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FDA Issues New Guides on Use of Electronic Health Information in Clinical Trials

July 23, 2018

The FDA is urging researchers to work with electronic health record keepers to help improve clinical trial accuracy and efficiency. The agency doesn’t typically regulate companies or organizations that maintain electronic medical records (EMRs). But it says it’s weighing in to highlight and clarify ways electronic health record (EHR) systems can help clinical trials run more smoothly and use data from foreign studies conducted outside investigational new drug applications and device exemptions. In guidelines released July 18, the FDA encourages sponsors and investigators to use approved EHR or electronic capture data capture (EDC) systems to exchange key information, noting that doing so can dramatically speed up information sharing and precision.

Other FDA tips:

  • Sponsors and investigators should use EHR systems endorsed by the Office of the National Coordinator for Health Information Technology (ONC). If they lack access to ONC-certified systems, they should make sure security measures are in place to protect study data.
  • Study monitors should have easy access to “all relevant information” detailed in consent forms, including how long identifying records will be kept. (Federal law requires investigators to keep records from drug or human biological product trials for at least two years after marketing applications have been approved or trials have been scrapped and the FDA notified. Records relating to medical devices must be retained for at least two years after an investigation wraps up or after it’s determined they are no longer needed to support premarket approval applications or notices of completion.)

Read the FDA’s guidance here: https://www.fdanews.com/07-18-18-HealthRecordData.pdf.

AbbVie Blood Cancer Drug Fails Phase III Trial
AbbVie has announced that ibrutinib doesn’t appear to enhance benefits for blood cancer patients being treated with the R-CHOP chemotherapy cocktail. Researchers at AbbVie subsidiary Pharmacyclics and Janssen Biotech had hoped that adding ibrutinib to R-CHOP — a mix of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone — would improve outcomes for patients with untreated diffuse large B-cell lymphoma. But a Phase III study found it was no more effective than a placebo at improving event-free survival. Ibrutinib has been available in the U.S. since 2013. It’s approved for use in five different B-cell blood cancers and chronic graft-versus-host-disease.

NCI, VA Boost Veteran Access to Clinical Trials
The National Cancer Institute (NCI) and Department of Veterans Affairs are teaming up to make it easier for vets with cancer to get into clinical trials testing novel cancer treatments. The NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE) is rolling out in a dozen VA centers around the country, boosting the ability of veterans to participate in NCI-sponsored trials and receive promising new treatments locally. “VA centers often face challenges initiating and completing externally-funded trials because of the need for partners to navigate the system,” the agencies said. “This program aims to overcome these challenges with dedicated staffing and a sustainable infrastructure, and to address existing barriers to trial enrollment that veterans, including minority patients, often experience.” NAVIGATE is being launched in VA centers in Atlanta; New York; Charleston, South Carolina; Denver; Durham, North Carolina; Hines, Illinois; Long Beach, California; Minneapolis; Palo Alto, California; Portland; San Antonio and West Haven, Connecticut.

Finnish Company Opens Phase III Trial of ALS Drug
Finnish drug company Orion has recruited its first patients for a Phase III trial to see if orally administered levosimendan can help ease ALS symptoms. Some 450 patients with the neurodegenerative disease Amyotropic Lateral Sclerosis are set to participate in placebo-controlled trials at clinical sites in Europe, North America and Australia, the company announced last week. Orion said it plans to spend about 60 million euros (nearly $70 million) over the next three years to support its levosimendan research. ALS, also known as Lou Gehrig’s Disease after the New York Yankees’ beloved slugger who died from the illness, causes rapidly progressive muscle weakness. It specifically affects nerve cells (motor neurons) that control muscles that help us move, speak, breathe and swallow. There’s no cure for ALS but Orion researchers hope levosimendan — which helps strengthen respiratory muscle function — may help slow disease progression and keep patients breathing longer on their own.

FDA Hopeful New Extended-Release Opioids Will Help Curb Addiction
The FDA has released more than two dozen new product-specific draft guidances for generic drug trial designs and revised 17 others in a move aimed at getting less expensive drugs to market faster. The proposed guidelines cover a range of drugs from antibiotics such as ciprofloxacin to the antiretroviral drug ritonavir — and shed light on the FDA’s view of three different opioids (two of them extended release and a third that combines morphine with the opioid antagonist naltrexone) using so-called abuse-deterrent formulations. “We recognize that the science of abuse deterrence is relatively new and we need to continue to study and confirm the potential role of ADFs in reducing the rate of misuse and abuse via different routes when used in a population,” FDA Commissioner Scott Gottlieb said in announcing the new proposals. “Both the formulation technologies and the methods for evaluating those technologies are rapidly evolving. We believe that transitioning from the current market, dominated by conventional opioid analgesics, to one where most opioids have abuse-deterrent properties may have the potential to further reduce misuse and abuse.” Two of the revised opioid proposals deal with extended-release hydrocodone bitartrate (the generic name for Vicodin, among others) and extended-release oxycodone HCL tablets. Both encourage researchers to conduct two sets of studies (involving participants who either fast or eat before taking pills) to determine if the meds can help patients resist addiction: one in which participants chew pills and another in which they absorb the drugs through a nasal spray. The guidance urges researchers not to use naltrexone or other opioid antagonists in the trials. The third revised draft focuses on an extended-release capsule containing morphine sulfate and naltrexone hydrochloride. It urges researchers to conduct three bioequivalence studies: one in which participants fast before doses, another in which they eat first and a third in which fasting subjects take the drug sprinkled into applesauce. It also encourages investigators to conduct a pair of risk-abuse trials. Gottlieb said he’s optimistic the opioid tests will yield medicines that “can’t be easily abused” but cautioned it’s important to remember that no opioid is “abuse-proof.”

Feds to IRBs: Drop Grant Application Reviews
It’s not necessary for IRBs to review grant proposals or applications to ensure patient safety, the HHS says in a new draft guidance. “Experience suggests that review and approval of the application or proposal is not a productive use of IRB time,” say the proposals issued by HHS’s Office for Human Research Protection. Federal officials say the change won’t increase patient risks because IRBs will still have to review research protocols for any studies that seek federal funding. Read the draft guidance here: www.fdanews.com/07-23-18-IRB.pdf.

FDA OksBreast Cancer Drug after Successful Trials Pilot
The FDA has greenlighted anti-breast cancer drug Kisqali, making it the first drug approved under a new pilot program designed to help bring cancer drugs to the market more quickly. The agency OK’d the use of Kisqali in combination with aromatase inhibitors to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic cancer. It also approved using Kisqali with fulvestrant for postmenopausal women with the same cancers. The go-ahead gives Kisquali “the broadest first-line indications” of any drug in its class, drug maker Novartis said in a statement. The move comes less than a month after the company submitted its application for the FDA’s approval. The FDA credited the fast turnaround to two pilot programs it launched earlier this year — one in which regulators are given “real-time” review of data from oncology trials and another in which applicants work from a single template created by regulators.

HHS Mulls Waiving Continuing IRB Review Rules
Federal officials are considering waiving rules that require continuing IRB review of a small sample of expedited and late-stage clinical trials. New regulations easing IRB review requirement are scheduled to take effect in January. But HHS’s Office for Human Research Protection last week issued a draft guidance to address studies pending the change. If the FDA adopts the recommendations, IRBs won’t have to continue monitoring trials in transition that are eligible for expedited federal review or in which data analysis is complete and participants are already in follow-up treatment. Nothing in the pending rules or the draft guidance exempts researchers from reporting problems or patient risks uncovered during studies. Read the draft guidance here: www.fdanews.com/07-23-18-ContinuingReview.pdf.