Alignment: A Big Hurdle in Clinical Trial Disclosure

November 19, 2014 Monique Garrett

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Clinical trial disclosure can be a very complex and time consuming process. Sponsors spend a great deal of time and effort ensuring that disclosed data is accurate and timely. But when a sponsor has to disclose data in different formats, at different times, to different registries (or to their own branded websites), the task becomes increasingly complex. The management of living content that is constantly moving and changing can be a significant challenge. And that is why alignment - of content and of supporting organizational structures - is critical. 

  • Alignment of content refers to the management and tracking of disclosure data across registries. Sponsors want and need to make sure that content is accurately disclosed regardless of the publication site. Contradicting trial information among clinicaltrials.gov,  EudraCT and the sponsor's own site would lead to confusion in the public audience and compliance concerns from relevant health authorities. Both of these outcomes go against the reason for disclosing in the first place.  In global sponsor organizations, a disclosure team may be dispersed around the globe. This requires the team members to be able to draw from the same authoritative data source, regardless of the output mechanism.
  • Alignment of the organization refers to orienting a team and their processes toward proper disclosure and compliance. Data disclosure review and approval processes and all associated quality check points must be aligned toward the final goal: accurate and timely disclosure data across registries. The common goal helps to address information silos, organizational boundaries and departmental "turf wars". It requires internal process transparency across clinical disclosure, publicaiton planning, regulatory and compliance groups. 

Content and organizational alignment lead to smoother, more efficient processes. But both of these types of alignment take time and an ongoing commitment. This is not a "once and done" task. Alignment requires continuous monitoring of the process and the outcomes to ensure that quality is not compromised. 

The TrialScope team has a boatload of experience helping sponsors address alignment using PharmaCM. If you would like to learn more about the PharmaCM platform, download the PharmaCM data sheet. And feel free to contact the TrialScope team with any clinical trial transparency questions.

  PharmaCM Data Sheet

See our related blog: Introduction to Clinical Trial Disclosure

 

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