Adaptive Clinical Trial Design

The use of adaptive study design in early phase studies is beneficial as it allows time- and cost-efficiencies whilst ensuring optimal safety. Richmond Pharmacology actively works to maximise return on our Sponsors trials, having routinely developed and conducted adaptive protocols for over 6 years.

Cost Efficient

  • Collection and analysis of only relevant and essential data to meet objectives within a limited budget
  • Adding value by gathering more and highly relevant data

Time Efficient

  • Fast and efficient adaptive protocol development using a transparent & systematic 3-step approach
  • Streamlined study conduct from set up through clinic to final clinical study report
  • Immediate implementation of adaptive changes as long as they are within the authorised adaptive scope
  • Efficient scheduling of adaptive ‘umbrella’ protocols using essential data outputs for early decision making

Safe

  • Tailor-made study specific adaptive limits and control mechanisms to manage potential risks
  • Limitation of assessments and participant exposure to what is relevant and essential

From First-Time-in-Human to Proof of Concept

Richmond Pharmacology actively works to maximise return on our Sponsors’ trials, having routinely developed and conducted adaptive protocols to support rational “no-go” or “where to go next” decisions. The benefits of using adaptive design can be best exploited in combined “umbrella” protocols, whereby an entire early phase programme from First-Time-in-Human (FTIH) to Proof of Concept (POC) can be performed within one trial protocol in a single centre. Value can be added by integrating ethnic comparison elements and further drug development can be de-risked by integrating intensive cardiac assessments and other biomarkers into a combined protocol.

Systematic and logical protocols

Our transparent and systematic 3-step approach ensures that all potential adaptive features, their boundaries and study control mechanisms are considered and fully described to allow continuous learning from data that is being gathered. Such a strategy allows us to adapt and modify the trial design without undermining the validity and integrity of the trial.

Competent and Fast Decisions

We have a highly specialised medical team who, in collaboration with our dedicated in-house data management team and multidisciplinary partners, maintain close communication with our Sponsors for competent and fast decision making. Our goal is to constantly review emerging and quality controlled data to modify the study within the pre-approved limits and boundaries to meet the study objectives and guarantee a rapid trial progression while focussing on participants’ safety.



Rapid approval

Richmond’s established adaptive protocol format enables us to run entire Phase I programmes, including first evaluation of efficacy in groups of patients as part of one protocol and following a single regulatory and ethical approval. We have an excellent track record for starting studies on time and effectively managing ethics and regulatory submissions, with processes that are tailored to ensure a minimum of queries and rejection letters.

Whilst progressing through the various parts of a combined trial, there is no need to share interim data with the competent authority or ethics committee, unless there is intention to go beyond pre-defined and approved adaptive boundaries.

One single centre approach for faster development to POC-flexible protocols, simple trial logistics, enhanced data quality

Phase I programmes from FIH to POC are performed and completed in 4-9 months

Richmond Pharmacology has a proven track record of MHRA and Ethics approval within 4 weeks of submission

Our experts


With over 20 years of experience, Dr Lorch has been Principal Investigator in more than 120 Early Phase studies at Richmond Pharmacology and Co-Investigator in over 100 further studies. She is a pioneer in adaptive study design.

View Dr Ulrike Lorch's Profile ›
Medical practitioner and CEO of Richmond Pharmacology which he co-founded in 2001. He has worked in pharmacology for 24 years and during that time he has conducted more than 400 early phase studies in patient, paediatric and healthy volunteers.

View Dr Jorg Taubel's Profile ›

Set-up

  • Unremitting Phase I accreditation since 2008
  • Located within large London NHS hospitals with immediate access to acute medical services

Special

  • Long-term practical adaptive study design and conduct expertise
  • Frequent presentations at conferences and workshops

We are

  • Reputable: Known to regulatory agencies in EU, USA and Japan
  • Personal: Richmond’s team of senior early phase drug development experts personally look after every study and closely interacts with sponsors throughout

Latest presentations

Complex Study Design

31st July 2014

HRA Phase One Advanced Training Course

View Presentation ›

Adaptive Study Design in Early Phase Clinical Research

11-12 April 2013

The Joint Conference of European Human Pharmacological Societies

View Presentation ›