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NCT02843685 · ClinicalTrials.gov registry record
Regression Discontinuity Design to Evaluate of Drotrecogin Alpha Effectiveness
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 12,492
- Enrollment target
NCT02843685 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 12,492 participants.
The verdict
NCT02843685 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 12,492 participants
- Enrollment target
Study Summary
Many health care interventions and medications found to have benefits ("efficacy") in experimental, tightly-controlled, human research trials are later found to lack real-world health benefits ("effectiveness"). Inadequate surveillance of real-world clinical effectiveness may falsely reassure clinicians and those who monitor healthcare quality, propagating unrecognized ineffective or harmful treatments at high costs to patients and society. The failure to translate potential health benefits into realized gains, or to detect unexpected harms in healthcare delivery, stems from a lack of methods with which to robustly measure real-world (in)effectiveness. Current methods to detect changes in outcomes 'before and after' implementation may be biased by secular trends in healthcare practice and outcomes; other methods to compare outcomes for treated and untreated patients may be biased by unmeasured factors. The current project aims to develop and demonstrate - as a proof-of-concept - the use of a quasi-experimental research method called 'regression discontinuity design (RDD)' in surveillance of real-world clinical effectiveness. RDD had previously found use in the evaluation of educational programs in which students scoring below a threshold were assigned an intervention. The US Department of Education considers RDD designs to have quality similar to randomized trials.
Interventions
- DRUG Drotrecogin alfa activated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,492 participants |
| Start Date | 2002-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02843685
The ClinicalTrials.gov registry entry for NCT02843685 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12,492 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Drotrecogin alfa activated is the first listed.
NCT02843685 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02843685 about?
NCT02843685 is a clinical study titled "Regression Discontinuity Design to Evaluate of Drotrecogin Alpha Effectiveness". Many health care interventions and medications found to have benefits ("efficacy") in experimental, tightly-controlled, human research trials are later found to lack real-world health benefits ("effectiveness"). Inadequate surveillance of real-world clinical effectiveness may falsely reassure clinic...
What is the current status of trial NCT02843685?
This trial is currently completed. The enrollment target is 12,492 participants. The study started on 2002-12.
What interventions are being tested in trial NCT02843685?
The interventions under investigation include: Drotrecogin alfa activated (DRUG).
Who is sponsoring clinical trial NCT02843685?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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