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Retrospective Clinical Study

The Situation

A U.S. based class II (US) and IIb (EU) Active medical device manufacturer wants to determine how surgeons are using the manufacturer's 510(k)-cleared medical device with respect to soft tissue ablation.

The Solution

Over a six month period, RQMIS' work led to an independent analysis of the safety profile of the manufacturer's medical device, which demonstrated that the use of their device was safe and could support the initiation of a phase II prospective clinical study in the selected patient population.

RQMIS helps US manufacturer design/conduct retrospective clinical study on device used to treat pancreatic cancer

Background:

Client wished to determine how surgeons were using their 510(k) cleared medical device with respect to soft tissue ablation. Surgeons were choosing to use the product for soft tissue tumor ablation in the pancreas. Although a clinical study collected/analyzed retrospective clinical data, Client wanted to use a prospective study protocol, case report forms, gain IRB approval and comply with HIPAA regulations. There was potential for using this clinical dataset in future FDA submissions.

RQMIS Approach:

RQMIS created a project team consisting of a Senior Clinical Consultant, Senior Regulatory Consultant and Clinical Monitor. In addition, RQMIS interviewed and trained three surgical oncologists to become members of the study’s Data Safety Monitoring Board (DSMB). We also retained an independent radiologist to critically review MRI/CT imaging.

Once the protocol and study related documentation was designed and placed under document control, RQMIS assisted two well respected clinical sites in preparing IRB submissions. In addition, RQMIS negotiated contracts with these clinical sites. Both IRBs granted approval within 45 days of submission.

RQMIS collected patient demographics, baseline and all followup visit blood chemistry, imaging, adverse events and clinical scores/outcomes on 21 patients with Stage III Pancreatic Cancer. Data collection, coding adverse events per MedDRA and database freeze occurred within 30 days of initiating data collection. Both the independent radiologist and the DSMB reviewed the relevant source data within 30 days of database freeze. All of the reviews were included within the data package for statistical analysis. Statistical analysis and the clinical report was drafted/finalized within 30 days of DSMB review.

Since RQMIS consultants had previously designed, implemented and managed over 20 phase II and III clinical studies in the US and EU the knowledge was available to execute this project in an efficient and effective manner. We utilized our network of Field Monitors to effectively manage data collection to expedite the process as well.

Challenges And Issues:

  • Executing a retrospective study has numerous challenges including determining data that is available for collection, quality of radiographic imaging, etc. However, the primary objective of this study was to determine the safety of use of the subject active medical device with a secondary objective of determining patient outcomes.
  • There was a clear objective from all parties involved that the data should be collected by an independent third party (RQMIS), analyzed by an independent group of oncological surgeons (DSMB)/radiologist to provide an independent evaluation of patient outcomes when this technology was used.

Benefits/ Results:

The client received an independent analysis of the safety profile of their medical device. The clinical report demonstrated that the use of their device was safe and could support the initiation of a phase II prospective clinical study in this patient population. All of this work was completed within a six - seven month timeframe.

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