Information Sharing & Harmonization
- The Clinical Data Transparency (CDT) Initiative authored assets that provide guidance and model approaches for redacting privacy information found in clinical study reports, anonymizing patient level data shared with the broader healthcare community and preparing and distributing layperson summaries to the general public and study participants. As of May 2019, the revised papers Protection of Personal Data in Clinical Documents – A Model Approach and De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach can now be found on PhUSE’s website. PhUSE will continue to update the papers as needed. PhUSE was well-positioned to own these bodies of work as it can leverage a broader set of stakeholders around the globe to facilitate increased holistic thinking around these assets so these papers can live on in the R&D ecosystem.
- The Common Protocol Template (CPT) Initiative published the Japanese translation of the updated the Basic Word Edition Core Template and Patient Library that were released in November 2018. These materials can be accessed here.
Improve the Patient & Site Experience
- In honor of Clinical Trials Awareness Month, TransCelerate sponsored a TweetChat titled, “Today’s Trials, Tomorrow’s Medicines.” The event was moderated by Eli Lilly’s Joe Kim, MedCity News’ Senior Reporter Alaric DeArment, and patient advocate Lilly Stairs. The conversation drew a large and engaging crowd of people interested in ways to improve the patient experience within clinical research.
- The Patient Technology Initiative recently launched a new toolkit to support sponsors in the adoption of patient technology within their own organizations. The toolkit is inclusive of an Implementation Framework, Discussion Guide, Regulatory Landscape Tool, Site Feedback Questionnaire and additional resources on our website.
- Since the release of ICH E6 Release 2, TransCelerate and the Society for Clinical Research Sites (SCRS) have collaborated on supplemental updates to the Site Qualification and Training (SQT) Informational Programs.
Enhance Sponsor Efficiencies & Drug Safety
- The Value of Safety Information Data Sources (VSIDS) Initiative published its first pillar paper in Drug Safety, titled, “Pooling Different Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection in Pharmacovigilance.” The paper concluded that simulated data suggests that pooling adverse event data from solicited sources with spontaneous case data may impact the results of disproportionality analyses, masking true safety signals and identifying false positives. Therefore, increased volumes of safety data do not necessarily correlate with improved safety signal detection. The paper can be found here.
- In addition, this analysis supported a proposal from EFPIA and PhRMA to the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), recommending that the organization update its ICH E2D Guideline for risk-based information management. As such, the ICH announced they will begin efforts to update the ICH E2D Guideline to enable greater safety signal detection and improve public health. Learn more through this press release.
- The Interpretation of Guidances and Regulations (IGR) Initiative has made its FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guidepublicly available. The Guide attempts to identify the challenges associated with interpreting the relevant guidances and offers suggestions for practical application. It provides points to consider for combinations products approved under a new drug application (NDA)/abbreviated new drug application (ANDA)/biologics license application (BLA) that contain a device constituent part.