Was the SELECT-D (Study Evaluating Long-term Clinical Outcomes with Diabetes drugs) trial terminated early?

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Was the SELECT-D Trial Terminated Early?

Yes, the SELECT-D trial was terminated early, specifically the second randomization phase of the trial which was closed prematurely due to low recruitment, enrolling only 92 of the planned 300 patients. 1

Background on the SELECT-D Trial

The SELECT-D (Anticoagulation Therapy in Selected Cancer Patients at Risk of Recurrence of Venous Thromboembolism) trial was designed to evaluate anticoagulation treatments for cancer patients with venous thromboembolism (VTE). The trial had two phases:

  • The initial 6-month phase compared rivaroxaban to dalteparin for treatment of acute VTE in cancer patients 2
  • The second randomization phase was intended to assess the benefits of extended anticoagulation (additional 6 months) with rivaroxaban versus placebo in patients with active cancer and residual deep vein thrombosis (RDVT) or index pulmonary embolism (PE) 1

Details of Early Termination

The second randomization phase of SELECT-D was terminated early due to:

  • Low recruitment - only 92 of the planned 300 patients were enrolled 1
  • This represents less than one-third (30.7%) of the target sample size 1

Impact of Early Termination

The premature termination had several consequences:

  • The study was underpowered to detect a statistically significant reduction in recurrent VTE with extended anticoagulation 1
  • Despite this limitation, the data showed a trend toward benefit with rivaroxaban (4% VTE recurrence) compared to placebo (14% VTE recurrence), with a hazard ratio of 0.32 (95% CI, 0.06-1.58) 1
  • The incomplete enrollment limited the ability to draw definitive conclusions about the optimal duration of anticoagulation in cancer patients 1

Context of Trial Termination in Clinical Research

Early termination of clinical trials is not uncommon:

  • Approximately 12% of trials with results posted on ClinicalTrials.gov are terminated early 3
  • Insufficient accrual (slow recruitment) is the leading cause of early termination in many trials (57% of trials terminated for non-data-related reasons) 3
  • In leukemia trials specifically, slow accrual accounts for 38.2% of early terminations 4

Reporting Standards for Terminated Trials

The CONSORT guidelines emphasize the importance of fully reporting why a trial ended early:

  • Trials may stop early for various reasons including reaching sample size goals, scheduled closure dates, interim analysis results showing benefit or harm, futility, or becoming unviable (e.g., funding issues, inability to recruit participants) 2
  • Full reporting of why a trial ended is important for evidence-based decision making 2
  • Trials that stop early for reasons independent of trial findings (like recruitment difficulties) are unlikely to introduce bias in the results 2

The SELECT-D trial's early termination falls into this category of trials that end due to recruitment challenges rather than due to efficacy or safety concerns, which helps maintain the validity of the data that was collected, albeit with reduced statistical power.

References

2
Guideline

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Dr.Oracle Medical Advisory Board & Editors, 2025

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This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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