Introduction:

As a free, open-access website, ClinicalTrials.gov allows anyone with a connection to the Internet to obtain information about more than 130,000 clinical trials. Access to such a vast amount of information leads to the question: How should this information be used? There is a concern that patients will read the results of a clinical trial on the site and expect to receive treatment based solely on those results.

Background:

Clinical trials are research studies performed in humans, which are designed to determine ways to improve people’s health. They commonly involve administering two or more types of treatment to different groups of people and then comparing the effects of the types of treatment. In response to a growing interest in increasing global access to information about research regarding medications, medical devices, and other forms of treatment, an increasing number of websites have been developed that provide information about clinical trials. These websites compile the trials in registries or databases, which provide varying amounts of information about the trials.

A large number of Internet-based clinical trial registries have been developed in the past two decades. Registries have been established by the World Health Organization and many individual countries, drug companies (e.g. Lily, GlaxoSmithKline), and disease organizations (e.g. Alzheimer’s Association). ClinicalTrials.gov is the largest clinical trial registry in the world. It is funded by the Unites States government and managed by the US National Library of Medicine at the National Institutes of Health. It currently includes 132,505 clinical trials from the US and 179 other countries.

The ClinicalTrials.gov registry contains basic information about the type of trial, the disease and/or treatment being studied, whether the trial is still being conducted, who can enroll as a volunteer in the study, and whom to contact about the trial. For those trials that are completed, ClinicalTrials.gov contains the main results, as well as links to articles that have been published about the trial. The information provided in the registry has many potential uses. It can allow: patients to find trials in which they may be able to participate; members of the public to find out about current treatments that may be useful for themselves or their family, friends, or acquaintances; healthcare providers to learn about the recent development of treatments that may be useful for their patients; researchers to identify other studies that may be related to their research; and drug companies to discover information that may be relevant for their products.

Issue:

Should patients receive treatment based solely on the results of a clinical trial reported in the ClinicalTrials.gov registry?

Rules:

Patients should receive treatment based solely on the results of a clinical trial reported in ClinicalTrials.gov registry only if both of the following criteria are met:

1. the results are known to be completely accurate

2. the results are explained by the researcher(s) primarily responsible for the study

Analysis:

The results are known to be completely accurate

The results of trials in the ClinicalTrials.gov registry are entered into the registry by the researcher(s) responsible for conducting the trial or the company (such as a drug company) sponsoring the trial. Before the results are published on the website, staff at the National Library of Medicine review the results to determine if they appear to make sense. The staff examine whether the results seem to be correct, but they are not given the actual data from the individuals enrolled in the trial, so they cannot determine with certainty whether the results are accurate.

Thus, it is left to the person entering the results to submit accurate and unbiased information and, either intentionally or unintentionally, this may not always occur. Indeed, as reported by the Citizens for Responsible Care and Research, “once and a while we run across overly-optimistic information that seems better suited to a stock prospectus or a link to the manufacturer’s website where the investigational drug is promoted and otherwise hyped.” One therefore cannot be certain that the results of trials in the ClinicalTrials.gov website are completely accurate.

The results are explained by the researcher(s) primarily responsible for the study

The ClinicalTrials.gov registry does not contain an area where the researcher(s) can explain the results. The results are merely presented in tables, with no discussion of how they should be interpreted or how they relate to other information that is known about the disease or treatment. Without such explanations, it is often difficult for the reader to fully appreciate the meaning of the results and determine how they can be used to make decisions about treatment for specific patients.

Conclusion:

Patients should not receive treatment based solely on the results of a clinical trial reported in the ClinicalTrials.gov registry because it is not possible to know that the results of trials in the registry are completely accurate and the registry does not allow researchers to provide an explanation of their results.

For more information on this issue, contact the Kulkarni Law Firm.