Bioanalytical Community

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Is anyone aware of a summary table? e.g., something that explains when different regulations apply based on country/region and intended use of data - In my ideal world it would be a single page w/ links and cover all laboratory generated data used in drug development- ICH M10, GCP, GLP, 21 CFR Part 11, CLIA, EU IVDR, FDA LDT Rule, ISO 13485 etc. 

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Hi Stephanie-

You could form a working group to create one. I'd join. But recruit Eric Woolf also.

Tom

Thomas Tarnowski 

Is anyone aware of a summary table? e.g., something that explains when different regulations apply based on country/region and intended use of data - In my ideal world it would be a single page w/ links and cover all laboratory generated data used in drug development- ICH M10, GCP, GLP, 21 CFR Part 11, CLIA, EU IVDR, FDA LDT Rule, ISO 13485 etc. 

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Hi Stephanie-

You could form a working group to create one. I'd join. But recruit Eric Woolf also.

Tom

Thomas Tarnowski 

Is anyone aware of a summary table? e.g., something that explains when different regulations apply based on country/region and intended use of data - In my ideal world it would be a single page w/ links and cover all laboratory generated data used in drug development- ICH M10, GCP, GLP, 21 CFR Part 11, CLIA, EU IVDR, FDA LDT Rule, ISO 13485 etc. 

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

It should be relatively straightforward to put together such a listing.  It might be good to include someone from the Regulatory Science community as well as from this community to participate.

Hi Stephanie-

You could form a working group to create one. I'd join. But recruit Eric Woolf also.

Tom

Thomas Tarnowski 

Is anyone aware of a summary table? e.g., something that explains when different regulations apply based on country/region and intended use of data - In my ideal world it would be a single page w/ links and cover all laboratory generated data used in drug development- ICH M10, GCP, GLP, 21 CFR Part 11, CLIA, EU IVDR, FDA LDT Rule, ISO 13485 etc. 

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

If we are going to start such an initiative, please include myself also. 

- Steve Lowes

It should be relatively straightforward to put together such a listing.  It might be good to include someone from the Regulatory Science community as well as from this community to participate.

Hi Stephanie-

You could form a working group to create one. I'd join. But recruit Eric Woolf also.

Tom

Thomas Tarnowski 

Is anyone aware of a summary table? e.g., something that explains when different regulations apply based on country/region and intended use of data - In my ideal world it would be a single page w/ links and cover all laboratory generated data used in drug development- ICH M10, GCP, GLP, 21 CFR Part 11, CLIA, EU IVDR, FDA LDT Rule, ISO 13485 etc. 

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

If we are going to start such an initiative, please include myself also. 

- Steve Lowes

It should be relatively straightforward to put together such a listing.  It might be good to include someone from the Regulatory Science community as well as from this community to participate.

Hi Stephanie-

You could form a working group to create one. I'd join. But recruit Eric Woolf also.

Tom

Thomas Tarnowski 

Is anyone aware of a summary table? e.g., something that explains when different regulations apply based on country/region and intended use of data - In my ideal world it would be a single page w/ links and cover all laboratory generated data used in drug development- ICH M10, GCP, GLP, 21 CFR Part 11, CLIA, EU IVDR, FDA LDT Rule, ISO 13485 etc. 

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

I agree with Jim on the patient privacy issues, but there are additional considerations for the application of GCPs. One is that GCPs are intended to prevent patient harm. Normally, bioanalytical data don't fall into that category but things like mis-dosing where higher than expected concentrations are observed or when there is a exposure threshold put the BA data as part of patient safety considerations and require rapid reporting of the results.

Additionally, in 2012, EMA published a reflection paper "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples".  The Scope of that document notes "The nature and purpose of laboratory work conducted as part of a clinical trial is extremely broad. Laboratories perform a wide range of activities which provide data that is used to monitor trial subject safety, assess pharmacokinetic parameters and to measure end points. Consequently, because of the diverse nature of laboratory work associated with clinical trials, it is very difficult to provide guidance which is wholly applicable in all situations. It is acknowledged that the recommendations set out in the paper may not be applicable in their entirety to some laboratories. The paper is primarily aimed at contract research organisations, sponsors laboratories and non commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial. However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised."

Because PK is not always a primary endpoint, the guideline is not always applicable, but many clinical studies do include PK as a primary endpoint (e.g., DDI, Food-effect, BA, BE).  It also raises the question in today's world when bioanalytical labs are measuring biomarkers, they are sometimes listed as primary endpoints.

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

For patient privacy types of issues, GCP do apply.  For pure BA work, one should follow ICH M10. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

I would recommend reading this white paper as a starting point.  However, the clinical study sponsor's role extends beyond the bioanalytical laboratory, as the responsibility also includes clinical investigator site inspections. From a BA perspective, this is sample management, which must align with sample stability information.  

https://www.tandfonline.com/doi/full/10.4155/bio-2024-0055#abstract

------------------------------
James Zanghi, PhD
Senior Principal Scientist
BioAnalytical Sciences
Genentech

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 11-21-2024 09:57
From: Anonymous Member
Subject: Why does or doesn't clinical BA work fall under GCP?

This message was posted by a user wishing to remain anonymous

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

I agree with all of the points mentioned above.  One point that is often overlooked is the fact that GLP or GCP says nothing about the quality of the science/methodology used for the bioanalytical work.  GLP, which applies only to pre-clinical work, focuses primarily on documentation and the ability to reproduce the "compliant" work.  It is quite possible to do poor science in a GLP compliant manner.  Similarly, the aspects of GCP that are mentioned above as being applicable in a BA lab focus primarily on patient privacy and safety, not the science of the method being used for the bioanalytical work.  Scientific rigor comes into play when ICH M10 is applied to method validation and sample analysis.

------------------------------
Eric Woolf Ph.D., FAAPS
Souderton PA
[email protected]



Original Message:
Sent: 11-22-2024 14:02
From: James Zanghi
Subject: Why does or doesn't clinical BA work fall under GCP?

I would recommend reading this white paper as a starting point.  However, the clinical study sponsor's role extends beyond the bioanalytical laboratory, as the responsibility also includes clinical investigator site inspections. From a BA perspective, this is sample management, which must align with sample stability information.  

https://www.tandfonline.com/doi/full/10.4155/bio-2024-0055#abstract

------------------------------
James Zanghi, PhD
Senior Principal Scientist
BioAnalytical Sciences
Genentech

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 11-21-2024 09:57
From: Anonymous Member
Subject: Why does or doesn't clinical BA work fall under GCP?

This message was posted by a user wishing to remain anonymous

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Thanks everyone- I'll look to set something up so we can get started on this in January. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Thanks everyone- I'll look to set something up so we can get started on this in January. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?

Thanks everyone- I'll look to set something up so we can get started on this in January. 

Are there specific reasons why companies view bioanalytical (BA) work to support clinical studies as needing or not needing to follow GCP regulations?