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Guidance for Conducting Clinical Trials During COVID-19 Quarantines

The FDA has issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. The organization recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices, and biological products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19. These challenges may lead to difficulties in conducting the clinical trials.

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The FDA is aware that protocol modifications may be required and there may be unavoidable protocol deviations due to COVID-19. Although the impact of COVID-19 on trials will vary depending on many factors, including the nature of disease under study, the trial design, and in what region(s) the study is being conducted, the FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits, and offering additional safety monitoring for those trial participants who may no longer have access to an investigational product or the investigational site.


"With this guidance issued, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials," said Anand Shah, MD, FDA Deputy Commissioner for Medical and Scientific Affairs. "The FDA released this guidance to emphasize that, at all times, patients' safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants."


CART-ddBCMA Receives Orphan Drug Designation for Treating Multiple Myeloma

The FDA has granted Orphan Drug Designation to CART-ddBCMA, an engineered T-cell therapy utilizing a novel binding domain for the treatment of multiple myeloma. Patients are currently being enrolled in a phase I trial of CART-ddBCMA therapy for the treatment of relapsed and refractory multiple myeloma, the first in a series of clinical trials planned.


"We are pleased to be one of the first sites to test this new technology in the clinic," said Matthew Frigault, MD, Assistant Director of the Cellular Therapy Service at Massachusetts General Hospital Cancer Center and an instructor at Harvard Medical School. "The novel deimmunized binding domain utilized in this trial may be potentially less immunogenic than the single chain variable fragment (scFv) or camelid binders used in conventional CAR T-cell therapies."


The open-label phase I trial is evaluating an engineered T-cell therapy that uses a novel synthetic binding domain in the treatment of patients with relapsed and refractory multiple myeloma. In the trial, a patient's T cells are engineered to express a receptor targeting the B-cell maturation antigen (BCMA) on the tumor cell surface using the novel binding domain, which is a deimmunized synthetic protein.


Device Granted Breakthrough Device Designation for Pancreatic Tumors

The OncoSil medical device has been granted breakthrough device designation by the FDA for the use of treatment of patients with advanced and unremovable pancreatic cancer in combination with systemic chemotherapy.


The device is a targeted radioactive isotope (phosphorus-32) that implants a pre-determined dose of beta radiation directly into cancerous pancreatic tissue via endoscopic ultrasound guidance. The ultrasound then uses high-frequency sound waves to produce detailed images of the lining and walls of specific organs. The beta particles that are emitted travel a short distance in the tissue, causing damage to cancer cell DNA. Chemotherapy is used in tandem with this device to destroy the cancerous cells.


Cytology Test to Aid Clinicians in Improving Cervical Cancer Prevention

The FDA approved the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas 4800 HPV Test. This biomarker technology simplifies clinical decision-making by providing easy-to-understand results so that clinicians and women are clear on next steps.


The CINtec PLUS Cytology test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers. It enables clinicians to more confidently determine which women should be referred to immediate further diagnostic procedures, helping to prevent women from developing more advanced cervical disease.


While most HPV infections resolve on their own, some women who test positive for the virus or whose co-testing results are inconclusive-HPV-positive and Pap cytology-negative-may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer. Early identification of women who are most at risk is vital. This test provides definitive information about which HPV-positive women may benefit most from immediate referral to colposcopy versus repeat testing. This is a major step forward to individualize a woman's care and prevent both overtreatment and undertreatment.


FDA considered data from the IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled more than 35,000 women in the U.S. to clinically validate the CINtec PLUS Cytology test as a triage test in different screening scenarios. Publication of study data is pending.


The new test can be performed using the same liquid sample that is used for HPV or Pap cytology testing. This eliminates the need for additional or repeat sample collection or time spent waiting to find out if an infection is clearing. Primary screening demonstrated high sensitivity and specificity to detect transforming HPV infections reliably and cost-effectively.