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Post-Authorization Study Develops Into Crucial Part of Drug Development Design
BERLIN, GERMANY - Apr 20, 2016 -
Post-authorization safety studies (PASS) are becoming an integral part of the medicines development. Planning the design of PASS in the early phases of a clinical trial will translate into significant time- and cost-efficiency of pre-approval research. Supporting this trend, recent regulatory requirements and recommendations are to assure the highest level of quality, transparency and credibility of real-life data collected.
Increasing significance of PASS was one of the topics at the recent DIA EuroMeeting 2016, which took place on 6-8 of April in Hamburg. Magdalena Matusiak, Pharmacovigilance Team Lead at contract research organization KCR, highlighted the direction of recent changes in the PASS concept during the presentation, which was a part of the Session entitled Assessing the benefits and risks as the basis of the benefit-risk management.
PAS studies are becoming a vital part in drug development, especially for biological medicinal products, said Magdalena 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-authorization is the essential condition for marketing approval.
A post-authorization safety study is conducted after the drug marketing authorization to collect further information on the medicine's safety and to assure that benefits of the therapy outweigh the risks. Each marketing authorization 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-authorization studies.
The significant value of real-world evidences has recently been recognized and well understood by regulatory authorities and manufacturers, added Ms. 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-authorization studies, and this discussion starts at the beginning of the cooperation with a client, added Mr. 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, she summarized.
Ms. Matusiaks presentation entitled Is the ongoing surveillance a blessing or a curse? is already available here. If you would like to contact Ms. Matusiak directly, please send your request to Joanna Lewandowska, PR & Marketing, at joanna.lewandowska@kcrcro.com. Please include your full contact details in the query.
About KCR
KCR is a Contract Research Organization (CRO) providing strategic clinical development solutions for the pharmaceutical, biotechnology and medical device industries. More than 300 professionals support clients with full-service capabilities across our three main service areas: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP). Focusing on knowledge, quality and innovation, KCR offers high value solutions customized to clients' needs. The companys geographical set up suits perfectly to deliver optimized trial execution strategies. Headquartered in Berlin, Germany, KCR operates across 19 countries in Europe as well as the U.S. For more information, visit www.kcrcro.com.
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Contact:
Joanna Lewandowska
Associate Director, PR & Marketing KCR
Mob: +48 605 053 164