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Spectrum: Autism Research News

News The latest developments in autism research.

Autism Drug Trial Tracker: User Guide

by  /  12 January 2022

Spectrum’s Autism Drug Trial Tracker provides interactive, curated information about hundreds of clinical trials for autism and related conditions. For details about how we filtered our data, please read the article announcing the tracker. For information on how to use the tracker, see below.

Which trials are included in the drug trial tracker?

The Autism Drug Trial Tracker includes clinical trials from the ClinicalTrials.gov database, which was launched in September 2008. Our tracker includes placebo-controlled trials that are Phase 2 and higher, mainly because Phase 1 trials can vary greatly in their designs. Some drugs have been tested in combined Phase 1/2 trials, which our tracker similarly excludes. We also excluded trials based solely on behavioral interventions.

We worked with clinicians and researchers, some of whom have designed and performed their own clinical trials for people with autism, to choose our data inclusion criteria.

For each clinical trial, we also manually curated information that is not available from ClinicalTrials.gov. For instance, we independently determined whether each drug was previously approved by the U.S. Food and Drug Administration (FDA) for a different condition, and identified trials with a ‘combined modality,’ meaning that they combined multiple drugs in one trial or mixed a drug intervention with a behavioral therapy. We also identified peer-reviewed articles for each clinical trial, where available on PubMed, and have written an editorial description for each drug, more than 100 of which are included in the tracker.

The tracker includes trials of therapies for autism and the following related conditions: Angelman syndrome, dup15q syndrome, fragile X syndrome, Phelan-McDermid syndrome, Prader-Willi syndrome, Rett syndrome, Timothy syndrome, tuberous sclerosis complex, Williams syndrome, and 16p duplications and deletions.

How were data collected?

Clinical trials that are placebo-controlled and phase 2 or higher were collected by querying the Clinical Trials API with custom Python scripts. Data were cleaned and filtered using the Python Pandas library. A Python script, executed once monthly, checks for new and updated clinical trials. Drug descriptions were manually written and fact-checked for each drug.

The Python scripts and un-edited datasets are freely available on GitHub. Please see the README file for additional information regarding column names and how to use the scripts in your own work.

How do I filter the data?

The drug trial tracker can be accessed directly through the Spectrum website.

At the top of the tracker, we state when the data were last updated. This refers to the last date on which clinical trial data were updated or added.

The core feature of the drug trial tracker is a table that is scrollable vertically and horizontally. The table contains information for hundreds of clinical trials. For each trial, we provide its NCTId (a unique code, assigned by the FDA for a clinical trial). Click on any NCTId to navigate to the clinical trial’s webpage on ClinicalTrials.gov. By default, data are sorted by text from A to Z based on the “Drugs tested” column. Click on that column’s name to instead sort the data from Z to A. Click on any other column name to similarly sort the data alphabetically.

For detailed descriptions of the column names, consult the NIH Glossary. Additional column descriptions are provided below:

Drugs tested: The drugs that were studied in the trial.

Condition: The condition, such as autism or Rett syndrome, that was treated in the trial.

Previously approved: Indicates whether the tested drug has previously been approved by the FDA for another condition.

Approved conditions: The conditions, if any, the drug has been previously approved for.

Combined modality: Indicates whether the trial tested multiple drugs, or tested a drug in combination with behavioral therapy.

Placebo: Indicates whether the trial was placebo-controlled.

Status: The current known status of the trial, such as ‘Recruiting’ or ‘Completed.’

Drug description: A curated description of the biological mechanism by which the drug is thought to act on the human body, where available, along with additional information from Spectrum articles and other sources. This column offers only an editorial description of perceived drug mechanisms and details from our previous coverage.

Spectrum coverage: A link to a Spectrum article about the clinical trial, where available.

Paper: DOI links to papers, listed on PubMed, based on an input NCTId.

Design allocation: Indicates whether the study participants were randomly assigned to treatment groups (randomized) or not (non-randomized).

Design intervention: The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: crossover, factorial, parallel, sequential and single-group assignment.

Design masking: A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single-blind masking and double-blind masking.

Enrollment count: The number of participants enrolled in the trial.

Gender: The gender of trial participants: male, female or all.

Minimum age: The minimum age of participants in the trial, in years.

Maximum age: The maximum age of participants in the trial, in years.

Lead sponsor: The name of the lead sponsor; typically a company or individual associated with an academic lab.

Sponsor country: The country in which the lead sponsor is headquartered, determined by Google searches.

Start date: When the clinical trial began.

Start date type: Indicates whether the start date is an actual or expected value.

Completion date: When the clinical trial was completed.

Completion date type: Indicates whether the completion date is an actual or expected value.

Results first posted: The date on which results were first posted, if applicable.

Last updated: The last date on which Spectrum updated data on the trial.

Data in the table can be filtered by trial sponsors, whether the drug was previously approved, and other criteria. Simply click on a button to do so. To filter the data by enrollment count, drag the slider. Each filter can be cleared at any time by clicking the ‘Clear Selection’ button.

How do I download the data?

To download the data as a .csv file, click on the button labeled “Download data.csv.” The file size attached to this label automatically updates in real time, based on how much data is present in the filtered table.

Clicking the button will download a .csv file that includes only trials listed in the filtered table, and only those columns provided in the drug trial tracker. A dataset containing all clinical trials — with additional data and columns — is also freely available.

How do I use these charts?

The charts below the table update in real time. They always reflect the filtered data that is present in the table.

Two charts can be customized: a frequency plot, also referred to as a histogram; and a scatter plot. The histogram can be used to plot one column of the filtered data at a time, whereas the scatter plot can be used to compare two variables at a time.

Histogram: This chart has three dropdown menus. The first, called ‘x-axis,’ is used to select the data column to be plotted. The second menu, ‘Number of bins,’ is a slider. Drag the node to increase or decrease the number of bins that are displayed in the chart. The more bins, the higher the level of detail, which is often useful when viewing hundreds of data points. The third menu, ‘Color by…’ is used to color the histogram based on a variety of criteria, such as the condition being treated or the gender of participants in the trial. The figure legend, above each chart, automatically updates to reflect the ‘Color by…’ selection.

Example: To determine the number of trials that have been completed in 2021, select ‘Completion date’ from the x-axis dropdown menu. Then, select ‘Start date type’ from the ‘Color by…’ dropdown menu. Hover over the dark red bar positioned in the year 2021. More than 100 clinical trials were completed in 2021.

Scatter plot: This chart has three dropdown menus. The first, called ‘x-axis,’ selects the data plotted in the horizontal dimension. The second menu, ‘y-axis,’ selects the data plotted in the vertical dimension. The third menu, again, provides options to color the data points based on various criteria.

Example: To determine how long it takes clinical trials to be completed, select ‘Start date’ from the x-axis dropdown menu. Then, select ‘Completion date’ from the y-axis dropdown menu. Finally, select ‘Completion date type’ from the ‘Color by…’ dropdown menu. Dark red dots correspond with trials that have actually been completed. Hover over any dot to see additional information about the trial. One clinical trial (NCT00718341) began in 2009 and wasn’t completed until 2021!

Example: To determine which drugs have been tested for which conditions (such as autism or fragile X syndrome), select ‘Condition’ from the x-axis dropdown menu. Then, select ‘Drugs tested’ from the y-axis dropdown menu. The chart automatically updates; arbaclofen has been tested for both autism and fragile X syndrome, for example, whereas oxytocin has been tested for autism, fragile X syndrome and Phelan-McDermid syndrome.

How can I submit feedback?

Please email [email protected] with any comments, feedback or missed data.