Clinical trials

As part of the KPA Biostatics & Healthcare analytics offering, we provide full support for your preclinical and clinical trials, from DoE consulting to define the design space, building an electronic CRF to ensure data integrity in collection and validation of the patient data, maintaining a trial database, planning and executing statistical analyses, and consulting on next steps based on the trial results.

DoE consulting – Planning your design space before embarking on your preclinical or clinical trials is a task not to be undertaken lightly. Too much redundancy – overlap – in your trial criteria will result in a more costly experimentation project, producing results that are hard to condense into the precious information that is so important to your development. However, paring down the study conditions in order to save time and resources carries the risk of leaving holes in your methodology, requiring extra time and resources to fill in the gaps, or worse - it could lead you to make decisions based on incomplete information.

This is why an expert’s input at this early stage of the process is so important. KPA has a team of dedicated experts in statistics and biostatistics, who can assist you in making the decisions that will shape the format and quality of the data you collect, and thus the future of your product. eCRF – The immense advantages of entering trial data directly into a database are well known, but their extent is not always fully appreciated. The electronic data collection form offered by KPA is fully adaptable to your specific trial, and offers the following benefits, to name a few:

• Validate data as it is entered, rather than querying items at a later stage, when it can be very hard – and at times impossible - to correct invalid values, or to obtain missing information
• This includes validating:
  • Dates of events (visits, procedures)
  • Data that affects inclusion/exclusion decisions
  • Impossible values (i.e. height of 3.5m, weight of 0.5kg)
  • Conditional validation – if a box is ticked for a certain condition, another linked question cannot be left blank
  • Automatic alerts for any trends warranting termination of study – eg. Certain amount of decline in a measurement over several visits, low compliance with defined critical study conditions, etc
• Avoid having to skip unneeded questions – relevant follow-on questions appear only if warranted by previous data (e.g. questions probing into nature of family history disease only if box ticked for family history, or questions about severity of side effects mentioned in a previous visit)
• A central dashboard that enables access to the relevant patient’s eCRF, after one login process, the investigator can access any of his patients
• Alternatively, for patient-completed questionnaires, patient can be sent a personal, unique link to fill in the data. Email reminders can be sent, and completion tracked by the investigator from the trial dashboard.

Database management – The three main issues to bear in mind when making a plan for database management are convenience of data input, data accuracy and quality, and convenience of layout for subsequent data analysis. KPA’s meticulous attention to detail and strong experience in statistical data collection, management and analysis make us an excellent choice for managing your preclinical or clinical study database.

Planning and executing statistical analyses – KPA’s world-renowned expert statisticians can advise you on preparing a detailed a priori statistical plan, and performing the analyses, along with relevant post hoc analyses, to generate insights from your data in the best possible way.Finally, the KPA Biostatistics & Healthcare analytics team can assist you with writing up interim and final trial findings, to meet the requirements of funding bodies, Ethics Boards, and academic journals, providing concise and accurate descriptions of the main findings along with generating insights, conclusions and future avenues for exploration where relevant.

Overall, the KPA Biostatistics & Healthcare analytics team can provide an end-to-end support solution for your preclinical and clinical trials, ensuring smooth handover between stages of the process, and guaranteeing an efficient and successful study for all involved.