Revised FIH guidelines: AstraZeneca reflects a year later

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Eli Ammos)
(Image: Getty/Eli Ammos)

Related tags: First-in-human, CRO, Clinical trial, Fda, Ema, Pharmacodynamics, Pharmacokinetics, Risk management

Sponsors have had to take steps to follow the new EMA guidelines for first-in-human clinical trials, which can pose risk and operational challenges.

AstraZeneca’s Henrik Forsman will be speaking on the subject at PCT Europe in Barcelona, Spain later this month. Forsman, who is the director of scientific project management at AstraZeneca Sweden, said the First-in-human (FIH) guidelines released by European Medicines Agency​ (EMA) in November 2017 can affect the progression and speed of early phase clinical trials.

“A guideline is not regulation and therefore gives some room for interpretation. It is our experience that we need to submit a few trial applications to more than one regulatory authority to understand how the guideline will be interpreted,”​ Forsman told us.

He further explained, “We have already seen that the guidelines are interpreted differently by different regulatory authorities.”

The ‘most important risk managed’

The guidelines outline risk management strategies to address the uncertainty associated with FIH trials. It stresses that sponsors should describe how potential risks will be addressed within the trial’s design.

“The most important risk that needs to be managed is to protect the participants in a study while still being able to explore a wide enough dose spectrum. This is also the main purpose of the FiH guidance,”​ Forsman said.

“As first in human trials are becoming increasingly more complex, with the aim to study more than pharmacokinetic (PK) and safety and tolerability, the industry is in need of FiH guidelines to preserve the safety of participating subjects and to ensure an efficient approval process with regulators,”​ he added.

Revision and scientific rationale

In 2016, a revised concept paper​ on FIH trials was drafted by the Committee for Medicinal Products for Human Use (CHMP), following the death of a clinical trial participant. The EMA thus set out the framework for review and assessment of preclinical drug candidates, and clinical trial design.

A spokesperson for the EMA told us ​previously that per the guidelines, sponsors are provided with criteria about when to stop a study, the rolling review of emerging data with special reference to safety information for trial participants, and the handling of adverse events.

The EMA’s approach to FIH must be supported by a “well-documented scientific rationale from the outset and be responsible to data emerging over the course of the trial itself.”


Related news

Show more

Related products

show more

Using SDTM, ADaM, and SEND

Using SDTM, ADaM, and SEND

Formedix | 09-Nov-2022 | Technical / White Paper

This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how...

How to design an effective CRF

How to design an effective CRF

Formedix | 10-Oct-2022 | Technical / White Paper

CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical...

The Complexities of Ophthalmic Drug Development

The Complexities of Ophthalmic Drug Development

Altasciences | 04-Oct-2022 | Technical / White Paper

Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory...

Because When It's On the Line... Capability Matters.

Because When It's On the Line... Capability Matters.

Baxter BioPharma Solutions | 01-Oct-2022 | Product Brochure

Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their commercialization objectives by providing scientific expertise,...

Related suppliers

Follow us


View more