Insight provides a full range of services in study design for a health research project (these include providing support in obtaining ethical and regulatory approval).

It is important to recognize that every project will be unique in a number of ways including:

• The needs of a client (including whether these needs are well understood by the client or are likely to change during the project)

• Ethical and regulatory requirements

• The balance between time, cost and quality

• The way in which previous studies and literature will impact the current study

• Availability of patients and health technologies

• The way in which data enters the project (including data collection as part of the project, and the receipt of previously collected data)

• The deliverables – including written reports, prepared datasets, and IT solutions (hardware and/or software)

Some of the components that could be involved in study design include:

• An initial understanding a client’s needs - for any project to be successful it needs to start with a thorough understanding of a client’s needs. This usually involves an initial meeting between Insight and client, and the production of the initial Project Plan.

• Literature Review – previous studies and relevant literature are examined for relevant details such as the methodologies employed, challenges that might be faced in project execution, and lessons learnt for the interpretation of statistical results.

• Evaluation Frameworks – in a typical Monitoring and Evaluation project a number of research questions are asked by a client and related stakeholders (these questions often explore the short-term and long-term changes that are expected to occur as a result of the program being evaluated). The client and/or Insight then reviews these questions to identify what datasets could be obtained or collected in order to answer each of these questions. This strategy is documented in an Evaluation Framework.

• Survey Design – the design of surveys takes considerable skill in order to produce high-quality data (including aspects such as validity, reliability, reproducibility, and representativeness). Survey design often involves a review of surveys that have been previously used, and testing proposed surveys with pilot groups from the target population.

• Clinical Trial Design – the design of clinical trials involves considering a number of factors including the definition of the patient population for the clinical trial (including the sample size), the nature of the medical intervention and how it will be administered to patients during the study (including treatment allocation), the patient measures that will be recorded throughout the trial, and the statistical analysis methods that will be employed.

• Qualitative Research – many studies involve the use of quantitative data (such as numeric data) and qualitative data (such as textual data recorded during interview and focus groups). Insight firmly believes in the strengths of both quantitative and qualitative research. Insight focuses primarily on work involving quantitative research, and we work closely with our business partners who work in qualitative research to provide a multi-disciplinary team and methodology.

Health research involves a close working relationship with ethical and regulatory review committees. Insight works closely with a client to obtain approval from relevant committees and in the reporting required throughout the research study. This includes writing relevant text and collating data for research proposals and reporting, and addressing issues raised by committees.

See details about our workshops in the design and management of clinical trials.

Insight is based at the Gold Coast Health and Knowledge Precinct. The Precinct contains Griffith University Gold Coast, the Gold Coast University Hospital, the Gold Coast Private Hospital, and the Cohort and Lumina tech parks. Insight provides research, consulting, training, and IT support services for clients across the Precinct and for the broader international community.