In the realm of clinical trials, transparency is not just a buzzword but a fundamental principle guiding the advancement of medical science. However, amidst the push for transparency across regulators such as Health Canada, the FDA and EMA, one significant challenge looms large: handling company confidential information (known also as confidential business information (CBI) when referring to Health Canada).
What exactly constitutes company confidential information in the context of clinical trials, why is it so challenging to manage, and what potential solutions exist to strike a balance between transparency and protecting sensitive data?
Defining Company Confidential Information
Before delving into the complexities, it's crucial to establish what falls under the umbrella of company confidential information in clinical trials. Simply put, it encompasses proprietary data that clinical trial sponsors consider integral to maintaining a competitive edge. This could include:
- Intellectual Property: Details of proprietary technologies, formulations, or processes integral to drug development.
- Financial Information: Data pertaining to budgets, expenditures, and revenue projections.
- Clinical Data: Preliminary findings that are yet to be disclosed to regulatory bodies or the public.
- Trade Secrets: Any information giving a company a competitive advantage and not publicly known.
- Commercial Strategies: Marketing plans, distribution channels, or pricing strategies crucial for market positioning.
For further clarification, EMA defines CCI as:
“...any information contained in the clinical trial information submitted to the CTIS which is not in the public domain, or publicly available, and where disclosure may undermine the legitimate economic interest or competitive position of the owner of the information”.
Examples of What is NOT Considered Confidential Information:
- Information already in the public domain including sponsor website, registries, FDA, and / or scientific literature
- General information such as unit of measure where the value may be CCI but the measure is not e.g.; 3.2mL →
mL
- Countries where the study was conducted
The Tightrope Walk: Why It's Challenging
Balancing the imperative of transparency with the need to protect company confidential information is akin to walking a tightrope. Several factors contribute to the complexity of this task:
- Regulatory Compliance: Regulatory bodies like Health Canada, FDA and EMA advocate for increased transparency in clinical trials. However, they also recognize the importance of safeguarding proprietary information.
- Competitive Edge: Trial Sponsors invest billions in research and development. Disclosing sensitive data prematurely could undercut their competitive advantage and impede innovation.
- Legal Ramifications: Unauthorized disclosure of confidential information could lead to legal repercussions, including breaches of contract or intellectual property disputes.
- Data Security Concerns: With the rise in cyber threats, ensuring the security of sensitive data presents a formidable challenge.
- Public Trust: Striking a balance between transparency and confidentiality is crucial for maintaining public trust. Overemphasis on secrecy can breed skepticism, while excessive transparency may compromise commercial interests.
Charting a Course: Potential Solutions
While navigating the labyrinth of confidentiality in clinical trials may seem daunting, several strategies can help reconcile competing interests:
- Clear Guidelines: Establishing clear guidelines delineating what constitutes confidential information and how it should be handled fosters transparency while mitigating risks.
- Transparency Protocols: Implementing robust transparency protocols ensures that only non-confidential data is disclosed to the public, protecting sensitive information.
- Anonymization Techniques: Employing anonymization techniques such as risk-based anonymization of patient data allows for the release of trial results without compromising confidentiality.
- Secure Data Infrastructure: Investing in secure data infrastructure fortified with encryption, access controls, and regular audits bolsters protection against unauthorized access.
- Collaborative Approach: Encouraging collaboration between internal stakeholders, partners and vendors, and advocacy groups facilitates dialogue on transparency standards while addressing concerns about confidentiality.
Practical CCI Strategies & Considerations
Things to Know
- Before you redact, Sponsors should be aware of the information already available in the public domain for their product’s development
- The extent of the redaction should be limited only to the word(s), figure(s) and pieces of text that can be considered CCI
- For CTR projects, EMA has indicated you may indicate CCI in non-public version documents for purposes of Member State awareness (e.g.; highlight or apply a red box around the perimeter of CCI text)
- For EMA Policy 0070 projects, preparing a robust justification for your CCI redactions is critical to avoid unnecessary rejections. While justifications are not required for CTR public version documents, we recommend you create an internal justification log and store it in case it is needed in response to an Request for Information (RFI).
Limiting Company Confidential Information
- Limit unnecessary sharing of confidential information during the authoring process; often referred to as “minimization”
- Involve Real Life Sciences who retains relevant and practical experience with scientific and technical skills in the CCI identification process
- Follow a consistent decision-making process and tag references to CCI during authoring
A Suggested Three Step Process for Handling CCI
- Rule out information in the public domain
- Confirm the information is innovative and could undermine the economic interest of the business
- As an exception, determine if the information is not deemed to be innovative but could still undermine the economic interest or competitive position of the business
Use Technology to Streamline your CCI Identification and Redaction Process
A purpose built enterprise-ready system, such as RLS Protect, is designed to support your clinical document redaction process from end-to-end. Example capabilities include, but are not limited to
Efficiency and Quality
- Single system to track the work tasks and redact the documents
- Automated searching for key entities (e.g.; dates, IDs, names, email addresses, CCI, BMI, Race, Gender…)
- Customized and configured document and project specific searching. Ability to re-use saved searches across projects and documents
- Capture CCI decisions to apply to future documents
- Share visibility to project and document status
- Version control
- Redaction reporting per document
- Review, comment and revision
Collaboration & Visibility
- Alerting and notification
- Task assignment to individual user(s)
- Commenting
- CCI justifications
- Review and approval workflow
Security
- Permissions and roles
- Auditing
- Data encryption
- Sanitize (removal of all document metadata)
Conclusion
In the quest for transparency in clinical trials, navigating the labyrinth of company confidential information is a formidable challenge. Yet, by adopting a balanced approach that safeguards sensitive data while promoting openness, stakeholders can forge a path toward greater transparency without compromising innovation or commercial interests. As the landscape evolves, maintaining a nuanced understanding of confidentiality will be paramount in unlocking the secrets to advancing medical science for the benefit of all.
