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Regulatory Focus - Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity

Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.

The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), the National Center for Health Research (NCHR), the American Society of Clinical Oncology (ASCO) and the National Association for Rare Disorders (NORD), among others.

BioSpectrum Asia - "Improving trial efficiency and lowering trial costs is a big challenge"

Historically, getting patients in clinical trials is the biggest challenge to healthcare breakthrough. But now data can used to replace patients in clinical trials. A key priority for the life sciences and pharmaceutical industry is to speed up clinical trials in order to bring treatments to market faster. But modernizing clinical trials is easier said than done, with the large number of participants needed for trials and participants’ fears of being assigned to placebo (‘fake’ treatment) proving to be a challenge.

Cure - A Trial for Every Patient and a Patient for Every Trial

Clinical trials can be less reflective of the general population with cancer, due to the exclusion of those with certain comorbidities. The use of expanded clinical trial inclusion criteria would nearly double the percentage of patients eligible to enroll in clinical trials, according to the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.


The researchers drew this conclusion based on a study that examined the health records of over 10,000 patients with advanced non–small cell lung cancer (NSCLC) from ASCO’s CancerLinQ database.


Oncology Nursing News - Patients With HIV May Be Good Candidates for Cancer Clinical Trials

Cancer clinical trials have been notoriously exclusive, and for years there has been no exception when it comes to patients with HIV. However, according to recent research, patients with lymphoma, Kaposi sarcoma, and liver cancer who were HIV-positive benefitted from treatment with pembrolizumab (Keytruda), and had a similar adverse event (AE) profile. This highlights the fact that many trials can be expanded to include patients with HIV.


The Cancer Letter - Medicaid should pay for patients to enroll in clinical trials, coalition tells Congress

The bill, H.R. 913, was introduced in the House of Representatives by Rep. Ben Ray Lujan (D-NM) and Rep. Gus Bilirakis (R-FL).

“Clinical trials have tremendous potential to help patients with life-threatening illnesses, and for patients with cancer, clinical trials of ten of fer the best available treatment option,” Howard A. Burris, president of American Society of
Clinical Oncology, said in a statement. “It is imperative that every patient, regardless of how they are insured, have access to clinical trials.”


BioCentury - Broadening role for external control arms in clinical trials

External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The field is largely split between those drawing on past clinical trials versus real-world data, and at least one company is pushing the approach further by simulating artificial patients to augment control arms in complex, chronic indications like Alzheimer’s disease.


The ASCO Post - Accelerated Approval Program: For the Benefit of Patients

A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening, and there is no known cure.” After decades of patient advocacy, the U.S. Food and Drug Administration (FDA) acknowledged that urgency by establishing its Accelerated Approval Program in 1992.

BioNews Feed - Keytruda Found to be Safe as Cancer Treatment for HIV Patients, Phase 1 Trial Shows

The immune checkpoint inhibitor Keytruda (pembrolizumab) was found to be a safe treatment for different cancer types among people living with HIV, data from a Phase 1 trial show.


The results are likely applicable to other immune checkpoint inhibitors targeting the same pathway as Keytruda, the investigators said.


Oncology Times - Advice on Charting an Innovative Path Forward for Cell Therapies

Cellular advances in the field of immunotherapy such as chimeric antigen receptor (CAR) T-cell therapy and tumor-infiltrating lymphocytes are generating great interest in oncology even as scientists, manufacturers, and regulators grapple with the challenges of bringing them to the clinic.


Targeted Oncology - FDA Issues Draft Guidance to Broaden Clinical Trial Inclusion

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.1 The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.