Clinical Research Group Launches Site Accreditation Program

The Alliance for Clinical Research Excellence and Safety (ACRES) has announced its new global accreditation program for clinical research sites.

The ACRES Site Accreditation and Standards Institute will base its processes on quality standards the nonprofit group developed over the past six years with input from clinical research experts across the industry and in partnership with the British Standards Institution, a global standards organization focused on the aerospace and aviation industries.

The institute also will develop criteria for training specialists to evaluate sites applying for ACRES accreditation.

For more information on the institute, click here: https://bit.ly/2ZnENDP.

FDA Finalizes Guidance on Drugs to Prevent Delayed Kidney Graft Function

Trials of therapies to prevent delayed kidney graft function should have two arms, a new final guidance from the FDA says.

The agency believes sponsors of new drugs should run two trials where an active treatment is compared against placebo, as there are currently no drugs approved for DGF by the agency. It also recommends a pre-approval safety database of at least 300 patients. Under certain circumstances a single trial or a smaller safety database may be allowed, the guidance noted.

The guidance suggests short-term assessment endpoints for trials, including a binary endpoint of whether the patient required dialysis within seven days of transplantation. As an alternative, sponsors can propose the development of a DGF severity scoring system. A sponsor may also select a short-term endpoint based on definitions of suboptimal renal allograft function, the document stated.

Read the guidance here: https://bit.ly/2YzHGUR.

ClinOne to Launch Direct-to-Patient Recruitment Platform

Colorado software company ClinOne will launch a direct-to-patient recruitment platform in late 2019 or early 2020, offering it initially to sponsors at no cost.

Sponsors will test pilot the platform, ClinTrialConnect, on U.S.-based trials in the first quarter of 2020.

The platform will provide patients with information about their disease and include screening questions to match them to specific trials. It also will enable patients to share clinical trial details with family members and include a calendar to manage study appointments, including reminders and Google Maps navigation.

ClinTrialConnect will be integrated with disease associations and include a document library for study documents provided by trial sites. ClinOne also has partnered with Uber to provide patient transportation services to clinical trial sites.

The company plans to expand the program to regions outside the U.S. in the second quarter of 2020.

FDA Issues Draft Guidance on Pharmacology for Neonatal Studies

The FDA issued draft guidance on neonatal studies, which complements the FDA’s 2014 draft guidance on pediatric study considerations, to help drug and biologics sponsors develop studies that keep in mind the special characteristics of neonatal populations.

For example, conventional pharmacokinetic studies that use intensive blood sampling can rarely be used in neonate studies due to their limited circulating blood volume. There’s also a large amount of variability in the study population, as they are rapidly and varyingly maturing, making the collection of clinical pharmacology information difficult.

The agency recommends population pharmacokinetics and physiologically based pharmacokinetic modeling, and/or pharmacokinetic/pharmacodynamic modeling approaches for informing a study’s design and dose selection.

FDA also issued final guidances on efficacy considerations in trials of drugs for treatment of three women’s health issues: bacterial vaginitis, uncomplicated urinary tract infections and vulvovaginal candidiasis.

Read the full neonatal studies draft guidance here: https://bit.ly/2SYXafE.

Read the bacterial vaginitis final guidance here: https://bit.ly/2GGeqBC.

Read the uncomplicated urinary tract infections final guidance here: https://bit.ly/2YzLcP3.

Read the vulvovaginal candidiasis final guidance here: https://bit.ly/2GJuanw.

First U.S. Inside-the-Body CRISPR Study to Launch

Allergan and Editas Medicine will conduct the first inside-the-body gene editing trial in the U.S. beginning in the fall.

Using the experimental gene editing technique commonly known as CRISPR, the trial will focus on altering the DNA of patients to replace the gene that causes Leber congenital amaurosis, an inherited form of blindness.

The trial will enroll up to 18 participants from across the U.S.