RQMIS helps US manufacturer design/conduct a retrospective clinical study on devices used to treat pancreatic cancer
The client wished to determine how surgeons were using their
510k 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, the Client wanted to use a prospective study
protocol, and case report forms, gain IRB approval and comply with HIPAA
regulations. There was potential for using this clinical dataset in future FDA
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 were 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 follow-up
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 the database freeze. All of the reviews were included
within the data package for statistical analysis. Statistical analysis
and the clinical report were drafted/finalized within 30 days of the DSMB
Since RQMIS consultants had previously designed, implemented, and
managed over 20 phases 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, the quality of
radiographic imaging, etc. However, the primary objective of this study
was to determine the safety of the 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) and analyzed
by an independent group of oncological surgeons (DSMB)/radiologists to
provide an independent evaluation of patient outcomes when this
technology was used.
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 phase II
prospective clinical study in this patient population. All of this work
was completed within a six - seven-month timeframe.