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Historical Review
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
Donald D. Vogt, Michael Montagne
In 1970, "substantial evidence" was defined in greater detail. Now, adequate and well-controlled investigations had to include a formal test with explicit objectives, defined selection procedures for subject and control groups, methods for observation and recording, and statistical analysis. The test drug could be compared with a placebo, another drug known to be active from past studies, or with no treatment. Clinical experience was relegated to the final stage (i.e., Phase IV) of drug testing well after the commitment to manufacture and promote the drug had been made. Consequently, the trend in the 1980s is toward the conceptualization and implementation of postmarketing surveillance systems to detect the occurrence of problems with a drug's safety and efficacy.
Pharmaceutical and Medical Device Product Liability Litigation
Published in Julie Dickinson, Anne Meyer, Karen J. Huff, Deborah A. Wipf, Elizabeth K. Zorn, Kathy G. Ferrell, Lisa Mancuso, Marjorie Berg Pugatch, Joanne Walker, Karen Wilkinson, Legal Nurse Consulting Principles and Practices, 2019
Vicki W. Garnett, Stacy Newsome
Unfortunately, adverse events related to drugs and devices do occur, and the FDA established a reporting system to conduct post-marketing surveillance and risk assessment programs to track adverse effects. As previously discussed, pharmaceutical and biologic products undergo extensive evaluation through the clinical trial process, and consumers can assume a reasonable expectation the drug will be safe and effective if consumed for the approved indication and dosage and the consumer adheres to the instructions outlined in the drug label. However, when a new drug is released to a broader population, post-marketing side effects are identified, and additional testing is sometimes required. The FDA Adverse Event Reporting System (FAERS; USFDA, n.d.-a, n.d.-e) is a database used to track, store, and analyze post-marketing safety surveillance reports. Reports are evaluated by CDER scientists to monitor and enforce drug safety. Based on CDER’s analysis, the FDA may enforce regulatory action such as requiring the pharmaceutical manufacturer to revise the drug label, include a black box warning, send out a “Dear Health Care Professional” letter, or withdraw the product from the market (USFDA, n.d.-g).
Pharmaceuticals: Some General Aspects
Published in Peter Grunwald, Pharmaceutical Biocatalysis, 2019
In some cases, a Phase 4 trial also known as Postmarketing Surveillance Trial is conducted (particularly after approval under FDA Accelerated Approval Program) with several thousands of volunteers to additionally test drug safety and efficacy. In Table 1.4, the data associated with the development of a new drug are compiled (see also Palgon, 2017; Tufts CSDD, 2017).
The correlations between steady-state concentration, duration of action and molecular weight of GLP-1RAs and their efficacy and gastrointestinal side effects in patients with type 2 diabetes mellitus: a systematic review and meta-analysis
Published in Expert Opinion on Pharmacotherapy, 2023
Ruoyang Jiao, Chu Lin, Shuzhen Bai, Xiaoling Cai, Suiyuan Hu, Fang Lv, Wenjia Yang, Xingyun Zhu, Linong Ji
In general, GLP-1RA treatment led to glycemic benefit and weight loss, but also accompanied with an increased risk of GI adverse events. Long-acting GLP-1RA or high-concentration GLP-1RA seemed to show greater glucose-lowering effects but lower incidence of GI adverse events when compared with short-acting one or low-concentration one according to our results. Apart from the efficacy and adverse effects mentioned in this article, other benefits and risks may need further evaluations in the process of translating the research findings into clinical practice, such as cardiovascular and renal outcomes [45]. Moreover, individualized assessments should also be encouraged in order to weight the benefits and risks. Of course, long-term trials and post-marketing surveillance is warranted to fully assess both long-term efficacy and safety.
Current trends in PLGA based long-acting injectable products: The industry perspective
Published in Expert Opinion on Drug Delivery, 2022
Omkara Swami Muddineti, Abdelwahab Omri
Even though several safety issues can be recognized during clinical trials, the abnormal action of the commercialized product that was not detected in clinical trials remains a possibility during post-marketing surveillance. Hence, USFDA has set continuous monitoring for post-marketing surveillance programs from manufacturers, hospitals, and the public. For example, after the market launch of Risperdal Consta, it was identified that the drug could increase the risk of cardiovascular or infectious-related deaths. Hence, the FDA allotted a black box warning for Risperdal Consta that excluded its use for the relevant patients. In addition, inherent risks of LAIs such as complexity in formulation, the drug-release kinetics, the longer residence times in the body, particularly in the vicinity of the injection sites (IM, SC spaces), and the unexpected toxicity due to dose dumping, which result in concentration spikes in the plasma should be monitored appropriately.
Discovery, preclinical development, and clinical application of pralsetinib in the treatment of thyroid cancer
Published in Expert Opinion on Drug Discovery, 2022
Pietro Locantore, Roberto Novizio, Andrea Corsello, Rosa Maria Paragliola, Alfredo Pontecorvi, Salvatore Maria Corsello
FDA recently approved a diagnostic test OncomineTM Dx Target Test (Thermo Fisher Scientific) as a tool to identify more candidates for treatment with pralsetinib, also in order to get more data and better define the profile of this innovative drug [36]. The phase I/II ARROW trial is ongoing, with conclusion expecting date on December 2021. An essential phase III clinical trial is planned to study pralsetinib in MTC. Moreover, about NSCLC, a new trial named ‘AcceleRET Lung’ has recently started and is being conducted as postmarketing commitment. It is an international, open-label, randomized, phase III study, evaluating the efficacy and safety of pralsetinib compared with platinum-based chemotherapy regimen as first-line treatment in patients with RET fusion-positive metastatic NSCLC, with primary endpoint being progression-free survival compared to investigator’s choice of Standard Of Care treatments according to a blinded independent central review (RECIST 1.1) [34]. Larger sample size, long-term follow-up and comparative studies are needed to better evaluate efficacy and tolerance of pralsetinib and define its role in the treatment of RET-altered cancers. A postmarketing surveillance study (phase IV) is required.