Sponsors voluntarily submitting drug development tools (DDT), such as biomarkers and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance the agency issued Friday.
The draft guidance divides DDTs into three buckets: biomarkers, clinical outcomes assessments and animal models. Once the FDA has qualified a DDT, it can be used in future trials without additional reviews.
This guidance replaces a 2014 draft guidance of the same name and follows another draft guidance issued in December 2018 that helps researchers produce valid biomarkers (CenterWatch Weekly, Dec. 17, 2018).
To apply for qualification, sponsors will need to complete three sequential steps: a letter of intent, a qualification plan and a full qualification package, the guidance says.
The letter of intent, which needs to include the scientific rationale for the DDT, will be reviewed by the agency within three months.
If the FDA gives the DDT the go-ahead, the next stage is submission of a qualification plan that should include available relevant data, knowledge gaps and data collection and analysis methods.
The third stage is a full qualification package, which includes detailed descriptions of all studies, analyses and results as requested by the FDA. The three-step process could take up to 13 months, the guidance says.
Approved DDTs are then included in the biomarkers, endpoints, and other tools (BEST) glossary, which is used as a resource for research professionals to access proven tools.
Comments on the draft guidance are due by Feb. 12, 2020.
Read the draft guidance here: https://bit.ly/2YP3IAK.
A new FDA draft guidance for sponsors developing cancer drugs would require NDAs and BLAs submitted after Aug. 18, 2020, that present a new active ingredient to include reports of molecularly targeted pediatric cancer investigations unless a deferral or waiver is granted by the FDA.
Applicants that are subject to the pediatric study requirements must submit an initial pediatric study plan (iPSP) that references studies of pediatric-related factors, such as tolerability, dosing, pharmacokinetics and activity response.
The guidance includes two lists for sponsors to reference on molecular targets relevant to pediatric cancer. One list is of molecular targets that are relevant to the growth or progression of a pediatric cancer; the other list is for targets that are not relevant to pediatric cancer studies and would warrant a waiver.
The FDA also explains in detail the three conditions that must be met for a deferral in cases where there is insufficient evidence of relevance to pediatrics and the four conditions that must be met for a waiver, i.e., concerns about the drug’s toxicity.
Sponsors can include pediatric populations in rare cancer trials by building a pediatric cohort, embedding a pediatric trial within an existing trial in adults, involving adolescent patients, looking at tissue agnostic studies and using master protocols, such as basket and umbrella trials, to minimize the number of pediatric patients being exposed to ineffective therapies, the agency says.
Comments on the draft guidance are due by Feb. 12, 2020.
Read the draft guidance here: https://bit.ly/2qM4YYJ.
The Senate confirmed Stephen Hahn yesterday in a 72-18 vote as the 24th FDA commissioner, taking over for acting FDA Commissioner Brett Giroir.
In his confirmation hearing, Hahn committed to increasing innovation and drug approvals, saying that he is supportive of accelerating the approval of generics.
Hahn also said part of the solution to the opioid crisis is to approve more non-opioid treatment options for pain and look into medical devices that can help with pain relief.
Hahn’s nomination was backed by the five most recent FDA commissioners. The Senate committee on Health, Education, Labor and Pensions voted 18-5 on Dec. 3 to advance Hahn’s nomination to the Senate floor.
Hahn will be joining the agency from the MD Anderson Center in Houston, where he served as chief medical executive. He is a practicing radiation oncologist and a former researcher and clinician.
The FDA has yet to announce Hahn’s start date.
The Center for the Study on Clinical Research Participation (CISCRP) and 10 pharmaceutical companies have launched a consortium to focus on building clinical trial participation in diverse communities across the U.S.
Members of the consortium include Merck, IQVIA, Biogen, Otsuka, CSL Behring, Janssen, WCG Clinical, Boston Scientific, EMD Serono and Pfizer. Representatives from each member company will make up a steering committee that will develop live educational events in five targeted urban centers annually, starting in 2020.
The consortium plans to mobilize a pop-up educational exhibit in the targeted cities in the weeks leading up to each live event.
The University of Nebraska Medical Center (UNMC) has joined with the Alliance of Clinical Trials in Oncology (ACTO) to give rural Nebraska residents access to advanced experimental cancer treatments.
The collaboration with ACTO, a National Cancer Institute cooperative, gives the UNMC’s Morrison Cancer Center ready-made resources, systems and processes to conduct clinical trials in a community hospital setting.
WCG ACI Clinical has updated its endpoint adjudication platform, enhancing the user interface and workflow management.
The Adjudication Information Management System allows global medical experts to review and share opinions on clinical trial data and design.
CenExel Clinical Research has expanded its trial network with the acquisition of five Research Centers of America (RCA) sites in Florida.
The RCA sites joins CenExcel’s network of facilities in California, Georgia, Maryland and Utah. RCA specializes in mental health and central nervous system disorders, substance use disorders, and sleep studies. RCA also works with the Fort Lauderdale Behavioral Health Center for psychiatric inpatient and outpatient trials.