PHASTAR push for CDASH standards

PHASTAR push for CDASH standards

Most sponsor companies have recognised the need for, and have long been working to, data collection and processing standards. Great. But when you think that these standards are typically specific to a company, a therapeutic area or the project team conducting the study, then the amount of "standards" in play is quite considerable. Now that the FDA is requesting the submission of clinical trial data in common CDISC format, in order to ease the burden of their review process, the various formats employed and held on to so closely and for so long are no longer viable.

The current trend is to convert resulting datasets into the required SDTM format, either during the conduct of an ongoing study, or even once the study has ended for older legacy studies. As a CRO, we receive data from multiple clients, in multiple therapeutic areas and all can attest that the level of programming effort required for this task varies according to the format in which the data are obtained. In instances where data needs to be pooled and the data from each of the studies has been provided in different formats, this effort needs to be duplicated as the programs will need to be tailored to each of the formats. This is obviously very time consuming.

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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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