For pharmaceutical and biotechnology companies focusing on research and development, prioritizing data transparency and clinical study reporting (CSR) is a necessity.

On January 16, 2018, commissioner Scott Gottlieb announced the FDA’s initiative to enhance the transparency of clinical trial information in support of innovation and scientific inquiry related to new drugs. The intent of the pilot program is to evaluate whether sharing certain information included in CSRs improves public access to drug approval information. The FDA hypothesizes that enhancing CSR public availability following a drug’s approval will provide relevant parties with “more information on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process.”

In addition to developing its transparency pilot program, the FDA also intends to introduce ClinicalTrials.gov identifier numbers (NCT #s) to facilitate online tracking of clinical research. These numbers allow patients, academics, and scientific communities to more seamlessly follow clinical research from a drug’s development throughout the regulatory process. Ideally, inclusion of this number on FDA materials could improve development and provide rich information for those who are interested.

FDA is striving to create a more open environment that promotes sharing clinical information and gleaning new insights from studies. Pharmaceutical and biotech companies should be proactive in taking measures to assess their readiness for such change. Organizations that invest in data sharing will not only be able to operate within the FDA’s new environment, they may be able to take advantage of strategic patient-facing opportunities.

Adjusting to New Clinical Study Reporting Regulations

Preparing, reviewing, and approving a CSR for public release can present a significant, and somewhat daunting, obstacle. For many R&D organizations, pivoting internally to implement the necessary reporting tools and logistics will be a major burden.

While an emphasis on transparency is unlikely to alter the way clinical trials are executed, it will force companies to generate new processes and systems in anticipation of CSR disclosure.

Depending on the company, such curation of CSRs can involve the redaction of private or confidential information, as well as the anonymization of sensitive patient data.

While companies must evolve to become more transparent, such adjustments are not entirely new in the industry. Strategies and precautionary protocols have already been established in R&D organizations with networks in Europe, where document disclosure has been required since 2015, and General Data Protection Regulation (GDPR) since May 25^th, 2018.

Challenges in Data Security Climate Will Impact R&D

The recent changes to transparency and data sharing regulations have accompanied, to a large degree, the shifts in culture attributed to cybersecurity and the storage of personal data. Most noticeably, the Cambridge Analytica scandal demonstrated the failure of privacy efforts in protecting data within millions of Facebook accounts. In a response to the Cambridge Analytica events, Medical Marketing & Media asserted there is a certain “level of sensitivity when it comes to accessing and using personal health information.” This recent focus on data sharing and cybersecurity only projects to gain importance in the future, and now pharmaceutical and biotech companies are in the hot seat.

Will medical data security affect the willingness of patients to volunteer for clinical trials?

Patients Want Access to their Information

According to Clarkston’s 2018 Pharmaceutical and Life Sciences Trends report, patients are becoming increasingly more engaged with their care. With the ability to feed, clothe, and transport themselves via a few finger taps, modern patients are now demanding the same flexibility and capabilities from their health resources. Clinical trial patients want to know the exact outcomes of their trials as they develop, as, in many cases, their health is directly affected. By volunteering to participate, clinical trial patients expose themselves to a high degree of risk, and because of this, they want to be as well informed as possible about the details and outcomes of R&D organizations’ experiments.

Many pharmaceutical and biotech companies have succeeded in adapting to patient demands. For example, Takeda has created an online portal with expanded access to clinical trial information, allowing patients, researchers, regulators, physicians, and trial participants to browse enrolling, ongoing, complete, and prematurely ended clinical trials. However, despite positive steps in the right direction, the industry, which has maintained control and confidentiality, is far from achieving widespread transparency.

Keys to Addressing Data Sharing and Transparency

• Assessing state of process compliance with respect to changing regulations
• Accelerate the development of a compliant quality system
• Create an ideal IT Strategy and roadmap for logging, and later publishing, CSR and trial information throughout study development
• Demonstrating an emphasis on compliance and consideration of patients’ information

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Coauthor and contributions by Adam Kershner