What is research?

Clinical trials

This is a way of comparing different treatments to find out which is most effective or which is safer, for example comparing drugs.

Clinical trials are also used to test new methods of screening, diagnostic tests etc.

As well as measuring effectiveness and safety, a clinical trial might also aim to compare side effects between different drugs and help establish the correct dosage.

Randomised Controlled Trial (RCT)

This is when participants are randomised to the different arms of a clinical trial; people will be allocated randomly to receive one treatment or intervention rather than another.

Case control study

In this trial, a group of patients with a particular condition or disease are selected and ‘matched’ with a control group.

The control group are likely to be a healthy people that match the patient group in a variety of ways. For example, they might be of similar age and gender, in a similar geographical area, or perhaps the same social class.

The researchers can then take a history of each person and compare how the two groups differ.

It might be particular lifestyle choices account for the development of disease in later life; similarly exposure to different things in the environment could also account for the development of certain diseases.

Researchers need to take a wide history to identify potential causes of the disease.

A case control study cannot prove that one particular thing has caused the disease, but may demonstrate a statistical association and could help point researchers in a useful direction.

Cohort Study

This involves following a group of people over time. Study participants are not deliberately exposed to any experimental interventions.

Usually, an initial baseline assessment is made of participants and then in the future a follow-up contact is made to collect further information.

Participants may be divided into groups based on their condition, their lifestyle or their exposure to a particular environmental trigger.

Follow-ups can take place after just a few years or after several decades.

Surveys are commonly used in all types of research to collect information about people’s behaviour, attitudes and beliefs, as well as their health status, quality of life and patient experience.

Surveys take the form of a structured questionnaire and can be:

• face-to-face interview surveys
• telephone surveys
• paper-based questionnaires to be either handed in or posted back to researchers
• online surveys which respondents can complete at home or elsewhere

Researchers often use ‘off-the-shelf questionnaires’ which have been validated to measure health status and quality of life.

Some of these are generic and others are disease-specific. Using this type of questionnaire allows researchers to compare their findings with scores for different population groups elsewhere.

Surveys can be identifiable (but kept confidential) or they can be anonymised and designed so as to cause minimal possible disruption to patients.

Qualitative research – unlike all the types of research referred to previously – does not try to quantify anything or use statistical methods.

Rather, it seeks to understand other people’s perspectives and motivations.

Qualitative research can take many forms, such as:

• focus groups
• in-depth interviews
• semi-structured interviews
• observation

Unlike a structured questionnaire where all the questions and variables are defined up front, qualitative research is open to participants determining the important issues.

Researchers may think they know what is important to patients and service users, but sometimes it is not until discussions are held with them, that the real issues emerge.

This means qualitative researchers will work with topic guides which outline the issues to be discussed and allow some freedom around those topics, as opposed to a tightly defined questionnaire.

Qualitative research is often combined with other methods to give further insight.

When an organisation agrees to sponsor a study, it takes on a major responsibility.

To ensure participant safety and scientific quality, these studies are closely regulated.

Requirements can include obtaining national approvals – MHRA approval, favourable ethical opinion, HRA approval, and permission from involved NHS Trusts.

Throughout its life, a study is required to have quality standards and monitored for those.

It is the sponsor’s responsibility to ensure the study documentation and procedures associated with it are developed in detail, monitoring must be arranged, all researchers must be trained, and there must be sufficient resources available for safe and effective conduct of the study.

Sponsor

The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project.

All health and social care research has a sponsor. This is normally expected to be the employer of the lead researcher in the case of non-commercial research, or the funder in the case of commercial research.

The Trust acts as sponsor for many studies designed and conducted in the organisation as well as hosting studies for commercial sponsors or universities who act as sponsor for research studies.

A range of organisations, from the public and not-for-profit sectors to private companies and international organisations, fund research in the UK.

The many sources of public funding are the research councils, higher education funding councils and UK government departments.

In addition, much research is funded by charities, learned and professional societies, and universities and research institutes themselves.

International sources of funding include the European Union, NATO and a number of other European and international public bodies.

The Trust’s Research and Development Directorate also manages some research funding through trading accounts held on behalf of researchers in the organisation.

The scopes of these funding organisations differ dramatically. Some fund research across a range of areas, while others only provide funding within specific sciences or humanities subjects.

Research funding organisations run schemes tailored to their particular objectives.

The Trust has been successful in being awarded grants from organisations such as the National Institute for Health and Care Research (NIHR) through Research for Patient Benefit (RfPB) and Health Technology Assessment (HTA) schemes, Innovate UK, Academic Health Science Network (AHSN), and various charities along with pharmaceutical and medical device companies and range from £5,000 to £10,000 to nearly £2 million investment.