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RCT Background

  RCT is a specialist clinical trials organisation which provides a complete clinical service from portfolio review and early clinical development strategy, study protocol development, clinical conduct of studies, statistical analyses & data management to reports

RCT specialises in phase I/II clinical studies in asthma, allergy and COPD; and utilises the clinical and scientific expertise that has been established at the Brompton Hospital over many years of research in the respiratory area. RCT is able to offer a range of associated services relevant to clinical studies such as regulatory advice and filing; data analysis with statistical services, and expert report writing. In addition RCT has developed or applied a range of laboratory techniques to develop novel surrogate markers; these techniques enable accurate & reproducible measurements to be made of the effects of new drugs and therapeutics on the inflammatory response.

RCT will undertake to provide all or part of the required services needed to perform clinical studies in the respiratory area using it’s own dedicated clinical trials unit, The Heart Lung Centre (see Clinical Trials Unit). In some circumstances RCT will sub-contract selected clinical service to CRO’s or other Academic Units. For example in a multi-centre study carefully selected sites will be trained in the techniques by the RCT team. This ensures that a high quality of clinical research is maintained and reflected by accurate and reproducible data. Similarly our statisticians are experienced in the therapeutic area and we are able to provide expert statistical analysis, interpretation of data and expert reports.

We are also able to include a range of novel surrogate markers in studies where relevant to enable early evaluation of novel compounds or important observations of novel mechanisms of existing compounds. Surrogate markers can be developed as required.
   
  For example we have recently performed studies using an allergen challenge model to evaluate markers of inflammation in patients with allergic rhinitis following nasal challenge with allergen. This model has proved successful in establishing proof of concept and dose relationships with novel anti-inflammatory agents.

The allergen challenge model is used in combination with other techniques; multiple cytokine / chemokine assays (up to to 12 per array) are performed on nasal fluid (or other bodily fluid) obtained during the challenge procedure; these assays are performed simultaneously using a sophisticated luminometer system to obtain a complete pattern of inflammatory response before and during drug therapy.

In addition whole blood assays have been developed using GAFS technology to measure the shape change and chemotactic response of eosinophils and neutrophils to defined stimuli.
 

These in vitro assays are useful in determining the structure / activity relationship of compounds; to determine the relative potency compounds and selection of lead candidates; to determine the PK / PD relationship before clinical studies and to confirm this relationship ex vivo following drug exposure in man

RCT is able to provide all the necessary services required from drug development strategy; protocol writing, Ethics Committee and regulatory submissions, conduct of clinical trials, data processing and statistical analysis, through to final report writing. We shall ensure studies are carried out safely and effectively, and meet competitive budgets and time lines.


 
Clinical trial activities include:

 
Drug development for asthma,
COPD and allergy
Clinical development plans: early drug development strategy
Target profiles and medical needs
Study & protocol design including ethics submissions
Providing regulatory submissions to the MCA and EMEA
Data handling, full statistical analysis and report writing
Lung function measurements (full service available)

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