Drug Safety and Effectiveness in the Real World

Dear Colleagues,

Drug safety evaluation is an important issue throughout the lifecycle of drug product development. It is considered an ongoing activity because the premarket testing of drugs cannot detect all potential adverse effects, especially rare events. Therefore, real-world evidence plays an essential role. It is extremely important for clinicians to confirm the effectiveness and safety of treatments and further provide the optimal therapeutic drugs to the patients. Randomized controlled trials are considered to provide the highest level of scientific evidence for clinical therapies. However, drug safety in the real world still presents several challenges. For instance, several specific populations such as children and elderly people are commonly excluded from randomized controlled trials due to ethical issues. Furthermore, drug–drug interactions, inappropriate usage of medications, overdosing and long-term and rare adverse effects are not easily evaluated in traditional clinical trials. Therefore, clinicians must evaluate the benefits and risks and make decisions regarding therapies from various sources, including clinical trials and real-world evidence. In general, using real-world data with appropriate study designs, suitable epidemiological methods and well-controlled bias and confounding effects, real-world evidence can be generated. Such evidence can also bridge the gap from randomized controlled trials to demonstrate the efficacy and safety of medications or medical products in the real world.

Authors are invited to submit original and review articles on drug safety, therapeutic effectiveness and the economic burden of all common therapies which can be published in the Special Issue ‘Drug Safety and Effectiveness in the Real World’ of Pharmacoepidemiology.

I look forward to your valuable contributions.

Dr. Li-Ting Kao
Dr. Yu-Tien Chang
Dr. Ke-Ting Pan
Guest Editors

Manuscript Submission Information

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