Difference between revisions of "Interorganizational SEND"

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(Accomplished)
 
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==Accomplished==
 
==Accomplished==
 +
* Between March 2014 and March 2015
 +
:* Survey of industry ''SEND data from Small/Medium Service Providers: How prepared are they to supply data in SEND format?''
 +
:* Template to Facilitate Creating Pharmacokinetic SEND datasets
 +
::* [[File:PC_template_with_formulas.xlsx]]
 +
 +
 
* Between March 2013 and March 2014
 
* Between March 2013 and March 2014
:* Summaries of actual experience with scenarios [Scenario Experience]
+
:* Summaries of actual experience with scenarios [[Scenario Experience]]
 
::*[[File:MPI_Research_I-SEND_Scenario_Feedback_2013-05-03.docx]]
 
::*[[File:MPI_Research_I-SEND_Scenario_Feedback_2013-05-03.docx]]
 
::*[[File:INDS_Testing_Scenario_3.docx]]
 
::*[[File:INDS_Testing_Scenario_3.docx]]
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::*[[File:Scenario_2_w_numbering.pdf‎]]
 
::*[[File:Scenario_2_w_numbering.pdf‎]]
 
::*[[File:Scenario_3_w_numbering.pdf‎]]
 
::*[[File:Scenario_3_w_numbering.pdf‎]]
:* Points to consider list when preparing to create SEND datasets for studies that involve multiple organizations: [[SEND_Implementation_Wiki_-_SEND_between_Organizations]]
+
::*[[File:PP13_SEND_Datasets_for_Interorganizational_studies.pdf]]
 +
:* Points to consider list when preparing to create SEND datasets for studies that involve multiple organizations:
 +
::* [[SEND_Implementation_Wiki_-_SEND_between_Organizations]]
 +
::*[[File:PP08_Selecting_a_CRO_for_SEND.pdf]]
 +
:* The role of GLP in SEND files http://www.phusewiki.org/wiki/images/d/d7/PP12_Quality_System_for_SEND_-_flat.pdf
  
 
* Between March 2012  and March 2013
 
* Between March 2012  and March 2013
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==Plans==
 
==Plans==
At the 2013 PhUSE/FDA conference we made the following plans:
+
At the March 2015 meeting:
* Test each of the work-flows presented at the 2013 conference by November with as close to real processes as possible and with 3 of the CROs participating in this working group
+
*It was determined that the remaining tasks envisioned for this group are a lower priority than the other pressing needs for collaboration in nonclinical computational sciences. As a result this project is complete.  
* Prepare a whitepaper/poster for 2014 FDA/PhUSE conference to share what we learned.
+
* The following items were considered as the next work for this team; so, as priorities adjust in the future, these may be worked on again:
 
+
:*Create a template for PP data and enhance the PP template to provide organizations without SEND capabilities a way to provide TK data in a format that can more easily be integrated into a set of SEND datasets for a study.
This table is being populated with the names of sponsor companies and the quarter of 2013 that will be testing the secnario with each CRO.
+
::*Pilot its use
{| border="2" bgcolor=""
+
::*Create a "points to consider" list
! Workflow                                                                            !! Covance        !! CRL                !! MPI Research
+
::*Adjust the template as needed
|-
+
::*Publish the results on the PhUSE SEND Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium.
| Scenario 1: CRO Study with SEND Dataset Assembled by CRO      ||  Sanofi q2-4  ||  J&J q4        || Lilly q2-3 done.
+
:*Evaluate the applicability of other CDISC standards CDASH, ADaM, ODM for non-clinical studies and publish the results on the PhUSE SEND Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium.
|-
 
| Scenario 2: A CRO generating SEND with PK/TK data from outside ||  Sanofi, GSK; Pfizer(SafetyPharm)    ||    BMS  2014q1      || Lilly q2-3 done.
 
|}
 
Scenarion 3 will be tested by INDS in Q2 and Roche in Q3.<br>
 
The common Regulatory Data Flow will be tested by GSK and possibly others.
 
