Adaptive Clinical Trial Design

From First-In-Human to Proof of Concept

Our substantial experience of developing and conducting adaptive protocols enables us to maximise the return on our sponsors’ trials whilst guaranteeing the safety of our participants

adaptive phase 1

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
adaptive phase 2

Time Efficient

  • Fast and efficient adaptive protocol development using a transparent and systematic three-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
adaptive phase 3

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-In-Human to Proof of Concept

We maximise return on our sponsors’ trials. Using adaptive design to support rational “no-go” or “where to go next” decisions, an entire early phase programme from First-In-Human to Proof of Concept can be performed in one trial protocol, in one trial centre.

We add value by integrating ethnic comparison elements, intensive cardiac assessments, and other biomarkers into a combined umbrella protocol. This means potential risks in further drug development can be avoided.

Systematic and logical protocols

Our three-step approach allows us to adapt and modify the trial design without undermining the validity of the data and integrity of the trial. We achieve this by continuously learning from the data, scrutinising any adaptive features, their boundaries and study control mechanisms and ensuring complete transparency.

Competent and Fast Decisions

We guarantee rapid progression of your trial. Our specialised medical and data management teams collaborate with our multidisciplinary partners, communicating closely with sponsors for competent, fast decision making. We review emerging quality-controlled data and use this to modify the study within pre-approved limits, whilst safeguarding participants and ensuring the study objectives are met.

Rapid approval

We have an excellent track record for starting studies on time and effectively managing ethics and regulatory submissions. Our processes are tailored to ensure a minimum of queries and rejection letters. This 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.

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

Dr Ulrike Lorch - MD FRCA FFPM
(Medical Director

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.

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Dr Jorg Taubel - MD FFPM
(CEO)

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.

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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 news

Upcoming Event

The Future of Healthcare.

13:00 – 17:00, 8th December 2021
Join Richmond Pharmacology, The Royal Free Hospital and Richmond Research Institute as we share breakthroughs in cardiac health from gene editing to RNA interference therapies.
View event

The future of clinical workforce training programmes, an exclusive interview with MedCity

November 30, 2021
Ulrike Lorch discusses the future of clinical workforce training programmes in an exclusive interview with MedCity
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Richmond Pharmacology’s Dr Emma Akuffo joins fellow EUCROF task force members as a finalist at TOPRA Awards 2021

November 17, 2021
EUCROF task force members compete for a prize at the TOPRA Awards 2021
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Developing talent in the fast-changing clinical research environment

November 2, 2021
In a feature article for PharmaTimes, Dr. Ulrike Lorch, Medical Director at Richmond Pharmacology, outlines how investing in the clinical research workforce is crucial to delivering high quality, cutting-edge trials and achieving faster drug development
Read more