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You will find a comprehensive book delineating the basics of clinical trials. It is useful for novice persons entering the clinical trials arena, but also for more experienced clinical trial professionals. It is available in English, Chinese, Portuguese and Spanish.
Clinical trials are conducted in a strict manner, often according to a pre-defined study protocol. To ensure that all colleagues — novice and experienced study staff — work in harmony and in compliance with the GCP Guidelines, a full set of Study Site Standard Operating Procedures have been developed. The 55 SOPs can be downloaded as word files and subsequently adjusted for the individual study site.
Between 1%-2% of industry-sponsored trial sites overseen by the US FDA are inspected, including inspections for the clinical investigators. The results of each inspection are posted on the US FDA homepage and the database is updated. We present the inspection results in a more readable format. You can find detailed results - investigator name and inspection results - for each country. There are also summary statistics and comparisons of the inspection outcomes between countries, also updated every three months.
If you are interested to learn about the globalization of industry-sponsored clinical trials, you can find details on CTM's homepage. The data is downloaded from the US trial registry — www.clinicaltrials.gov — and are presented according to country and continent. There are also results showing the trends over time. The data is updated.
From the perspective of a study site, it is important to understand which disease areas and conditions are being studied (conducting trials) the most and the least with respect to all industry-sponsored clinical trials. The volume — number of trials and subject — are fairly constant over time, but the disease focus changes. One example is hepatitis C, where numerous trials have been conducted in recent years (to become a front-runner), whilst the opposite is true for hepatitis B. CTM presents a ranking for all diseases under study and provides information about the current trends. The data is updated.
CTM started as a free monthly newsletter in 2008 and all reports and articles published have been made available free of charge. They are a valuable source of information for both the industry and investigative sites. Three in-depth reports were written in 2013-14, and they are also available free of charge. CTM plans to add additional reports to the list. Any new report listed will be announced by email to CTM Members.
A few surveys were conducted by CTM, involving its members. The topics addressed areas such as indirect fee on trials budget, ethics committee fee, and investigator incentives to participate in sponsored clinical trials.
There is a detective story posted in CTM that addresses fraudulent behavior, such as insider trading of clinical trial results and bad manufacturing practice. The book can serve as a base for discussions among groups of clinical trial professionals.