Clinical Trials

An analytical tool that helps identify competitive intelligence related to clinical trials.  Its interactive and intuitive interface assists users in viewing information on clinical trials from a global summary level all the way to an individual study level.

SEARCH

• All Fields: The 'All Fields' search queries all sections of clinical trial records except for inclusion and exclusion criteria (eligibility criteria).  The entity specific vocabularies are also searched for the extraction (from the title of the trial and entity specific field), normalization and synonym expansion.  This search behavior is designed for broad coverage without sacrificing the relevance of results.  Eligibility criteria are excluded from search because of the inaccurate and overly broad results that are returned when these sections are queried.  For example, many times exclusion criteria mention a long list of diseases that are not the focus of the study. 

• Condition: This entity specific search field queries the 'Condition' and 'Title' fields of the trial record.  Condition refers to a disease, disorder, syndrome, health risk, life span, quality of life, illness, or injuries. The search on a broader term includes narrower and related terms including synonyms based on the MeSH hierarchy.  As an example, search on Prostatic Neoplasm will include  Prostate Cancer.

• Intervention: This entity specific search field queries the 'Intervention' field and 'Title' field of the trial record. Intervention refers to drugs, biologics, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. that is the focus of a clinical study.

• Sponsor: This entity specific search field queries the 'Sponsor' and 'Collaborator' fields of the trial record. Sponsor refers to the responsible representative of the trial who oversees the implementation of a clinical study and analysis of the study data.

  • MOA: The Mechanism of Action (MOA) refers to the specific biochemical interaction through which a drug (Intervention) substance produces its pharmacological effect.  The mechanism of action usually mention the specific molecular targets to which the drug binds, such as receptors, enzymes, etc. This entity specific search field queries the 'Title' , 'Intervention' and 'Description' fields of the trial record. The search results are also based upon the Drug and Target relationship established in the CRN Mechanism of Action Vocabulary.  

  • Target: A target is a molecular structure that will undergo a specific interaction with drugs. This entity specific search field queries the 'Title' , 'Intervention' and 'Description' fields of the trial record. The search results are also based upon the Drug and Target relationship established in the CRN Mechanism of Action Vocabulary.

• Include Synonyms: A synonym term could be a word/phrase that means similar to its preferred term. When 'Include synonyms' (the default) is selected, the synonym expansion behavior from thesaurus gets activated. The system will process the search term against all its synonyms and displays the preferred term in the application. Deselection of the 'Include Synonyms' option will query only the search term and displays its preferred term in the application.

Entity specific searches for Condition, Intervention, Sponsor, MOA and Target fields include auto-suggest option via a drop-down list to assist users in making term selection. Please note that the drop-down list includes only those terms that occur in documents in the current data sources. A synonym term will include its preferred term in parenthesis in the drop-down list. As an example, Velcade will appear as Velcade (Bortezomib) in the drop-down list.

RESULTS

Results of the search are presented in two tabs: Overview (chart/facet panel view) and Trials view.

The Overview is a summary view of the search results and contains a selection of interactive charts and facet panels.

• Conditions: The 'Conditions' panel lists the preferred condition terminology based on the relevant trial records retrieved by the search query.  Due to the exploding capability, the retrieved results contain the MeSH heading as well as all of its narrower and more specific terms.  Corresponding to each condition, a count of trials retrieved is displayed.  Next to the trial count is provided a link to the condition profile page.  MeSH thesaurus (latest version) from the National Library of Medicine is being used for normalization, synonym expansion and hierarchical structure of condition names. The application uses only the following MeSH descriptors: Diseases [C], Mental Disorders [F03] and Supplemental Concept Records [T047: Disease & Syndrome].

• Interventions: The 'Interventions' panel lists all the drug names from trial records retrieved by the search query.  Corresponding to each intervention, a count of trials retrieved is displayed.  Interventions extraction is primarily limited to drugs of both chemical and biological type.  Next to the trial count is provided a link to the intervention profile page.  The CRN intervention vocabulary and ChemIDPlus vocabulary (from the National Library of Medicine) are being used for normalization and synonym expansion of drugs names.

