Software Can Help Manage Clinical Trials

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

An MD&DI April 1997 Column HELP DESK

Data management may well be the most challenging aspect of planning and sponsoring clinical trials of medical devices. Fortunately, there is a wealth of software available for seemingly every data-management need. By the same token, explains Nancy Stark, president of the Clinical Design Group in Chicago, choosing from among the software options can be correspondingly complicated.

What software applications are available for monitoring and reporting clinical trials?

This is a very broad question with a variety of potential answers, depending on the specific needs of the individual. To give the broadest possible answer, I've listed below all the relevant software programs I'm aware of, grouping them into common application categories and listing vendors for each. Many of these products offer features useful in more than one category; therefore, some programs are listed more than once.

Project management: Software for planning timelines, creating Gantt charts, and estimating human resource requirements for clinical trials and related projects.

Budget preparation: Software to estimate the cost of conducting a clinical trial.

Case reports: Software to help design case report forms.

Study management for sponsors: Software to track the progress of a clinical trial, including, for instance, patient enrollment to date, the progress of each patient throughout the study, and adverse event analyses.

Study management for investigators: Software to track such progress points as the names of potential subjects screened, reasons for rejection, payments received, and reports written.

Electronic data capture: Software to transmit data electronically from the investigational site to the sponsor's offices.

Data entry (with data trails): Front-end applications for entering data into a database.

Database engines or servers: Applications to store and manage data; many database engines are bundled with data entry tools, query tools, and reporting tools.

Query systems/data retrieval/data views: Independently sold applications designed to let users select specific subsets of data for analysis. These applications work with most of the commonly used database engines.

Statistical analysis: Software packages that can perform a variety of statistical analyses on data collected in a clinical trial.

Reporting: Independently sold applications that generate off-the-shelf reports of data. These applications work with most of the commonly used database engines.

Document management: Software designed to collate reports generated in many different applications (such as reporting tools, word processors, spreadsheets, and scanned documents), then paginate, apply common headers and footers, and insert tables of contents. These applications are designed for creating submissions, but can also be used to manage any family of documents, such as a library of case report forms.

Patient Databases: A compilation of complete medical histories of patients; useful for establishing subject selection criteria, determining common concomitant diseases, typical complications, and typical treatment plans.

Given the large number and diversity of software programs relevant to clinical trials, readers will be well advised to determine their exact needs before they begin investigating the software options. Otherwise, they will run the risk of quickly becoming entangled in this range of choices and lose sight of the problem they were originally trying to solve.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.

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