The trials and tribulations of drug development for functional gastrointestinal disorders

被引:4
作者
Chang, L. [1 ]
机构
[1] Univ Calif Los Angeles, Div Digest Dis, Ctr Neurobiol Stress, David Geffen Sch Med,VAGLAHS, Los Angeles, CA 90073 USA
关键词
drug development; functional gastrointestinal disorders; irritable bowel syndrome; treatment;
D O I
10.1111/j.1365-2982.2008.01093.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Functional gastrointestinal disorders (FGID) are common conditions seen in primary care and specialty practices but many affected individuals report a lack of satisfaction with available treatments. Despite the unmet need for more effective pharmacotherapy, drug development for these conditions can be challenging on many levels. This review will discuss the rationale and challenges of drug development for FGID. The reasons for engaging in drug development include that these conditions are highly prevalent, associated with a significant economic and healthcare burden, and associated with a lack of satisfaction with current therapies. The challenges include the lack of perception that FGID are legitimate disorders, the multidimensional and complex pathophysiology of FGID, the lack of a biological marker for diagnosis and treatment response, the heterogeneity of the patient population, the lack of consensus regarding the best outcome measures for clinical trials and the perceived increased risk-benefit ratio associated with drugs for FGID. Ongoing efforts are being taken to work towards a better understanding of pathophysiology, illness severity, patient-reported outcome measures, and benefit : risk assessment, and towards increasing education and communication amongst patients, clinicians, investigators, industry and regulatory agencies which will hopefully help optimize drug development strategies for FGID.
引用
收藏
页码:130 / 138
页数:9
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