Successfully mining the archive at ClinicalTrials.gov provides a cornucopia of business intelligence, logistical planning, and scientific insight useful for a wide range of users including industry and government planners, research investigators, clinical trial professionals, business developers, and financial analysts. However, wrangling the data to get at the insights is a challenge. Recognizing this, commercial information services curate the content and package it nicely. These solutions are compelling, but are not always flexible to answer unanticipated questions. Furthermore, license restrictions can sometimes make it difficult to share findings. Responding to this we created TrialIO, an easy to use web application to simplify mining, monitoring, reporting, and sharing key findings found at the ClinicalTrials.gov archive.
The Gold Standard for Generating Evidence To Support New Therapies and Devices
Clinical trials are the way pharma/biotech firms generate evidence to support new drug approvals and product introductions. The government requires trials requesting FDA approval be registered at ClinicalTrials.gov, ostensibly to help patients and referring physicians find trials they can apply to. Research investigators use the site to plan new trials. Looking at trial history for a given disease or indication, investigators can learn what worked for their predecessors and avoid the same mistakes.
The new NIH policy, and the Final Rule for FDAAA 801 increases the value of a solution for timely and flexible mining the archive at ClinicalTrials.gov.
Clinical Trials Planning
Each clinical trial document contains a wealth of information about that trial. In addition to the disease and intervention, trial documents contain additional information such as the sponsor, collaborators, key dates, sites locations, investigators, enrollment goals, study protocol details, secondary indications, eligibility criteria, and much more. The opportunity is to collate this data in aggregate, allow it to be sliced and diced, and analyzed and graphed over time to help trial planners communicate and plan successful trials.
Working with ClinicalTrials.gov Data
The public facing web site ClinicalTrials.gov gets more than 179 million visitors per month and helps more than 60,000 daily visitors find trials relevant to them. The site is made for patients, not trial planners and so provides only nominal aggregate statistics of disease studies by country. To go farther, clever trial planners use the site download facility to plot the data in Excel to generate reports and graphs. Data wrangling is cumbersome, and not efficient use of time for most decision makers or even decision support personnel.
Aggregate Analysis of Clinical Trials
Sensing the inherent value of looking at aggregate ClinicalTrials.gov data, the Clinical Trials Transformation Initiative publishes the Aggregate Analysis of Clinical Trials AACT as a series of relational database files, text files, or pre-formatted analytics files. However, putting the information to use is beyond the reach of most clinical trial professionals, requiring considerable computer systems and software skills. Thus, the AACT is a solution for firms with bigger IT staffs, and for information service businesses who curate, re-package, and add value to the presentation of this data.
Uses of ClinicalTrials.gov
Despite advances in technology and social media, patient recruitment remains one of the biggest reasons trials are delayed or over budget. One way to address this is help sponsors do a better job of picking sites for their trials. Using TrialIO, users can easily explore the "long tail" of clinical trial site sponsors and investigators. By identifying sites for which there is less competition for patients, recruitment may become more successful. In other words, sites that are lesser well known may have an easier time recruiting patients, as the competition is less at that site. If site planners can easily get this information, then they can use it.
Other ways to help patient recruitment is to help trial planners design protocols. An overly complicated study design often limits access to patients. Helping planners develop a protocol based on prior successful trials and can help planners design protocols and choose sites that are likely to succeed.
Technology succeeds when it allows users to use their knowledge to make discoveries in the data. In support of this idea, TrialIO provides an iterative user experience. Results of any search are the basis of launching the next question.
The Big Picture
Aggregate analysis of clinical trial data helps understand the priorities of a country, a sponsor, an institution, and an individual. When one understands another's priorities, communication is enhanced and decision making is improved.
A Web Experience
TrialIO is packaged in a secure, easy to use web application. Results respond to mobile device and web browser screen sizes. Because its a web app, users can easily bookmark and share reports. And, since the underlying data is refreshed nightly, reports react to the new information automatically saving time and drudge labor.
An Application Programming Interface (API)
Application developers can use the lifescience.io API to create new apps and new use cases. Picklists, aggregate analysis, and trial source documents are accessible via programming interface.
TrialIO Platform Opportunity
TrialIO is an application and an Application Programming Interface (API) we created.
The application is secure and can be accessed from any connected internet device. The powerful API behind TrialIO can be used by developers to create custom applications using aggregate and individual clinical trial records.
We are readying the TrialIO platform and are eager to engage users to who would value having a voice in the feature set of this powerful platform. If you are interested in learning more, please reach me directly at email@example.com or register for the public beta here.