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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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An Affordable HIV-1 Drug Resistance Monitoring Method for Resource Limited Settings
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Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials.

Scott R Rosas1, Jeffrey T Schouten2, Dennis Dixon3

  • 1Concept Systems, Inc., Ithaca, NY, USA srosas@conceptsystems.com.

Clinical Trials (London, England)
|July 2, 2014
PubMed
Summary
This summary is machine-generated.

Clinical trial development and implementation times vary widely, with later-phase therapeutic protocols taking longer. Analyzing these intervals can accelerate clinical research and reduce costs.

Keywords:
HIV/AIDS Clinical TrialsSurvival analysisprotocol developmentprotocol implementationtime-based analyses

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Area of Science:

  • Clinical trial management
  • Biomedical research operations

Background:

  • Efficient clinical trials are crucial for developing new disease interventions.
  • Understanding trial lifecycle bottlenecks is key to optimizing resource use and maintaining scientific rigor.

Purpose of the Study:

  • To model time-to-event data in clinical trials.
  • To explore relationships between protocol development and implementation timelines.
  • To identify factors associated with extended trial durations.

Main Methods:

  • Analysis of time intervals and participant accrual data from 111 interventional trials (2006-2011) from NIH HIV/AIDS Clinical Trials Networks.
  • Use of Kaplan-Meier estimates to assess event rates, stratified by study purpose and phase.
  • Examination of potential correlates for prolonged development and implementation.

Main Results:

  • Protocol development and implementation times showed significant variation, independent of phase grouping.
  • Phase III/IV therapeutic protocols trended towards longer development (median 2.5 years) and implementation (>3 years).
  • Protocols exceeding the median development time also had significantly longer implementation periods.

Conclusions:

  • Small sample size and protocol grouping may have limited detection of phase-specific differences.
  • Informative censoring, like investigator withdrawal, complicates interpretation of timing estimates.
  • Analyzing clinical trial intervals can drive process improvements to expedite research from concept to results.