Best practices for maximizing early-phase trial efficiency to accelerate regulatory timelines

By Amanda Knaggs, Associate Director, Recruitment & Enrollment, Peter Dewland, Medical Sciences Consultant, and Thin Thin Mencarini, Director, Project Management

The past few years have presented a range of challenges for regulatory agencies that have had a cascading effect on drug developers. In Europe, foremost among the impacts are regulatory delays in meeting timelines for the review of early-phase studies. In response, our experts at the Parexel Early Phase Clinical Units (EPCU) in London and Berlin have been advising sponsors on best practices for submissions and communications that can help regulators perform their jobs with utmost efficiency. A key aspect of this work is to help our clients fully understand the expectations and requirements of their regulatory counterparts. In parallel, we have been working with regulatory authorities to address these issues.

Initiatives in the UK

What has caused the delays? There is no one answer, and the challenges are multifaceted. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) experienced a deluge of applications, coinciding with staff shortages, that resulted in approval delays. This has since been rectified; Parexel’s London-based EPCU has seen a significant improvement in the responsiveness of the MHRA. In the fourth quarter of 2023, MHRA approvals were issued well within its 30-day target for the first review and 16 days for the second approval. Amendments are being reviewed in 19 days, less than the statutory 35 days.

Our experts at the London EPCU have been meeting with health authorities in the UK to help resolve specific issues related to Phase I research. The UK is taking the initiative to reduce all approval timelines to 60 days or less. It has committed to an investment of more than £120 million to improve the clinical trials regulatory process. Already, the MHRA is providing real-time data on commercial clinical trial activity. In addition, part of that initiative is a mandatory national approach to encouraging patients to participate in clinical research, involving clinical trial accelerator networks to support various research delivery efforts nationally and locally.

Initiatives in the EU

Meanwhile, a new European Union (EU) regulation, Clinical Trial Regulation 536/2014 (EU-CTR) was launched on 31 January 2023. It has radically changed the approach to interventional clinical trials for medicinal product application, assessment, and reporting, enforcing standard rules across the EU for Phase I through IV. The key features of the new process include:

• A single submission portal called the European Union Clinical Trials Information System (EU-CTIS). 
• A simplified application form for all clinical trials conducted in the EU, which includes essential information about the trial such as the study design, endpoints, and patient characteristics.
• A harmonized assessment procedure conducted by a group of member states called the "Member State Concerned," led by the reporting member state that streamlines the review process and reduces duplication of effort.
• Specific timelines and deadlines for the clinical trial approval process to ensure efficient and timely decision-making.
• Publication in the EU-CTIS database of clinical trial information after authorization for ongoing trials.
• Increased communication and cooperation between member states and sponsors and the provision of information on the outcome of the assessment.

Overall, the new EU-CTR process aims to simplify and harmonize the regulatory procedures for clinical trials throughout the EU, reducing administrative burden, enhancing transparency, and facilitating timely initiation of trials. Thanks to these harmonized processes for study submissions and new standard timelines for study approvals, we witnessed an improvement in approval timelines in the first half of 2023.  

Assurances from regulatory authorities

The strong commitment to accelerating approvals in Germany was confirmed in April 2023, when the Parexel EPCU received written notice from the German Regulatory Authorities (BfArM) that early-phase trials would be evaluated within 26 days after a successful validation. A flawless application could result in a decision within 30 days. We received a similar communication from the German ethics committees in August, confirming faster approval processes.

These assurances from the regulatory authorities have materialized, and we have seen a vast improvement in study approvals month after month over the past year. The most recent study submitted by our Berlin EPCU received approval in only 56 days – confirming the trend towards consistent review timelines of 60 days or less. These are encouraging developments, demonstrating the commitment of all stakeholders to our shared mission: to speed treatments to patients while ensuring safety and efficacy. 

Guidance and expertise from Parexel

Parexel developed a cross-functional EU-CTR Program enabling our staff to guide our clients through this significant regulatory change. We offer expertise and guidance to ensure compliance with EU regulations and successful completion of clinical trials in the EU. We work closely with our clients’ regulatory leads to ensure that submission packages are compiled and submitted properly and of first-time quality to avoid follow-up questions or requests for information. We are dedicated to helping our clients maximize trial efficiency, supporting them throughout the regulatory process. We are here to support clients throughout the EU-CTR process by providing comprehensive regulatory and clinical trial services to ease the burden. 

At Parexel Biotech, we’ve integrated our wide breadth of services across all our business units. That gives us the speed and flexibility to deliver anything you need, right when you need it, with all your services coordinated by a single point of contact. Together, we’ll integrate scientific, clinical, regulatory, and commercial considerations early on and throughout development, so your treatment has the surest path to approval and success. Let Parexel Biotech connect every step of development with you. Get the flexibility and adaptability it takes to impact patient lives. Connect with us today. 

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