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The Clinical Trials Registry and Results Database compiles information on publicly and privately supported clinical trial studies on a wide range of diseases and conditions. Its main goal is to provide an easy access to both privately and publicly funded clinical trials information for patients, their family members, healthcare professionals, researchers, and the public.
Overview
Overview
ClinicalTrials.gov is an online clinical trials database 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 ClinicalTrials.gov website, which was made available to the public in February 2000. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. The ClinicalTrials.gov Web site and database of clinical studies is commonly referred to as a "registry and results database."
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 200 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). 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.
The ClinicalTrials.gov results database contains summary information on study participants and study outcomes, including adverse events.
Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:
- Disease or condition
- Intervention (for example, the medical product, behavior, or procedure being studied)
- Title, description, and design of the study
- Requirements for participation (eligibility criteria)
- Locations where the study is being conducted
- Contact information for the study locations
- Links to relevant information on other health Web sites, such as NLM's MedlinePlus® for patient health information and PubMed® for citations and abstracts of -Scholarly articles in the field of medicine.
Some records also include information on the results of the study, such as:
- Description of study participants (the number of participants starting and completing the study and their demographic data)
- Outcomes of the study
- Summary of adverse events experienced by study participants.
License Information
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Schema
| Name | Description | Type | Constraints |
|---|---|---|---|
| Clinical_Study_Id | NCT ID is a unique identification code given to each clinical study registered on ClinicalTrials.gov. The format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419). | String | Required |
| Overall_Status | The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting". | String | Values: Completed, Enrolling by invitation, Not yet recruiting, Recruiting, Suspended, Terminated, Withdrawn, Unknown status, Temporarily not available, Active not recruiting, No longer available, Available, Approved for marketing, Withheld |
| Rank | The rank of the clinical study in the current selection. | Integer | Level: Ordinal |
| Clinical_Study_Secondary_Id | Secondary Id for the clinical study. | String | |
| Organization_Study_Id | Alternative organization specific Id. | String | |
| First_Received_Date | The First Received date is the date on which summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry. There is typically a delay of a few days between the First Received date and when the study information is available on ClinicalTrials.gov. | Date | |
| Last_Changed_Date | The Last Updated date is the most recent date on which changes to a study record were submitted to ClinicalTrials.gov. There may be a delay between the Last Updated date and when the updated study information is available on ClinicalTrials.gov. Also, this date may be different from the Last Verified date. | Date | |
| First_Received_Results_Date | This value is only available for studies that have results. It is the date when the results were first received. | Date | |
| Short_Title | A short title of the clinical study written in language intended for the lay public. | String | Maximum Length:3000 |
| Official_Title | The title of the clinical study, corresponding to the title of the protocol. | String | |
| Brief_Summary | A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public. | String | Maximum Length:5000 |
| Detailed_Description | Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures. | String | Maximum Length:32000 |
| Primary_Disease_or_Condition | The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus. | String | |
| Primary_Disease_or_Condition_Keywords | Words or phrases that best describe the protocol. Keywords help users find studies in the database. Use NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms where appropriate. Be as specific and precise as possible. Avoid acronyms and abbreviations. | String | |
| Primary_Outcome_Information | A description of each primary outcome measure (or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). Note: "Primary outcome measure" means the outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation. Most clinical studies have one primary outcome measure, but a clinical study may have more than one." | String | |
| Secondary_Outcome_Information | A description of each secondary outcome measure (or for observational studies, specific secondary measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). Note: "Secondary outcome measure" means an outcome measure that is of lesser importance than a primary outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention or interventions under investigation in a clinical study and is not specified as exploratory or other measures. A clinical study may have more than one secondary outcome measure. | String | |
| Study_Start_Date | The estimated date on which the clinical study will be open for recruitment of participants, or the actual date on which the first participant was enrolled. | Date | |
| Primary_Completion_Date | The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the prespecified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes. Once the clinical study has reached the primary completion date, the responsible party must update the Primary Completion Date to reflect the actual primary completion date. | Date | |
| Study_Completion_Date | The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the prespecified protocol or was terminated. Once the clinical study has reached the study completion date, the Responsible Party must update the Study Completion Date to reflect the actual study completion date. | Date | |
| Record_Verification_Date | The date on which the responsible party last verified the clinical study information in the entire ClinicalTrials.gov record for the clinical study, even if no additional or updated information is being submitted. | Date | |
| Study_Stopped_Reasons | A brief explanation of the reason(s) why such clinical study was stopped (for a clinical study that is "Suspended," "Terminated," or "Withdrawn" prior to its planned completion as anticipated by the protocol). | String | |
| Sponsor_Lead | The name of the entity or the individual who is the sponsor of the clinical study. The name of the entity or the individual who is the sponsor of the clinical study. The sponsor is the organization or person (see also Sponsor-Investigator) who oversees the clinical study and is responsible for analyzing the study data. | String | |
