Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402812
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
The Perceived Mismatch Between Dose Recommendations of PKIs and the Clinical Practice
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
The Perceived Mismatch Between Dose Recommendations of PKIs and the Clinical Practice
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 confoundersoutcomes 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
Main research question What are the perceptions from regulators and healthcare professionals regarding the dosing recommendations for PKIs in clinical practice
Design including population confoundersoutcomes 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None