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Estimates of Probabilities of Successful Development of Pain Medications: An Analysis of Pharmaceutical Clinical Development Programs from 2000 to 2020.
Anesthesiology ( IF 8.8 ) Pub Date : 2022-08-01 , DOI: 10.1097/aln.0000000000004265
Dermot P Maher 1 , Chi Heem Wong 2 , Kien Wei Siah 2 , Andrew W Lo 2
Affiliation  

BACKGROUND The authors estimate the probability of successful development and duration of clinical trials for medications to treat neuropathic and nociceptive pain. The authors also consider the effect of the perceived abuse potential of the medication on these variables. METHODS This study uses the Citeline database to compute the probabilities of success, duration, and survivorship of pain medication development programs between January 1, 2000, and June 30, 2020, conditioned on the phase, type of pain (nociceptive vs. neuropathic), and the abuse potential of the medication. RESULTS The overall probability of successful development of all pain medications from phase 1 to approval is 10.4% (standard error, 1.5%). Medications to treat nociceptive and neuropathic pain have a probability of successful development of 13.3% (standard error, 2.3%) and 7.1% (standard error, 1.9%), respectively. The probability of successful development of medications with high abuse potential and low abuse potential are 27.8% (standard error, 4.6%) and 4.7% (standard error, 1.2%), respectively. The most common period for attrition is between phase 3 and approval. CONCLUSIONS The authors' data suggest that the unique attributes of pain medications, such as their abuse potential and intended pathology, can influence the probability of successful development and duration of development. EDITOR’S PERSPECTIVE

中文翻译:

止痛药成功开发概率的估计:2000 年至 2020 年药物临床开发计划的分析。

背景 作者估计了治疗神经性和伤害性疼痛的药物临床试验成功开发的可能性和持续时间。作者还考虑了药物滥用潜力对这些变量的影响。方法 本研究使用 Citeline 数据库计算 2000 年 1 月 1 日至 2020 年 6 月 30 日止痛药开发计划的成功概率、持续时间和存活率,具体取决于疼痛的阶段、类型(伤害性与神经性),以及药物的滥用潜力。结果 从第一阶段到批准,所有止痛药成功开发的总体概率为 10.4%(标准误差,1.5%)。治疗伤害性和神经性疼痛的药物成功开发的概率为 13.3%(标准误差,2. 3%)和 7.1%(标准误差,1.9%)。成功开发具有高滥用潜力和低滥用潜力的药物的概率分别为 27.8%(标准误,4.6%)和 4.7%(标准误,1.2%)。最常见的减员期是在第 3 阶段和批准之间。结论 作者的数据表明,止痛药的独特属性,例如它们的滥用潜力和预期的病理学,可以影响成功开发的概率和开发持续时间。编辑的观点 结论 作者的数据表明,止痛药的独特属性,例如它们的滥用潜力和预期的病理学,可以影响成功开发的概率和开发持续时间。编辑的观点 结论 作者的数据表明,止痛药的独特属性,例如它们的滥用潜力和预期的病理学,可以影响成功开发的概率和开发持续时间。编辑的观点
更新日期:2022-05-03
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