As we continue our 10-part series on clinical trials, this post addresses confidentiality in clinical trials.
Confidentiality is an important provision in a clinical trial agreement. It’s a potentially divisive term for pharmaceutical companies (sponsor), principal investigators (PI) and institutions.
Typically, from the sponsor’s perspective, it will want to:
- Keep the information confidential for as long as possible.
- Have a broad definition of confidential information in order to ensure that all information provided to the PI and institution for the trial is protected.
- Safeguard its commercial interests by ensuring that all information (particularly proprietary information such as information relating to the investigational product, the protocol and intellectual property belonging to the sponsor before the start of the trial) is kept safe from third parties, including the sponsor’s competitors.
The third point is especially important – an institution could easily be conducting several clinical trials for various sponsors at the same time and on the same site.
By contrast, the institution and the PI will prefer to:
- Keep the information confidential for as short a time as possible.
- Have a narrow definition of confidential information as this decreases the risk of accidental disclosure and permits publications of the clinical trial results without causing a breach of confidentiality.
- Ensure their academic freedom isn’t hindered which includes their ability to promote and exchange ideas and collaborate with third parties. Also, the PIs want to use the research results for other purposes such as being recognised as thought leaders within the scientific and medical community via presentation or publication of their research.
As a sponsor, you need to be aware of the institution’s and the PI’s motivations and incentivise their involvement in the trial by setting clear parameters on the definition of confidential information and publication rights (our next blog).
One of the more contentious issues that may arise is the identification of clinical trial results. Here a sponsor’s desire to prevent disclosure of its confidential information is directly in conflict with an institution and PI’s desire to publish their findings.
This is usually resolved by distinguishing between different types of source data (such as medical records, laboratory reports, subject diaries, etc.) of the clinical trial results (which the sponsor cannot claim as its confidential information) and which may be used by the institution and PI in their publications and research.
The results provided in the case reports, however, which a sponsor could claim as its confidential information, may not then be used by the institution and PI as the sponsor would have a legitimate commercial need to prevent disclosure of such information.
Exceptions to Confidentiality
There are always exceptions to the confidentiality obligation such as:
- Information already in the public domain.
- Information already in the institution’s or PI’s possession.
- Information independently developed by the institution or PI as shown by contemporaneous records.
- Information required to be disclosed by law.
The confidentiality provision should also provide that the PI and institution may share information with its staff, ethics committees and other third parties on a need-to-know basis.
An obligation of confidentiality should survive termination or expiration of the agreement and should continue for at least ten years from the end of the agreement.
From the sponsor’s perspective, it’s ideal for the confidentiality obligations to last in perpetuity or at least for fifteen years after completion or discontinuation of the clinical trial, which is the length of time marketing authorisation holders must ensure that essential clinical trial documents are kept. In reality, it is rare for a sponsor to know definitively how long it will need to maintain confidentiality during the clinical trial process and confidentiality in perpetuity requires the institution and PI to maintain the agreement in perpetuity, which may not be reasonable. It is therefore typical to see confidentiality obligations lasting between seven to ten years.
Tune in next week for our post on Publication Rights.
This post was written by Sharmela Thevarajaha, Associate, Life Sciences & Intellectual Property at JAG Shaw Baker.