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Operations analysis report

Study title

Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer

NCT#

NCT02299141

Last updated

Jun 24, 2025

10 recommendations found

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Clinical Research Coordinator Analysis

Pharmacokinetic (PK) Sample Collection Logistics

Finding: The protocol (Section 7.3.1, Pharmacokinetics) mandates a PK blood sample at 24 hours (±2 hours) post-dose on Day 1. This effectively requires participants to return to the clinic on what is operationally Day 2, specifically for this blood draw, immediately following an already lengthy and procedure-intensive Day 1 (Baseline/Randomization/First Dose) visit. This presents a notable logistical challenge for site scheduling and a considerable burden on participants, potentially impacting recruitment, retention, and compliance with this specific sample collection. Recommendation: For operational planning, sites should:

1. Develop a proactive scheduling strategy that explicitly accounts for this Day 2 PK draw. This includes scheduling the main Day 1 visit (and first dose administration) at a time that allows the 24-hour post-dose window to fall conveniently within clinic operating hours on the following day.

2. Clearly and thoroughly explain the necessity and timing of this Day 2 return visit to potential participants during the informed consent process to manage expectations and confirm their ability to adhere to this requirement.

3. Prepare simple, participant-friendly reminders or visual aids emphasizing this short, but crucial, follow-up visit.

It would also be beneficial to confirm with the Sponsor if any flexibility exists for this window under exceptional circumstances, or to explore if (where feasible and compliant with local regulations/site SOPs) options like a certified mobile phlebotomy service could be pre-approved for this single draw to reduce participant travel burden.

Rationale: Implementing these proactive measures will improve participant adherence to this key PK sample collection, reduce the risk of missed visits or out-of-window deviations, minimize potential participant frustration, and facilitate smoother overall study conduct and resource allocation at the site.

Operations analysis report

Clinical Research Coordinator Analysis

Pharmacokinetic (PK) Sample Collection Logistics

Finding: The protocol (Section 7.3.1, Pharmacokinetics) mandates a PK blood sample at 24 hours (±2 hours) post-dose on Day 1. This effectively requires participants to return to the clinic on what is operationally Day 2, specifically for this blood draw, immediately following an already lengthy and procedure-intensive Day 1 (Baseline/Randomization/First Dose) visit. This presents a notable logistical challenge for site scheduling and a considerable burden on participants, potentially impacting recruitment, retention, and compliance with this specific sample collection. Recommendation: For operational planning, sites should:

1. Develop a proactive scheduling strategy that explicitly accounts for this Day 2 PK draw. This includes scheduling the main Day 1 visit (and first dose administration) at a time that allows the 24-hour post-dose window to fall conveniently within clinic operating hours on the following day.

2. Clearly and thoroughly explain the necessity and timing of this Day 2 return visit to potential participants during the informed consent process to manage expectations and confirm their ability to adhere to this requirement.

3. Prepare simple, participant-friendly reminders or visual aids emphasizing this short, but crucial, follow-up visit.

It would also be beneficial to confirm with the Sponsor if any flexibility exists for this window under exceptional circumstances, or to explore if (where feasible and compliant with local regulations/site SOPs) options like a certified mobile phlebotomy service could be pre-approved for this single draw to reduce participant travel burden.

Rationale: Implementing these proactive measures will improve participant adherence to this key PK sample collection, reduce the risk of missed visits or out-of-window deviations, minimize potential participant frustration, and facilitate smoother overall study conduct and resource allocation at the site.

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Find & fix bottlenecks in minutes

© 2024 Polytrial Corp.

Find & fix bottlenecks in minutes

© 2024 Polytrial Corp.