2018 regulatory round-up: Patient safety, data transparency, innovative trial designs

New proposal could delay implementation of the Common Rule​​

The revised Common Rule – “Federal Policy for the Protection of Human Subjects”​ – was initially slated to come into effect January 19, 2018. However, a proposal early in the month to delay came as a surprise to many in the institutional review board (IRB) community, said WCG compliance VP.

The Common Rule was revised in 2017​ to enhance protection for clinical trial participants. The US Department of Health and Human Services (HHS) and 15 other federal agencies published the final rule to update the regulations which had been in place since 1991.

Common Rule delayed 6 months or more following lack of guidance, other challenges​​

Not long after, an interim Final Rule delayed revisions to the policy for six months, with regulators citing the rule’s complexity, lack of guidance, and other challenges.

Implementation hit another roadblock in June​ and was further delayed until January 21, 2019.

FDA ‘taking an important step’ with new clinical trial transparency pilot program​​

Though facing challenges with the Common Rule, the US Food and Drug Administration (FDA) took an important step in late January, launching a new pilot program aimed at increasing clinical trial transparency.

EMA data transparency regulation upheld in ‘landmark rulings’​​

On the other side of the Atlantic, the European Medicines Agency’s (EMA) data transparency regulation was upheld in “landmark rulings” in February.

The agency’s decision to release clinical trial documents requested in accordance with its Transparency Regulation was upheld in court after companies filed to suspend the release in 2016.

AllTrials urges FDA to fine sponsors for not publishing trial results​​

February 17, 2018, marked 14 months since the FDAAA Final Rule​ was announced in the US. The law – which requires clinical trials sponsors to post summary results and adverse event information on ClinicalTrials.gov – came into force in January though the FDA to date has yet to levy any fines.

In response, AllTrials launched a tracker in February to publically flag sponsors and trials breaking reporting deadlines.

According to the tracker​, the US Government could have imposed fines of at least $1,286,912,422 as of December 12, 2018.

Patient payment in clinical trials: US FDA flags undue influence, reimbursement and consent​​

The agency in February issued an update to guidance on patient payments in clinical trials. The update urged institutional review boards (IRBs) and investigators be wary of undue influence affecting subject consent.

FDA issues final guidance in effort to protect clinical trial participants​​

In May, the joint guidance titled – “Institutional Review Board (IRB) Written Procedures; Guidance for Institutions and IRBs​” – was issued by the FDA in collaboration with the Office for Human Research Protections (OHRP).

The final guidance was released as part of the agency’s efforts to improve protection for participants in clinical trials and reduce regulatory burden.

Contentious ‘Right to Try’ bill heads to Trump’s desk for signature​​

Also in May, the hotly debated “Right to Try” bill passed in the US House of Representatives, making its way to President Trump’s desk where it was signed into law on May 30^th​.

Chinese gov't outlines changes to import tariff, clinical trial applications, IP protection​​

Throughout 2018, the Chinese Food and Drug Administration (CDA) – which also this year changed its name to the National Medical Products Administration (NMPA) – carried out a series of reforms to accelerate drug development timelines.

CROs respond: FDA guidance on expansion cohort use in FIH trials a ‘welcome step’​​

Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.

UK commits to post-Brexit clinical trial rule harmonization but uncertainties remain​​

In May the UK Government provided the “strongest possible reassurance” that it would implement the incoming European Union Clinical Trial Regulation, whatever happens in the Brexit negotiations – which remain ongoing.

UK reaffirms commitment to ‘a competitive service for clinical trial assessment’ post Brexit​​

In an August update to the implementation of the new Clinical Trials Regulation, the Medicines and Healthcare products Regulatory Agency (MHRA) expressed increased confidence that the UK will exit the EU with a deal – and reaffirmed its commitment to align with parts of the legislation “within the UK’s control.”

EMA pulls back on activity, with 30%+ staff losses expected​​

The same month the EMA revealed that it was coping with “significant staff losses” due to Brexit, temporarily cutting certain activities.

FDA guidance encourages EHR use but doesn’t solve interoperability challenges: Industry responds​​

Addressing EHR data use in clinical trials, but not addressing other sources of data, such as wearables, the guidance published in August was “one of the most prescriptive in recent memory,” – still, it does not solve interoperability challenges.

FDA guidance on clinical trial data disclosure falls short, while noncompliance remains high​​

Some were less than impressed with the FDA’s guidance released in October – guidance which tied penalties for not disclosing clinical trial results to formal inspections.

Clinical trial transparency: ‘There is no one answer to what must be disclosed’​​

The agency’s efforts arguably fall short of the public expectation that data should be readily available.

FDA looks to remove innovation barriers in digital health space, finding balance between speed and quality​​

With the industry receiving more funding and opportunities than ever before, the FDA prosed a new Center of Excellence for Digital Health in October.

Law to provide reimbursement for clinical trial costs, laying ‘a path forward for change’​​

Changes at the state and federal level this year paved the way for increased participation in clinical trials by providing patient reimbursement for study-related costs.

Pennsylvania in October became the second state – after California – to pass legislation providing reimbursement for patient expenses associated with participation in cancer clinical trials.

Adaptive designs and master protocols: ACRO, CROs welcome new FDA guidances​​

Further new guidances from the FDA updated language and provide clarity for innovative approaches to the design and execution of clinical trials.

FDA looks to reduce the number of clinical trials in dogs​​

As part of its overall commitment to reduce the number of animals used in research, the FDA in November proposed a study to create a non-animal based model for drug development.

FDA promoting innovative clinical trial designs as part of new pilot program​​

In another pilot program launched in 2018 the FDA targeted complex, innovative clinical trial designs as part of its commitment under PDUFA VI​.

FDA’s MyStudies release is a ‘major milestone’ with ‘profound’ implications, says Iqvia​​

The FDA recently released open source code and technical documents for its new mobile app – MyStudies – which is designed to collect information about medication use, health system touchpoints, and patient-reported outcomes.