• Sponsors: The 'Sponsors' panel lists all the sponsors and collaborators along with relevant trial counts. The count under the Lead column indicates the number of trials where the sponsor is a lead entity. The count under Collaborator column indicates the number of trials where the organization/person is functioning as the collaborator. The Total column provides the sum of trials where the sponsor is the lead and/or the collaborator. Next to the sum of trials count is provided a link to the organization profile page.  The CRN organization vocabulary is being used for normalization and synonym expansion of the sponsor and collaborator names.

• Mechanism of Action: The 'Mechanism of Action' panel lists all the mechanisms of action along with relevant trial counts. The CRN Mechanism of Action vocabulary is being used for normalization and synonym expansion of the MOAs.

• Targets: User can flip the 'Mechanism of Action' panel to view the Target Panel. The 'Targets' panel lists all the targets along with the relevant trial count. The IUPHAR vocabulary is being used for normalization and synonym expansion of Target.

  • Country: The 'Country' panel displays a world map based on the number of trials conducted at various sites in each country. A clinical study may be conducted at multiple sites in one country and/or may be conducted in multiple countries. A trial record specifies the country location of the study being conducted or otherwise the information is extracted from the Health Authority field of the trial.  The clinical trial site information at the state level can also be explored, if United States is the selected country location.  Selecting United States as the country filter will display the United Stated map with state level information data points.  Rolling the mouse over these data points will indicate the name of the state along with the number of trials being conducted in that state. The Details view link at the top right of the panel provides a tabular view of the clinical trial location information and Map View link toggles it back to the map.

  • Phase Chart: Based on the study characteristics, such as the objective, and number of participants, a clinical study is categorized into phase 0, 1, 2, 3 or 4. This panel presents different phases of trials (in addition to trials where phase is not specified) from the trial records retrieved by the search query in a bar chart format. In the 'Phase Chart', the trials are grouped based on the start date of the trial and distributed over the past 10 years. Trials listed in more than one phase (e.g. Phase 1/2) will be counted in both appropriate phases.

All the above described panels have interactive filtering capability.  Thus facet/chart panel allows users to further explore and refine the query by inclusion & /exclusion* of meta data from these panels.  Clicking left mouse button on one of the data values in a facet panel returns a subset of the results that match your query and contain the selected data value.  The selected data value in a facet panel gets highlighted in Green.  Clicking right  mouse button on one of the data value in a facet panel returns a subset of the results that match your query excluding the selected data value.  The excluded data value in a facet panel gets highlighted in Red.  Multiple rows can be selected by holding down the Control key while clicking on the data values within the facet.  Boolean logic can be added to the interactive filtering capability by selecting AND or OR from the top right of the respective panel view.  Selected data values for inclusion and exclusion appear as breadcrumbs and can be individually removed from the breadcrumb panel.  Multiple selections within a facet panel can be removed by clicking the filter icon.

Timeline: The Timeline chart view is a graphical overview about the sponsors trials data in time.  The time scale is in years and can be zoomed in or out using the wheel of the mouse.  The bar represents the clinical trials for the sponsors aggregated in chronological order based on their start and completion date of the clinical trials.  Other interactive fields to further slice and dice the data are: Trial Phase and Recruitment Status of the study.  The timeline chart view is helpful in visualizing and comparing the timespan for the sponsors trials.  

Exporting Data

Results of a search can be exported to a spreadsheet for offline analysis. The number of exported records is limited to 5,000.

The first worksheet in the export contains the search criteria that were used to generate the result set as well as the date and time the search was performed.

The second worksheet displays the clinical trials with all available fields for each trial that is exported. Default columns exported are: ID, Title, Recruitment Status, Enrollment, Lead Sponsors, Trial Phase, Conditions, Interventions, Principal Investigators, Study Results, Relevant News Releases, and Relevant Publications.  The user can select/remove the columns (except Trial ID) using the Columns menu in the table view in order to customize the Excel export.

Preview of the selected columns can be done under the trial tab as the Columns settings are applicable to both the table view and the exported spreadsheet. Columns that are not selected for display can still be viewed in the spreadsheet by performing an unhide function at the one before the last column.

The third worksheet summarizes the results by conditions, interventions, sponsors and country locations.