September 2, 2019
WCG Clinical has launched a new cloud-based clinical trial management platform that provides smaller sites and research institutions with an affordable option for centralizing operations.
Velos eResearch eXpress offers financial management, patient management, study management, calendaring, and reporting to help sites administer and document trial-related activities.
FDA Flags Ethical Concerns for Placebos and Blinding in Cancer Trials
The FDA urges careful consideration of placebo arms in oncology trials, saying in a final guidance last week that it is concerned about the use of “sham surgical procedures” in such trials.
Sponsors should only consider the use of placebos when surveillance is the standard of care, or with add-on trial designs, such as repeated intravenous treatments via an in-dwelling catheter, the agency says.
The agency cautions against blinding in trials without explicit justification for exposing patients to risk, noting that placebos present an ethical concern, as patients in the placebo arm do not receive the effective therapy.
The guidance underscores the need for informed consent in blinded studies to make patients aware of the progression of their condition. Sponsors should provide a detailed description in the trial protocol to justify the blinding, the guidance says.
Read the final guidance here: https://bit.ly/2ZAVZJa.
Include Men in Breast Cancer Trials, FDA Guidance Says
Sponsors of breast cancer trials should include male participants as well as women whenever possible, an FDA draft guidance says.
The draft guidance, issued last week, recommends that sponsors expand eligibility criteria to include both sexes, as well as include a scientific rationale when excluding males, who make up less than one percent of all breast cancer patients.
The historically limited role of men in breast cancer drug development has resulted in limited FDA-approved treatment options for males with breast cancer, the agency says.
Men are more likely to develop breast cancer at an older age and are more likely than women to have lymph node involvement. The additional data to address these concerns can come from a variety of trial designs using different data sources, the agency says, including small single-arm trials and studies using real-world data sources.
Comments on the draft guidance are due by Oct. 28.
Read the draft guidance here: https://bit.ly/2L5ibTV.
FDA to Finalize ALS Guidance in September
Draft guidance on the clinical development of drugs and biologics for amyotrophic lateral sclerosis (ALS) is slated to be finalized by the end of September, according to acting FDA Commissioner Ned Sharpless.
The agency issued draft guidance in February 2018 on clinical trial designs and the clinical development program for ALS drugs. The draft guidance focused on specific trial design issues only encountered in ALS studies rather than defining the amount of evidence needed to support approval.
Read the draft guidance here: https://bit.ly/2PjQFpE.
UCSD Investigating Whistleblower Complaints
The University of California at San Diego’s School of Medicine is conducting an internal investigation into accusations from an anonymous group of Human Research Protections staff that accused the university’s program and IRB of not protecting patients.
It’s not the first research issue that UCSD has dealt with this year. UCSD Institute for Genomic Medicine founder Dr. Kang Zhang resigned in July in the wake of questions of his financial ties to China. He had received an FDA warning letter in 2017 for clinical trial compliance issues.
UCSD spokesperson Scott LaFee said the university will have no comment until its investigation is complete.
Evidera, CSS Combine Efforts in Japan
PPD subsidiary Evidera and Japanese trial services organization Clinical Study Support (CSS) will establish a joint office in Japan to provide research services to global and Japan-based clients.
The two companies will collaborate on design and implementation of real-world studies, epidemiological studies, qualitative and quantitative patient-centered research, clinical outcome assessment development and validation, patient recruitment and modeling services.
Evidera and CSS also will focus on joint development of direct-to-electronic medical record (EMR) and EMR-enabled observational studies in Japan.