Presenting Live Procedures in Device Trials Raises Special Consent Issues
Clinical trials that ask participants to allow live broadcast or recording of their procedures must go to extra lengths to ensure proper informed consent, the FDA says.
In a final guidance aimed at clinical investigators and IRBs, the agency discusses special assurances that should be included in the informed consent procedure, including a statement that participating in a “live case presentation” provides no additional direct benefit to the patient. The subject also should be told that participation is optional.
The informed consent for a live case presentation may be a separate document, the agency says, as long as it clearly outlines any differences between the live procedure and the study protocol, and explains additional risks that may be presented by the live procedure, including to subject confidentiality.
FDA Guidance Sets Criteria for Trials of Hormonal Contraceptive Drugs
Trials of hormonal pregnancy prevention drugs would need to apply narrow enrollment criteria under a new FDA draft guidance released last week.
According to the guidance, trials should enroll nonpregnant, premenopausal women who have no history of infertility, engage in regular heterosexual vaginal intercourse with a normally fertile partner, have regular menstrual cycles and show no evidence of dysplasia or invasive cervical cancer upon screening. Trials also should represent all ages of premenopausal women, including adolescents.
In addition to enrollment criteria, the guidance advises on study type and length. Single-arm, open-label, historically controlled trials of at least one year in length are usually adequate for establishing efficacy, it says. Longer-lasting trials are recommended for long-acting reversible contraceptives like intrauterine systems. Shorter trials may suffice for products that include drug substances with well-characterized safety profiles.
Comments on the draft guidance are due by Sept. 11.
Altimmune has announced it will acquire Spitfire Pharma, including its product candidate SP-1373, a potent GLP-1/Glucagon receptor co-agonist for the treatment of NASH.
Spitfire, a portfolio company of Presidio Partners, was founded for the sole purpose of developing the NASH drug candidate, which will be renamed ALT-801. Altimmune hopes to begin phase 1 testing in 2020.
FDA Issues Recommendations on Pharmacokinetic Analysis in Trials
The FDA released a draft guidance on Thursday on the use of population pharmacokinetic analysis by sponsors of drug and biologic trials.
Population PK analyses can help in selecting dosing regimens, sampling schemes, exposure metrics and in pediatric study designs, the agency says. Population PK models can also be used to simulate drug exposures that are expected to occur following doses or dosing regimens that have not been directly investigated in prior clinical trials.
Comments on the draft guidance are due by Sept. 11.
