The new article provides additional details regarding the applicable regulatory requirements for the content and format of interim and final post-approval study reports.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to post-approval clinical studies. In accordance with the applicable regulatory requirements, the approval for the marketing and use of a medical device issued by the authority could be conditional on specific requirements including an obligation to conduct post-approval studies in order to collect additional information about the aspects related to the safety and performance of the device in question.
It is important to mention that guidance documents issued by the FDA are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The guidance describes, inter alia, the content and format of interim and final post-approval study reports.
According to the guidance, any and all reports related to post-approval studies should contain the following general information:
- PMA application number and, if applicable, the supplement number for which the PAS requirement was made a condition of approval in the PMA approval order;
- Sponsor name and contact information (name of the individual or entity holding the approved PMA);
- Report correspondent/contact information (if different from sponsor);
- Date of the original PMA or, if applicable, of the PMA supplement approval;
- Date of PAS protocol approval and, if applicable, date(s) of approval of protocol revision(s);
- Device trade name(s);
- Device model number(s);
- Date of report submission;
- Description of the data included in the report; and
- Indication of the type of submission.
PAS Enrollment Status Report
As further explained by the FDA, when requesting a post-approval study, the authority would also indicate the timelines for reports. Under the general rule, Enrolment Status Reports should be submitted by study sponsors on a regular basis until the enrolment for a study will be completed in full. According to the guidance, the data to be included in such reports should be sufficient for the authority to monitor the progress and milestones achieved. In particular, such data should include:
- Begin and end dates of period covered by the report;
- Start and completion dates for clinical site(s) recruitment;
- Number of IRB approvals and number of clinical sites at which the study was initiated;
- Subject-enrollment start date and expected completion date;
- Number of subjects enrolled (if applicable, this data should be presented for the entire subject population and for each subgroup, including sex, age, race, and ethnicity, as appropriate);
- Comparison of target versus actual enrolment dates based on enrolment milestones specified in the PMA approval order.
PAS Progress Reports
As it was explained in the previous article, there are two types of reports to be submitted with respect to post-approval studies: interim (progress) and final reports. The document further describes each of them in detail and highlights the key points to be considered.
For instance, the information to be included in the interim (progress) report should cover, inter alia, the following details:
- General information about the study (including its purpose, goals, objectives, and endpoints);
- A detailed description of the study population in terms of sex, race, and other characteristics;
- Main dates for the reporting period;
- The cut-off date to be considered when collecting data to be included in the report;
- Details about the measures for the prevention of bias;
- Explanations for any delays or incidents occurring during the study;
- Summary of all the data collected in the course of a study together with the interpretation of its results; and
- Proposed interim summary data to be posted on FDA’s PAS Program Database webpage.
Final PAS Study Status Reports
Another type of report to be submitted by study sponsors with respect to post-approval studies is a Final PAS Report. According to the explanations provided in the guidance, it should contain the details included in the interim report, and also such elements as:
- Final accountability of enrolled subjects compared to target;
- Final accountability of number of subjects at each study follow-up timepoint, for the entire population and broken down by subgroups, if applicable;
- Summary and interpretation of final safety/effectiveness findings; and
- Proposed summary data to be posted on FDA’s Post-Approval Studies (PAS) Database webpage.
In summary, the present FDA guidance provides an overview of the regulatory requirements to be considered with respect to the content of various reports to be submitted by study sponsors in the context of post-approval clinical studies. In particular, the document outlines the main types of reports and also describes the scope of information and data to be included in each of them in order to ensure the reliability and completeness of such reports. According to the guidance, the reports to be submitted in the course of a post-approval study include enrollment status reports, interim (progress) reports, and final study status reports.
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