<br>
 
 
 
===Questionnaire for Testing Organizations===
 
 
 
{| border="2" bgcolor=""
 
! Question !! Sanofi/Covance !! CRL !! MPI Research, w/ Lilly et al.
 
|-
 
| Does your experience match the scenario flow-chart?<br>&nbsp;&nbsp;&gt;If not, where does it differ? Which way is better?<br>&nbsp;&nbsp;&gt;If x happened instead of y, what was the impact? Is there a recommendation from these differences?
 
|| Scenario 1: The SEND datasets generated were prepared after report was finalized/approved as a data exchange exercise so the workflow differed greatly.  Data sets created by CRO, Sponsor reviewed datasets and interacted with CRO to address questions to finalize the datasets. 
 
|| 
 
|| For the most part.<br><b>Scenario 1:</b> The “CRO generates final datasets” step is not generally performed if everything was fine from the previous round.<br><b>Scenario 2:</b> there is an additional path necessary to split the case where the Sponsor provides the PK files in SEND format.  The handling varies whether or not the Sponsor adheres to the CRO’s conventions on such things as the USUBJID formation, representing either a plug-and-play situation or one requiring additional manipulation to incorporate with the main package.
 
|-
 
| Do you have any experiences with re-work initiated by a request from the FDA. How long did the process take, and what can you share about the experience?
 
||  This was not done as the datasets were not part of a current submission.
 
|| 
 
|| Use of the OpenCDISC Validator with resolution of any issues it uncovered removed the need for a feedback loop with the FDA.<br>During the pilot (and before a publicly available validator), there were cases where the sponsor was actively working with the FDA and required re-generation of datasets per some validator findings.  In this case, the process went pretty smoothly, wrapping up in a few days.  However, that was not “real” production.
 
|-
 
| What were the challenges and solutions for the scenarios?
 
||  How do we address study numbering and animal numbering conventions as well as conventions for arms and sets that have been defined by Sponsor
 
|| 
 
|| The biggest challenge is mapping trial design and exposure for non-boiler-plate cases.  This is something that previously did not have to be done, and has to be learned and then defined by the preparer using an interface.
 
|-
 
| &nbsp;&nbsp;&gt;What would you want to do differently in the future?
 
|| 
 
|| 
 
|| Work through “template” cases for some of the more common designs.
 
|-
 
| &nbsp;&nbsp;&gt;What would you need to work out in advance to ensure a smooth process?
 
||  Expectations that were defined ahead of time would reduce rework and questions about datasets. 
 
|| 
 
|| With expectations set ahead of time (decoupled from the study timeline), everything goes smoothly.
 
|-
 
| &nbsp;&nbsp;&gt;Where there any areas that you were unable to resolve?
 
||No 
 
|| 
 
|| No.
 
|-
 
| Timing<br>&nbsp;&nbsp;&gt;How long did it take?
 
||  It took Covance approx. 1 week to prepare dataset  this would also depend on the complexity and number of endpoints
 
|| 
 
|| Packaging of a submission takes between a few days to a couple weeks, depending on the complexity of the contents and the number of endpoints.
 
|-
 
| &nbsp;&nbsp;&gt;What were the activities that determined the length of the project (critical path)?
 
||  Complexity of study design and if PK data part of datasets could increase the timeline
 
PK data
 
|| 
 
|| Complexity of study design<br>Complexity of lot regimen<br>Manually collected data (e.g., paper or Excel)<br>PK data
 
|-
 
| &nbsp;&nbsp;&gt;Do you have any guides on estimating the effort to do the work?
 
|| No, not at this time 
 
|| 
 
|| Starting with a barebones tox study (inlife, path, clinpath), estimate the total work for that.  Then think through any add-on sets of endpoints or circumstances which equate to a chunk of work, such as adding pk, or adding a crazy study design, etc.  This can give you a rule of thumb for estimating the effort behind individual studies.
 
|-
 
| &nbsp;&nbsp;&gt;How many times have you done this? Is this the first experience?
 
||  1 with 1 CRO
 
|| 
 
|| 20-25 studies for about 10 Sponsors
 
|-
 
| &nbsp;&nbsp;&gt;If you have done this several times, can you describe the learning curve?
 
||N/
 
|| 
 
|| It takes a few studies to hit a stride. Special cases that pop up (such as a special study design that hasn’t been done in SEND yet) can represent an additional bump as they come along.
 
