A new medicine may start out in a laboratory but there is a long road between a promising discovery and something that can be used with patients. Clinical trials are the next stage in that journey.
Not every trial asks the same question. One study might ask, “Can this treatment prevent a disease?” Another may ask if a new diagnostic test can find a disease earlier. Another is comparing a new treatment to standard of care.
That is why the types of clinical trials are really important in research and healthcare professionals and in business plans for pharmaceutical, biotechnology and healthcare companies; and in patients’ health.
What Are Clinical Trials?
A clinical trial is a research study in which researchers prospectively assign participants to one or more interventions to assess impact on health at a clinical level.
Interventions might be medicines, medical devices, procedures, behaviour or other treatments.
The type of trial selected depends largely on the research question. For instance, if researchers want to know whether a new medicine works, they have to look into how a disease naturally progresses differently than they would do for this disease.
Major Types of Clinical Trials by Purpose
Clinical trials have to be structured according to what researchers want to know. Treatment, prevention, diagnostic, screening, behavioral and quality-of-life trials are the main categories.
Treatment trials
Treatment trials look at new or improved approaches to treatment of a disease or medical condition.
They may evaluate:
- New medicines.
- New combinations of medicines.
- Medical devices.
- Surgical approaches.
- Other treatments.
Depending on the study design, researchers may compare an investigational treatment with an existing treatment, placebo, or other appropriate control.
Prevention trials
Prevention trials are those that aim to prevent disease or an existing disease from re-emerging.
The intervention might involve medicine, vaccine, lifestyle intervention or another preventive initiative.
In these studies, people who are at risk of developing the disease can be used.
Diagnostic trials
A diagnostic clinical trial tests new strategies or means of detecting a disease or condition.
Researchers could examine if a new diagnostic test can detect a condition more accurately or provide useful information than an existing method.
Not necessarily to treat the patient—but to improve how a disorder can be detected.
Screening trials
Screening trials look for ways of finding a disease or health problem that might not show up immediately.
This is especially important to healthcare professionals when earlier detection may help them to make better decisions on follow-up care.
Behavioural trials
Behavioural trials are those which aim to impact behaviours connected to health.
Not every clinical trial involves a drug. These may be lifestyle, adherence, physical activity, diet or other behavioural factors.
The interventions and study design depend on the research question.
Quality-of-Life Trials
Living with chronic or serious illness is about more than whether a treatment modifies laboratory values or disease markers.
Quality-of-life (or supportive-care) trials investigate strategies that can improve comfort, functioning and quality of life for people living with illness.
Interventional vs Observational Studies
Another important distinction is whether researchers actually assign an intervention.
Interventional clinical trials
Participants are given an intervention according to the research protocol in an interventional study. Researchers then analyze the outcomes.
Randomized controlled trials are some of the most important forms of interventional research.
In a randomized study, participants are assigned to groups by chance rather than according to their or the researcher’s preference.
Observational studies
In an observational study, researchers collect and analyze information without assigning participants to a specific intervention.
Researchers might follow a group of patients over time and study how a disease gets worse or what factors are involved in health outcomes.
Observational studies can lead to hypotheses and also provide useful real-world information, but they cannot establish cause and effect in the same way as a well-designed randomized trial.
Other Ways Clinical Trials Can Be Classified
You may also see terms like:
- Randomized trials: Participants are assigned to treatment groups by chance.
- Controlled trials: The outcome is compared with a control group or another intervention.
- Blinded or masked trials: In such a way that participants, researchers or both are not told about treatment assignment to eliminate bias.
- Open-label trials: Participants and researchers are told which intervention is being administered.
These characteristics can be combined. A treatment trial can be randomized and double-blinded, for example.
Types of Clinical Trials vs Clinical Trial Phases
A common misconception is the difference between trial type and trial phase. They are not the same thing.
A trial’s type describes the area of inquiry investigators are trying to investigate (treatment, prevention, diagnosis, etc.).
A trial’s phase is the stage of development for a trial.
Phase I, II and Phase III clinical development generally proceed through Phase IV after approval in the appropriate setting.
Safety, effectiveness, and longer-term information are different in each phase.
This difference is very important when pharmaceutical companies are planning for clinical development.
Why Choosing the Right Clinical Trial Design Matters
A good research question needs a good study design.
And so sponsors and research teams need to take into account factors like:
- The aim of the study.
- The patient population of the study.
- Primary and secondary outcomes.
- Intervention and comparator.
- Participant eligibility.
- Study duration.
- Data collection requirements.
- Safety monitoring.
- Statistical considerations.
- Regulatory and ethical requirements.
A clinical trial protocol is a detailed approach for conducting the study and addressing the research questions while keeping participants safe.
And this is also where companies that need to work with a clinical trial company can find professional assistance for clinical research planning, execution and documentation and related activities.
Choosing Clinical Trial Support for Your Development Programme
For pharmaceutical, biotechnology and healthcare organisations, clinical research is much more than recruiting and collecting data.
Planning, study management, monitoring, documentation, data handling and regulatory requirements should be taken into account before hiring personnel for the study.
FrontroPharma offers clinical research and clinical trial support services in India and works with companies according to product, development status and study needs.
It provides services for planning, management, conducting, monitoring and documenting clinical research activities.
Need CRO Services? Talk to FrontroPharma.
If your organisation is planning a clinical research programme and looking for CRO services in India, contact FrontroPharma to discuss your needs.
Whether you’re developing a pharmaceutical product, healthcare intervention or another research project, the right clinical research support will help you to structure the next step of development around your specific objectives.
Contact FrontroPharma to discuss your CRO and clinical research requirements.
