Experiences in implementing uHTS--cutting edge technology meets the real world

Driven by growing corporate compound files, the demands of target biology, and attempts to cut cost, the number of solutions to HTS has spiralled. In quick succession new assay technologies and screening platforms are appearing on the market, with the promise of screening faster than ever in low volume high density formats whilst providing high quality data. Within this world of rapid change, Pfizer has applied cutting edge technology to HTS by introducing screening in 1 microl formats utilising single molecule detection technology. Instead of resource intensive in-house development, Pfizer entered into a collaboration with Evotec OAI / Evotec Technologies and introduced their Mark-II EVOscreen platform. In this article we will outline the benefits of the approach taken at Pfizer, Sandwich, and introduce the Mark-II EVOscreen platform, illustrating the potential but also possible pitfalls of HTS miniaturisation.     

浅谈真实世界研究中的因果推断

本文旨在通过介绍因果推断中常见的悖论、主要统计模型和相应的假设,浅谈真实世界研究中的因果推断.本文通过对Yule-Simpson悖论、Lord悖论、替代指标悖论进行简要的介绍,结合潜在结果模型和概率图模型的因果推断定义和主要假设分析偏倚的常见来源.良好的对照是识别因果效应的基础,完全随机是满足因果推断两个模型重要假设的...     

Pharmacoeconomic evaluation in the real world. Effectiveness versus efficacy studies.

Pharmacoeconomic data may be obtained within the context of randomised clinical trials (RCTs) and from effectiveness studies in the 'real world'. The differences between the 2 types of study design have implications for the types of data that can be obtained and the interpretation of the resulting findings. Because RCTs are designed to assess the safety and efficacy of pharmaceuticals, and because the study design of RCTs emphasises internal validity over generalisability, the pharmacoeconomic data collected from them are limited. The data may not be applicable to the more heterogeneous patients encountered in actual clinical practice, and cost estimates may be inaccurate because of protocol requirements. Effectiveness studies, in which treatments are studied under real-world conditions, remedy some of these limitations. Generalisability to actual users is generally enhanced in effectiveness designs, but data may be biased in other ways. This brief review compares the 2 study designs as they relate to pharmacoeconomic evaluations in terms of the research questions they address, design differences and their implications for study bias, data collection and data analysis and the generalisability of their results.     

真实世界2247例应用连花清瘟胶囊的老年患者用药模式分析

目的 探索连花清瘟胶囊老年患者的人群特点和用药规律,为药品监测或老年患者流行病学研究提供基础资料.方法 从全国18家三级甲等医院信息管理系统(HIS)中,提取2004年9月30日至2015年12月31日应用连花清瘟胶囊的老年患者的医疗数据,规范化后用Apriori算法建立模型,Clementine18.0软件进行关联规...     

Good real world example of wood-based sustainable chemistry

One of the principles of Green chemistry is the usage of biomass instead of crude oil for the production of chemicals and chemical goods. Wood refers to the term biomass along with agricultural residues, energy crops, and the biogenic part of waste such as solid municipal waste, landfill, sewage gas and farming waste. Wood is mainly composed of cellulose, lignin and hemicelluloses. Cellulose is the main component of wood and lignin is the main by-product of cellulose extraction. Our green approach to both of these polymers resulted in creating a new process for hydrocellulose fiber production and a new sorbent for oil spills removal based on hydrolysis lignin. It is worth pointing out that our approach provides the use of two main wood components in the frame of “cradle to cradle” cycle (Fig. 1) that supports the circular economy concept for research and process development (Clark et al., 2016).     

血管紧张素受体拮抗剂的真实世界:临床研究证据说明了什么

血管紧张素受体拮抗剂(ARB)在受体水平对肾素-血管紧张素-醛固酮系统(RAAS)发挥抑制作用,因此理论上可能较血管紧张素转化酶抑制剂(ACEI)作用更充分,特别是ARB对血管紧张素(Ang)Ⅱ的阻断作用可能更完全.但上述假设并未获得循证医学证据证实.本文对临床循证研究进行回顾提出,患者在不能耐受ACEI时使用ARB替代治疗可取,但不推荐以ACEI与ARB联合治疗高血压患者.     

用于支持药械注册的现实世界研究统计学思考

目的 探讨现实世界研究(RWS)获得现实世界证据(RWE)的统计学问题.方法 对现实世界数据(RWD),RWS的因果推断方法及RWE的评价方式进行总结,分析现存问题.结果 获得可靠的RWE用于支持药械监管是RWS的重要目标,适当的RWD通用标准是进行数据质量评价的前提,规范化的数据治理和完善的数据质量评价体系是规范开展...     

From research to the real world: Buprenorphine in the decade of the Clinical Trials Network

The National Institute on Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999 to bring researchers and treatment providers together to develop a clinically relevant research agenda. Initial CTN efforts addressed the use of buprenorphine, a mu-opioid partial agonist, as treatment for opioid dependence. Strong evidence of buprenorphine's therapeutic efficacy was demonstrated in clinical trials involving several thousand opioid-dependent participants, and in 2002, the Food and Drug Administration approved buprenorphine for the treatment of opioid dependence. With the advent of a sublingual tablet containing both buprenorphine and naloxone to mitigate abuse and diversion (Suboxone), buprenorphine appeared poised to be the first-line treatment for opioid addiction. Notwithstanding its many attributes, certain implementation barriers remained to be addressed in CTN studies, and these efforts have brought a body of knowledge on buprenorphine to frontline clinicians. The purpose of this article is to review CTN-based buprenorphine research and related efforts to overcome challenges to the implementation of buprenorphine therapy in mainstream practice. Furthermore, this article explores current issues and future challenges that may require additional CTN efforts.