Clinical research is a broad area of patient care that investigates diseases, diagnostic methods and treatments, and plays a crucial role in progressing medical solutions to improve global health. This helps develop medical knowledge of how to identify, prevent, treat and manage health conditions.
The importance that clinical research has on the development of medical technology and healthcare cannot be understated, which is backed by the UK government’s “The future of UK clinical research delivery” plan.
There are several different types of clinical research that investigators use depending on the main aim of the study. For instance, the aim of one research may be to treat a disease, whilst another might aim to improve the way it is diagnosed.
Common types of clinical research include treatment research, prevention research and diagnostic research, each of which examine diseases from a unique perspective in order to improve patient care.
This article discusses the different kinds of clinical research, and how they are used to advance different areas of medical knowledge.
What is the difference between clinical trials & clinical research?
The terms clinical trial and clinical research can sometimes be used synonymously, as the term “clinical research” is a more general term that encompasses multiple observational and interventional studies. It is worth noting that there are considerable differences between the two.
The main difference between clinical trials and clinical research is that clinical research refers to the broad scientific study of treatments and conditions, and clinical trials refer to the specific study of treatments and conditions in human participants.
| Clinical research | Clinical trials | |
| Definition | Clinical research is the broad term that is used to cover all investigations based around health and diseases. | Clinical trials are a specific type of clinical research, and focus on testing new drugs and medical solutions for safety and effectiveness. |
| Scope | Includes observational studies, genetic studies, and interventional studies like clinical trials. | Interventional study, where a group receiving the intervention is compared to a control group receiving a placebo, for more accurate data. |
| Goals | The main objective of clinical research is to progress medical understanding, enhance patient care, and discover new approaches for disease prevention, diagnosis, and treatment. | The goal of clinical trials is to test the safety and efficacy of new drugs through phases. As the trial moves through phases 1–3, the number of participants greatly increases, assuming earlier trials show data of the trial being safe. |
Why do researchers conduct different kinds of clinical research?
There are many reasons for conducting a clinical study, for instance:
- To identify what causes a disease and its underlying processes
- To test new treatments and how they affect the condition
- To develop new diagnostic techniques
- To improve disease prevention strategies
- To improve patients’ quality of life
In order to investigate the many different aims of clinical studies, a different research approach is required. Additionally, no two diseases are the same, meaning that researchers must take a tailored approach to researching each unique disease.
Types of clinical research
Whilst all research is unique and tailored to the requirements of the study and its participants, different types of clinical research can be broadly grouped into the following categories.
- Treatment Research
- Prevention Research
- Diagnostic Research
- Screening Research
- Quality of Life Research
- Genetic Studies
- Epidemiological Studies
- Pilot Studies
Treatment Research
Treatment research is one of the most common types of clinical research. The main aim of treatment research is to investigate how safe and effective a new development drug is. This kind of research aids the clinical development process, providing empirical research data that proves the drug is safe and effective for human use.
Treatment research is mostly conducted through clinical trials, testing on healthy and patient human volunteers, starting from phase 1 clinical trials. For instance, one way that researchers test the safety of a drug is through dose escalation clinical trials. An example of this is Simbec-Orion’s recent work supporting Cardiff University’s MDI with new treatment research for cognitive impairment.
As a type of clinical research that investigates new therapies, treatment research can also be carried out to investigate new medical devices, psychotherapies and surgical approaches.
Prevention Research
Prevention research focuses on stopping diseases from developing or recurring. This type of research is different from typical treatment research, in that prevention research aims to investigate how health professionals and patients can reduce the risk of a particular condition occurring, rather than treat the condition once it has occurred.
Prevention strategies can include medicine, vaccine, lifestyle, vitamin and mineral research depending on the type of condition being studied. One of the more prevalent examples of a recent breakthrough in prevention research is the vaccine development for COVID-19, which played a pivotal part in saving lives during the COVID-19 pandemic.
Diagnostic Research
Diagnostic research involves clinical studies that investigate improved ways to identify a particular condition. This type of clinical research aims to improve patient lives and medical knowledge with advanced insights into diagnostic methods.
This can involve the advancement of diagnostic technologies, or a developed understanding of how a particular health condition is formed. The advancement of technology especially can prove to be effective when it comes to furthering diagnostic research.
A recent example of this is how AI can be used to help diagnose rare diseases, making the process much faster and more effective. In this example, achieving a faster diagnosis can mean a faster response time, which can potentially make a big difference on the quality of someone’s life.
Screening Research
Screening research is similar to diagnostic research, in that it aims to improve the ability to detect diseases and health conditions. For instance, this type of clinical research has been conducted to improve methods of identifying early signs of cancer before the patient experiences symptoms.
This makes research into screening methods a key aspect of oncology research. Screening trials are usually completed in order to determine how effective the new tests are at detecting particular health conditions.
Quality of Life Research
Quality of life research aims to find ways to make the lives of people with chronic or terminal illnesses much more comfortable and manageable. Clinical trials in this field usually collect quantitative and qualitative data, applying patient engagement strategies to accurately understand how treatments and interventions may be improving patient lifestyles.
This type of clinical research usually focuses on health conditions where, unfortunately, there are limited treatment options available to patients, as well as conditions that have a more significant impact on patient lifestyles.
Genetic studies
Genetic studies are used to help predict the occurrence of diseases and health conditions with a stronger understanding of the relationship between genes and illnesses.
This helps researchers identify potential gene variations or mutations that may increase the risk of developing an illness.
