RRCT - Registrybased Randomised Clinical Trials

Our experience includes:

• Study design and planning of RRCTs
• Use of quality registries as platforms for clinical trials
• Screening and recruitment
• Data collection, data management and statistical analysis
• Academic and industry-sponsored trials
• Trials across a wide range of therapeutic areas
• Trials addressing regulatory questions

RRCT, Registry Based Randomised Clinical Trial, is a randomised clinical trial (RCT) in which registries are used for one or more parts of the trial.

The method has been developed at Uppsala Clinical Research Center (UCR) in collaboration with national quality registries over the past 20 years.

When is RRCT suitable?

RRCT is particularly well suited to disease areas and countries with high-quality registries.

By using data already collected in routine healthcare, parts of the traditional data collection in a clinical trial can be simplified or replaced. When all required information is not available in registries, registry data can be supplemented with traditional data collection in a hybrid solution.

RRCTs can be designed in different ways depending on the research question and the needs of the trial. A trial can be open-label or blinded and can use either placebo or an active comparator.

How can registries be used in a trial?

Registries can be used for several parts of a trial, for example:

• Background information and study design
• Screening and recruitment
• Collection of baseline data
• Collection of outcome data
• Long-term follow-up

Benefits of RRCT

By using existing registry data, parts of the trial can be conducted more efficiently while reducing the burden on both participants and healthcare professionals.

RRCT can contribute to:

• More efficient data collection
• Reduced need for separate trial-specific data collection
• Faster and more representative patient recruitment
• Fewer additional patient visits through registry-based follow-up
• Reduced workload for healthcare professionals and patients
• Opportunities for long-term follow-up
• More cost-effective clinical trials

RRCT in regulatory trials

RRCTs can be designed to meet regulatory requirements for the approval of both medicinal products and medical devices.

There are examples of RRCTs that have been designed to support regulatory decisions on expanded indications for medicinal products and new indications for medical devices in Europe and the United States.

The method has also been used internationally and is compatible with the implementation of the Health Technology Assessment (HTA) Regulation and the European Health Data Space (EHDS) Regulation.

Registry-based solutions can also create new opportunities for efficient long-term follow-up and safety monitoring after market authorisation.

More than 20 years of experience and a large number of completed trials

Over the past 20 years, around 20 large RRCTs have been conducted using the SWEDEHEART quality registry as a platform. Six of these trials were sponsored by pharmaceutical or medical device companies, and two were designed to support regulatory submissions for new indications.

In addition, at least 16 RRCTs have been conducted using other Swedish quality registries.

Trials have been conducted across a wide range of therapeutic areas, including:

• Cardiology
• Neurology
• Oncology
• Diabetes
• Gynaecology
• Orthopaedics
• Obesity
• Vascular surgery
• Kidney diseases
• Rheumatic diseases