There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing pressure to get to market faster, timelines are under more scrutiny than ever. The pandemic set a precedent that it’s possible to “go faster.” So, senior management may feel more validated than ever before to expect accelerated regulatory submissions and approval timelines. But how fast is realistic?
Benchmarking regulatory submission processes against industry standards helps identify opportunities for improving business performance. Clearly defining regulatory submission metrics and tracking trends within your organization will also help manage expectations. The challenge is that both industry and organizational benchmarks are difficult to find and variables influencing timelines between submissions are many.
This article aims to help regulatory leaders establish and monitor organizational submission metrics based on the work to be done. To help fill the gap in industry data, Integrated Project Management Company, Inc. (IPM) provides top-line metrics collected while leading more than 100 submission teams. Learning how your organization compares may uncover adjustments to make when tracking your own submission projects.
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The first step in defining regulatory submission metrics is to clearly define each milestone to be measured. The team must understand them, so everyone is working toward the same goal. For instance, various milestones could signal the conclusion of a clinical study. These include last patient screened, last patient dosed, last patient out, last patient last visit, or last patient follow-up. Depending on the study’s design, these dates can vary widely. If you clearly define the conclusion of clinical studies, you’ll avoid confusion and be able to consistently report and accurately compare study durations.
Similarly, to define metrics for the time required for activities after database lock, it pays to agree on the milestones in advance. The time needed to produce top-line results varies depending on the size of the database, how much data clean-up is needed, and how many resources will do the work. Some organizations choose to accelerate downstream submission activities by basing them on draft tables, listings, and figures (TLFs). They accept the risk that they may need to do some rework once final TLFs become available. However, if significant changes occur between draft and final TLFs, rework may require more resources and could delay the timeline.
One of the most closely tracked submission metrics is the time needed to develop a clinical study report (CSR). Producing the CSR for a pivotal clinical study is often on the critical path for a late-stage submission. Tracking the duration between key milestones of CSR development provides valuable insights about how the cross-functional team is working together. Tracking milestone metrics will also help you anticipate—and potentially mitigate—submission delays. Otherwise, small early delays can snowball into bigger delays. They can be an early indicator that the submission is in trouble.
Download the complete article for detailed milestones and related metrics.
The submission project manager is responsible for identifying the resources required to support the submission. He or she also works with the functions, Clinical Research Organizations (CROs), and/or other vendors to define the durations of activities and dependencies between activities.
Senior management typically wants to know these durations at a higher level:
Organizations often use these higher-level metrics to compare submissions within a company and between companies. However, products and development processes vary widely. You can’t compare the complexity of a small molecule NDA submission against a large biologic BLA submission since each submission may or may not have the same number of pivotal clinical studies. Also, each organization’s processes and procedures are different. Team members have differing levels of experience preparing submissions. Each of these factors increases the level of variability, thereby decreasing the reliability of the comparison regarding how long it should take to prepare a submission dossier.
Get the complete article for top-line metrics collected from more than 100 submission teams, plus five key success factors for accurately projecting a submission date.
Regulatory submissions are on the critical path to getting new therapeutics to patients. Product development and submission precede product review, approval, and commercialization. The better the quality of the submission dossier, the easier it is for health authorities to review. Regulatory submission metrics can be tactical, such as tracking and reporting progress toward completion of each module in the dossier. Metrics can also be strategic, such as accurately identifying a target submission date that supports business objectives.
A key measure of organizational efficiency is defining and tracking submission metrics, outlining a realistic number of submission scenarios, identifying an achievable target submission date, and successfully submitting a quality dossier according to the integrated project plan. Tracking the right metrics can help determine an accurate submission timeline or the impact of a potential delay.
When senior management knows what to expect and when to expect it, they are less likely to continually ask for updates, thereby minimizing distractions for the submission team. Well-defined submission metrics are the key to providing insights on how to improve the overall submission process and better ensure on-time submissions to health authorities for the ultimate benefit to patients.
Authors:
Susan E. Carino, MBA, MS, PMP, RAC, Principal Consultant
Troy Kinney, PMP, MBA, Senior Consultant
Greg Palagi, PMP, Senior Consultant
Integrated Project Management Company, Inc.
Services: Regulatory Submissions
Industries: Life Sciences