As part of Phase 3 of the EMA’s Business Continuity Plan and its relocation to Amsterdam, this change provokes many questions in clinical trial data transparency. To assist in clearing up any initial questions, we connected with redaction expert Rashmi Dodia, Senior Regulatory Operations Specialist, MMS, for insight.
Question: How does this news affect sponsors?
Rashmi Dodia (RD): Putting this important transparency initiative on hold will affect the study team engagement that is required for company confidential information (CCI) gathering and justifications. This pause may cause team members at the sponsor level to lose momentum built. What teams need to remember is that this is a pause, not an elimination of the requirement. The indefinite suspension of Policy 0070 may also increase confusion among smaller pharmaceutical companies.
Large pharmaceutical companies may already have clinical trial transparency processes established. This allows them the ability to simply put the initiatives on hold, if they choose, and come back to it when Policy 0070 is mandated once again. On the other hand, smaller pharmaceutical companies that may be struggling to get their first Marketing Authorization Application (MAA) together for posting may not know the next steps forward, as they may not be familiar with the procedure yet.
Question: How will things change when this Policy 0070 suspension is lifted?
RD: It is hard to know for sure what will happen when the suspension is lifted, but it may be tough getting started again. Currently, the EMA is still catching up with backlogs from the first quarter of 2017. Additionally, they are issuing invitation letters six months in advance of the proposal submission date.
Once the EMA settles into their new headquarters in Amsterdam and takes the time to bring more trained staff onboard, the time allotted for the preparation of MAA proposals may be reduced.
Question: Will this cause rework for pharmaceutical companies globally?
RD: Putting these activities on hold abruptly may increase the chances of rework later, especially if the internal processes and tasks within the company are not wrapped up and parked in a logical way. As with any suspended internal program, priorities tend to shift towards tasks on hand and essential knowledge may be lost, which may not be readily available when its time to hit the ground running again.
Furthermore, the EMA Business Continuity Plan states that only the assessment of Policy 0070 reports and their subsequent publication will be put on hold, while the Technical Anonymisation Group (TAG) related work in the context of Policy 0070 implementation will continue. This means that the chances of having additional, or revised, guidance and newer requirements upon reinstatement of Policy 0070 are quite high.
Question: What is the positive side of this temporary suspension?
RD: The silver lining is that the EMA has made it clear in the initial guidance itself that quantitative risk-based methods, including data transformation, is the way forward for protecting personal information. This is in place of non-analytical approaches like redaction that severely impacts data utility.
Pharmaceutical companies can take this time to re-evaluate their current approach and develop more robust analytical methods for de-identifying personal data in clinical reports, for instance. It is important for all sponsors to stay the course in the area of redactions, continuing to develop robust processes in advance of the regulation taking effect. This will allow them to be ready and proactive to get going when the suspension is lifted.
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