Providing in-depth platelet function assessment in clinical trials
Quality control of platelet aggregation in clinical trials
Platelet function studies provide vital pharmacodynamic and population response data in trials of antiplatelet and other drugs, but most trial sites are not familiar with these assays, and data quality may suffer in multicentre trials. Our various quality control services will give more reliable platelet function data:
- Deployment of an experienced study management team, ensuring that client and site personnel understand the factors critical to the success of platelet aggregation studies.
- Provision of expert training of site personnel and validation of operators before patient recruitment.
- Preparation of user-friendly site training manuals and daily checklists for platelet aggregation assay operators.
- Expert, independent review of platelet aggregation data to ensure the validity of results and to confirm uniform quality standards.
- Specification of required corrective action when quality issues are identified.
- Assay data management.
- Identification of unexpected platelet aggregation responses due to drug interactions or during shoulder periods of drug concentration.
- Provision of ongoing expert technical support by the Java Senior Scientist to site personnel.
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Tailored studies of platelet responses
We design, manage and interpret clinical trial substudies to address issues such as pharmacokinetics; pharmacodynamics and signalling; pharmacogenomics and other sources of variability. With our involvement these studies will address crucial uncertainties in areas such as safety, mechanism of action, metabolism or population variation.
- Pharmacogenomic assessment of patient responses in the study population.
- Measurements of receptor occupancy and activation (e.g. for GP IIb/IIIa antagonists), and other flow cytometry based studies of platelets.
- Tailored analysis of particular signalling pathways, including through the P2Y12 and PAR-1 receptors, to determine platelet activation status and the effect of drug treatment more accurately.
- Pharmacodynamic assessment of drug-drug interactions.
- Assessment of the effectiveness of antiplatelet therapy using an array of platelet activating agents to reflect the range of stimuli experienced by a platelet in vivo.
- Appropriate use of platelet assay systems such as the VerifyNow system from Accumetrics and the PFA-100 device from Siemens.
- Use of ‘-omic’ technologies to identify platelet responses and population variability.
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Consultancy on the assessment of antiplatelet drugs
Areas in which our consultancy services may valuable include:
- Use of clinical trial data to facilitate product differentiation.
- Strategic trial design to provide maximum information on drug responses.
- Tailoring of information to convince key opinion leaders.
Java personnel include clinicians and basic researchers with a track record in the investigation of platelet function, with particular interest in assays measuring their effectiveness in clinical settings.
We conduct research in areas such as:
- Using thromboxane to measure platelet activation in patients undergoing myocardial infarction and thrombolysis | [Pubmed] | [Pubmed] |
- The characterisation of aspirin resistance in patients with cardiovascular disease | [Pubmed] | [Pubmed] | [Pubmed] |
- Pharmacogenomic studies of variable population responses to antiplatelet drugs | [Pubmed] | [Pubmed] |
- Investigations of GPIIb/IIIa antagonists, that helped explain the limitations of oral antagonists in chronic use | [Pubmed] | [Pubmed] |
- Identifying novel mechanisms of platelet activation through the thrombin receptor PAR1 | [Pubmed] |
- Pioneering gene expression analysis in platelets | [Pubmed] |
- Applying proteomics to platelets to identify risk factors for thrombosis and signals of platelet responses to drugs.
As a result, Java has great interest and experience in trials of antiplatelet drugs, and we provide particular expertise, insights from basic research and strategic advice to our clients.