Industry Insights for Q4

With ongoing developments in the Brexit negotiations creating further uncertainty and a multitude of updates from various regulatory bodies, Christina Hägglund has compiled our final industry update for 2018, with news from around the globe.

BREXIT

‘No Deal’ Preparations Advice

The government has released further guidance notes on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal. The updated information has been provided for stakeholders so they can make informed plans and preparations in the event of leaving the EU with no deal.

Brexit and Patient Protection

UK health service and industry representatives are asking the government and the EU to ensure cooperation on medicines safety and regulation is a clear priority in the final version of the Brexit Agreement: read more here.

European Medicines Agency (EMA) and Brexit

On 01 October, the EMA’s Brexit Preparedness Business Continuity Plan (BCP) officially entered Phase 3. The aim is to safeguard its core activities as it prepares for relocating to Amsterdam in March 2019 and deals with associated significant staff losses whilst at the same time managing the consequences of UK’s exit from the EU. Full details here. 

Brexit and the EU Clinical Trial Regulation (CTR)

The planned implementation of the new EU CTR is scheduled to coincide with the transition period that will be in place as the UK exists the EU. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a statement on the implementation of the EU CTR following Brexit.

MHRA Guidance on Brexit

The MHRA has provided guidance relating to the Brexit implementation period and an Exit no-deal contingency legislation for the regulation of medicines and medical devices. Follow the links to latest advice:

Clinical Trial Data Sharing

Study Subjects Supportive of Clinical Trial Data Sharing

The New England Journal of Medicine has published findings from a survey which show that patients understand and value the positive benefits of data sharing. The benefits include:

  • Clinicians and patients are able to make best-informed decisions.
  • It may prevent/uncover inaccurate reporting of data.
  • It may facilitate efficiencies and innovation in drug development.

The negative side relate to the potential risks, in particular regarding privacy and data re-identification.

Clinical Trial Registries – Incorrect and Incomplete

The European Commission’s (EC’s) requirement is for all trials on the EU Clinical Trials Register to have their results posted within 12 months of completion. Recent analyses show errors and contradictory entries in the data posted.

The research also identifies features associated with non-compliance and it ranks sponsors according to their compliance.

European Agencies

EC Consults on Draft Good Clinical Practice (GCP) Guidelines for Advanced Therapy Medicinal Products (ATMPs)

This draft guidance was issued for consultation in order to collect relevant evidence and information to enable the EC to further develop the guideline.

European Agencies Aim to Boost the Development of Paediatric Medicines

In October 2018, the EC and EMA published a joint action plan to support the development of medicines for children. The plan aims to increase the efficiency of paediatric regulatory processes and boost the availability of medicines for children.

In addition, a new EMA guideline on Good Pharmacovigilance Practice (GVP) for paediatric populations came into effect 08 November.

Clinical Trial Design Development and Metrics

UK – New Guidance on Electronic Informed Consent

The National Health Service Health Research Authority and the MHRA have issued a joint statement describing the legal and ethical requirements for obtaining informed consent using electronic methods.

UK – 2018 Metrics on Clinical Trial Applications (CTAs) and Substantial Amendments

The MHRA reviewed on average 85 CTAs and 368 substantial amendments per month. The vast number of substantial amendments has a huge implication on the cost of clinical drug development.

Food and Drug Administration (FDA) – New draft Guidance on Adaptive Trial Design

An adaptive clinical trial design has the potential to provide a better chance of detecting the true drug effect, while reducing the number of subjects exposed to ineffective investigational treatments.

The FDA has released draft guidance that describes the principles for designing, conducting and reporting the results from adaptive clinical trials.

Oncology Clinical Trials

Encouraging Trends in Modern Phase I Oncology Trials

A recent survey questioned the perception that only 5% of patients in Phase I oncology trials experience a benefit. This 5% relates to a genuine clinical benefit (tumour shrinkage). In addition, reported data suggested that phase I oncology patients may have unrealistic high expectations of the likely clinical benefits of trial participation.

The survey was of more than 200 Phase I oncology trials and suggests an overall beneficial response of nearer 20%. This is published in the New England Journal of Medicine by French researchers.

New Oncology Guidance