|-
 
| &nbsp;&nbsp;&gt;How long (calendar time, person hours) did each phase take? (determining what needs to be done, doing the work, confirming/closing the project)
 
|| Few hours to several days
 
|| 
 
|| Estimation: 0-1 hour.<br>Doing the work/closing: Anywhere from a few hours to several days for a reports person, and 0-2 hours for an IT resource to assist.
 
|-
 
| What tools (software) did you use?
 
|| CRO tool 
 
|| 
 
|| Custom-developed add-on to reporting solution.
 
|-
 
| Were any domains not provided? Why?
 
||Yes, some domains are not collected while others currently cannot be provided by CRO 
 
|| 
 
|| No, but there could be cases where they are not, to cut down on costs for non-GLP studies where the Sponsor just wants key data to subsume into their own system for discovery/mining purposes.
 
|}
 
 
 
==Participation Needs==
 
In 2013 as we will contiue this work,  we will need participation from individuals with the following areas of expertise with an interest and ideally gaining some experience exchanging data or reports with other organizations to contribute to this effort:
 
*Scientists
 
*IT Specilists
 
*SEND implementers
 
*GLP QA auditors
 
 
 
The total group will be limited to 12-20 people, with representation from all of the above areas of expertise.
 
 
 
'''What is the commitment?'''
 
* Time - will vary widely (minimum of 1 hour every two weeks for team meetings, up to 4-8 hours / month)
 
* Expected to contribute, not just be a spectator
 
 
 
'''If you would like to participate''', please contact the co-leads for this group:
 
*Debra Oetzman (debra.oetzman@covance.com)
 
*William Houser (william.houser@bms.com)
 
 
 
==Communications==
 
 
 
1 telecon every 4 weeks at the same time. One such meeting is 2pm Eastern Jan 6, 2014.
 
  
 
==Project Team==
 
==Project Team==
 
:*Pranav Agnihotri, PointCross
 
:*Pranav Agnihotri, PointCross
 
:*Kenjie Amemiya, Genentech
 
:*Kenjie Amemiya, Genentech
 +
:*Brian Argo, MPI Research
 +
:*Rich, Buchanan, Preclinical Data Systems
 
:*Kathryn Brown, Sanofi
 
:*Kathryn Brown, Sanofi
 
:*Susan DeHaven, Sanofi
 
:*Susan DeHaven, Sanofi
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:*Jennifer Feldmann, Instem
 
:*Jennifer Feldmann, Instem
 
:*Jeff Foy, Celgene
 
:*Jeff Foy, Celgene
:*Liz Graham, MPI Research
 
 
:*Geoff Ganem, Genentech
 
:*Geoff Ganem, Genentech
:*Erika Gigante, Amgen
 
 
:*Nancy Gongliewski, Novartis
 
:*Nancy Gongliewski, Novartis
 +
:*Elizabeth Gram, Zoetis
 
:*William Houser, Bristol-Myers Squibb
 
:*William Houser, Bristol-Myers Squibb
 +
:*George Kahlbaugh, Boehringer-Ingelheim
 
:*Laura Kaufman, Preclinical Data Systems
 
:*Laura Kaufman, Preclinical Data Systems
:*Jyotsna Kasturi, Johnson & Johnson
+
:*Rihab Kordane, Charles River Laboratory
 
:*Lou Ann Kramer, Eli Lilly
 
:*Lou Ann Kramer, Eli Lilly
 
:*Wayne Kung, Genentech
 
:*Wayne Kung, Genentech
 
:*Carolyn McGary, Bristol-Myers Squibb
 
:*Carolyn McGary, Bristol-Myers Squibb
:*Maureen Rossi, Roche
 
 
:*Connie Marvel, Bristol-Myers Squibb
 
:*Connie Marvel, Bristol-Myers Squibb
 
:*Shree Nath, PointCross
 
:*Shree Nath, PointCross
Line 165: Line 72:
 
:*Kathleene Powers, Pfizer
 
:*Kathleene Powers, Pfizer
 
:*Gerard Randoph, Roche
 
:*Gerard Randoph, Roche
 +
:*Maureen Rossi, Roche
 
:*Lynda Sands, GlaxoSmithKline  
 
:*Lynda Sands, GlaxoSmithKline  
 
:*Paul Sidney, Charles River Laboratory
 
:*Paul Sidney, Charles River Laboratory
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:*Troy Smyrnios, Zoetis
 
