Clinical Trial Lost to Follow Up Patient Tracking

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Patient TrackingClinical Trial Lost to Follow Up Patient Tracking
Clients:
Multiple innovative pharmaceutical companies
Description:

With clinical research costs escalating and regulatory agencies placing growing importance on potentially rare side effects, pharmaceutical companies need to ensure that every possible patient entering a clinical study is accounted for in the trial results. In some cases, just a handful of lost-to-follow-up (LTFU) patients can jeopardize the validity of an entire study, particularly if losses occur disproportionately across trial arms. All of this is occurring in the larger context of an increasingly globalized clinical research sector where legal, regulatory, language, cultural, and other factors present additional challenges to patient tracking. Responsibility for tracking LTFU patients has traditionally fallen on the clinical trial site but these facilities usually lack the resources and motivation to execute all but the most cursory of LTFU efforts.

The first requirement of tracking LTFU patients is to ensure that search efforts are conducted in full compliance with national and regional data privacy laws and regulations. VOI understands these regulations and their implications for LTFU searches. We have also developed on-the-ground resources to execute searches and a methodology that assists investigative sites with bringing patients back into the trial.

Results:

To date, VOI has greater than 75% success rate in locating or otherwise confirming the status of LTFU patients in the majority of leading trial locations around the world. We have developed compliant methodologies that are applicable to any trial in these countries and we work with clients to develop country-specific data disclosure text in informed consent documents that will expedite the LTFU process in the future.

Categories:

Clinical trials, regulations, data disclosure, patient privacy, informed consent, lost-to-follow-up, LTFU.

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