The development and implementation of a Clinical Study to support a new claim is critical in not only monitoring the clinical use of your product but also addressing additional marketing claims that compete with other products on the market. These marketing claims do not change the indication for use of the medical product (and cleared by the regulatory authorities), but may speak to claims such as fewer adverse events, faster healing, reduced insurance costs, and so on.
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 address all patient safety concerns as it will be reviewed by the local Institutional Review Board.
Sponsors of clinical studies of expanded claims prefer to have an investigational plan that assures the product is used within the cleared indication for use, such that costly regulatory oversight by the regulatory authorities is not required. However, in the interest of gaining regulatory clearance of the expanded claim, the sponsor is equally interested in assuring the necessary data is being collected to support this future commercial regulatory submission -- 510(k) or Pre Market Approval (PMA) Supplement. 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 clinical study at multiple US sites to determine if bone growth using their cleared bone replacement material allows bony fusion to occur at the same pace as that of bone autograft. The sponsor wants this study to begin 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 data supporting an effectiveness claim without requiring an Investigational Device Exemption (IDE) approval.
The sponsor, of course, had no desire to manage a study that was not designed to collect the necessary data that the regulatory authorities would need to clear the expanded claim but also would prefer to avoid the cost of submitting and maintaining FDA approval of an IDE study.
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 claim-specific Protocol requirements
- Develop an investigational plan that assured data integrity, patient safety, and study efficiencies (minimize cost).
- Assure data generated would support a regulatory clearance for the expanded claim
RQMIS Clinical Project
Manager, Data Manager, and Clinical Trial Assistant assigned to the study worked together with the investigators to develop clinical and 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 and 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 and investigational plan to the sponsor in the agreed-upon timeframe (one month)
- Assured protocol design would collect the necessary data to support the future regulatory clearance
- Received approval from the central IRB with no revisions
- Was granted management of the clinical study