety and monitoring committees appointed to oversee the progress of clinical trials (6). 

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