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CompletedNCT06402812Updated May 7, 2024

The Perceived Mismatch Between Dose Recommendations of PKI's and the Clinical Practice

An observational study in Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
18
Ages
16 Years and older
Sex
All
01

Study summary

A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.

Read the detailed description
  • Background Protein kinase inhibitors (PKIs) are increasingly used as targeted therapy in the treatment of cancer. Currently, most PKIs are administered following the recommended dosage from the registered label based on pharmacokinetic and pharmacodynamic data, toxicity and tumor response as observed in clinical trials. Often, the recommended dose is selected based on the principle of the maximum tolerated dose (MTD). However due to pharmacokinetic and pharmacokinetic differences within patients, this registered flat starting dose often leads to toxicity. In addition, the fit and selected clinical trial patients are not always representative of the patients in clinical practice. This raises the question if the policy around dose development and recommendation is optimal. The objective of this study is therefore to increase patient safety, by exploring the perceptions of regulators and healthcare professionals on the perceived mismatch between the recommended dosage and the dose used in clinical practice for PKIs.
  • Main research question What are the perceptions from regulators and healthcare professionals regarding the dosing recommendations for PKIs in clinical practice?
  • Design (including population, confounders/outcomes) A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
  • Expected results This research aims to contribute to patient safety of PKIs in cancer treatment by exploring the opinions regarding the dosing recommendations at registration and their use in clinical practice from regulators and healthcare professionals. By gathering perceptions from important, preselected, stakeholders regarding dose regulations for PKIs, substantive knowledge will be gathered on the subject. This study will increase the knowledge base on the sufficiency of the standards for dose recommendations regarding PKIs and potentially aid in the generation of new policy recommendations.
02

Conditions studied

  • Cancer
03

In context

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Regulators and professionals

Inclusion criteria

  • Regulators involved in the regulation of oncolytic products. Healthcare professionals who prescribe PKI's as a treatment for cancer in clinical practice (e.g. oncologists).

Exclusion criteria

Exclusion Criteria:

  • No exclusion criteria will be maintained.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • Regulators

    Regulators

    Other: Interview

  • Proefssionals

    Professionals

    Other: Interview

Interventions

  • OtherInterview

    A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.

06

What researchers measure

Primary outcomes

  1. Interview

    Spoken words of participants will be gathered via interviews which have been conducted following an pre-set up interview guide.

    Time frame: 3 months

07

Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06402812
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
May 7, 2024
Start date
Feb 6, 2024
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Last update
May 7, 2024

Study contacts

Esther Broekman, MD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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