СОДЕРЖАНИЕ
История
В результате давления со стороны ВИЧ-инфицированных мужчин в гей-сообществе, которые требовали более широкого доступа к клиническим испытаниям, Конгресс США принял Закон 1988 года о продлении программ омнибуса в области здравоохранения (публичный закон 100-607), который предписал разработку базы данных Информационная служба по клиническим испытаниям СПИДа (ACTIS). Эти усилия послужили примером того, что можно было бы сделать для улучшения доступа общественности к клиническим испытаниям, и побудили другие заинтересованные группы, связанные с заболеваниями, настаивать на чем-то похожем для всех болезней.
Национальная медицинская библиотека при Национальных институтах здравоохранения сделала ClinicalTrials.gov доступным для общественности через Интернет 29 февраля 2000 года. В этом первоначальном выпуске ClinicalTrials.gov в первую очередь включала информацию об исследованиях, спонсируемых Национальным институтом здравоохранения, без учета большинства клинических исследований. испытания проводятся частным сектором. 29 марта 2000 г. FDA выпустило проект руководства под названием «Информационная программа по клиническим испытаниям серьезных или угрожающих жизни заболеваний: создание банка данных и внесение его в In) в надежде, что это расширит его использование в промышленности». После того, как в июне 2001 г. был выпущен второй проект руководства, 18 марта 2002 г. было выпущено окончательное руководство под названием «Руководство для отраслевой информационной программы по клиническим испытаниям серьезных или угрожающих жизни заболеваний и состояний». Закон о лучших лекарственных средствах для детей 2004 года (Публичный закон 107-109) внес поправки в Закон о государственной службе здравоохранения, требуя включения дополнительной информации на сайт ClinicalTrials.gov.
В результате обеспокоенности по поводу отслеживания токсичности, возникшей после изъятия некоторых лекарств с рынка рецептов, ClinicalTrials.gov был дополнительно усилен Законом о внесении поправок в Управление по санитарному надзору за качеством пищевых продуктов и медикаментов 2007 года (Государственный закон США 110-85), который требовал расширения ClinicalTrials.gov. для лучшего отслеживания основных результатов клинических испытаний, требующих:
Лента новостей
Жизненный цикл пробной записи
Как правило, испытание проходит через этапы: первоначальная регистрация, текущее обновление записей и отправка базовых сводных результатов. Каждая запись о судебном разбирательстве ведется менеджером по записи о судебном разбирательстве. Менеджер записи испытаний обычно обеспечивает первоначальную регистрацию испытания до включения в исследование первого участника. Это также облегчает информирование потенциальных участников о том, что в испытании больше не набирают участников. После того, как все участники были набраны, запись испытания может быть обновлена, чтобы указать, что набор участников закрыт. После того, как все измерения собраны (испытание формально завершено), статус испытания обновляется на «завершено». Если испытание прекращается по какой-либо причине (например, отсутствие регистрации, свидетельство начальных неблагоприятных исходов), статус может быть изменен на «прекращено». После того, как станут известны окончательные результаты испытаний или соблюдены установленные законом сроки, менеджер записи испытаний может загрузить основные итоговые результаты в реестр, заполнив сложную веб-форму или отправив соответствующий файл XML.
Более поздние разработки
На встрече представителей Национального института здравоохранения в 2009 году ораторы заявили, что одна из целей состоит в том, чтобы иметь более четко определенные и последовательные стандарты отчетности. По состоянию на март 2015 года NIH все еще рассматривал детали этого изменения правила.
ClinicalTrials.gov Background
Contents
What Is ClinicalTrials.gov?
ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials ( expanded access ). Studies listed in the database are conducted in all 50 States and in 220 countries.
ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device). See FDAAA 801 and the Final Rule for more information. However, the rate of study registration has increased over time as more policies and laws requiring registration have been enacted and as more sponsors and investigators have voluntarily registered their studies.
ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was made available to the public in February 2000.
The ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trial registration information to be submitted. The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database, which contains summary information on study participants and study outcomes, including adverse events. The results database was made available to the public in September 2008. FDAAA 801 also established penalties for failing to register or submit the results of trials. In September 2016, HHS issued the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifying and expanding the registration and results information submission requirements of FDAAA 801. This regulation takes effect in January 2017.
An account of the development and expansion of ClinicalTrials.gov in response to changes in policies and laws is provided on the History, Policies, and Laws page.
Searching ClinicalTrials.gov does not require registration or personal identification. Because ClinicalTrials.gov is a Government Web site, it does not host or receive funding or advertising from commercial entities or display commercial content.
What Information Can I Find on ClinicalTrials.gov?
Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:
Some records also include information on the results of the study, such as:
For Researchers
ClinicalTrials.gov is a registry and results database of publicly and privately supported research studies conducted in the United States and around the world. Sponsors or investigators of certain clinical trials are required by U.S. law to register their trials on and submit summary results to ClinicalTrials.gov. Other international policies also require trial registration. See the Why Should I Register and Submit Results? page for more information.
