连接数据源，以促进DAP目标设定中准确的发病率和患病率估计

Clinical Trial Diversity Action PlansWill Take 100 Hoursto Prepare, USFDA Predicts by Sue Sutter The agency’s Center for Drug Evaluation and Research(CDER)expectsto receive 200 plans annually, with 40 plans expected to go to thebiologics center. Drug and biologic product sponsors will spend on average 100 hours to prepare and submit eachclinical trial diversity action plan required under a 2022 law, the US Food and DrugAdministration(FDA)estimates. Each request for a waiver from the diversity action plan (DAP) requirement is expected to take 16hours, according to aFederal Registernoticerelated to a recent draft guidance on DAPs. Under the 2022 Food and Drug OmnibusReform Act, sponsors must submit a DAPfor Phase III or other pivotal studies thatspecifies goals for enrollmentdisaggregated by race, ethnicity, sex, andage group demographic characteristics ofthe clinically relevant population. Key Takeaways •The FDA estimates that drug and biologicproduct sponsors will spendanaverageof100 hours preparing and submittingeach diversity action planthat isrequiredunder FDORA.Each waiver request is estimated to take16 hours to prepare and submit.• The FDA released draft guidance in lateJune describing the format and contentof DAPs, including the timing andprocess for submitting the plans and theagency's evaluation criteria and processfor waiver requests. In addition toenrollment goals,plans must include the rationale for the goals and measures toaccomplish them. CDER andCenter for BiologicsEvaluation and Research(CBER)expectto receive a total of 240 DAPs annually.• Enrollment goals generally should beinformed by the estimated prevalence orincidence of the disease in the USintended use population, the guidance states. However, greater than proportional enrollment may be needed in some populations to identify potentially clinically important differences inresponses between subsets. DAPs should be succinct, generally running no more than 10 pages. Waiver requests should befiled early and only will be granted in rare instances, the FDA said. Submissionestimates Action plans for drug and biological products must be submitted to the investigational new drugapplication and, in some cases, sent in eCTD format through the FDA’s Electronic SubmissionsGateway. Based on the agency’s experience with current IND submissions, the agency estimates it willreceive 240 DAPS annually for the drug and biological programs. Most will go toCDER. The agency estimates CDER will receive four waiver requests annually, while the Center forBiologics Evaluation and Research will receive one. “We intend to revise the scope of the information collection to account for DAP submissionsand waiver requests and to adjust our estimated burden for the activities in the relevantinformation collection after evaluating DAP submissions received,” the agency said. Open For Comments The reporting burden estimates are open for comment until mid-September (Regulations.govDocket #FDA-2024-N-1298). The FDA seeks comments on: Whether the proposed collection of information is necessary for the proper performance of•••the FDA’s functions, including whether the information will have practical utilityThe accuracy of FDA’s burden estimates, including methodologyvalidity/assumptions usedWays to enhance the quality, utility and clarity of the information to be collectedWays to minimize the collection burden, including through automated collection techniques,when appropriate, and other forms of information technology.• The notice does not include an estimate of the agency's estimated review time for eachsubmission. Depending on the specifics of each clinical development program, the relevantdivision in CDER or CBER may or may not provide feedback on a DAP, the draft guidance states. Experienceunder 2022guidance The FDA gained some experience reviewing diversity plans under an April 2022 draft guidance onenrolling representative numbers of participants from historically underrepresented racial andethnic populations. Sponsors submitted a total of 91 race and ethnicity diversity plans to CDER from April 2022 toApril 2023. About 84% went to the oncology divisions. The FDA provided feedback on 31 of the 76 oncology diversity plans. The average time from planreceipt to FDA sending comments was 61 days. Only a small proportion of plans that includedFDA feedback were deemed acceptable. The 2022 draft guidance did not require a collection of information, so no burden estimates weresupplied at the time of its publication. DAPs must be submitted for Phase III or other pivotal clinical trials of drugs or biologics whereenrollment begins 180 days after publication of the agency’s final guidance. FDORA directed theFDA to issue final guidance within nine months of the end of the comment period on the draft,which is 26 September. (DocketFDA-2021-D-0789) The agency was six months late in issuing the draft, which was supposed to be released byDecember 2023, accordi