Medical Science Liaisons in Real-World Evidence Studies: Experience of AstraZeneca Russia

Autor: Nikolay Suvorov, Vera Karaseva, Vladimir Bulatov, Elkhan Sanay, Ekaterina Stukalina, Vera Petrakovskaya
Rok vydání: 2018
Předmět:
Zdroj: Therapeutic Innovation & Regulatory Science. 52:57-61
ISSN: 2168-4804
2168-4790
Popis: There is no doubt that real-world evidence studies have the potential to improve and accelerate the development and delivery of safe and cost-effective innovative medicines to patients as well as influence the way we approach health and health care. Real-world evidence studies are a great challenge in terms of development and conduct, so there should be a good collaboration between the study team and clinical sites at all times, resulting eventually in timely and efficient enrollment. Engaging the sites and key external experts as early as possible during feasibility and routine visits, as well as highlighting the science rationale behind AstraZeneca's portfolio at investigator meetings and during medical science liaison (MSL) interactions, can create a positive impact on physician perception of a particular study and prioritization of patient recruitment in such studies. Therefore, we would like to underline the important role of MSLs in the risk-based monitoring setting of real-world evidence studies, with special attention to the studies with complicated patient profiles, tough timelines, and/or seasonal factors. This approach will be used further for other real world evidence projects of AstraZeneca Russia MC to ensure timelines and budget deliverables are met for the generation of high-quality evidence and eventually better health care for all of us.
Databáze: OpenAIRE
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