基于GM(1,1)模型的我国去中心化临床试验发展趋势预测

Prediction of the developing trend of decentralized clinical trials in China based on GM(1,1)model

目的:通过构建GM(1,1)灰色预测模型,分析我国去中心化临床试验未来的发展趋势,为相关企业和政府决策提供参考。方法:采用SAS 9.4软件批量读取源自clinicaltrials.gov网站的数据包,使用文献中收集的关键词提取近10年采用数字产品进行的临床研究数据,并使用最终数据进行分类统计和构建GM(1,1)灰色预测模型,进而对未来6年去中心化临床试验的发展趋势进行预测。结果:该模型精度等级较高,且能够用于中长期的预测。从模型预测结果来看,未来6年采用数字产品远程进行药物临床试验的数量会有明显上升趋势,但其占实验性临床研究总数的比值不会发生显著变化,仅使用电话访视的临床研究数量和占比则有减少的趋势。结论:去中心化临床试验将不断增加,但可能受到试验本身的限制、技术发展和产品规范的时间限制以及政策发展等因素的影响,其占比的增长速度会稍显缓慢。此外,电话远程访视的方法可能逐渐被更加高效的数字化产品替代。

Objective:To analyze the future developing trend of decentralized clinical trials in China by constructing GM(1,1)gray prediction model,providing reference for the decision-making of relevant enterprises and government.Methods:SAS 9.4 was used to read data packets from clinicaltrials.gov in batch,and the keywords in the literature were collected to extract eligible data from clinical researches conducted with digital products in the last decade.The final data were classified and statistically analyzed,and the GM(1,1)gray prediction model was constructed to predict the development trend of decentralized clinical trials in next six years.Results:The model is of high accuracy and good fitting degree,and can be used for medium and long term prediction.According to the predicted results of the model,the number of drug clinical trials conducted remotely by digital products will significantly increase in next six years,but its ratio to the total number of experimental clinical research will not significantly change,while the number and proportion of clinical studies conducted only by telephone visits decrease.Conclusion:Decentralized clinical trials is predicted to remarkablely increase,but the rate of growth will be slower due to the limitations of the trials themselves and the time constraints of technological developments and product specifications.In addition,telephony remote visits may be gradually replaced by digital products which are more efficient.