Link To ::
Alphabet Soup (U.S. Federal Agencies): CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of DHHS); DHHS: Department of Health and Human Services; NCI: National Cancer Institute (part of NIH); NIH: National Institutes of Health; OHRP: Office For Human Research Protections (part of DHHS); ORI: Office of Research Integrity (part of DHHS); OIG: Office of the Inspector General
Commercial and University Registries | NCI Cooperative Oncology Group Registries | Clinical Trial Web Sites
Clinical Trial Registry: A database containing entries with basic information about a clinical trial.
Study Results Database: A database with summaries of unpublished (usually) clinical trials.
Follow this link for the CIRCARE webpage on Study Results Databases and Suggestions for Use
Some thoughts and commentary on the good, the bad, and the ugly of Clinicaltrials.gov.
These organizations are affiliated with the National Cancer Institute, part of the U.S. National Institutes of Health.
Ongoing Studiesto find the trial registry.)
Findfunction of your web browser to find principal investigators by last name.)
Another way to locate clinical trials is to search for the sponsor's press releases. You can try searching at BioSpace.com, the sponsor's web site (if you know who this is), or in the case of public companies, you can search their filings with the U.S. Securities and Exchange Commission. Try the EDGAR Database, or SECInfo.com. The latter requires free registration and offers a search feature, which can save time and headaches.
Look at The Lancet Protocol Reviews, for comprehensive summaries of clinical trial protocols peer-reviewed by The Lancet. These trials are underway. In return for peer-review of their protocols, investigators agree to submit their results to the journal for publication. Although The Lancet retains the right to reject manuscripts, the publication of protocols in and of itself makes a valuable contribution toward fostering scientific integrity.
Large studies may have a dedicated web site where they publish study protocols, consent forms, and other information for investigators, research subjects, and the public in general. We've begun collecting study web sites because many of them provide valuable information not available elsewhere.
ALLHAT Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Available from http://allhat.sph.uth.tmc.edu/ (NHLBI/NIH funded; closed.)
National Heart, Lung, and Blood Institute (NHLBI) Information on ALLHAT. Available from http://www.nhlbi.nih.gov/health/allhat/index.htm (General information and study publications.)
ACCORD — Action to Control Cardiovascular Risk in Diabetes. Available from http://www.accordtrial.org/public/index.cfm (NHLBI/NIH funded.)
ARDSNet — Acute Respiratory Distress Syndrome Clinical Network. Available from http://www.ardsnet.org/ (NHLBI/NIH funded.)
CESAR — Conventional Ventilation or ECMO for Severe Adult Respiratory Failure. Accessed on 2007-02-21 at: http://www.cesar-trial.org/
Research in Congenital Heart Defects-Secundum Atrial Septal Defect (known as ASD), Perimembraneous Ventricular Septal, and AV Canal Defects. Available from http://www.uihealthcare.com/depts/med/pediatrics/congenitalheart/ (NHLBI/NIH funded.)
Framingham Heart Study. Available from http://www.nhlbi.nih.gov/about/framingham/index.html (NHLBI/NIH funded.)
Jackson Heart Study. Available from http://www.nhlbi.nih.gov/about/jackson/index.htm (NHLBI/NIH funded.)
NETT — National Emphysema Treatment Trial. Available from http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm (NHLBI/NIH funded.)
Women's Health Initiative. Available from http://www.nhlbi.nih.gov/whi/index.html (NHLBI/NIH funded.)
Women's Health Initiative Participant Website. Available from http://www.whi.org/
RESOLVE-AF Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation. Trial to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF). Available from https://www.resolve-af.com/index.html (Industry funded.)
Standard, Universal, and Master Clinical Trials Agreement. Available from http://www.utsystem.edu/ogc/intellectualproperty/dbmock.htm. (Courtesy of the University of Texas System, Office of General Counsel.)
ClinicalTrials.gov is world's largest and most comprehensive clinical trial registry. ClinicalTrials.gov is cooperatively run by FDA, NIH, and the National Library of Medicine. Any research sponsor can register a trial and many sponsors are required to register their trials. For example, all trials sponsored by NIH must be registered, as well as drug trials conducted under FDA Investigational New Drug applications (INDs) if the drug is being tested for the treatment of life-threatening diseases and disorders or if the purpose of the study is to assess effectiveness. Study sponsors or their designees are responsible for entering information through the online Protocol Registration System. Like all things, ClinicalTrials.gov has good qualities, not-so-good qualities, and problems.
