TransCelerate’s Member Company experts and initiatives were featured in the press this past summer on a variety of topics, including COVID-19, improving the patient experience and how to navigate quality tolerance limits (QTLs) to abide by Health Authority requirements.
Read on to catch up on some stories you may have missed.
Collaboration against COVID-19
Like many R&D consortia and biopharma companies, TransCelerate is doing its part in the fight against COVID-19.
In June, we announced that we will include data from investigational arms and control arms of COVID-19 trials in our DataCelerate® platform. This data sharing module is unique in that TransCelerate expanded access to eligible non-member biopharmaceutical companies and biomedical research agencies.
Pfizer’s Rod MacKenzie, Peter Honig, Judy Sewards, Robert Goodwin and Marie-Pierre Hellio—who are also leaders within TransCelerate—mentioned TransCelerate in an article they penned for Nature Reviews Drug Discovery. This commentary opined that R&D should implement the changes that catalyzed the R&D ecosystem to accelerate the search for a COVID-19 vaccine or therapeutic should filter down to all clinical trials, regardless of illness. TransCelerate was mentioned as an important player to help facilitate sponsors to share knowledge amongst each other.
Our Clinical Research Access & Information Exchange Initiative authored a piece for Clinical Leader, “Searching for Clinical Trials: How Can We Improve the Patient Experience?”. Summarizing its recently released PLOS One manuscript, “Patient Preferences when Searching for Clinical Trials and Adherence of Study Records to ClinicalTrials.gov Guidance in Key Registry Data Fields,” this article stresses some improvements that can be made to ClinicalTrials.gov to help patients and families find potential clinical trials easier. These include improving the caliber of the brief title and brief summary that sponsors submit to the search platform to include patient-friendly language in these fields.
Our Patient Experience initiative published two separate manuscripts in DIA’s Therapeutic Innovation & Regulatory Science (TIRS). The first, “Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient Centered Clinical Studies,” describes the importance and application of its Patient Protocol Engagement Toolkit (P-PET) and Study Participant Feedback Questionnaire (SPFQ) to engage patients in gathering meaningful patient feedback. “Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)”delves deeper into the SPFQ and studied if the content in tool is effective in both English-speaking patients and non-English-speaking patients and countries.
Finally, our Interpretation of Guidances & Regulations-Clinical initiative published “Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development” in TIRS. To support The International Council for Harmonisation (ICH) E6(R2)’s integrated addendum guideline to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) 2016, TransCelerate developed a framework to guide industry sponsors and their agents in implementing quality tolerance limits (QTL) and maximize efficiency and minimize confusion in QTL implementation.Want to read up on all recent news articles? Check out our just-launched News & Events page for a full archive of our media interviews.
About the author:
Leigh Anne is the Communications Manager at TransCelerate Biopharma, Inc. In this role, she is responsible for all corporate communications, public relations, and marketing efforts on behalf of the company. This includes creating and executing public relations campaigns; maintaining and drafting content for blogs, newsletters, press releases and other internal and external communications; media relations; and planning conference strategies. Leigh Anne has over 15 years of experience and holds a BA in Public Relations from Susquehanna University.