Break & Learn
Break away from your daily activities and Learn something new in 30 minutes. During the Break & Learn webinars, content-knowledgeable presenters will share their insights in a particular topic. The planned webinars are listed below and we will add more in the coming months. The webinars are free to attend. In addition, the link to the recording will be send within 1 week after the webinar. Feel free to register and share this site with others.
If you do not get a confirmation page and/or E-mail after you registered, please send us an E-mail via firstname.lastname@example.org and we will send you the invite directly.
Stakeholder commitment: The key to innovation success in clinical research
29 June 15:00 CET / 09:00 EST
The pharmaceutical industry is rapidly changing. Old siloed approaches of doing research are replaced by new integrated solutions and processes. In addition, new and diverse data sources are emerging which need to be integrated and standards adoption and efficiency is becoming more and more important in a (semi-) automated data pipeline.
To make each change successful, we not only need to look at technical and procedural solutions but also at the people who have to implement and/or use them. Who are these stakeholders? Are they supportive and well informed? The experience is that when they are not, this can cause huge delays or even failure of an implementation or change project.
During this 30-minute break & learn session, Berber Snoeijer and Kemi Olutunbi will dive into commonly occurring stakeholder issues from their experience. This includes stakeholder identification, stakeholder profiles and concerns and stakeholder communication strategies.
Breaking down the silos using the digital data flow
13 September 16:00 CET / 10:00 EST
Have you ever considered where the digital data flow of a clinical study nowadays starts and where it could start? Actually, information generation for a clinical study starts with the drug development planning phase, where we define what studies to perform and how. We start with a study’s main design concepts: objectives, endpoints, indication, interventions, blinding, and more. Once the protocol is written, more details are added and the full study path is laid out. Thereafter, additional operational aspects and data collection details are added to the data flow. All of this put together, already a lot of design and meta information is available before the start of the actual study.
Nowadays, this pre-study information is mainly stored as text and fragmented pieces of information in documents and unlinked databases. What if all this data was digitized and linked? Would it be possible to work together on one single combined data source without the risk of compromising each other’s work?
In this 30-minute Break & Learn session on 13 September, Berber Snoeijer will demonstrate how the recently published CDISC USDM data model* can help store this information in a standardized data structure, how this can inform downstream processes and how different departments can work together on the same linked data source. Achilleas Zaras from eClinical solutions will share some examples of the latter using the elluminate data platform and different user solutions.
* The CDISC USDM data model is developed in cooperation with the TransCelerate Digital Data Flow initiative.
How to assess relevance and provenance of real-world data
Recorded on 25 May 2023
The new FDA guideline on “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drugs and Biological Products” (Draft Sept 2021) indicates that the relevance and reliability of real-world data is very important to consider and substantiate when this data is used to support regulatory decisions on effectiveness or safety. Although the guideline is still draft, regulatory agencies in general strongly advise seeking early authority feedback on the planned use of real-world data. The substantiation of the relevance and reliability of real-world data is an important aspect in this feedback.
During this 30-minute presentation, we will dive into some practical aspects of this substantiation with a focus on relevance and governance of the data. How do we assess that a data source is fit for regulatory submission purposes? What information do we need and what questions can we ask the vendors? At the end of the webinar there will be room for questions and comments.
How to overcome process inefficiencies in clinical research
Recorded on 19 April 2023
While automation, outsourcing and standardization are seen as efficiency solutions in clinical research, in practice, these are often not experienced as such. In this 30-minute Break & Learn webinar, we will present current process issues from the data management and analysis perspective and look into the potential solutions of overcoming them. Co-presenters Aldir Medeiros Filho, Christy Boer and Berber Snoeijer will touch upon issues from different perspectives including alignment with the clinic, the laboratory and reporting colleagues. At the end of the webinar there will be room for questions and comments.
Interoperability and automation:
How we handle the increasing complexity of data sources
Recorded on 22 March 2023
In the last few years, the evolvement in decentralized trials, patient reported outcomes and real world evidence studies resulted in an increasing volume and complexity of data. While the adoption of new and modern data exchange techniques was slow in our industry, it now becomes evident that these techniques are necessary to maintain the oversight, quality and traceability of data. What has changed in interoperability and the corresponding automation? And why is this relevant for the statistical programmer and analyst? In this 30-minute webinar, we will also dive into the question whether we can do without any human intervention in the clinical data ingestion and transformation process. This presentation will be illustrated by Achilleas Zaras with examples of the eClinical elluminate platform.
Reducing the validation burden of clinical reporting
Recorded on 22 February 2023
Validation of clinical report content such as tables, listings and figures (TLFs) is a considerable burden in the clinical trial process. This includes validation of output formats, cross-checks with specifications and between tables, and double programming of output statistics. In this 30-minute Break & Learn session, we will dive into the reasons why this extensive validation is needed and we will discuss potential solutions for reducing the burden. The webinar will end with an automated validation use case by Beaconcure and additional time for questions and comments.
Strengths and limitations of real-world data sources for clinical trials
Recorded on 25 January 2023
Real-world data sources are increasingly used for clinical trials. Not only for feasibility assessments, patient selection and follow-up, but also for regulatory submission purposes. The requirements for using real-world data vary depending on the use case. In this 30-minute webinar, we will look into the strengths and limitations of real-world data; where does the data come from; how is it collected and what are the corresponding caveats and biases? Correspondingly, we will discuss how we can overcome these issues. We will finish this Break & Learn session with a use case of real-world data utilization presented by BC platforms and with additional time for questions and comments.