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A Preview of Cytel’s Contributions to PHUSE EU 2022

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Although many of you can’t wait for the start of the Football World Cup 2022 (less than two weeks while I’m writing), myself I’m counting the days for the next PHUSE EU Connect 2022 (less than a week away). Believe it or not, this is not simply because my team didn’t get qualified (once again, guess which team?), but PHUSE EU Connect 2022 will be my first live conference after about three years since the start of the pandemic, and this is likely the same for many of the attendees.

Ironically, I have good memories of those days when lockdowns started as it was an occasion to spend more time with my wife and my three kids. I also remember my first virtual conference, the CDISC-EU Interchange in April 2020. The picture below is from a post I made just before the start of the conference. The left side the screen shows my slides almost ready for the speech and, on the right side, my wife and my little daughter preparing ravioli. The funny thing is that, despite the many professional and hopefully useful posts I do on LinkedIn, this post, and the reposts, was my most viewed and liked ever, with more than 10,000 views, more than 100 likes, and about 20 comments — mainly people asking for the ravioli recipe.

Good Data Doctor LinkedIn post

This year, PHUSE EU will be in Belfast and again this is something new to me. Cytel will contribute to this event with three presentations and at least two of them are data standards related.

Previously, I noted that “our industry has not defined any approach, nor does an official regulatory agency preference/recommendation exist on how to integrate data of different studies to support either an Integrated Summary of Safety (ISS) or an Integrated Summary of Efficacy (ISE)” and outlined a handful of integration approaches, as well as the pros and cons to each.

My upcoming presentation, “The Integration Dilemma,” which will be part of the Standards and Implementation stream, expands on that March 2021 article. I will share more examples from Cytel experience on challenges when integrating data from different studies to support sponsors with ISS. I will share some of the “key” learnings, challenges, and technical tips we applied to streamline, for example, the integration of several legacy studies into an iSDTM.

In our integrated submission experience, we did apply all data integration scenario discussed by PHUSE in its 2020 whitepaper:

  1. SDTM(s)  iADaM
  2. ADaM(s) iADaM
  3. SDTM(s) iSDTM iADaM

All three options have pros/cons and their applicability strictly depend on whether and how standards were applied in individual studies.

Regardless of which option you adopt for your next ISS/ISE, traceability and proper documentation are crucial, and so is early planning and discussion of your integration strategy with your sponsor and, of course, with the relevant regulatory agency, e.g., the FDA.

In general, option 2 can be considered the best option to choose. This option is slightly quicker and simpler than options 1 and 3 and it ensures everything is consistent with individual study ADaMs and so the individual study CSRs.

However, our experience showed also that option 2 might not always be the right option to choose even when all concerned studies made use of CDISC standards for both source (SDTM) and analysis datasets (ADaM), unless the sponsor is able to make an appropriate surveillance of CROs work, especially if studies are outsourced to multiple vendors. The sponsor needs to make sure that not only is the structure of ADaM datasets consistent, but also that definitions are consistent across studies, e.g., derivations.

Stay tuned and, after the conference, I will share more details from my presentation.

My colleague Nicolas Rouillé, Senior Director, Statistical Programming, will present “From Artifact to Metadata: A Divergent Approach to Automatization Through Standardization” in the Data Standards and Governance stream. Nicolas will discuss our experience from one our Strategic Automation Initiative and how we tackle, as a CRO, the use of metadata to automatize some aspects of our output production process. I’m sure this presentation will be of great interest and could generate a valuable debate.

Finally, my colleague Principal Statistical Programmer Alexander Carrington will speak on “Health Authorities Inspections: What to Expect? A Statistical Programmer Experience” in the Submission & Agencies stream. In his presentation, Alex will share his unique experience as a statistical programmer during a virtual inspection of the FDA and will provide some tips to prepare for such an inspection.

It will also be time to celebrate! Both Cytel and myself are celebrating two important anniversaries: Cytel is celebrating 35 years, while I’m celebrating 10 years at Cytel.

At the conference, Cytel will have a booth where you can stop by, have a chat with my business development and recruiter colleagues; with me, Nico, and Alex; or with my three others statistical programmer colleagues, Cedric Marchand, Global Head of Statistical Programming, Guillaume Herve, and Pierre Diether.

Looking forward to seeing colleagues and friends again around the world and to meeting new ones!

 


 

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What motivated you to explore this topic and why is this moment significant? What are the stakes of the questions being explored?

