TransCelerate has been actively monitoring the evolving COVID-19 crisis and we are providing our Member Companies a trusted and collaborative forum to discuss the ongoing disruption to drug development. TransCelerate Member Companies are using this informal forum to voluntarily discuss best practices and various options for addressing multiple drug development matters as the situation evolves. These discussions are helping Members Companies more expeditiously and more efficiently identify possible solutions for difficult problems during these uncertain times, although each company is making its own decisions on how best to respond to the changing circumstances resulting from the COVID-19 threat. There are no current plans for TransCelerate to issue materials related to these informal member-to-member discussions.
We continue to have a dialogue with colleagues from PhRMA, EFPIA, and other organizations within the drug development ecosystem. During this time of crisis, it is important for all stakeholders to work together to help the industry find the best solutions as quickly as possible.
In addition, we are actively evaluating our portfolio of ongoing & future initiatives, and reprioritizing activities to focus on solutions that have the potential to help immediately and in the longer term.
Several specific TransCelerate solutions can be referenced by sites and sponsors to support the continuity of clinical trials
- Tools to support centralized trial monitoring: TransCelerate’s Risk-Based Monitoring methodology and tools can be leveraged to transition from conventional, onsite monitoring. The model guidelines for targeted, risk-based clinical trial monitoring, ultimately aiming to improve data quality and patient safety. The methodology and tools can be adopted by any size organization and adapted to any type or phase of a clinical trial.
- Tools to support the development of clinical study reports (CSR): TransCelerate’s CSR Considerations for Studies Disrupted by the COVID-19 Pandemic was created by clinical scientists, pharmacovigilance experts, data scientists, and other experts to identify the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19. At this time, no further updates to this content are planned, though TransCelerate will be seeking further input from experts and regulators to guide CSRs for studies disrupted by COVID-19. In 2022, ACRO and TransCelerate have taken the lessons learned from the past three years and published proposals to address these challenges in “Points to consider when developing a Clinical Study Report (CSR) for a clinical trial that has been disrupted due to unforeseen circumstances.“
- Tools to support protocol deviation management: With the COVID-19 pandemic drastically affecting clinical trial operations, protocol modifications may be required and there may be unavoidable protocol deviations. To help stakeholders navigate multiple aspects of protocol deviation management, TransCelerate has released a Protocol Deviations Toolkit earlier than anticipated. The toolkit offers clarification of the definition and provides a holistic approach to protocol deviations management, including a process guide, process map, decision tree, and an assessment tool. These tools were developed with feedback from Sites, CROs, and Health Authorities.
- Tools to support issue and risk management: A Quality Management System aims to address quality and monitor and improve performance in complex clinical development-specific environments. TransCelerate’s Risk and Issue Management Tools provide a framework to provide end-to-end management of risks and issues and support an effective Corrective and Preventive Actions (CAPA) process.
- Tools to support the use of patient-friendly technology: TransCelerate’s Patient Considerations Guide provides insights on patient perspectives and key considerations for using technology in clinical trials. As global health authorities have surfaced that trial participants may not be able to visit the investigational site for protocol-specified visits, sponsors may evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit) could be used. The guide provides considerations to aid a sponsor’s decision to use technology with patients to help in the current environment.
COVID-19 Data Sharing via DataCelerate®
TransCelerate has expanded COVID-19-related patient-level clinical data sharing via DataCelerate® to eligible non-members. Data shared may include both the investigational product and control arms of COVID-19-related clinical trials along with supporting study-level documentation.
Qualified biopharmaceutical companies and certain government biomedical research agencies may apply to donate and access shared data via an application form demonstrating they satisfy minimum eligibility criteria (summarized below) and by signing requisite legal agreements developed to govern the use, contribution, security, and privacy of data. To initiate the application process, please contact CV19Info@TransCelerateBioPharmaInc.com
Summary of Eligibility Criteria:
- Quantifiable human health research track record
- Ongoing or planned clinical COVID-19-focused research project
- Executive Officer Certification of:
- Good Clinical Practice adherence
- Sufficient funding to conduct proposed research
- Reasonable and appropriate data security, access and transparency/disclosure policies
- Appropriate technical and organizational measures to meet requirements of applicable privacy and data protection laws and regulations
- Completion of a security checklist specifying requirements for systems on which data will be housed
- Compliance with the terms of applicable legal agreements