Glass Harold E
TTC, LLC, Elkins Park, Pennsylvania 19027, USA.
Dis Manag. 2004 Spring;7(1):77-87. doi: 10.1089/109350704322919014.
The advancement of science requires the cooperation of clinical investigators. Recent discourse, which attempts to relate pharmaceutical company grant payments to clinical investigators to subsequent preferential prescribing behavior, erodes the physician/patient relationship and may lead to an inadequate number of investigators. This study was designed to determine why the level of grant payments to Phase 3 clinical investigators differs for comparable levels of work and whether these differences are related to subsequent prescribing behavior of either the study drug or other drugs from the same sponsoring company. From a database of 100,000 investigator contracts, 2,108 U.S. physicians participating in Phase 3 trials at 2,897 clinical sites for new drugs launched in 1999-2000 were randomly selected in 10 outpatient indications. The relative grant amounts (RGAs) paid to the investigators were compared with their subsequent prescribing of the study drug and other sponsor company drugs for a period of six months after study drug introduction. The RGA is the payment percentile represented by the absolute cost per patient grant paid to any specific investigator compared with other similar studies, including such considerations as the number of patient visits, the number and types of medical procedures performed, the investigator's geographic location, and whether the study was conducted at the investigator's office or hospital. Linear regression correlations were calculated between study, investigator, and drug characteristics with the RGA, and the correlation between the RGA and subsequent prescribing behavior of the study drug and other drugs from the sponsor company at three and six months after study drug product launch. Five variables were statistically significantly related to the RGA received by an investigator: compound therapeutic novelty, the number of similar studies being conducted at same time, investigator clinical research experience, and the inverse of drug class prescription volume. Most significantly, investigators' post-study prescribing behavior was not related to RGA. Drug development and market forces explain the RGA, but RGA is not related to subsequent sponsor or study drug prescribing.
科学的进步需要临床研究人员的合作。最近有一些论述试图将制药公司给临床研究人员的资助款项与随后的优惠开药行为联系起来，这破坏了医患关系，并且可能导致研究人员数量不足。本研究旨在确定为何给予3期临床研究人员的资助款项水平在工作量相当的情况下存在差异，以及这些差异是否与随后对研究药物或来自同一赞助公司的其他药物的开药行为有关。从一个包含100,000份研究人员合同的数据库中，随机选取了1999 - 2000年推出的新药在2,897个临床地点进行3期试验的2,108名美国医生，涉及10种门诊适应症。将支付给研究人员的相对资助金额（RGA）与他们在研究药物引入后的六个月内对研究药物和其他赞助公司药物的后续开药情况进行比较。RGA是指支付给任何特定研究人员的每位患者资助绝对成本相对于其他类似研究的支付百分位数，其中考虑了患者就诊次数、所执行的医疗程序的数量和类型、研究人员的地理位置以及研究是在研究人员的办公室还是医院进行等因素。计算了研究、研究人员和药物特征与RGA之间的线性回归相关性，以及研究药物上市后三个月和六个月时RGA与研究药物及赞助公司其他药物后续开药行为之间的相关性。有五个变量与研究人员获得的RGA在统计学上显著相关：化合物治疗新颖性、同时进行的类似研究数量、研究人员的临床研究经验以及药物类别处方量的倒数。最显著的是，研究人员研究后的开药行为与RGA无关。药物开发和市场力量解释了RGA，但RGA与随后的赞助公司或研究药物开药无关。