Each study record includes a summary of the study protocol, including the purpose, recruitment status, and eligibility criteria. Study locations and specific contact information are listed to assist with enrollment. See How to Read a Study Record to learn more about the information found in a study record.
Some study records include summary study results in a tabular format. The results information submitted to ClinicalTrials.gov includes the number of participants starting and completing the study, baseline characteristics, outcome measures, and adverse events. See About the Results Database for more information.
Contents
Register a Study or Submit Results
The Submit Studies section of the site provides information for investigators who want to register a study, submit results, or update a study record. See the For Study Record Managers page for more information.
Find Studies on ClinicalTrials.gov
ClinicalTrials.gov is updated daily. Please check the site frequently for new information.
The Find Studies section of the site includes different options for finding studies, along with instructions on how to find the studies you are looking for and how to read study records. In this section, you can:
Resources
The Resources section of the site includes scholarly publications by ClinicalTrials.gov staff, news on clinical alerts, statistics about ClinicalTrials.gov, and information on downloading content from the database.
See the Downloading Content for Analysis page for help with downloading large numbers of study records from the database in Extensible Markup Language (XML) or formats that are compatible with Microsoft® Excel such as comma-separated values (CSV) format.
Submit Studies to ClinicalTrials.gov PRS
The ClinicalTrials.gov Protocol Registration and Results System (PRS) is a Web-based data entry system used to register a clinical study or submit results information for a registered study. You must have an account in order to Login to ClinicalTrials.gov PRS
New to registering studies? See For Study Record Managers.
Why Should I Register and Submit Results?
Learn about the purpose of study registration and results submission. Includes an overview of applicable laws and policies.
FDAAA 801 and the Final Rule
Learn about the requirements for registering and submitting summary results information for applicable clinical trials described in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). This page includes summary information to help responsible parties understand their obligations under FDAAA 801 and the Final Rule and links to key regulatory provisions and related discussions.
How to Apply for a PRS Account
Learn how to apply for a PRS account to access the Protocol Registration and Results System (PRS), the Web-based system used to submit study data to ClinicalTrials.gov.
How to Register Your Study
Review the basic steps for study registration, find out what data elements are required, and learn about the record review process.
How to Edit Your Study Record
Learn about required updates, how to edit study records, and how to view earlier versions of a record.
How to Submit Your Results
Review the basic steps for submitting results, find out what data elements are required, and learn about the record review process.
Frequently Asked Questions
Review frequently asked questions about PRS and entering study data.
Support Materials
Find data element definitions and resources related to study registration and results submission, as well as links to relevant laws and policies. Includes links to resources on external sites such as the Food and Drug Administration and International Committee of Medical Journal Editors.
Selected Publications
This page contains links to scholarly publications about ClinicalTrials.gov and clinical research, written by ClinicalTrials.gov staff and others. Titles of journal articles link to the PubMed® abstract for the publication, when available. Links to full-text versions of articles that are available for free are also provided.
Zarin DA, Fain KM, Dobbins HD, Tse T, Williams RJ. 10-year update on study results submitted to ClinicalTrials.gov. N Engl J Med. 2019 Nov 14; 381:1966-1974. [Full Text]
Zarin DA, Williams RJ, Tse T, Ide NC. The role and importance of clinical trial registries and results databases. In: Gallin JI, Ognibene FP, Johnson LL eds, Principles and Practice of Clinical Research. 4th ed. London: Academic Press; 2017: 111-25.
Dobbins HD, Cox C, Tse T, Williams RJ, Zarin DA. Characterizing Major Issues in ClinicalTrials.gov Results Submissions (Full Text). Presented at: Eighth International Congress on Peer Review and Scientific Publication; September 2017; Chicago, IL. [Poster (PDF)]
Zarin DA, Tse T, Dobbins HD. Beyond feasibility: Assessing the ClinicalTrials.gov results database (Abstract). Presented at: Seventh International Congress on Peer Review and Biomedical Publication; September 2013; Chicago, IL. [Full Text (PDF)]
Zarin DA, Tse T. Clarification about ClinicalTrials.gov. IRB. 2013 May-Jun;35(3):19. [Full Text]
(Note: The article is free, but users must register to access it.)
Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM. Time to publication among completed clinical trials. JAMA Intern Med. 2013 May 13:1-3. doi:10.1001/jamainternmed.2013.136. [Full Text]
Zarin DA, Williams RJ, Bergeris AM, Dobbins H, Ide NC, Loane RF, Robbins A, Tse T. ClinicalTrials.gov and Related Projects: Improving Access to Information about Clinical Trials: A report to the Board of Scientific Counselors. Bethesda, MD: Lister Hill National Center for Biomedical Communications, US National Library of Medicine; April 2013. Technical Report TR-2013-001. [Full Text (PDF)]
Tse T, Zarin DA, Williams RJ, Ide NC. The role and importance of clinical trial registries and results databases. In: Gallin JI, Ognibene FP, eds, Principles and Practice of Clinical Research. 3rd ed. Amsterdam: Academic Press; 2012: 171-81.
