Clinical Trial Disclosure

Dr. Satish Tadikonda, Virtify

Recent and evolving laws, mandates and guidance by regulatory bodies and international health organizations necessitate that medical device companies disclose greater amounts of clinical trial information. The goal is to achieve more transparency through the disclosure of clinical trial results and adverse events in publicly available databases.

As a range of new medical devices is being developed, the focus on transparency and public trust has only intensified. But while global registries are certainly an effective way to address public fears and patient safety, many medical device companies are struggling to fully understand and comply with these new disclosure requirements, specifically:

• What impact will these new requirements have on current clinical trial processes, systems and infrastructure?

• What are the recommended best practices for complying with these requirements?

• How does a company optimize its clinical trials disclosure solution as an integral part of an enterprise-wide structured content management strategy?

• How do firms streamline current processes to more effectively comply with today’s clinical trial disclosure mandates and future directives?

To satisfy new and existing disclosure mandates, avoid costly penalties and the potential negative impacts to their brand image, medical device sponsors must take stock of their existing business processes and technology systems to ensure effective communication of specific data to the public domain—compliant with all guidelines pertaining to information disclosure and timelines.

Best practices as well as new, domain-specific technologies can have a huge impact when it comes to addressing these challenges. Below are suggestions on how to use optimized processes and available technologies to improve the compliance process and meet the requirements for clinical trial disclosure.

Best Practice Overview

If a medical device firm’s current processes are manual, they are vulnerable to errors and discrepancies. They also may lack the ability to easily track history and gain visibility into whether or not a submission is compliant. A two-step process can help companies achieve an automated workflow:

Step 1. Look for an easy-to-use content management environment which has regulatory guidelines built in. It should include an XML-based submissions protocol to mimic postings on industry disclosure database Web sites. Make sure that the clinical trial disclosure system (CTDS) is designed to manage the entire life cycle 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 tracking 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.

Step 2. During this phase, the CTDS is integrated with 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 Forms Submissions Through “Collaborative” Authoring

Traditionally, CTD form submission procedures have not been conducive to multiple authors and reviewers. A significant amount of time and effort 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 needs to be compiled.

The ideal CTDS features collaborative authoring capabilities with role-based access control. This enables authorized authors and reviewers to work on a document simultaneously, greatly reducing review 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 CTDS automatically should 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 CTDS are designed specifically for compliance with U.S. regulations and ClinicalTrials.gov submissions. Posting clinical trial data to international registries should not require the reinvention of the wheel every time to ensure compliance with unique standards and requirements. Look for a CTDS with global capabilities built into the software architecture to optimize the content that is already in your system.

Enable Easy Adaptationto 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 organizations be able to adapt their submissions to adhere to emerging regulations.

Seek out a CTDS that is 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 needed. The CTDS should allow you to rapidly add new form fields or modify existing ones. If the CTDS is used as a software-as-a-service (SaaS), the form change is made automatically without requiring action on your part. In addition, look for a CTDS that meets 21 CFR Part 11 requirements and provides validation with a built-in audit trail, security and authentication.

Software as a Service vs. Traditional Software Licensing

Today, commercial CTDS are available in two models: 1) perpetual licensed software, which is installed and operated in-house and 2) SaaS, where the software is delivered and paid on a monthly basis, eliminating the costs associated with software purchase, implementation, and ongoing maintenance.

If the company is a smaller organization without large in-house data collection systems, CTDS vendor-hosted SaaS is an appropriate model. But as needs grow, or if a larger company needs to integrate the CTDS with existing in-house systems, purchasing the software may make more sense.

Finding a CTDS provider that supports both models and will work with companies to implement a phased approach with a view toward gradually integrating all data sources with the CTDS is an important criteria in vendor selection.

Built for Business Users

The right CTDS allows you to optimize resources to complete submissions and should offer a familiar easy-to-use interface that doesn’t require a change in behavior on the part of your users. Look for a Microsoft Office-like authoring environment with integrated business rules. For example, a system with built-in intelligence will prevent users from creating content that is in conflict with specific submission or registry requirements.

Following the Right Steps

By following these guidelines and evaluating a solution based on these simple requirements, a firm can take greater control of the clinical trial disclosure life cycle and be able to:

• Streamline disclosure planning, preparation and tracking

• Lower the risk of missed deadlines, incomplete submissions and costly penalties

• Validate your disclosure information to ensure data integrity

The optimal CTDS enables firms to predictably prepare quality, consistent clinical trial disclosure submissions which meet the numerous regulatory requirements throughout the world, ensuring both compliance and clinical trial transparency. The right CTDS will accelerate the path to compliance and transform your current business process with a quantifiable return on investment.

Dr. Satish Tadikonda is the founder and president of Virtify Inc. (www.virtify.com) a provider of enterprise content compliance software solutions for life sciences companies. With more than 20 years of experience in the life sciences industry, Tadikonda’s expertise spans drug and medical device development, and commercial software development for optimizing eSubmissions, global labeling, clinical trial disclosure, medical imaging, and product life cycle management. He is an active participant in a variety of standards committees and has played a leadership role in the development of a number of global regulatory standards. He can be reached at [email protected].

Clinical Trial Issues Unique to Medical Devices

• Iterative development cycles for medical devicesusually require higher frequency of clinical trials

• Medical devices usually require smaller clinical trial samples due to more rigorous testing

• Devices yield local impact versus systemic impact of drugs

• Mechanical versus chemical function

• More predictable outcomes based on rigorous, physical testing