FDA guidance

In 2016, The FDA finalized guidance on safety data collection for late-phase and post-approval trials. With this announcement, the FDA has coined the term “Selective Safety Data Collection” and aims to provide guidance on when selective safety data collection is appropriate without undermining the importance of collecting sufficient data.

The FDA has specified that “selective safety data collection” may be considered in the following situations:

  • The number of patients and their characteristics, the duration of exposure and the dose range used in previous clinical investigations are sufficient enough to characterize the safety profile of the drug for common, non-serious adverse events.
  • The occurrence of common, non-serious adverse events has been generally similar across multiple clinical investigations.
  • The drug’s safety profile is established to the extent that it is reasonable to conclude that the occurrence of common, non-serious adverse events in the population to be studied will be similar to rates observed in previously conducted clinical investigations.

Read the full summary of the FDA’s announcement.

One important recommendation from the FDA is that Sponsors should plan on discussing their data collection plans with the FDA at the end of Phase II when preparing for selective safety data collection in Phase III.

CROS NT highlights strategic considerations for your safety data strategy

Consider a centralized data approach with biostatistics guidance and consultancy

Given the importance of your Phase III trial design to allow for selective safety data collection, Sponsors should consider their data collection, reporting and analysis leading up to this phase. Centralizing clinical data with a data centric, niche vendor allows Sponsors to keep data in one place and unify data standards and processes. Through a centralized approach, Sponsors have access to the same data management, biostatistics, pharmacovigilance and medical writing team throughout the entire drug development process.

In terms of biostatistics methodology and analysis, a centralized approach keeps the same study biostatistician with the Sponsor throughout the project. This means the biostatistician is available for regulatory review meetings, interpretation of results and feedback and the submission process. A biostatistician was safety data experience will be able to support with the selective safety data collection process by defining a strategic approach in the Statistical Analysis Plan.

Be strategic about Pharmacovigilance and Regulatory Planning

Pharmacovigilance has become a very pressing issue in drug development. Regulations are changing constantly and Sponsors need to be able to mitigate risk by ensuring a complete pharmacovigilance solution from data entry and case processing to safety system selection and quality and compliance services.

Does your company have a pharmacovigilance expert on hand knowledgeable about regulations and competent in supporting with safety data review meetings? Is your pharmacovigilance team able to prepare safety narratives in line with regulatory guidelines?

Consider having a pharmacovigilance and/or regulatory consultant on your team as you plan to enter late phase studies.

Deploy a safety system to optimize safety and risk management decisions

Having an up-to-date and compliant safety system for collecting and managing safety data can be a make or break decision for Sponsors. If Sponsors are running outdated or legacy safety systems, they could be at risk for security breaches or non-compliance issues with regulatory authorities.

Optimal safety systems produce real time metrics and on-demand reporting and allow for customization based on customers and study needs. Most importantly, global and comprehensive safety systems handle case processing, signal detection and periodic submissions and should be E2B compliant regarding newly required data extract formats.