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New Product Development: FDA Issues Final Guidance on IVD Oncology Trials

by | Nov 15, 2019 | Essential, FDA-nir, National Lab Reporter

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements. Entitled the “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” the guidance was developed by the FDA Oncology Center of Excellence.

The New Streamlined Submission Process

Typically, IVD tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. The final guidance allows companies to submit for simultaneous review for the clinical trial. The new streamlined process is optional but the FDA “encourages sponsors to use it. . . when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory approval.”  Sponsors should submit to the Center for Devices and Radiological Health (CDER) or Center for Biologics Evaluation and Research (CBER) all information about the oncology codevelopment program (including information about the investigational IVD) in the trial protocol for the investigational new drug application (IND).

One sponsor should take the lead in communicating with FDA about the IND, says the final guidance. To indicate its intent to use the streamlined process, the sponsor should include the text “Streamlined IVD SRD” in either:

  • In Section 11 (under “Other”) of the Form FDA 1571, Investigational New Drug Application; or
  • The cover letter it submits with the IND (along with a reference to which section(s) of the electronic common technical document contains relevant information).

IVD Information to Include in Submission

The final guidance also lists the additional information about the IVD and how it will be used in the trial that the sponsor should list in the protocol it submits for the IND, including:

  • A description of the device;
  • How the results from the investigational IVD will be applied in the clinical trial;
  • A description of the population and information regarding what is known about the prevalence of the biomarker (evaluated by the investigational IVD) in the patient population;
  • The specimen type that will be collected for investigational IVD testing (including the anatomical site) and whether any biopsy conducted exclusively for investigational IVD testing could present a potential for serious risk to the health, safety or welfare of the subject.

By signing Form FDA 1571 (section 17) sponsors provide assurance of an institutional review board review of the complete clinical trial protocol and activities for the investigational IVD and the investigational drug, the final guidance specifies.

The CBER or CDER will then use the information to determine as part of the IND review and within the 30-day review period whether use of the IVD is significant risk (SR), nonsignificant risk (NSR) or exempt from investigational device exemption (IDE) requirements.

DeterminationConsequence
NSRCBER or CDER confirms determination in appendix to Study May Proceed Letter + reminds sponsor to follow NSR procedures in obtaining biopsies for testing + submit unanticipated adverse device effect reports to IND
SRCBER or CDER confirms determination in appendix to Study May Proceed Letter + asks sponsor to submit IDE application to CBER or Center for Devices and Radiological Health (CDRH) + not start trial until after IDE is approved
ExemptCBER or CDER confirms determination in appendix to Study May Proceed Letter

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