Clinical trial data transparency is now a hot topic in the life sciences industry. As a commitment to both patients and researchers, the biopharmaceutical industry is changing their expectations about allowing access to this historically proprietary patient-level data. In fact, at the recent PhUSE annual conference in Brussels, seats were difficult to find in conference sessions featuring the data transparency topic.
The tremendous interest in the subject is being stimulated by regulatory authorities, researchers and the AllTrials data transparency campaign – among others. Multiple stakeholders have put pressure on the life sciences industry to provide complete transparency into the patient-level data and results from the clinical trials on which regulatory decisions are based.
But before embarking on an initiative, you can equip yourself and your organization with valuable knowledge to apply on your path to data transparency.
The five steps to success
Here are five steps that can move your organization forward to implement clinical trial data transparency.
1) Deciding to participate
After weighing complex factors such as potential regulatory mandates and the potential impact on public opinion, each company’s executives must decide whether or not to make clinical trial results available to researchers.
2) Making the data decisions
Once you decide to proceed with a clinical trials data transparency initiative, there are a number of data decisions that must be made, such as:
- What information is available to researchers?
- What is the process for granting access to researchers?
- How is data de-identified?
In general, the data owners may not be willing to open the data for general exploration. Instead, researchers will be asked to submit a valid research proposal detailing their intended use of the data.
Data contributors need to ensure that the clinical trials data isn’t available in a format that allows identification of the trial participants. In order to protect the participant’s confidentiality while allowing the information to be used for general research, you should develop a consensus approach to data de-identification.
3) Implement a governance process
In order to implement proper oversight of the data transparency program and promote participation from both data contributors and researchers, you need to establish an independent governance process. The governance process should focus on issues such as:
- How to accept and evaluate research proposals.
- The process for releasing research results.
- How to review findings that may conflict with approved marketing applications.
4) Deploy a secure data repository with built-in analytics
At the heart of the data transparency program, you need a process to securely transfer information to a globally available, secure clinical trials data repository. This data repository needs to include easy access to industry-leading analytics, such as SAS.
In order to limit access for each researcher to the data required for their project, build access controls into the system. These controls may also be needed to limit data extracts or exports from the system.
When researchers have questions, technical support should be available to provide answers and insight. The availability of online training and “how-to” videos may help to reduce technical support questions from researchers.
5) Inform the research community and public
Data transparency initiatives demonstrate a commitment to both researchers and the general public. It’s important to publicize the availability of clinical trials data to researchers – and to share the results of research projects with the public. This information sharing will help to widely promote the benefits of data transparency and improve the public’s perception of both clinical trials and the life sciences industry.
Learn more about clinical trial data transparency
During the past few months, many outstanding articles have been written on the subject of data transparency, including one on big data collaboration by Dan Munro from Forbes that highlights the data transparency plans of a leading life sciences company, GlaxoSmithKline. A more recent article on data transparency in Life Science Leader outlines GlaxoSmithKline’s data transparency rationale. Another excellent source of information is the article “Drug Companies Promise More Data Transparency” published by The New York Times.
It’s becoming clear that clinical trial data transparency is going to continue its momentum as an emerging trend in the life sciences industry. When properly implemented, data transparency enables the verification of clinical trial results. It also serves as a valuable resource for the generation of new medical knowledge that has the potential to improve public health while also increasing public trust in the industry. Taking into consideration these five steps to success will help steer your initiative in the right direction.