Author Topic: Difference between ASUR and DSUR  (Read 10497 times)

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Offline Kiranchvs

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Difference between ASUR and DSUR
« on: Fri, 4 Sep 2009 »
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Hi,
Can any one clarify me difference between ASUR (Annual Safety Report) and DSUR (Deva lopmental Safety Update Report)

Regards,
Kiran

Offline Yeshpal Mathangi

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Re: Difference between ASUR and DSUR
« Reply #1 on: Fri, 4 Sep 2009 »
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Hello Kiran,

ASR is Traditional country specific Pre-Approval Periodic Safety Reporting Requirement During Clinical Trials (Post IND Approval ).

  *US IND Annual Report (AR)
  *EU CT Directive’s Annual Safety Report (ASR)

DSUR is Relatively new developed by CIOMS- VII, A Harmonized Approach to Periodic Safety Update Reporting During Clinical Trials (Post IND Approval ), Extension of PSUR to pre-approval;One annual report for all regulators.

Hope this helps,

Cheers,
Yeshpal Mathangi
Dr. Yeshpal Mathangi, Iam LinkedIn: Come Join Me: http://www.linked***personal email not allowed***/groups?gid=1871207
{Medical and Clinical Subject Matter Experts Group}

Offline Kiranchvs

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Re: Difference between ASUR and DSUR
« Reply #2 on: Mon, 7 Sep 2009 »
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Hi Yeshpal,
Thank you for your input. But is it DSUR the term we use now in for PSUR in clinical trials

Offline praveenbhise

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Re: Difference between ASUR and DSUR
« Reply #3 on: Mon, 7 Sep 2009 »
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Hello Yeshpal.. Thanks for a very nice explanation can you plase provide the source for the same!!!
Praveen Bhise
Nutrition Officer
"If you have knowledge, let others light their candles in it".

Offline Yeshpal Mathangi

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Re: Difference between ASUR and DSUR
« Reply #4 on: Mon, 7 Sep 2009 »
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Hello Kiran,

Yes DSUR is Extension of PSUR to Clinical trials;

Alignment of the DSUR is in similar format and content with that of the established outline of the PSUR
(consistent terminology and definitions for pre-and post-approval).

Analogy: Development Core Safety Information (DCSI) evolving into the Company Core Safety Information (CCSI) – a logical, sequential process.

Regards,
Yeshpal Mathangi


Offline Kiranchvs

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Re: Difference between ASUR and DSUR
« Reply #5 on: Tue, 8 Sep 2009 »
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hi yeshpal,
Thanks a lot ..i am clear now

Offline dkbhatt

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Re: Difference between ASUR and DSUR
« Reply #6 on: Sat, 26 Sep 2009 »
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I am sure Yeshpal knows about the following sources:

US IND Annual Report: 21 CFR 312.33
EU ASR: Vol 9A &  Clinical Trial Directive (already quoted by him)
DSUR: ICH Draft guideline E2F :Developmental Safety Update Report" also available as FDA Guidance to the Industry.

Darshan Bhatt
Consultant Drug Safety & Pharmacovigilance

Offline Yeshpal Mathangi

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Re: Difference between ASUR and DSUR
« Reply #7 on: Sun, 27 Sep 2009 »
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Thank you Dr.Darshan Bhatt for providing reference.

Hello Members,

Here is the Concept Paper for the DSUR:

source: http://www.ich.org/cache/html/3382-272-1.html
Reference: http://www.ich.org/LOB/media/MEDIA3302.pdf


Development Safety Update Report

Type of Harmonization Action Proposed

It is proposed that ICH develop a guideline on periodic reporting of safety information from clinical trials. This guideline would define the preferred content, format, and timing of such reports. The CIOMS VI Working Group referred to this type of report as a Development Safety Update Report (DSUR). The DSUR would be used by industry to regularly inform appropriate stakeholders of new safety data and the evolving safety profile of drugs, vaccines, and therapeutic biologic products before they are marketed, and also when new indications, formulations, etc. are being studied for marketed products. The objective of the proposed DSUR for clinical trials would be similar to that of the Periodic Safety Update Report (PSUR) that is commonly used for marketed pharmaceutical products.

Statement of the Perceived Problem

Until recently, very few countries required periodic reports on investigational compounds. The US FDA has required IND Annual Reports for quite some time, but this report is a general update on the progress of the clinical development program, and is not focused strictly on safety. The recently implemented EU Clinical Trial Directive also requires an Annual Safety Report, but its content, format, and timing are quite different than that required by FDA. As the provisions of the Clinical Trial Directive are being incorporated into regulation by each Member State, it is becoming obvious that interpretation of its provisions varies among regulatory authorities, and different regulators are requiring different report formats, content, and/or timeframes for the same compounds. This not only leads to a duplication of effort on the part of study sponsors, but could also lead to inconsistency in the information each regulatory authority receives regarding the safety of the investigational compounds. In addition, even where there is a single standard for the content of periodic reports, such as in the US, the information provided varies considerably from one sponsor to another.

Since most global companies conduct multi-country studies during product development, a standard safety report with defined content, format, and timing would improve the business efficiency of both industry and regulators. An ICH Guideline on DSURs would serve to define expectations for these reports; provide practical and useful guidance regarding provision of meaningful information to regulators; and facilitate consistency among sponsors and regulators. This would promote a focus on high value activities, such as data interpretation, and regulatory authorities worldwide would have access to the same data in the same timeframes.

Background to the Proposal

The recent implementation of the EU Clinical Trial Directive has accelerated the need for global harmonization of annual safety reporting for developmental programs. Harmonization is necessary to stem the emergence of technical variations across different regulatory jurisdictions that will have a great impact on resource, but little impact on the public health. An ICH consensus effort would complement that of CIOMS; the concept of a DSUR was introduced by the CIOMS VI Working Group, and the CIOMS VII Working Group was established to produce additional detail for DSURs. Timelines for issuance of recommendations from the CIOMS VII Working Group are such that they can be incorporated into the ICH Step 2 document. When more fully developed, the ICH guidance document for DSURs will describe the relationships with stakeholders, including CIOMS and the EU Clinical Trials Facilitation Group, and will provide background on the experience with PSURs.

Regards,
Yeshpal Mathangi


Concept Papers for all Quality, Safety, Efficacy and Multidisciplinary topics  & The Concept Papers of the topics currently going through the ICH Process for Harmonisation are available below :

http://www.ich.org/cache/html/3558-272-1.html#E2F

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