Through the Statistical Programming group I lead at Cytel, “Standards, Systems, CDISC Consulting,” we have supported several clients in conducting data gap-analysis of their study datasets packages in past years, for both closed and ongoing studies, where we also do CRO surveillance for them. Therefore, we have been exposed to hundreds of study data packages, legacy or CDISC, on several indications, from which we also “matured” our experience with the different data integration methods that I will discuss in my presentation at PHUSE.

We also had the opportunity to talk with health authorities such as the FDA, indirectly, by contributing to documentation to support discussion with reviewers, or directly, by attending meetings with different divisions of the FDA, for example, where we had data submission and data integration strategy as a topic in the agenda.

Compared to what was shared during the PHUSE webinar in 2021 where the white paper mentioned above was discussed also with some FDA representatives and compared to other experience presented by other companies in previous events on the same topic, I believe our experience is unique because of the multiple of scenarios we had to face, not only on several indications, but, most important, with different sponsors.

Therefore, after also having collected and discussed lessons learnt from other colleagues at Cytel with their submission data integration, I thought it was the right moment to share our experience!

How is Cytel positioned in this work? What can we offer our clients in regard to this topic?

Cytel has provided clinical trial submission support for over 150 successful studies for NDA submissions to the FDA, EMA, PMDA, Health Canada, and numerous other global regulatory bodies. To the FDA, specifically, we do on average around 5 submissions per year.

Our expert statisticians and CDISC experts can guide and implement rigorous data pooling and analysis strategies to optimize the likelihood of success.

 


 

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What motivated you to explore this topic and why is this moment significant? What are the stakes of the questions being explored?

The data/metadata engineering pipeline is a hot topic for any company in our industry; usage of metadata is key, with its promise to speed time-to-market and improve adherence to the increasing requirements of our regulated industry.

Deployment of metadata repositories (MDR) for standards management is currently the “go-to” solution to facilitate collaboration along the data workflow between cross-functional stakeholders to increase adherence to industry and sponsor standards while accelerating study timelines. The challenges associated with leveraging metadata to enable standardization and automation differ from sponsor and CRO perspectives.
With my presentation, I will explore the differences and similarities faced by pharma, biotech, and services in this regard through examination of the approach Cytel used in the development of its automation tools and the current and future opportunities the approach enables for sponsors and CROs alike.

How is Cytel positioned in this work? What can we offer our clients in regard to this topic?

Against the backdrop mentioned above, at Cytel, we employed an approach to metadata and standards use as an accelerator of automation across its delivery processes focusing on the metadata extraction inherent in artifacts such as mock shells from the Statistical Analysis Plan. This is built from our “foundational” standards implemented in our tools, which start with SAP and mock shells, from which standard outputs, such as Tables, Figures, and Listings, have been developed, as well standard ADaM datasets. By adhering to our foundational standards, we guarantee to our client adherence, efficiency, quality, and consistency throughout the study life cycle development. This is also true with other similar initiatives and standards deployed in other departments at Cytel, such as in data-management where standard CDASH libraries have been developed in our supported EDCs, from which we could "smoothly” derive SDTM datasets and packages.

 


 

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What motivated you to explore this topic and why is this moment significant? What are the stakes of the questions being explored?

A lot of statistical programmers are likely to be involved in an NDA submission in some capacity. I had been involved in numerous submissions prior to this year, but this was the first time that a regulatory inspection of the sponsor was confirmed and Cytel’s attendance and input was required.

There’s a lot of information readily available about regulatory inspections from a sponsor’s perspective, but not a great deal from a CRO’s, or more specifically, a statistical programmer’s point of view. Secondly, due to the nature of the combined inspection held by the EMA and FDA, I think this offers a unique insight for statistical programmers and a great opportunity to share Cytel’s experience.

 



After attending the presentations, make sure to stop by our Table 17 to meet Cytel's Talent Acquisitions team! They will be discussing career opportunities at Cytel, our mission, culture, and more. Further questions? Book a meeting with a Cytel team member at PHUSE EU to learn more!

Book a Meeting

 


About Angelo Tinazzi

Angelo

Angelo Tinazzi is Senior Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel. He is a well-published and recognized expert in statistical programming with over 20 years' experience in clinical research. The application of CDISC standards in different therapeutic areas is part of his core expertise since 2003 in particular in the context of data submission to health authorities such as the FDA and PMDA.

Angelo is an authorized CDISC instructor and member of the CDISC ADaM Team as well as the CDISC European Committee where he also manages the Italian-speaking CDISC User Network.

 


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