In the News

This article looks at the Cell and gene therapies (CGT) landscape, the challenges biopharma companies face in running clinical trials and tips on how to surmount those obstacles.

What is the role and significance of language and medical translation within clinical trials? ICON Language Services Director Patrick Majewski shares the importance of and key considerations in clinical trial translations.

In this article in Pharmaceutical Market Europe, Dr Peter Schueler and Dr Isaac R Rodriguez Chavez outline the role of digital health technology tools in supporting medical adherence. 2022 PM Group

Together with Amazon Web Services (AWS), the ICON team worked to understand how to develop voice capabilities in the context of an operational plan to establish a framework that can be extended when demand for Voice in clinical research grows.

By understanding how to develop a private AMAZON VOICE SKILL using ALEXA/LEX framework for eCOAs including ePROs, and documenting future integration points with the ICON Digital Platform (IDP), ICON has completed foundational steps in the implementation of voice capabilities.

This blog outlines considerations for integrating voice-enabled diary data within a clinical trial, and serves as an example of how ICON applies innovation to enable efficient and effective patient participation in clinical research.

Devra Densmore, Senior Lead of Patient Advocacy Strategy at the Centre for Rare Diseases at ICON, discusses the importance of DEI in rare disease clinical trials and shares actionable points for a more inclusive approach.

Expert Q&A: The impact of the clinical trial liaison function

The clinical trial liaison (CTL) function was first introduced in 2014 to help sponsors differentiate themselves from the competition by driving recruitment success in clinical trials.

FirstWord spoke with Elizabeth Pash, Senior Director of Global Site Engagement Operations at ICON, to find out exactly what this relatively new role involves, its value in developing and delivering optimal clinical trials and how it is set to evolve in future.

Summary points from the interview:

• In the competitive world of pharmaceutical research, sponsors can differentiate themselves by driving recruitment success in clinical trials.
• The CTL role was introduced in 2014 to bring doctorate-trained clinical research professionals into the clinical trial process to support site identification, activation and recruitment, ensuring optimal productivity of clinical trials.
• While CTLs and clinical research associates (CRAs) are both considered protocol experts and build relationships with sites, CTLs focus on the scientific aspects of a protocol rather than the eligibility criteria and schedule of assessments.
• At ICON, CTLs have contributed to a 20% boost in the targeted recruitment rate and helped approximately 70% of sites achieve their baseline recruitment goals. In the past five years, they have also helped sponsors bring nine new compounds to market and receive two new indication approvals for already-approved medications.
• As more clinical trials begin to incorporate more decentralised approaches, the need for roles like CTLs is set to steadily increase across the industry.
• Potential is increasing for CTLs to establish partnerships earlier with sponsors, supporting trial and protocol design, conducting targeted investigator interviews and applying the information in the early stages of clinical development.

[Subscription is required to view the entire interview]

In this article, Will Maier outlines the importance of utilising real world evidence from rare diseases in accelerating product approval and development.

In this article,Brian HuberandTamie Joeckel, consider how cell and gene therapies could change the future of cancer treatments and bring new options to patients.

The five process groups of a process-based approach to project management are: Initiate, Plan, Execute, Monitor and Control, and Close, according to the Project Management Body of Knowledge Guide (PMBOK). This article presents opportunities for using a project management framework when strategising for CMC regulatory submission projects. The authors discuss PMBOK nomenclature, project performance domains, project constraints, process groups, examples of scenarios that may be encountered during a submission project, and templates that can be used to support the project framework.

Rapp EA, Imperial R. Application of project management strategy to postapproval CMC submissions.

RF Quarterly. 2022;2(3):42-51. Published online 30 September 2022.

Rose Kidd, Executive Vice President, Quality and Compliance at ICON, discusses how predictive analytics provide a real opportunity to develop new and innovative processes in the area of QA.

This article is taken from International Pharmaceutical Industry, Volume 14, Issue 3, pages 32-33. Senglobal Ltd