:*Troy Smyrnios, Zoetis
 
:* Eric Sun, Sanofi
 
:* Eric Sun, Sanofi
:*Nathan VanSweden, MPI Research
+
:* Kevin Trimm, Charles River Laboratory
 
:*Audrey Walker, Charles River Laboratory
 
:*Audrey Walker, Charles River Laboratory
 
:*Heather Williamson, PointCross
 
:*Heather Williamson, PointCross

Latest revision as of 12:30, 14 March 2016

Interorganizational SEND Project

Welcome to the Wiki for our project to identify challenges and propose solutions to help Sponsors and CROs, to work efficiently together, in a world where nonclinical data, possibly derived from different organizations, will be required to be aggregated in SEND format, for submission to the FDA.

Need/Challenge

The responsibilities for creating the SEND files for a study is often shared across organizations. Clarity is needed on how these responsiblities can be effectively managed.

Accomplished

  • Between March 2014 and March 2015
  • Survey of industry SEND data from Small/Medium Service Providers: How prepared are they to supply data in SEND format?
  • Template to Facilitate Creating Pharmacokinetic SEND datasets


  • Between March 2013 and March 2014
  • Points to consider list when preparing to create SEND datasets for studies that involve multiple organizations:
  • Between March 2012 and March 2013
  • We developed a framework to classify and prioritize scenarios in which data from multiple orginzations needs to be aggregated.
  • We selected 3 scenarios and for each developed workfows "on-paper" to create and submit SEND datasets.
  • While considering these scenarios we identified several questions that needed to be answered and collaberatively developed answers. These have been published on the PhUSE SEND User's Group wiki: Handling of SEND in Study Documentation
  • We started preparing a Scenarios White Paper
  • We published a poster at the 2013 FDA/PhUSE Computational Science Symposium, which is available as slides File:I-SEND Poster 2013 as slides.pdf

Plans

At the March 2015 meeting:

  • It was determined that the remaining tasks envisioned for this group are a lower priority than the other pressing needs for collaboration in nonclinical computational sciences. As a result this project is complete.
  • The following items were considered as the next work for this team; so, as priorities adjust in the future, these may be worked on again:
  • Create a template for PP data and enhance the PP template to provide organizations without SEND capabilities a way to provide TK data in a format that can more easily be integrated into a set of SEND datasets for a study.
  • Pilot its use
  • Create a "points to consider" list
  • Adjust the template as needed
  • Publish the results on the PhUSE SEND Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium.
  • Evaluate the applicability of other CDISC standards CDASH, ADaM, ODM for non-clinical studies and publish the results on the PhUSE SEND Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium.

Project Team

  • Pranav Agnihotri, PointCross
  • Kenjie Amemiya, Genentech
  • Brian Argo, MPI Research
  • Rich, Buchanan, Preclinical Data Systems
  • Kathryn Brown, Sanofi
  • Susan DeHaven, Sanofi
  • Steven Denham, MPI Research
  • Jennifer Feldmann, Instem
  • Jeff Foy, Celgene
  • Geoff Ganem, Genentech
  • Nancy Gongliewski, Novartis
  • Elizabeth Gram, Zoetis
  • William Houser, Bristol-Myers Squibb
  • George Kahlbaugh, Boehringer-Ingelheim
  • Laura Kaufman, Preclinical Data Systems
  • Rihab Kordane, Charles River Laboratory
  • Lou Ann Kramer, Eli Lilly
  • Wayne Kung, Genentech
  • Carolyn McGary, Bristol-Myers Squibb
  • Connie Marvel, Bristol-Myers Squibb
  • Shree Nath, PointCross
  • Louis Norton, Covance
  • Debra Oetzman, Covance
  • Daniel Potenta, Novartis
  • Kathleene Powers, Pfizer
  • Gerard Randoph, Roche
  • Maureen Rossi, Roche
  • Lynda Sands, GlaxoSmithKline
  • Paul Sidney, Charles River Laboratory
  • Jared Slain, MPI Research
  • Troy Smyrnios, Zoetis
  • Eric Sun, Sanofi
  • Kevin Trimm, Charles River Laboratory
  • Audrey Walker, Charles River Laboratory
  • Heather Williamson, PointCross
  • Peggy Zorn, INDS

Conference Calls and Minutes

Interorganizational SEND Minutes

Last revision by William.houser,03/14/2016