How to PASS the test in clinical trials

The importance of post-authorisation safety studies (PASS) is becoming increasingly significant, as recently highlighted by Magdalena Matusiak, KCR

The increasing significance of post-authorisation safety studies (PASS) was one of the topics at the DIA EuroMeeting 2016, Hamburg. Magdalena Matusiak, pharmacovigilance team lead at contract research organisation KCR, highlighted the direction of recent changes in the PASS concept during the presentation, which was a part of a session entitled, Assessing the benefits and risks as the basis of the benefit-risk management.

PASS is becoming an integral part of the development of medicines. Planning the design of PASS in the early phases of a clinical trial will translate into time and cost-efficiency of pre-approval research. Supporting this trend, recent regulatory requirements and recommendations help assure a high level of quality, transparency and credibility of real-life data collected.

“PAS studies are becoming a vital part in drug development, especially for biological medicinal products,” said Matusiak. “Currently, biological drug development is the fastest growing segment in the healthcare industry. For the vast majority of biopharmaceuticals the long-term observation of post-authorisation is the essential condition for marketing approval.”

A post-authorisation safety study is conducted after the drug marketing authorisation to collect further information on the medicine's safety and to assure that benefits of the therapy outweigh the risks. Each marketing authorisation holder (MAH) is obliged to set up and maintain the safety management system for the purpose of monitoring, collection and assessment of adverse events reported during the clinical development of the medicinal product as well as during the post-authorisation studies.

“The significant value of real-world evidences has recently been recognised and well understood by regulatory authorities and manufacturers,” added Matusiak. “Only additional monitoring in real-life cycles allows for observation of the long-term safety and immunogenicity, interactions between products, effects of switching between similar therapies, as well as safety and efficacy assessment in other types of population not observed during clinical research.”

Current flexible regulatory approach facilitates fast and effective marketing approval. The tendency to streamline and shorten the time of the pre-approval development phase for the benefit of post-approval observation is becoming more and more prevalent. Decreased time and lower costs of the pre-approval research allow for accelerated and wider patients’ access to advanced therapies.

PASS should be considered an integral part of the medicinal product development, not only for biopharmaceuticals. “There is a growing role for scientific consulting services to provide creative and smart design of pre- and post-authorisation studies and this discussion starts at the beginning of the cooperation with a client,” added Matusiak. “The process of collecting and assessing real-world evidences remains a broad area for innovative solutions, however advanced ideas are of great value only when translated into successful outcome.”