Skip to content

Commit

Permalink
Merge pull request #38 from phuse-org/reg-experiences
Browse files Browse the repository at this point in the history 
include regulatory experiences table
  • Loading branch information
@MichaelRimler
MichaelRimler authored Sep 26, 2024
2 parents 8c49650 + 9a373d3 commit aeb893d
Showing 1 changed file with 103 additions and 0 deletions.
103 changes: 103 additions & 0 deletions reg_accept.qmd
View file
Original file line number Diff line number Diff line change
Expand Up @@ -40,6 +40,109 @@ Yet still some doubts persist. If a sponsor submits analytical results using Too

And what about agencies who typically do not re-analyse sponsor data? How can the industry provide reassurance and proof that analytical environments are validated: accurate, reproducible and traceable? When installation of software into an environment is a one-step process, we can be pretty sure of consistency across analysts. But if there are multiple steps involved, and the software can change almost daily, then how do we ensure this consistency and reproducibility? This is not just the job of IT organisations within sponsor companies, but the responsibility of the individual analyst, to ensure that they are working compliant with organisational processes and in validated environments. Audit trails and traceability helps ensure this, but it is a potential source of doubt for both sponsor and regulatory authority.

## Industry Experiences

The industry offers a diverse range of experiences that can significantly enhance your professional growth. Below is an overview of various industry experiences gathered so far:

```{=html}
<table>
<colgroup>
<col style="width: 25%">
<col style="width: 25%">
<col style="width: 50%">
</colgroup>
<thead>
<tr>
<th>Sponsor</th>
<th>Agency</th>
<th>Experiences</th>
</tr>
</thead>
<tbody>
<tr>
<td><strong>RConsortium Pilot</strong> <br/><a href="https://github.com/RConsortium/submissions-wg">Info</a></td>
<td>FDA</td>
<td>Submitted<br/><ul><li>Accepted</li></ul></td>
</tr>
<tr>
<td rowspan="5"><strong>Novo Nordisk</strong><br/><a href="https://www.youtube.com/watch?v=t33dS17QHuA">Presentation</a></td>
<td>FDA</td>
<td>Submitted<br/>
<ul>
<li>Big data ADaM programmed in R and pre-announced this during Type C and B meeting packages</li>
<li>Remaining ADaM in SAS and double programmed in R (where applicable)</li>
<li>All TFL in R</li>
<li>Following requests from FDA all TFL programs and internal R packages submitted. Packages packed using pkglite.</li>
<li><a href="https://github.com/NNaikp/phuse-css-2023/blob/main/submission-files/instructions-to-programs-in-r.pdf">Additional guidance</a> and informal meeting with FDA statisticians on restoring R environment was held</li>
</ul>
</td>
</tr>
<tr>
<td>EMA</td>
<td>Submitted content using R</td>
</tr>
<tr>
<td>NMPA</td>
<td>Same as PMDA</td>
</tr>
<tr>
<td>PMDA</td>
<td>
Submitted<br/>
<ul>
<li>Big data ADaM programmed in R and pre-announced during additional eSubmission meeting</li>
<li>Remaining ADaM in SAS and double programmed in R (where applicable)</li>
<li>All TFL in R programs submitted</li>
</ul>
</td>
</tr>
<tr>
<td>Health Canada</td>
<td>Submitted content using R</td>
</tr>
<tr>
<td rowspan="3"><strong>Roche</strong> <br/><a href="https://www.youtube.com/watch?v=BlJNILSoZlM&t=2187s">Presentation</a></td>
<td>FDA</td>
<td>Submitted content using R <br/>
<ul>
<li>Initial pushback from the FDA reviewer to accept R, they wanted SAS instead.</li>
<li>Roche pushed back and submitted in R (based on Technical Conformance Guidance)</li>
<li>Key message - acceptance of R may vary between different agency reviewers</li>
<li>Key message - have the content & format discussions early with the agency</li>
</ul>
</td>
</tr>
<tr>
<td>EMA</td>
<td>Submitted content using R <br/>(no comments received so far)</td>
</tr>
<tr>
<td>NMPA</td>
<td>Submitted content using R <br/>(no comments received so far)</td>
</tr>
<tr>
<td><strong>SwissMedic</strong></td>
</tr>
<tr>
<td><strong>Merck</strong></td>
<td>FDA</td>
<td>Submitted <br/>
<ul>
<li>Multiple successful submissions</li>
<li>GxP platform available</li>
<li>Reproducible environment</li>
</ul>
</td>
</tr>
<tr>
<td><strong>Astellas Pharma</strong></td>
<td>FDA</td>
<td>(2021) for using R markdown to submit programs <br/> <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/212608Orig1s006.pdf">Example</a></td>
</tr>
</tbody>
</table>
```

## Discussion

Contribute to the discussion here in GitHub Discussions:\
Expand Down

0 comments on commit aeb893d

Please sign in to comment.