Clinical Trials

OPRI’s collaboration with a unique global network of general practitioners and specialists places it in a unique position to be the research organisation of choice for the delivery of clinical trials in real-world settings. We work alongside experienced clinicians with access to real-life patients thus improving site effectiveness.

OPRI also works with a team experienced in evaluating the broad spectrum of available trial designs and data sources to select the most appropriate and cost effective study methodology to answer your research question. OPRI’s study design proposals always account for an integrated research framework bounded by population and ecology of care, as shown below (figure 1)

Ecology of Care

Pragmatic Trials

In recognising the limitation of evidence solely derived from randomised controlled trials (RCTs) OPRI focuses on the use of pragmatic studies to support healthcare decisions and inform how a treatment may be applied by clinicians outside of the classical clinical trial environment.

These pragmatic trials invoke randomisation, typically in a broader range of patients and study sites. The outcomes of interest tend to include a greater emphasis on quality of life and long term clinical impact, than the typical RCT providing the true risks, benefits and costs of an intervention in routine clinical practice (real-life)

What can we offer?

OPRI’s research team have been leading the successful delivery of pragmatic clinical trials and can help you design and successfully execute small to large scale pragmatic studies to:

  • Study a broader patient population
  • Study sites/patients that are representative of usual care settings
  • Establish effectiveness in patient subgroups, typically excluded from conventional RCTs
  • Measure impact and uptake of an intervention in real-life settings
  • Understand real-world adherence
  • Understand acceptability for patients in real practice
  • Determine evidence gaps for comparisons with routine standard of care
  • Determine the position of new treatments within current treatment paradigms

Cluster Randomised Controlled Trials

OPRI recognises that evaluating interventions in real life clinical practice can sometimes require groups of patients (GP practices) rather than individual patients to be randomised. Cluster randomised controlled trials can be a practical and financially viable approach to evaluating interventions in a real world setting without high intensity patient level intervention and randomisation. These can be particularly useful when assessing patient factors such as adherence.

OPRI is a uniquely placed research institute to support the development and delivery of cluster randomised controlled trials via our preferential access to:

  • A network of over 650 UK general practices to assess feasibility
  • A longitudinal electronic health record database of over 5.2 million + patients with fully characterised chronic diseases data
  • A real time data source drawing from clinical information systems

Classical Randomised Controlled Trials

Efficacy trials have long been the backbone of evidence-based research and a necessary component of drug licensing and the evaluation of short term efficacy, adverse events and safety. RCT’s seek to optimise conditions by using highly selected patient populations and close clinical monitoring to assess true cause and effect between an intervention and an outcome.

OPRI have experience in the delivery of Phase III clinical trials and can offer end to end services of a clinical research organisation including:

  • Project management,
  • Protocol development,
  • Electronic Case Record Form (eCRF),
  • Randomisation Tools,
  • Biostatistics,
  • Pharmacovigilance,
  • Remote data monitoring,
  • Clinical monitoring