News and Views: Evidence based prescription opioids, Additional tropical diseases for PRV, Quality Metrics Site Visit Program, Placebo controlled oncology clinical trials
New steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
Need to reexamine how opioid analgesics are being prescribed
- Arm health care providers with the most current and comprehensive guidance on appropriate pain management
- Work together with medical professional societies to develop evidence-based guidelines
Contract with National Academies of Sciences, Engineering, and Medicine (NASEM)
- Advance development of evidence-based guideline and understand needed evidence
- Identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed
- Scan existing opioid analgesic prescribing guidelines, how developed, gaps in evidence
- Outline research needed to generate that evidence
- Meetings and public workshops with broad range of stakeholders
FDA Adds Four Tropical Diseases to Priority Review Voucher (PRV) Program to Encourage Development
Addition of:
- Lassa fever
- Chikungunya virus disease
- Rabies
- Cryptococcal meningitis
Applicants who submit drug/biological products applications may qualify for a Priority Review Voucher (PRV)
- Can be used to obtain priority review of a subsequent drug application that does not itself qualify for priority review
Quality Metrics Site Visit Program for CDER & CBER; Information Available to Industry; Extension of the Proposal Period
Quality Metrics Site Visit Program for FDA staff involved in development of FDA’s Quality Metrics Program
- Gain exposure to robust quality metrics programs
- Through on-site visits, tours of operations, discussions
- Observe how quality metrics data are gathered, collected, reported to management
The intended timeframe of the on-location Quality Metrics site visits is from October 1, 2018 to September 30, 2019
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
Placebo-controlled design only in selected circumstances
- where surveillance is standard of care
- with certain trial design features (e.g. if the trial uses an add-on design, when the
endpoint intended to support a labeling claim has a high degree of subjectivity, such as patient reported outcomes
Considerations:
- Rationale for the trial design
- Justification in the setting of sham surgical procedure or when invasive methods required for administration of the placebo (e.g., intrathecal administration, repeated 78 intravenous administration via an indwelling catheter)
- No requirement of patient-level maintenance of blinding at time of disease
- Unblinding patient at time of documented disease recurrence or progression to ensure optimal patient management
Image credit: FDA