The positive features of ClinicalTrials.gov are the large number of trials listed, the comprehensive organization of information in each entry, lack of restrictions on who may register trials, and excellent search engine. All of this is the result of hard work and encouragement on the part of the federal agencies that run ClinicalTrials.gov. Other positives include staff at the National Library of Medicine who respond to questions or concerns when you email them, and (some) entries for closed studies that provide study results, usually by linking to publications in PubMed. There is some discussion at FDA about requiring sponsors to post study results but this is probably a long way off. At present ClinicalTrials.gov is a registry and not a study results database.
In the absence of federal oversight, however, the accuracy and balance of information in trial entries depends upon the sponsors' good nature and understanding of applicable regulations and ethical principles. In practice this means entries can include incomplete or inaccurate information, misleading information, and false information. Much of this is innocuous or relatively so. Studies often begin after projected start dates so it can be confusing when you find a trial that supposedly began in 2004 yet is labeled Not Yet Enrolling
in mid-2005. Some problems are not so innocuous. 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 web site where the investigational drug is promoted and otherwise hyped. To be fair, when we complained about the content of a manufacturer's web site linked to a study entry, staff at the National Library of Medicine promptly forwarded it to FDA for evaluation and the web site was subsequently revised.
The entry for a study titled Mistletoe Extract and Gemcitabine for the Treatment of Solid Tumor Cancers
provides the following false and misleading information to vulnerable patients with advanced refractory cancer:
The FDA has approved mistletoe extract for use in cancer treatment studies. Mistletoe extract has been used either alone or together with conventional anti-cancer drugs to treat cancer in tens of thousands of patients in Europe.
Source: http://www.clinicaltrials.gov/ct/show/NCT00044161. Accessed on 2005-11-24.
The statement that FDA has approved mistletoe extract for use in cancer treatment studies
is false because FDA doesn't approve drug studies. In fact FDA warns investigators not to make this claim in the Guidance for IRBs and Clinical Investigators — 1998 Update, Guide to Informed Consent. The fact that mistletoe has been used by tens of thousands of patients in Europe
is misleading because it encourages readers to believe mistletoe might be safe and effective for their condition, but wide use
does not equal safety or efficacy, and mistletoe may or may not be safe or effective when administered with Gemcitabine in this study. Providing false information to induce subjects to enroll in research is unethical and reprehensible. Fortunately these problems appear to be rare.
Some entries may be incomplete. Many sponsors provide locations and contact information for each study site along with the name of the principal investigator and her contact information. Some sponsors don't provide this information and as a result people looking for information are forced to make dozens of phone calls to find information that should have been available to them in the first place.
A few sponsors don't include the name of the drug being tested. Updated 2007-09-05: on 2005-09-07, this Pfizer study titled A Phase 2 Study of the Safety and Efficacy of a Novel Anti-Inflammatory Investigational Drug in Adult Asthmatics was testing an investigational drug obtusely named Investigational Study Drug.
Apparently Pfizer edited the trial entry on 2006-10-30 and added the name of the drug: Tofimilast. The earlier (silly) version is available at: http://www.goldbamboo.com/topic-t1090-a151385.html.
The most vexing problem with ClinicalTrials.gov is that not all sponsors who are required to register studies do so. The most recent survey by FDA in August, 2005 found that only 35% of industry-sponsored studies that were required to register were actually registered. This suggests widespread ignorance or non-compliance and it's difficult to understand in view of industry's continual lamentation about how difficult it is to recruit study subjects. To find more information about this problem, read the FDA report: FDAMA Section 113: Status Report on Implementation. Available from http://www.fda.gov/oashi/clinicaltrials/section113/113report/default.htm. August, 2005. You can find additional information in the selected resources indexed under the title Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov
which is available at http://www.fda.gov/oashi/clinicaltrials/section113/default.htm.
Pending litigation
appears as an exclusion criteria in a study testing various techniques of chiropractic manipulation. One of the conditions for IRB approval is that the selection of the subjects is equitable. Involvement in litigation is unrelated to medical status. A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique. Available from http://clinicaltrial.gov/ct/show/NCT00163124?order=4. Accessed on 2005-11-25.
Last Updated: 2010-03-26
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