| Investigator_Information | The principal investigator is designated by the sponsor as the responsible party for conducting the study. The principal investigator has access to and control over the data from the study; has the right to publish the results of the study, and has the ability to meet all of the requirements for submitting and updating clinical study information. | String | |
| Sponsor_Collaborators | Other organizations (if any) providing support, including funding, design, implementation, data analysis and reporting. The responsible party is responsible for confirming all collaborators before listing them. | String | |
| Study_Type | The nature of the investigation or investigational use for which clinical study information is being submitted. | String | Values: Expanded Access, Interventional, Observational, Observational [Patient Registry] |
| Oversight_Info | Studies a U.S. FDA-regulated Drug Product - Indication that a clinical study is studying a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of the Public Health Service Act. | String | |
| Study_Phase | For a clinical trial of a drug product (including a biological product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21 and in 21 CFR 312.85 for phase 4 studies. N/A: Trials without phases (for example, studies of devices or behavioral interventions). | String | Values: Early Phase 1, Phase 1, Phase 1/Phase 2, Phase 2, Phase 2/Phase 3, Phase 3, Phase 4 |
| Study_Design_Allocation | The method by which participants are assigned to arms in a clinical trial. | String | Values: Randomized, Nonrandomized, Non-Randomized, RandomSample |
| Study_Design_Primary_Purpose | The main objective of the intervention(s) being evaluated by the clinical trial. | String | Values: Treatment, Prevention, Diagnostic, Supportive Care, Screening, Health Services Research, Basic Science, Device Feasibility, Educational/Counseling/Training, Other |
| Study_Design_Intervention_Model | The strategy for assigning interventions to participants. | String | Values: SingleGroupAssignment, SequentialAssignment, ParallelAssignment, FactorialAssignment, CrossoverAssignment |
| Study_Design_Intervention_Model_Description | Provide details about the Interventional Study Model. | String | |
| Study_Design_Observational_Model | Provide details about the Observational Study Model. | String | |
| Study_Design_Time_Perspective | Temporal relationship of observation period to time of participant enrollment. | String | Values: Longitudinal Retrospective/Prospective, Cross-Sectional, Longitudinal Retrospective, Cross-Sectional Retrospective, Longitudinal Prospective, Longitudinal, Cross-Sectional Prospective, Retrospective/Prospective, Cross-Sectional Retrospective/Prospective, Retrospective, Prospective, Cross-sectional, Other |
| Study_Design_Masking | The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants. Select all that apply. Roles, if Masking: Participant Care Provider, Investigator, Outcomes Assessor: The individual who evaluates the outcome(s) of interest, No Masking | String | |
| Study_Design_Masking_Description | Provide information about other parties who may be masked in the clinical trial, if any. | String | |
| Interventions | Specify the intervention(s) associated with each arm or group; at least one intervention must be specified for interventional studies. For observational studies, specify the intervention(s)/exposure(s) of interest, if any. If the same intervention is associated with more than one arm or group, provide the information once and use the Arm or Group/Intervention Cross-Reference to associate it with more than one arm or group. | String | |
| Interventions_MESH | Keywords that identify the interventions associated with each arm or group. | String | |
| Conditions_MESH | The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus. | String | |
| Number_of_Arms | The number of arms in the clinical trial. For a trial with multiple periods or phases that have different numbers of arms, the maximum number of arms during all periods or phases. Note: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. | Integer | Level: Nominal |
| Arm_Group_Information | A description of each arm of the clinical trial that indicates its role in the clinical trial; provides an informative title; and, if necessary, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. | String | |
| Number_of_Groups | Number of study groups/cohorts. Enter "1" for a single-group study. Many observational studies have one group/cohort; case-control studies typically have two. | Integer | Level: Nominal |
| Participants_Enrolled | The estimated total number of participants to be enrolled (target number) or the actual total number of participants that are enrolled in the clinical study. Note: "Enrolled" means a participant’s, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for a study, but do not participate in the study, are not considered enrolled unless otherwise specified by the protocol. | Integer | Level: Nominal |
| Eligibility_Study_Population_Description | A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town). | String | |
| Eligibility_Sampling_Method | Indicate the method used for the sampling approach and explain in the Detailed Description. | String | Values: Probability Sample, Non-Probability Sample |
| Eligibility_Criteria | A limited list of criteria for the selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. | String | Maximum Length: 15000 |
| Eligibility_Gender | The sex of the participants eligible to participate in the clinical study. | String | Values: Male, Female, All |
| Is_Eligibility_Gender_Based | The sex and, if applicable, gender of the participants eligible to participate in the clinical study. | Boolean | |
| Eligibility_Gender_Description | If eligibility is based on gender, provide descriptive information about Gender criteria. | String | Maximum Length:1000 |
| Eligibility_Minimum_Age | The numerical value, if any, for the minimum age a potential participant must meet to be eligible for the clinical study. | String | |
| Eligibility_Maximum_Age | The numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study. | String | |
| Is_Healthy_Volunteer_Accepted | Indication that participants who do not have a disease or condition, or related conditions or symptoms, under study in the clinical study are permitted to participate in the clinical study. | Boolean | |
| Is_Expanded_Access | An investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol. | Boolean | |
| Expanded_Access_Info | This field is used to describe new protocol flags that only appear on records with study type, "Expanded Access" | String | |
| Patient_Data_Sharing | Specifies if the study will shade patient data and if so under what conditions. | String | |
| Location_Facilities | For each participating facility in a clinical study, the following information: Facility Name: Full name of the organization where the clinical study is being conducted. City State/Province: Required for U.S. locations (including territories of the United States) ZIP/Postal Code: Required for U.S. locations (including territories of the United States) Country | String | |
