July 1, 2009 (Vol. 29, No. 13)

Best Practices and Technology Help Ensure Compliance and Minimize Disruption

New and evolving laws, mandates, and guidance from regulatory bodies and international health organizations necessitate that all companies performing clinical trials provide increased transparency. They must do this through specific disclosure processes detailing their clinical trial procedures, results, and, soon, adverse events in publicly available databases.

While world health officials and national regulatory authorities hope these global registries help inform the public about the nature and outcomes of the trials and allay public fears about the clinical trial process and patient safety, many biotechnology companies are scrambling to fully understand and comply with these requirements.

To satisfy existing and upcoming disclosure mandates while avoiding costly penalties and the potential negative impact on their brand image, clinical trial sponsors must take stock of their existing business processes to ensure that effective and compliant communication of specific data is available in the public domain. They must be compliant with all guidelines pertaining to information disclosure and timelines.

Best practices and technology can have a huge impact when it comes to addressing these challenges. This article provides suggestions on how to use optimized processes and technology to facilitate compliance and meet the requirements for clinical trial disclosure.

Automate workflow to simplify compliance. Manual processes are vulnerable to errors and discrepancies and often make it harder to track history and gain visibility into whether or not a submission is compliant. A two-step process can help achieve an automated workflow.

Step 1. Look for an easy-to-use content management environment that has regulatory guidelines built in. It should include an XML-based submissions protocol to mimic postings on industry disclosure database websites. Make sure that the clinical trial disclosure (CTD) system is designed to manage the entire lifecycle of the clinical trial disclosure process—from internal review, approval, and external posting to comparing, reconciling, and maintaining regulatory documents going forward. It should be configurable to automatically track milestones and notify stakeholders and content contributors when a form has moved to the next stage in the workflow and/or requires an action from them (Figure).

Step 2. During this phase, the CTD system is integrated with the user’s existing information systems (e.g., clinical trial management systems), automating workflow and minimizing manual data entry for a highly automated clinical trials disclosure process.

Eliminate bottlenecks and optimize form submission with collaborative authoring. Traditionally, CTD form submission procedures have not been conducive to multiple authors and reviewers. A significant amount of effort and time is wasted throughout the process as contributors wait to be e-mailed their section to add content or review. Then, once that process is completed, the content and feedback must be compiled.

The ideal CTD system features collaborative authoring capabilities with role-based access control. This enables authors and reviewers to work on a document simultaneously, reducing cycle time. Reviewers can add comments for authors to complete or format fields in a particular way and use automatic notifications to alert others when sections are ready for approval or editing. The CTD system should automatically facilitate version control, tracking all changes so there’s no risk of overwriting another’s work accidentally. In addition, the system should retain every detail of revision history in the event of a future change or audit.

Reuse and repurpose form data to satisfy global requirements. Many CTD systems are designed specifically for compliance with U.S. regulations and clinicaltrials.gov submissions. Disclosing clinical trial data in other parts of the world should not require the wheel to be reinvented each time to ensure compliance with unique standards and requirements. Look for a CTD system with global capabilities built into the software architecture to optimize the content that is already in the system.

Enable easy adaptation to evolving regulations. As clinical trial disclosure standards evolve, the information required for submission is likely to change. For example, fields may be removed or added; fields that were once designated as optional may become mandatory. It is critical that an organization be able to adapt its submissions to adhere to emerging regulations.

Seek out a CTD-system solution based on FDA and other global requirements and designed to absorb and validate changes as quickly as possible. Moreover, select a solution that does not require a development and test effort every time a change to a form is made. The CTD system should allow the user to rapidly add new form fields or modify existing ones. If the CTD system is used as a software-as-a-service (SaaS), the form change is made automatically. In addition, look for a CTD system that meets 21 CFR Part 11 requirements and provides validation with a built-in audit trail, security, and authentication.

Today, commercial CTD systems are available in two models: 1) perpetual software that is installed and operated in-house, and 2) SaaS, where the software is provided in a licensed format, eliminating the costs associated with software purchase and ongoing maintenance. Smaller organizations without large in-house data collection systems may find that a CTD system with vendor-hosted SaaS is an appropriate model. For larger companies that need to integrate the CTD system with existing in-house systems, purchasing the software may make more sense.

Finding a CTD system solution provider that supports both models and will work with the user to implement a phased approach with a view toward gradually integrating each data source with the CTD system is an important criterion in vendor selection.

Facilitate User Adoption. The right CTD system allows the user to optimize resources to complete submissions and features a familiar intuitive interface that doesn’t require a change in behavior on the user’s part. Look for a Microsoft Office®-like authoring environment with the rules built into the solution. For example, a system with built-in intelligence will prevent the user from creating content that is in conflict with the rules. Toolbars should be modifiable to allow only the format conventions permitted by the FDA or other regulatory body for that particular part of a submission.

Following these guidelines allows companies to take greater control of the CTD lifecycle and be able to:

  • Streamline disclosure planning, preparation, and tracking
  • Lower the risk of missed deadlines, incomplete submissions, and costly penalties
  • Validate disclosure information to ensure data integrity

The optimal CTD system enables the user to predictably prepare quality, consistent clinical trial disclosure submissions that meet the disparate regulatory requirements throughout the world, ensuring true clinical trial transparency. The right CTD system will accelerate the path to compliance and transform the current business process with a quantifiable return on investment.

Satish Tadikonda ([email protected]) is founder and president of Virtify. Web: www.virtify.com.

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