Additional Information Clinical Study

Additional Information You Should Know Before Performing a Clinical Study

In Clinical, Regulatory by Anney Majewski and Nicole Feist

When performing a clinical study, it is essential to carefully evaluate all aspects of the study before it comes to fruition. Knowing how race and ethnicity data should be collected, when a clinical study should be reported as well as when it is necessary to report adverse events are three important aspects to plan for before conducting a clinical trial.

Race and Ethnic Data. When collecting race and ethnicity data for clinical trials, FDA recommends using a two-question format whether the trial is conducted inside or outside the US. It is also suggested that the participant reports the information themselves unless they are incapable of doing so.

For gathering ethnic information, FDA recommends the following two categories:

  • Hispanic or Latino
  • Not Hispanic or Latino

For racial information, the five options listed below are suggested:

  • American Indian or Alaska Native
  • Asian
  • Black or African American
  • Native Hawaiian or Other Pacific Islander
  • White

The term ‘African American’ is not recommended to be used if the if the clinical trial is being conducted outside of the US. FDA also proposes using additional, more detailed categories, if necessary, to best fit the ethnicities and races that are in the country the trial is being performed in. However, any additional options that are listed when gathering data must be able to be traced back to the original categories suggested above.

Medical Device Reporting. Medical device clinical studies that are conducted with the intent to support a marketing application for FDA must be registered at Clinicaltrials.gov. A similar portal and database is currently in the development process in the EU for clinical trials that are applying for or have been granted marketing authorisation.

If the trial is small and designed to establish the feasibility of a device and not the health outcomes, it may be exempt from registration. Any clinical study that is to be published in a well-known journal is required by the International Committee of Medical Journal Editors (ICMJE) to be registered and have final results reported. Submitting such information helps journal editors and end users understand the study results, provides a public record and reduces biased publications.

The sponsor of a clinical trial is responsible for registering and for submitting results unless the principal investigator has been designated with the responsibility. Required clinical trial information for registration must be submitted within 21 days after the first participant enrolls. Trial results should be submitted no later than 12 months after completion as long as the device has been approved, licensed or cleared by FDA. Failure to register or report results can lead to financial penalties and/or withholding of grant funds.

Adverse Event Reporting. As a manufacturer doing business in the US, reporting an adverse event, such as a reportable death, serious injury or malfunction, should be conducted immediately but no later than 30 days after being informed of the event. If the adverse event requires remedial action or if FDA sent a written request regarding a reportable event, the event must be reported within 5 days after becoming aware. Should an adverse event occur during the clinical trial of an IDE (investigational device exemption), the investigator is required to submit a report to the sponsor and to the reviewing IRB (institutional review board) within 10 days of the event. During a sponsor evaluation of an adverse event that occurred with an IDE, the sponsor is responsible for reporting the event within 10 days to the reviewing IRB and FDA. Follow up reports may be necessary if new information regarding a previously reported event is discovered.

In EU, it is mandatory for all adverse events that occur during a clinical investigation to be immediately recorded and reported to the competent authority of the Member State in which it is being performed. Specifically in the UK, adverse events must be reported no later than 24 hours after becoming aware. So while the time to report may be different in the US and EU, it is important to understand the required reporting time structures for every clinical trial regardless of the location. Understanding these requirements is key to adequately plan for such event.

If you missed the previous blog in this series, Differences and Similarities in Investigator Selection Between the US and EU, you can view it here.

Authors:

Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.

Nicole Feist, BA (nfeist@namsa.com) is a Medical Research Manager with NAMSA. Before joining NAMSA, Nicole held senior-level clinical positions at medical device organizations and contract research organizations. She specializes in helping companies create strategic clinical pathways for adoption of new technologies by developing and managing first-in-human, IDE, and postmarket clinical trials for US and outside-US approval.