| Location_Countries | The list of countries where the study is conducted. | String | |
| Removed_Countries | The list of countries removed from the study. | String | |
| Responsible_Party | The contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Administrative information to identify and enable communication with the responsible party by telephone, email, and regular mail or delivery service. Responsible Party Contact Information is for the individual who is the responsible party or of a designated employee of the organization that is the responsible party. (Will not be made public - for administrative purposes only.) | String | |
| Overall_Official | Person(s) responsible for the overall scientific leadership of the protocol, including study principal investigator. Include the following information: First Name, Middle Initial, Last Name, Degree, Organizational Affiliation: Full name of the official's organization. If none, specify Unaffiliated. Official's Role: Position or function of the official. Select one of: Study Chair, Study Director, Study Principal Investigator | String | |
| Source | The source of the data. | String | |
| Results_Participant_Flow_Recruitment_Details | Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and types of location (For example, medical clinic), to provide context. | String | |
| Results_Participant_Flow_Pre_Assignment_Details | Description of significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to an arm or group, if any. For example, an explanation of why enrolled participants were excluded from the study before assignment to arms or groups. | String | |
| Results_Participant_Flow_Group_List | Arms or groups for describing the flow of participants through the clinical study. In general, it must include each arm to which participants were assigned. | String | |
| Results_Participant_Flow_Period_List | Discrete stages of a clinical study during which numbers of participants at specific significant events or points of time are reported. There is no limit to the number of periods that may be used to describe a single study. Each subsequent period represents a study stage following the previous period. That is participants "flow" from earlier to later periods. | String | |
| Results_Baseline_Population | If the Overall Number of Baseline Participants (or units) differs from the number of participants (or units) assigned to the arm or comparison group and overall, a brief description of the reason(s) for the difference such as how the analysis population was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. | String | |
| Results_Baseline_Analyzed_List | The statistical analysis section is a table associated with an Outcome Measure. It summarizes the results of any scientifically appropriate tests of statistical significance or other parameters estimated from the Outcome Measure data. If a statistical analysis is provided, it must include either a P-Value[] or an Estimation Parameter[]. You may include as many statistical analyses as is necessary to accommodate all data calculations. | String | |
| Results_Baseline_Group_List | Arms or groups for describing the flow of participants through the clinical study. In general, it must include each arm to which participants were assigned. | String | |
| Results_Baseline_Measure_List | A description of each outcome measure. | String | |
| Results_Outcomes | Detailed description of the outcomes observed during the clinical study. These are the actual outcomes while Primary and Secondary outcomes are the ones anticipated at the beginning of the study. | String | |
| Results_Reported_Events_Time_Frame | The specific period of time over which adverse event data were collected. | String | |
| Results_Reported_Events_Group_List | Arms or groups for describing the flow of participants through the clinical study. In general, it must include each arm to which participants were assigned. | String | |
| Results_Reported_Events_Serious | A table of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study. | String | |
| Results_Reported_Events_Others | A table of anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold (for example, 5 %) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study. | String | |
| Results_Agreements | The existence of agreements that restricts the results publication or discussion at a scientific meeting or any other public or private forum. Information indicating whether there exists an agreement between the sponsor or its agent and the principal investigators (unless the sponsor is an employer of the principal investigators) that restricts in any manner the ability of the principal investigators (PIs), after the completion of the study, to discuss the results of the study at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the study. This does not include an agreement solely to comply with applicable provisions of law protecting the privacy of participants. | String | |
| Results_Limitations_and_Caveats | Describe the significant limitations of the study. Such limitations may include not reaching the target number of participants needed to achieve target power and statistically reliable results or technical problems with measurements leading to unreliable or uninterpretable data. | String | Maximum Length: 500 |
| Results_Point_of_Contact | Point of contact for scientific information about the clinical study results information. | String | |
| First_Received_Results_Disposition_Date | Date when a sponsor indicates that they will be delaying the posting of results (and are certifying initial approval or new use), or when they apply for an extension of the deadline. | Date |
Data Engineering Overview
We deliver high-quality data
- Each dataset goes through 3 levels of quality review
- 2 Manual reviews are done by domain experts
- Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
- Data is normalized into one unified type system
- All dates, unites, codes, currencies look the same
- All null values are normalized to the same value
- All dataset and field names are SQL and Hive compliant
- Data and Metadata
- Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
- Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
- Data Updates
- Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted
Our data is curated and enriched by domain experts
Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:
- Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
- Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
- Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
- The data is always kept up to date – even when the source requires manual effort to get updates
- Support for data subscribers is provided directly by the domain experts who curated the data sets
- Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.
Need Help?
- If you have questions about our products, contact us at info@johnsnowlabs.com .
About Us
John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.
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