Internet clinical trials

The widespread acceptance and use of the Internet as a means for communication in clinical trials has revolutionized the way clinical trials information is disseminated among the various individuals and collaborating organizations running and monitoring these trials. A trial s web site provides trial... 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

Computer-controlled systems [54] are commonly used in clinical trials to control dispensing and manage site inventories of trial supplies. Such systems are implemented with telephone voice-based or Internet web-based systems. 

Further information and advice related to the use of the clinical trial design can be found in a variety of sources including textbooks, manuscripts, organizations and Internet sites. In addition to the chapter reference list which cites helpful sources of information related to clinical trial protocol development, design and analysis, the following sources are also recommended. 

ClinicalTrials.gov, [Internet]. URL http //clinical-trials.gov/ct/gui, accessed 7-22-2000. 

Pharmacogenetics provides a rational framework to minimize the uncertainty in outcome of drug therapy and clinical trials and thereby should significantly reduce the risk of drug toxicity. The reader is referred to the Internet sources in Table 20.1 for more details on pharmacogenetics and drug development. Potential improvements in patient inclusion criteria will be addressed later in this chapter. 

This final chapter will spotlight some of these areas of research and the potential that they hold. In the future we may be able to grow new hearts to replace damaged ones and monitor ischemia and the progression of the disease via the internet and apply new therapies to arrest adverse remodeling before it leads to the syndrome of heart failure. Most of what will be described here is in the realm of research and application to humans in clinical trials is yet to occur. Despite this, these wonderful advances offer hope to patients for the future. 

Like other potential biopharmaceutical products, FDA, Center for Biologies Evaluation and Research (CBER) regulates the production, testing and use of AAV vectors in human clinical trials, in the US. Many regulatory documents are available to help guide the researcher. These documents are available via the Internet on http //www.fda.gov.cber/guidelines.htm. Review of these documents prior to significant work towards production of vector for... 

L Moench. Unleashing the electronic tiger How the Internet is changing clinical trials. Applied Clinical Trials 5 50-55, 1998. 

Committee for Medicinal Products for Human Use (CHMP). Position paper on non-clinical safety studies to support clinical trials with a single microdose. London European Medicines Agency 2004. (Internet at http /www.emea.eu.int/pdfs/human/swp/ 259902en.pdf accessed August 31, 2005.)... 

As nutraceuticals are not classified as medicinal products, their manufacture is often not legally regulated. Nutraceuticals are widely available for sale, and the many suppliers may formulate their products differently this leads to variations between products of different manufacturers. Products available for purchase are not necessarily of the same quality as those used in reported clinical trials. For effective and safe use, the products must contain the same active ingredient, at the same concentration, have known bioavailability per delivery system, and state detailed and correct information on packaging or patient leaflet. However, possibly due to purchase from non-pharmaceutical sources such as the Internet, there is often little information on efficacy, drug interactions, effect of long-term use, abrupt discontinuation, or potential adverse effects available to patients. 

NDA Pipeline. FDC Reports, 5550 Friendship Blvd., Suite. 1, Chevy Chase, MD 20815-7278, U.S.A. Phone +1 301-665-7157, Fax - -1301-656-3094, E-mail FDC.Customer.Service Elsevier. com. URL http //www.fdcreports.com. FDC Reports, a division of Elsevier has published the annual The NDA Pipeline for 20 years and has recently produced an electronic database version. The database, which can be found at http //www.ndapipeline.com, is updated weekly and allows the user to monitor drug development throughout the clinical trial process. The database is available through Internet subscription and onhne. 

Use an Internet search to determine if satraplatin has completed its clinical trials and is now an approved anticancer medicine. 

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