Long-Term Safety Programs
Long-term safety data to support registrational trials
Clinical trials for products to treat chronic conditions require long-term safety data to support marketing approval. Increasingly, stakeholders — like regulators, payers, physicians and even patients — are seeking evidence on the long-term effectiveness and safety of drugs under consideration for approval. In addition, manufacturers need to be prepared with real-world evidence that supports long-term product use. UBC is an experienced, strategic research partner that can develop late phase studies that follow good pharmacoepidemiology practices.
Pre-planning is key for long-term safety studies for registrational packages as well as for product safety profile support. UBC can lay the framework for long-term safety studies that attract the right patients and produce evidence of long-term safety and efficacy. UBC experts will:
- Focus on local, regional, and national decision makers
- Recommend study designs that minimize the burden on physicians’ office staff
- Provide the opportunity for patients in placebo comparative studies to gain long-term exposure to the drug under development
- Leverage technology, including proprietary software and social media, as appropriate, to enhance study designs
- Provide real-world evidence of patient outcomes that will drive your product’s performance
- Position your brand for future success
Data is driving the emerging scientific standards. Increasingly complex information is being collected more frequently and in more robust formats. Tapping into this data can produce evidence of the long-term value of a product versus competing therapies, which can influence prescribing decisions. Manufacturers must continue to develop a product’s value proposition at product launch and as the product ages.
Proactively implementing a long-term safety study is the first step toward an extended value story and continued commercial success. Contact us to learn more.