Consent

FDA Clinical Inspection Summary:Mirvaso (brimonidine tartrate) submitted by Galderama research and development

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection summary for Mirvaso (brimonidine tartrate) submitted by Galderama. Four sites were inspected. Inspections lasted from three days to over one month. Sites were inspected on the basis of enrollment and treatment response. One site received a FDA Form 483.

Dr. Jarratt was cited for:

  • Failing to conduct an investigation in accordance with the investigational plan, specifically:
    • Enrolling a subject without completing screening serum chemistry
    • A subinvestigator completed assessments of eighteen subjects prior to completing required training.
  • Failing to maintain adequate and accurate case histories, specifically
    • Site staff signed a reconsent document for one patient over a month after the patient signed the document.

At a different site, a study coordinator falsified one blood pressure reading. The investigator did not receive a 483 for this. FDA notes that the site had SOPs in place and the study coordinator was fired and the single data point did not contribute to efficacy and was not a safety concern. FDA notes that monitoring had promptly identified this issue and escalated it to the PI. 

 

FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. 

Dr. Khan was warned for failing to retain records, specifically:

  • IP accountability
  • Informed consents
  • Case histories

FDA notes that the PI misunderstood the record retention requirements to be two years after the termination of the study at the site, as opposed to two years beyond the last marketing application. 

FDA Clinical Inspection Summary: Beponsa (Inotumuzab Ozogamicin) submitted by Wyeth

FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the recent Clinical Inspection Summary for Beponsa (Inotumuzab ozogamicin) submitted by Wyeth. Three sites were selected for inspection. Inspections ranged over 5 to 7 days. Once site received a FDA Form 483.

Dr. Kantarjian was cited for failing to properly consent a patient, specifically:

  • The patient had noted dated the informed consent form prior to initiating investigational therapy. A properly executed consent form was not obtained  until one week later.

FDA Clinical Inspection Summary: Blincyto (blinatumomab) submitted by Amgen

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Blincyto (blinatumomab) submitted by Amgen. Three sites plus the sponsor were inspected. Sites were selected for inspection based on response rate, as well as enrollment. Site inspections ranged over five to seven days, and the sponsor inspection took place over nine days. One site received a FDA Form 483.

Dr. Laron was cited for:

  • Failing to properly execute informed consent
    • Site personnel who were not delegated to obtain informed consent consented two patients
    • Three subjects were not consented to a revised consent that contained new risk information.
  • Failing to properly report adverse and serious adverse events
    • Failing to report febrile neutropenia which prolonged a hospitalization
    • Reporting another case of febrile neutropenia within 11 days instead of one day.
    • Reporting upper limb tremors within 5 days instead of one day.
    • Failing to report a rise in LDH and increased risk of tumor lysis syndrome in one patient.
    • Reporting steroid induced myopathy over one month late. Additional events related to this led to the patient's death, which was also reported late.
  • Failing to adhere to eligibility requirements for the study
    • Enrolling two subjects who did not meet the criteria for hemoglobin values.

Additionally, the FDA notes that subinvestigator Financial Disclosure forms were not collected at the time two subinvestigators began participation in the trial, serious adverse events were not submitted to the IRB as required in some cases and some subinvestigators lacked documented training to the protocol. 

FDA Clinical Inspection Summary: Juxtapid (lomitapide mesylate) submitted by Aegerion

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week.  From the archives, here is the Clinical Inspection Summary for Juxtapid (lomitapide mesylate) submitted by Aegerion. Three sites plus the sponsor were selected for inspection. Sites were selected on the basis of enrollment. Site inspections lasted three to four days and the sponsor inspection took place over six days. One site received an FDA Form 483.

Prof. du Toit Theron was cited for:

  • Consenting subjects using an Informed Consent Document in the Afrikaans language when the IRB/IEC had only approved the consent in the English language.

A notable theme through all the inspection summaries is that the line listings provided the the BIMO investigator did not contain all adverse events. It is noted that the sponsor remedied this during the sponsor inspection and FDA was provided with the correct dataset.