Information Sharing & Harmonization
- The Common Protocol Template Initiative’s 2019 annual release is now live. The team has rebranded—now called the Clinical Content and Reuse (CC&R) Initiative—to reflect the expansion and evolution of the initiative’s vision to develop common content for reuse across clinical trial documents. With this release, the TransCelerate Clinical Template Suite and eTemplates now encompass common structure and model language for clinical trial protocols, statistical analysis plans (SAP) and clinical study reports (CSR). New for 2019, the technology-enabled versions of the eSAP and eCSR have been added to eTemplates along with updated versions of the previously available Word editions. This release and all supporting tools and resources are available on the redesigned CC&R assets page.
- The eSource team released its refreshed assets page. The site makes it easier for users to extract value from the eSource Initiative for implementation and continues to alleviate the pain points of the industry to further expedite clinical development. It also clearly delineates for users the four eSource categories (Non-Case Report Form, Devices and Apps, Direct Data Capture, and Electronic Health Records) and provides a library of tools to help with challenges to eSource adoption in companies. Check out the webpage here.
- The Placebo and Standard of Care Initiative published a paper, titled, “Sharing Historical Trial Data to Accelerate Clinical Development.” In this piece, the team describes a solution that is being developed to enable data sharing across the biopharmaceutical industry and some of its early successes.
Improve the Patient & Site Experience
- The Electronic Data Capture System Training Mutual Recognition (EDC MR) Program, including the asset’s webpage, was decommissioned in December 2019. In 2016, SQT developed a process to enable a voluntary mutual recognition of EDC system training across companies. This addressed a pain point in the industry at that time by allowing previously completed EDC system training taken by investigator site personnel and monitors to be recognized by other companies, making it unnecessary to retrain separately for each company. Based on an evaluation performed by the SQT team in 2019, it was determined that the industry has evolved to address this gap that previously existed. Therefore, the decision was made to retire the EDC program.
- The Clinical Research Access & Information Exchange team launched its Clinical Trial Registration Tool, which aims to improve patients’ awareness and access to clinical trial information. The tool is a result of the National Institute of Health, which maintains ClinicalTrials.gov, providing feedback to TransCelerate’s Registry of the Future concept that better-quality data should be submitted into these government-owned clinical trial registries. It can be used by individual clinical trial sponsors to proactively evaluate the quality of the clinical trial registration data, specifically ‘Brief Title’ and ‘Brief Summary’ fields, they submit to government-owned registries. In addition, the tool evaluates the patient friendliness of the data, as preferred by patients. A short video demonstrating how to use the tool is also available.
- The Clinical Research Awareness team has published a paper entitled “Exploring the Impact of Shared Decision Making in Clinical Trial Consideration.” This paper proposes a set of considerations for shared decision-making tool development that incorporates a patient’s preferences and priorities along with those from clinical, industry and social stakeholders.
Enhance Sponsor Efficiencies & Drug Safety
- The Common SAE Fields Initiative team has successfully completed its objective in identifying the common core fields collected and reported following a serious adverse event. To do so, the team worked to compile a list of SAE fields that would better support a complete clinical picture of a serious adverse event. The proposed list contains more than 130 unique fields spread across nine sections of data. Additionally, in mid-October, the team transitioned its work to CDISC’s CDASH SAE Standard team, who has proceeded with the development of an industry standard surrounding SAE data collection. The SAE Data Collection Standard is planned to be released in Q1 2021. For more information surrounding the draft standard public commenting period and standard release dates, visit the Common SAE Fields’ newly launched asset page.
- The Interpretations of PV Guidances and Regulations (IGR-PV) released its Safety Issue Notification Guide. This resource seeks to provide a greater understanding of safety issue notification related to Health Authority requirements, insight on interpretation of several country guidances for implementation to help make operationalizing compliance more efficient and can aid Marketing Authorization Holders’ ability to meet signal and safety issue notification requirements for in-scope countries like Australia, Canada, Israel, New Zealand, Saudi Arabia, Switzerland, and Turkey.
- The Risk Based Monitoring Initiative team reviewed and provided input on a CRO Forum paper, which is published and available for download on the ACRO website. The manuscript, “Risk Based Quality Management (RBQM)—A Collaborative Approach to Holistic Clinical Trial Oversight,” focuses on how an RBQM encourages cross-functional engagement in a holistic and risk-based approach to clinical trial management and oversight.
- The Digital Data Flow (DDF) Infinitive launched its new deliverables page with a suite of assets for users. These tools include:
- Digital Data Flow concept video: Articulates the overall vision for the DDF Initiative.
- Solution Framework and Conceptual Design: Describes how the solution will help technology providers create an innovative, central protocol platform that will be accessible, open, flexible and vendor-agnostic toward downstream clinical applications.
- Executive Summary: Provides a high-level overview of a potential Solution Framework and Conceptual Design that would optimize processes and automate asset development from study concept finalization through study start-up (SSU).
- DDF Problem Statement and Future State Narrative: Describes a technology-enabled business process for defining a clinical study design supported by a Study Builder platform.
- The Value of Safety Information Data Sources Initiative team published a paper, “Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety,” in DIA’s Therapeutic Innovation & Regulatory Science (TIRS). Over the past decade, the volume of adverse events reported to marketing authorization holders and regulators has been rapidly increasing each year, which has led to significant challenges in patient safety assessment. Three data sources that have largely contributed to the expansion of adverse event reports are patient support programs (PSPs), market research programs (MRPs) and social media. In this paper, TransCelerate sought to further understand the contribution of these safety data sources to the characterization of a product’s safety profile. Give it a read here.