Practicing physicians frequently obtain laboratory assessments of kidney function in their routine management of patients with diabetes. Two tests that are commonly performed are the estimated glomerular filtration rate (eGFR) and the urinary albumin to creatinine ratio (ACR). Results of these tests are often used to determine patient eligibility for clinical trials of drugs to treat patients with diabetic kidney disease (DKD).
One challenge that drug developers and clinical trialists face is in choosing eGFR and ACR criteria that support the aims of the clinical study—without hindering recruitment.
To address this issue, researchers at Covance and LabCorp queried a LabCorp database of 329,841 diabetic patients to analyze real-world data. They wanted to understand the distribution of eGFR and ACR values among diabetic patients in the United States and assess how these laboratory parameters predicted renal disease progression.
A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but actually refer less than 0.2% of their patients into clinical trials.1 In conjunction, more than 80% of patients 表示愿意参加临床试验，但真正参加的只有大约10%。2进一步的报告显示，虽然85%的患者一般都愿意告知医生自己找到的临床研究信息，但实际这么做的只有17%。3那些有兴趣参加临床研究的患者发现自己不合格以后，是怎么做的呢？当被问及发现自己不符合资格后下一步怎么做时，36%的人停止了寻找参加临床研究的机会。3考虑到目前有超过130项已计划或正在进行中的行业赞助II-III期风湿性关节炎（RA）研究可供选择（考虑任何类型的研究赞助者则超过210项），这后一项发现是惊人的潜在浪费。4 继续阅读 →