Safety Monitoring in Clinical Trials
Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2013-01-01
|
| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | http://www.mdpi.com/1999-4923/5/1/94 |
| _version_ | 1798038659490906112 |
|---|---|
| author | H. Amy Xia Qi Jiang Li Zhu Bin Yao |
| author_facet | H. Amy Xia Qi Jiang Li Zhu Bin Yao |
| author_sort | H. Amy Xia |
| collection | DOAJ |
| description | Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process. |
| first_indexed | 2024-04-11T21:43:05Z |
| format | Article |
| id | doaj.art-70def78429fc4d6095cfed399ce98299 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-11T21:43:05Z |
| publishDate | 2013-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-70def78429fc4d6095cfed399ce982992022-12-22T04:01:30ZengMDPI AGPharmaceutics1999-49232013-01-01519410610.3390/pharmaceutics5010094Safety Monitoring in Clinical TrialsH. Amy XiaQi JiangLi ZhuBin YaoMonitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process.http://www.mdpi.com/1999-4923/5/1/94clinical trialsafety monitoringData and Safety Monitoring Board (DSMB)sequential probability ratio test (SPRT)Bayesian methods |
| spellingShingle | H. Amy Xia Qi Jiang Li Zhu Bin Yao Safety Monitoring in Clinical Trials Pharmaceutics clinical trial safety monitoring Data and Safety Monitoring Board (DSMB) sequential probability ratio test (SPRT) Bayesian methods |
| title | Safety Monitoring in Clinical Trials |
| title_full | Safety Monitoring in Clinical Trials |
| title_fullStr | Safety Monitoring in Clinical Trials |
| title_full_unstemmed | Safety Monitoring in Clinical Trials |
| title_short | Safety Monitoring in Clinical Trials |
| title_sort | safety monitoring in clinical trials |
| topic | clinical trial safety monitoring Data and Safety Monitoring Board (DSMB) sequential probability ratio test (SPRT) Bayesian methods |
| url | http://www.mdpi.com/1999-4923/5/1/94 |
| work_keys_str_mv | AT hamyxia safetymonitoringinclinicaltrials AT qijiang safetymonitoringinclinicaltrials AT lizhu safetymonitoringinclinicaltrials AT binyao safetymonitoringinclinicaltrials |