The development and implementation of a Post Market or Phase IV Clinical Study are critical in not only monitoring the clinical use of your product but also addressing any postapproval requirements of the EU MDR or FDA. The most important document
in a clinical study is the protocol and more broadly the investigational plan. All parties within the study look to
the protocol/investigational plan for direction and clarity—the Principal Investigator, Investigational
Site Staff, Study Monitors, and the Clinical Team to name a few. The design of the protocol/investigational plan must also address all patient safety concerns as it will be reviewed by the local Institutional Review Board. Finally, sponsors of phase IV studies prefer to have an investigational plan that does not require the same level of intense clinical study oversight as a Phase II/III clinical study. Thus, the cost is always a consideration.
The situation: A newly acquired company with an FDA-cleared bone augmentation/replacement material (human tissue plus synthetic) needs to start a Phase IV clinical study at multiple US sites on the use of the
product in early 2019. The sponsor has no in-house clinical team to
assist in developing the Protocol/Investigational Plan, and in addition, wished to understand how a sponsor might collect specific indications for use when the cleared indication for use was generic and broad. The sponsor, of course, had no desire to manage a study that might be viewed as a Phase II/III study for a new indication for use simply because the surgeon was using it for a more specific indication for use that was not clearly described in the indication for use (e.g., product cleared for filling defects in bone versus a product used to treat bone defects/fractures caused by osteoporotic bone).
RQMIS acted as the sponsor's clinical team and developed the protocol/investigational plan for the sponsor. First steps:
- Align with the sponsor on clinical study goals
- Identify key stakeholders
- Communicate with potential surgeons to gather input
- Perform literature searches for background information
- Work with third parties to determine indication-specific Protocol requirements
- Develop an investigational plan that assured data integrity, patient safety, and study efficiencies (minimize cost).
RQMIS Clinical Project
Manager, Data Manager, and Clinical Trial Assistant assigned to the study worked together with the investigators to develop clinical/radiographic protocols and an investigational plan. While drafting, RQMIS
gathered sponsor and key stakeholder feedback on the processes and
procedures to implement. The investigational plan included the use of cloud-based electronic database/study management tools and the use of independent radiographic assessment tools. Once all parties approved the Protocol/investigational plan, RQMIS submitted the protocol to the surgeons and a central Institutional Review Board (IRB).
From the initial work writing the Protocol, RQMIS:
- Delivered clinical protocol/investigational plan to the sponsor in the agreed-upon timeframe (one month)
- Received approval from the central IRB with no revisions
- Was granted management of the clinical study