For instance, recent advancements in omics have allowed researchers to investigate the underlying tumour development processes of specific cancer types, examining these processes at a genome-level with translational research. This type of clinical research can lead to more targeted treatments based on the patient’s genetic make-up.
Epidemiological studies
Epidemiological studies investigate the distribution, causes and management of diseases and health conditions in specified populations. This is a type of clinical research that is most often associated with infectious diseases, but can also be applied to the study of non-infectious diseases.
For example, epidemiological studies may investigate how a new infectious disease is spreading, or environmental exposures that may trigger health conditions – such as air pollutants and asthma.
Pilot studies
Before the main clinical development process begins, investigators may firstly conduct a pilot study. Pilot studies are used to test the methods and feasibility of the proposed clinical research. This helps researchers identify potential challenges that may present themselves, and subsequently devise solutions to overcome these challenges.
Types of Clinical trials
Clinical trials are a major part of many types of clinical research. Clinical trials are designed to test treatment, prevention, diagnostic, or other types of clinical investigation on human patients and volunteers.
The results from clinical trials provide the basis for new treatment development and marketing, with solid data that proves the treatment is beneficial and is safe for human use. The overall safety and effectiveness cannot be accurately determined until human trials are complete. Clinical trials are made up of 3 different stages, starting at phase 1, and progressing to phase 3 trials.
Phase I trials: This phase of a clinical trial is predominately based around safety, where new treatments have various dosages tested to find out how much can be administered safely. Phase 1 trials usually have a very small cohort of participants, so each patient can be monitored carefully.
Phase II trials: When a drug is deemed safe to progress past the first phase, it is moved to phase 2 trials. This phase focuses on testing the efficacy of a drug or medical solution, to find if it is a viable solution. Often the number of participants in a phase 2 trial is much greater than in phase, sometimes numbering in the hundreds.
Phase III trials: Phase 3 is the final phase of the clinical trial process, and is based around comparing the effectiveness of the new treatment in comparison to existing solutions. The size of a phase 3 cohort is even bigger, and can sometimes be made up of thousands of participants.
Each clinical trial is tailored to the needs of the research. Broadly speaking, there are two main types of clinical trials: interventional and observational.
Interventional studies
Interventional studies are the most common type of clinical trial. Patients are administered a particular intervention or treatment by the trial investigator, which is then monitored and evaluated throughout the trial.
Clinical trials may investigate a new development drug, medical device, diet change, medical procedures, or other kind of intervention. Researchers will evaluate the safety and effectiveness throughout staged clinical trial phases.
Interventional clinical trials can compare new test treatments to existing treatments that are already available. This is to determine whether the new test treatment offers more benefits, or is less of a health risk than the existing standard treatments.
The outcomes of interventional clinical studies are used to determine whether the drug is approved for market use and distribution.
Observational studies
Observational studies are conducted by investigators to monitor the health outcomes of particular patient groups, without assigning any specific kind of intervention or treatment.
This contrasts the approach of interventional clinical trials, where investigators assign a particular intervention to patients. In observational clinical research, investigators do not intervene. This is used to examine possible cause and effect relationships that can help explain more about the disease.
For example, observational research may investigate the effects of age on a particular condition. In this case, investigators would monitor different age groups within a patient population and examine the relationship between these variables.
Multi-Arm Multi-Stage (MAMS) trials
A multi-arm multi-stage (MAMS) trial is a trial that is characterised by having both several different treatment groups and a control group to compare to. The control group for MAMS trials is always kept the same throughout the entire trial, in order to act as an accurate control, providing more reliable data. In comparison, the treatment groups can change as the trial progresses.
One of the main advantages to using a MAMS-based clinical trial model is that new research groups can be created as new drugs or treatments become available. This typically is much faster than starting a new trial from scratch, potentially allowing for achieving faster results.
Case control studies
During case control studies, researchers will select individuals with a disease, referred to as cases, and those without, which form the controls. They then retrospectively assess prior exposure to specific risk factors in each group.
To help enhance the reliability of the data, researchers will try to set up the study for group comparability in key factors, like age and gender, which helps to reduce some of the variables present.
While case control studies offer efficiency and cost-effectiveness, especially when compared to cohort studies, their findings can be less dependable. This is often due to reliance on participants’ recall accuracy regarding past exposures. Such recall bias can impact the outcomes significantly.
Cohort studies
Unlike case control studies, a cohort study investigates groups of people over an extended period of time. Researchers often start with individuals without a particular condition, such as cancer, and track them over time. They observe who within the cohort develops the condition and analyse commonalities among those who do.
These studies are invaluable for identifying risk factors, especially when trialling new drugs or medical treatments. However, cohort studies are resource-intensive and time-consuming, only making them more suitable when alternative testing methods are impractical.
Dose escalation Trials
Dose escalation trials are used to find the maximum dosage that can be used safely for a treatment or drug. During these trials, a small dose is used to start with, with its effects monitored and recorded. If this is deemed safe, then the next dose will be slightly increased in the next group of participants. This is repeated until the largest dosage that doesn’t cause harmful side effects is found.
Typically, dose escalation trials are included within phase 1 clinical trials, as a safe-level of dosage needs to be found before it can be tested on a large cohort.
Clinical research with Simbec-Orion
At Simbec-Orion, we have designed and organised an extensive range of clinical studies. As an agile CRO, we deal with complex clinical research projects, devising tailored study designs to help sponsors achieve the research objectives in the best way possible.
Through our agile clinical trial design approach, our team has worked with many types of clinical research, including treatment, diagnostic, quality of life studies and many more.
Find out more about how we can help you with our clinical research services or speak to an expert.