Understanding Clinical Research

What is clinical research?

Research and clinical trials are an everyday part of the work done in the NHS.  The people who carry out research are mostly the same doctors and healthcare professionals who treat people.  Clinical research helps us to understand how to diagnose, treat, cure or prevent health problems.  There are many different types of research and they cover a range of activities, from working in a scientific laboratory to carefully noting patterns of health and disease and developing new treatments.

Here at the NIHR Leicester Respiratory Biomedical Research Unit, our research is based on examining and observing people with lung conditions, and sometimes comparing them with healthy people (people without lung conditions).  Research and research trials allows researchers to ask and answer questions in a way that provides reliable information in the bests interests of participants.  Research and research trials are an important part of the process the NHS goes through in making decisions about which approaches to prevention, diagnosis or treatment should be made available to the public.

There are two types of clinical studies: clinical trials and observational studies.

Clinical Trials
In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet. Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Observational Studies

In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions as well as safeguard the health of participants. It contains the following information:

• The reason for conducting the study
• Who may participate in the study (the eligibility criteria)
• The number of participants needed
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered about the participants

Why is clinical research important?

• To provide the best advice and treatments for people

• Increasing understanding about the human body and mind in health when living with illness

• Share knowledge and learning

• Improve patient care
  
• Exploring and measuring ways to improve the comfort and quality of life of people with a chronic illness through supportive care
  
• Examining methods for identifying a condition or risk factors for that condition

Why do we need you?

Our research could not be done if it were not for the hundreds of volunteers who help us each year.  Some patients come back time after time to help with our research.

We are always looking for adult volunteers for studies, whatever your age or breathing condition.  We are also looking for volunteers without breathing problems.  Every trial is different, and you may be suitable for some but not others.  Even if you have volunteered before and been turned down, we would still like to hear from you.

Is Research safe?

Large numbers of people take part in thousands of clinical trials and research studies in the UK every year.  Rigorous processes, including review by an NHS Research Ethics Committee, are in place to protect the rights, dignity, safety and well-being of participants.

How are participants protected?

Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

Are volunteers paid to take part in clinical trials and research studies?

Patients often join trials to help improve medical knowledge about how to treat their own condition, or in the hope of gaining benefit from a new treatment (if a clinical trial) or the support offered to people taking part.  When volunteers receive money it is to cover expenses, loss of earnings or their time.