Pooling Clinical Data - a medical writer's perspective

Pooling Clinical Data - a medical writer's perspective

Pooling of data is used by all companies involved in submitting clinical trial data. There are various reasons to pool data including the production of documents for Development Safety Update Reports (DSURs), publications and parts of an NDA submission.

One of the hurdles a project team (including the medical writer) face is the decision on how to best pool or not pool clinical trial data for submission to regulatory authorities. The first approach to pooling clinical data is planning. A plan should be developed to identify which studies and which data should be pooled for any given deliverable from both an efficacy and a safety perspective.1,2

The role of a medical writer is to tie the pooled datasets and analyses together into the final submission document. Medical writers are required to work closely with biostatisticians to understand what is expected of regulatory authorities.

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PhUSE 2016

Summary from PhUSE 2016, Barcelona

Barcelona, the beautiful Catalonian city on the Mediterranean coast of Spain hosted the annual PhUSE conference for 2016. With nearly 600 attendees, 44 exhibitors, 15 streams including more than 120 papers, six Hands-on Workshops and Discussion Clubs, this was a great opportunity for the data scientists in Pharma, CRO and related industries to come together and share latest development within the whole lifecycle of clinical data analyses and reporting. Phastar has proudly presented 2 posters and a paper in the data visualization stream.

The theme of this year" conference was "Fast Track to Approval: Speed and Efficiency". Many of the workshops and presentations discussed how we as data scientists can standardize, automate and become more efficient in order to reduce the time to approval for our drugs. This year two new streams were introduced "Real World Evidence" and "Data Visualization" both were well attended and received positive feedback from the audience.

There were presentations from three different regulatory authorities in the regulatory stream. Those were informative and a good experience to see things from their point of view.

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Clinical Trial Data Sharing

DIA - Clinical Trial Data Sharing

Sally Hollis spoke at the DIA Clinical Forum for Operational Excellence at the end of October on behalf of the EFSPI/PSI data sharing group, which she co-chairs. There has been increased emphasis on data sharing since 2010 when the EMA initiated work towards increased disclosure of clinical trials document. In response to calls for data transparency,  the pharmaceutical industry committed to responsible sharing of clinical trial data sharing from January 2014, including patient and study level clinical trial data, full clinical study reports, and protocols (see EFPIA and PhRMA principles [link http://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdf]).

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COS 2016

Summary from Annual Symposium of Clinical Outsourcing Strategies 2016, Brussels

PHASTAR attended the 4th Annual Symposium Of Clinical Outsourcing Strategies in Brussels on 20th to 21st October 2016.  The conference provided an excellent platform for both pharma and small, medium or large CROs to assess the current challenges associated with Clinical Trial Outsourcing and Clinical Operations. The agenda covered various interesting topics such as Risk Based Monitoring, understanding regulatory requirements for the development of paediatric studies, providing businesses with realistic budgeting requirements for the outsourcing of clinical trials, solutions to help with site selection and monitoring and optimising successful long-term relationships with CRO providers.

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Data Management Technologies and Directives

Data Management Technologies and Directives

These are exciting times in Data Management. In recent years new technologies and directives have induced a subtle change in the role of a Data Manager. The raison d’etre for Data Managers has always been the delivery of high quality data thereby ensuring the validity and integrity of the statistical results. With the advent of CDISC standards, EDC and ePRO and sponsors adopting a Risk- Based Monitoring approach, the role of the Data Manger as an interface with clinical and statistical programming teams has never been more crucial or diverse.

Data collection in accordance with CDASH initiatives means we have the tools to streamline our processes by standardising the definitions for the data that is collected over multiple studies facilitating easier transformation to SDTM for submissions.  Working with the programming team on the challenges of implementing CDASH (it's by no means a one-size fits all solution) brings an understanding across roles) what's good for SDTM does not always fit the bill for good eCRF design and optimal data collection - or abide by the flow of the Protocol. In these situations, additional mapping may be needed to create the final SDTM compliant datasets.  This essential understanding of the starting point to endpoint has promoted lively discussions and ensured all needs are met in the most efficient way.

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