CADTH invites industry representatives for new industry task force on real-world data for post-market drug evaluations

CADTH announces it is establishing a new industry task force to advance use of real-world data for post-market drug evaluations and issues public call inviting industry representatives to participate.

The Canadian Agency for Drugs and Technologies in Health (CADTH) has issued a press release setting forth its plans to establish an industry task force to develop advice on the use of industry generated real-world data (RWD) in its Post-Market Drug Evaluation (PMDE) Program, building upon its recently released Guidance for reporting real-world evidence. They are seeking two additional industry representatives to be part of this task force and are inviting applications until August 31, 2023.

CADTH launched its PMDE Program in September 2022 in order to provide real-world evidence (RWE) to federal, provincial, and territorial decision-makers about drugs that have been approved and are broadly available to people in Canada. With drug manufacturers collecting RWD and keen to share these data with health technology assessment agencies and decision-makers, RWE is key for post-market drug monitoring and evaluations — in particular for drugs with limited clinical trial data available, e.g., drugs for rare diseases.

“Substantial work is needed to effectively operationalize the use of industry-collected RWD”, states CADTH in the press release.

The focus of the new PMDE Industry Task Force will be to identify opportunities and barriers for using industry generated RWD in the PMDE Program. The venture will be task-oriented and time-limited, with the members meeting monthly for an initial period of five months, which may be extended. The group will report directly to the multistakeholder PMDE Advisory Committee and will work collaboratively to develop an options paper for CADTH advising on best practices and potential approaches for using industry RWD and identifying ways to mitigate risks and barriers.

The industry task force will comprise of 8–10 pharmaceutical industry delegates alongside representatives from Health Canada and CADTH. The industry representatives will include those of the PMDE Advisory Committee, plus 4–6 more recommended by Innovative Medicines Canada (IMC) and BIOTECanada. CADTH are offering an opportunity for involvement and will recruit two additional industry representatives who are not affiliated with either of these named associations through the public call for applicants to join the task force.

The CADTH call for applicants details: “Industry representatives who meet the requirements and bring experience within some of the following areas of expertise are encouraged to apply.”

Requirements:

• Currently employed by a pharmaceutical company with presence in Canada that holds Canadian data
• Minimum of 10 years’ experience in the health care landscape with at least 3 years of experience in a pharmaceutical company
• Not employed by an organization that is affiliated with IMC or BIOTECanada

Areas of expertise:

• Familiarity with regulatory affairs, health policy, and health technology assessment
• Experience in the execution of evidence-generation projects, including methodology, protocol design, RWD collection and analysis, and reporting
• Understanding of research governance, laws, and ethics
• Well-connected within their organizations (locally and globally) and externally with strategic partners.

CADTH voices that it intends to share information about the industry task force and the resultant options paper in due course.