FDA Revises Policy for Certificates of Confidentiality

The FDA on Friday issued a new draft guidance that would formalize its current process for issuing discretionary Certificates of Confidentiality (CoC) for commercial sponsors that seek to prohibit disclosure of identifiable information about a research participant.

In the past, a CoC protected a researcher from being compelled to disclose identifiable information about a research participant. The 21st Century Cures Act changed that, by affirmatively prohibiting CoC holders from disclosing such information unless a specific exemption applies.

The FDA typically approves about 150 such requests a year and doesn’t expect that number to change, although the agency warned sponsors that recent technological innovations make it easy for other parties to easily deduce a patient’s identity from deidentified data of a trial, including genomic data and biospecimens.

The guidance lists cases in which a researcher is legally permitted to disclose identifying data, including:

• If the disclosure is required by federal state or local law as a reportable disease;
• If the information is medically necessary to treat the participant with his or her consent; or
• If the researcher strips the identifiers from the data and uses it anonymously without consent.

The guidance recommends that CoC requestors evaluate the risk of privacy breaches by examining the type of information collected, whether the information is retained for further use, the extent of the information and the security of the data.

Comments on the draft are due by Jan. 8, 2020.

Read the draft version here: https://bit.ly/2qCiVbx.

Hahn Sails Through Senate Confirmation Hearing

In his mostly smooth Senate confirmation hearing on Wednesday, the administration’s nominee for FDA commissioner said that patient-focused endpoints of clinical trials were of particular interest to him.

“We have to be pragmatic, we have to make sure that they are validated endpoints,” said Stephen Hahn. “I am interested in working with all stakeholders on this.”

Members of the Health, Education, Labor, and Pensions (HELP) committee showed clear bipartisan support for Hahn, while probing for his views on topics including new drug approvals, drug pricing and opioids.

The five most recent former FDA commissioners, including Scott Gottlieb, have thrown their support behind Hahn’s confirmation, telling Senate leaders in a letter late last week that the agency “urgently needs a well-qualified permanent commissioner,” and that they hope Hahn can bring his experience to the agency “as soon as possible.” The commissioners had previously supported the selection of former acting FDA Commissioner Ned Sharpless for the permanent post.

Committee chair Lamar Alexander (R-Tenn.) announced that the committee will vote on advancing Hahn’s nomination to the full Senate on Dec. 3.

Large Sponsors Take Longer to Qualify Vendors But Have Higher Success Rates

More than 90 percent of all drug sponsors’ vendor assessments result in approval of the vendor, according to a new benchmark study.

According to the survey from the Tufts Center for the Study of Drug Development (CSDD), large sponsors take a much longer time than smaller sponsors to evaluate clinical trial providers and specialty labs. Large sponsors also use more complex processes with completion-to-contract stages than other smaller companies.

The average cycle time from a request to a signed contract was 19 weeks for vendors providing a single service compared to 26 weeks for multiservice providers.

Large sponsors have the highest rates of vendors failing to qualify (11.5 percent) due to deeper inquiry into vendor practices compared to 5 percent for medium-sized sponsors and 5.9 percent for small sponsors, according to the study.

The vendor qualification survey is the first industrywide benchmark study on the subject and measures sponsor metrics on the evaluation of clinical trial and specialty lab vendors.

The study was conducted in conjunction with the Avoca Group and was based on an analysis of data from 76 sponsors — 50 percent pharma companies, 38 percent biotech companies, 4 percent devicemakers and 4 percent other. In 2018, developers worldwide spent about $375 million on clinical trial vendor qualification and requalification.

Get a copy of the report here: https://bit.ly/2QHR18G.

EU Parliament Raises Concerns About Delays to CT Portal

The EU Parliament’s public health committee is concerned that repeated delays in the development of a new clinical trials database will postpone the effective date of new EU clinical trials regulations. The regulations are scheduled to go into effect in early 2020.

The new database, the Clinical Trials Information System (CTIS), will aggregate all European clinical trial data for access by sponsors, investigators and the public.

The European Medicines Association (EMA) management board endorsed a delivery timeframe in December 2015 for the CTIS to go live, but that date has been postponed multiple times due to technical difficulties with the development of the IT systems, according to the EMA.

In October, the EMA’s management board endorsed a six-month monitoring and audit of the CTIS developer’s performance with the goal of getting the new database up and running as soon as possible.

Petition to FDA Questions Prisoner Device Trial

A recent citizens petition to the FDA asks the agency to investigate a possible illegal clinical trial conducted in a Louisiana prison last spring.

In May 2019, BioCorRX implanted an investigational addiction device into one prisoner at the Louisiana Department of Corrections. The prisoner was unaware that the implant was not approved by the FDA for use and also that he was part of an experiment.

The company discontinued the trial after implanting only one of 10 intended participants. Neither the prison nor the sponsor had applied for IRB approval. The company was also planning on testing the device in homeless patients in Philadelphia.

BioCorRX says that it was in full compliance with the law in testing the device on inmates.

The FDA has yet to respond to the petition.

Read the full petition here: https://bit.ly/2D5uhaB.

Janssen’s Remote Trial Uses Wearables for Heart Study

Janssen has launched its first-ever completely decentralized mobile clinical trial using wearable device technology.

The phase 3 heart failure study is a randomized, double-blind, placebo-controlled, interventional superiority study that requires no in-person visits at a site. Instead, it relies on app-based clinical questionnaires, smartphones and wearable devices to measure activity.

Alkermes Picks Up Rodin for CNS Therapies

Biotech company Alkermes will acquire Rodin Therapeutics’ pipeline of drugs for central nervous system (CNS) diseases.

Rodin is currently conducting trials of oral brain-permeating drugs for CNS indications. Alkermes intends to build on Rodin’s pipeline to develop neuropsychiatric, neurodegenerative and neurodevelopment disorder drugs for Alzheimer’s, Huntington’s, dementia and depression.

Alkermes will also continue Rodin’s preclinical program on dementia patients and other work in hematology and cancer.

Dublin-based Alkermes is acquiring Rodin, based in Boston, for $950 million.