Planning and design of clinical research

The serious planning for the preclinical and clinical research is one of the most important tasks Aix Scientifics is concerned with. There are scientific, strategic, regulatory and logistical aspects to be considered.

Planning begins with research on

• the disease to be studied, its symptoms and consequences,
• the treatment options and their limitations,
• the relevant guidelines, policies, standards, regulations, etc.,
• the product to be investigated and alternatives,
• comparable clinical studies,
• the intentions and capabilities of the contracting authority (sponsor) and
• the market and the (subsequent) competing products, and
• the possibilities of obtaining clinical knowledge in the specific case.

Based on this information, we develop a strategy, together with the sponsor, for an appropriate and practicable approach. Objectives are:

• to collect sufficient data for certification
  in the European market (СЄ mark), the USA (FDA) and/or other markets and
• to acquire additional data to differentiate the product in the market and
• to get as much objective knowledge about the product as possible.

For each step the following has to be determined :

• parameters for measuring the success of treatment => primary Endpoints,
• inclusion and exclusion criteria,
• anticipated Adverse Events (AEs) (on the basis of a risk analysis),
• the sample size (based on statistical assumptions and calculation),
• the assembly of participating clinical centres (considerations:  )
• randomisation into study groups (Internet-based out-weighting or simply a-priory),
• the modus of data collection and processing (paper / Internet forms),
• measures for quality assurance (e.g., monitoring, audits)
• logistics of the study (for products, lab. samples, information, and tools)
• the leadership / management and monitoring of the study (e.g., by a Board)

In cooperation with the sponsor and investigators Aix Scientifics^® mostly designs study documents (including the protocol, the questionnaire (CRF), the patient information form, and if necessary instructions for diagnosis or sampling of probes). Other documents may typically be created by the sponsor (e.g. the information on the product). Usually, Aix Scientifics^® assembles the so-called Investigator's File.

The design of the study has major influence on the duration of the study, the quality of study data, and the charges incurred for the study, but ultimately also to the image of the sponsor and the future prospects of the product in the market. It is therefore, worthwhile, to invest in a good study design.