Better access to clinical trials information

Abstract

A new website that gives access to information on over 4000 US-based clinical trials is now open to the public. http://clinicaltrials.gov/ct/gui was developed by the US National Institutes of Health (NIH) in conjunction with the Food and Drug Administration (FDA). The developers of the website say that they hope to provide the latest information on promising patient-orientated research on hundreds of diseases and conditions. Although most of the trials currently in the database are sponsored by the NIH, they envisage that it will expand to include more trials sponsored by other organizations.The US Government legislated to widen access to healthcare information in 1997, when it ratified the Food and Drug Modernization Act. This legislation ensures that information on clinical trials is available to the public, especially patients involved in trials, their families, and potential trial participants. The new website, which is operated by the National Library of Medicine (NLM), is one step towards achieving this goal. It will be supplemented in 2001 with the addition of a free telephone service that will extend access to the database even further.The website is easy to use and quick to access without long download times. Users can search by disease or by sponsor – the NIH itself, other federal agencies, industry, or universities and other organizations. They can also identify trials that are taking place near to home. The trials are divided into five categories: completed, stopped recruiting, still recruiting, suspended, and not started recruiting. Summaries of each trial are easily downloaded and include information on the purpose of the study, the participants (inclusion and exclusion criteria, etc.), the investigators and contact information. In addition, there is sometimes information on relevant clinical papers and links to other sources of information, such as the American Heart Association and similar bodies, as well as sponsoring companies. General information on the disease being studied can also be found via links to Medlineplus, the general healthcare information service operated by the NLM.However, the only way to access the results and conclusions of completed studies is via direct links to Medline abstracts. This is an extremely useful link for medical researchers and healthcare professionals who have easy access to medical libraries and a good understanding of medical and scientific terminology. But, for others, many abstracts will be difficult to understand and it will not be easy to obtain copies of the full clinical papers, should they wish to find out more.In addition to accessing the new database, patients considering taking part in a clinical trial can also contact people who have already been involved in trials and find out about their experiences. Potential trial participants can do this through the NLM, which maintains a list of past participants who are willing to answer questions about their experiences.Unlike many websites, no registration is required and the NLM is quick to stress that people who use the site will not be contacted by the NIH or other bodies that sponsor clinical trials.