There are 10,000 clinical trials each year in the US alone. Of these, 70% are still paper based. Despite the promise of electronic data capture EDC as a means to reduce time and costs in the clinical trials process, the pharmaceutical sector has not embraced EDC due to a combination...
In this article Millennium Pharmaceuticals, Inc. and Schering-Plough Corporation discusses the initiation of a multicenter phase IIIb clinical trial to evaluate the benefit of INTEGRILIN when administered early to high-risk patients experiencing non-ST-segment elevation acute coronary syndrome. The trial, known as EARLY ACS (Early Glycoprotein IIb-IIIa Inhibition in Non-ST-segment Elevation...
Merck & Co., Inc. develops, manufactures, and markets innovative products to improve human and animal health. Merck ships confidential documents regarding its late-stage clinical drug trials to physicians around the country during the trials' course. Merck relies on the physicians to protect the documents' confidentiality after delivery. Merck evaluated Microsoft...
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a phase I clinical trial of MLN2704 (formerly known as MLN591DM1) in patients with metastatic androgen-independent prostate cancer. MLN2704 is designed to deliver the maytansanoid chemotherapeutic agent DM1 directly to prostate cancer cells through the MLN591 delivery mechanism, a targeting...
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a phase I clinical trial of MLN1202. MLN1202, a novel humanized monoclonal antibody that blocks the chemokine receptor known as CCR2, is being developed as a potential treatment for patients with rheumatoid arthritis and possibly other inflammatory diseases. The primary...
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a phase I clinical trial of MLN1021, an orally administered inhibitor of Factor Xa, a critical enzyme in the formation of blood clots. MLN1021 will be investigated for a variety of applications in patients with thrombotic disease, including preventing and...
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a phase I clinical trial of MLN3897, the first compound to enter clinical trials from its inflammation collaboration with Aventis Pharmaceuticals, Inc. MLN3897 (Aventis' compound code: AVE-9897), an orally-administered small molecule, is designed to block CCR1, a chemokine receptor found...
In this article Millennium Pharmaceuticals, Inc. discusses their preliminary results from a phase I clinical trial of MLN2704 in patients with progressive metastatic hormone- refractory prostate cancer. The findings from the study indicated that MLN2704 was very well tolerated and produced antitumor activity, including one partial response in a patient...
Phase Forward monitors clinical trials around the world and spurred the move to web-based trials ten years ago. But their boring technology helps us all not die from the latest meds. Which is sort of exciting.
The Food and Drug Administration rejected Genzyme's request to sell a version of its drug Myozyme made in a new factory, a decision some journalists and bloggers insist on casting as a black mark against the very notion of generic biotech drugs. There's just one problem: These...
As the volume of information collected in clinical trials continues to grow, data collection and management is becoming a priority for pharmaceutical and biotech companies. Capturing data in a more accurate and timely fashion is a critical component to reducing time to market for potential new drugs. Companies are aggressively...
Results of randomized clinical trials are the preferred "Evidence" for establishing the benefits and safety of medical treatments. This paper presents evidence suggesting that the conventional approach to reporting clinical trials has fundamental flaws that can result in overlooking identifiable subgroups harmed by a treatment while underestimating benefits to others....
The complexity and characteristics of the pharmaceutical firm present an intriguing context for underlying information management issues during clinical trials for new drug development. This paper reports on the evaluation and performance of MIS for information management in clinical trials in new drug development. The main objective of the study...
Compounding these problems, the process of drug development has never been so expensive and time-consuming, the main culprit of which is the clinical trial process. This article discusses how the latest generation of IT support tools is proving invaluable to the pharmaceutical industry as it tackles the spiraling costs and...
This white paper deals in carrying out a study to investigate the effects in a population of elderly with perceived poor health rather than the general population. It also involves testing whether nurses who are qualified at a lower professional level home nurses instead of public health nurses are able...
In this article Millennium Pharmaceuticals, Inc. discusses the CLEAR Platelets Clopidogrel Loading with Eptifibatide to Arrest the Reactivity of Platelets trial, the addition of INTEGRILIN, a potent glycoprotein GP IIb-IIIa inhibitor, to a commonly used antiplatelet regimen provided superior platelet inhibition and prevention of heart muscle damage associated with elective...
This paper comprises a series of studies conducted as part of the Cost of Cancer Treatment Study CCTS. The specific aims include exploring theoretical issues concerning the problem of representativeness in trial design with an explicit investigation of the causes of the under-representation of older adults in clinical cancer trials;...
The value of automated data capture in clinical trials has never been greater. While pharmaceutical companies are under increasing pressure to develop and test new drugs as quickly and efficiently as possible most clinical trials remain mired in seas of paperwork that consume vast numbers of staff hours, storage space...
The paper depicts that in the era of the large scale; randomized clinical trial will peak and pass. Randomized clinical trials may become the dinosaurs of the clinical trials process. One may need to revise the method of development - Phase I clinical trials through Phases III and IV -...
Though the concept of a comprehensive clinical trials database surfaced in the mid 1970's, nearly 30 years later, in the United States, there is still no all-inclusive system in place for organizing, tracking, and disseminating information about ongoing clinical trials. This pharmaceutical industry alert examines the issues and forces behind...
