Fourth Hurdle Consulting has extensive experience in conducting both prospective and retrospective research. We offer a full range of research services including:
• Development of concept protocols and study design
• Integration of economics and outcomes parameters into clinical studies
• Protocol writing
• Project management and implementation
• Data collection including:
  o Prospective data collection
  o Case note review
  o Database research
• Data analysis
• Effective communications of results

Our international capability through aegisnet; the International Network for Health Care Research, and our access to an extensive network of clinical and academic resources – including statistical analysts, epidemiologists, and experts in diseases – allow us to offer a broad range of integrated services with international reach, including the ability to consult specialises in a number of different areas if needed.

The Importance of Health Economics and Outcomes Data
A company’s development strategy for a new product or device must now meet the needs of health care decision-makers who seek evidence of value for money as well as clinical efficacy. In order to ensure key product value messages are supported with timely health economics and outcomes data, the data collection should be planned and included from the early stages of the clinical development programme through to Phase IV.

How Fourth Hurdle Consulting Can Help

Study Objectives and Design
Fourth Hurdle Consulting can help clients pinpoint key issues and identify target audiences. We can also advise on the most effective way to generate the required data, always taking into account technical, timing and cost constraints. Our extensive experience in the pharmaceutical industry means we understand the constraints faced by researchers when attempting to incorporate these measures into clinical development programmes.

Document Development
Once the study’s objectives are clear, Fourth Hurdle Consulting can develop a full set of study documentation, including the protocol, case record forms, patient questionnaires and procedures manuals.

Data Collection
Health economics and outcomes data are collected using a variety of study designs. The most frequently used are:

“Piggy-Back” Studies
Collecting additional data during RCTs – “piggy-backing” on an existing trial – is a method commonly used to generate health economics and outcomes data. “Piggy-back” studies can:
• Generate high-quality data
• Provide data in time for reimbursement
• Allow data to be collected less expensively than by conducting dedicated health outcomes studies

It is important to consider these parameters early on. While some study designs are not appropriate for collecting economic and outcomes data, small modifications to a study design at an early stage may allow for the collection of health economics data as well as clinical information.

Outcomes Studies
While RCTs are acknowledged as the “gold standard” for assessing the efficacy of a medical intervention, often they do not reflect how the intervention will perform in everyday use. This is for a number of reasons, such as the use of tightly defined patient populations and protocol-driven clinical practice. As a result, there has been an increasing move to perform “real life” outcomes studies that more accurately reflect day-to-day clinical practice and patient populations.

Observational Studies and Surveys
Sometimes it is difficult to collect health outcomes information in comparative studies – for example, when estimating the cost of an uncommon event or when a “piggy-back’ study would require unhelpful changes in the study design. In these cases, observational studies and surveys can be used to generate additional supportive data to be used in combination with data from RCTs.

Patient-Reported Outcomes
For many medical interventions, collecting information on the impact of treatment on the lives of patients – often called Patient-Reported Outcomes (PRO) – is of critical importance.

Fourth Hurdle Consulting can help companies collect the appropriate data to meet their needs. We have experience with the use of disease-specific PRO instruments, treatment compliance measures and patient preference questionnaires. In addition, we are well-acquainted with the use of generic health status measures such as the SF-36 and multi-attribute utility scales such as the EQ-5D. We also have in-depth experience in the collection of resource-use data in prospective trials.

For many reasons it may be appropriate to undertake a programme of retrospective research to support data collection. Two main sources of data for research are available:

• Case Note Review
Well-designed research protocols using anonymised data extracted from medical records can yield useful ‘real life’ data to support economic evaluations. Our team has a track record in designing, implementing and publishing research based on case note data extraction.

• Retrospective Database Research
Longitudinal databases contain a wealth of ‘real life’ health care data. Analysis of these data can provide important ‘real life’ data to support feasibility studies to guide further research, and to provide data to support economic modelling and evaluations. Our team has a track record in designing, implementing and publishing database research, as well as understanding and using these data in economic analysis.

Analysis
Health economics and outcomes data can require specialised analyses and unfamiliar statistical techniques. Fourth Hurdle Consulting can advise and work with a company’s statisticians to recommend appropriate analysis of data. In addition, we can also draft analysis plans.

Implementation and Project Management
In order to ensure that good quality data is successfully delivered, all documentation, study set-up and monitoring must be carried out efficiently, effectively and in a timely manner. Fourth Hurdle Consulting offers expert project management for outcomes studies and works closely in partnership with clinical contract research organisations to guarantee that good quality data is delivered correctly and on time.

Results Communication
Investing valuable resources in a prospective research programme is only worthwhile if the results are communicated effectively to the target audiences. Fourth Hurdle Consulting can help identify which messages need to be communicated, to which audience and in what format. We provide expertise in preparing final study reports to client specifications, manuscripts for publication, poster presentations, slide sets and a variety of promotional materials.