There is numerous terminology when it comes to research and trials; Kyara Bergstrom breaks down the basics for us.
Many patients believe that clinical research involves only the testing of new medications or devices. Though, let’s look at the definition of clinical: “Relating to the observation and treatment of actual patients rather than theoretical or laboratory studies.” Hence, clinical trials.
With this said, healthy volunteers are also needed so that researchers can compare their results to the results of the patients with the illness being studied.
Types of research
- Treatment research can be an intervention, such as medication, new devices, or new approaches to surgery.
- Prevention research looks at ways that can potentially prevent disorders from developing or returning. This may include medicines, vitamins, vaccinations, etc.
- Diagnostic research looks for better ways to diagnose disorders or conditions.
- Screening research looks for new ways to detect conditions or diseases.
- Quality of life research aims to improve the life of someone who is chronically ill or has a terminal illness.
- Genetic studies help us understand how certain genes can predispose a patient to a certain illness or disease. This can lead to treatments that help these diseases or illnesses.
- Epidemiological studies identify the patterns, causes, and control of disorders in groups of people.
Learn the lingo
- Multi-arm multi-stage (MAMS) trials are trials that have different treatment groups (arms) as well as a control group (untreated group) that stays throughout the whole trial. Though, the treatment groups can change.
- Cohort studies look at groups of people over a certain period. This is useful for finding out risk factors
- Case-control studies look at two groups: patients with the disease and people without the disease (controls).
- Cross-sectional studies can be carried out over a short period of time. For example, they observe who has been exposed to a certain risk factor, who developed cancer, and examine if there is a link between the two.
- Meta-analysis study combines data from many different research studies.
- Systematic review is a summary of clinical literature that is about a clinical issue.
Understanding the phases of trials
These usually involve only a small group of people to see if the drug acts the way it’s expected to from the laboratory studies. It is normally a small dose of the drug.
This may be done to see if the drug reaches cancer cells and how the body reacts to the drug, etc.
These are small trials, with a few patients, and tend to be patients with advanced cancer who have tried all available treatments. This trial may be done to see how much of the drug is safe, what side effects it causes, and if the treatment works for the cancer.
Some of the treatments tested in Phase 1 don’t always make it to Phase 2. This phase of trial can be for patients with the same type of cancer, or for people with different types of cancer. Their aim is to see what types of cancer will the treatment work for, get more information about side effects, and the dosage needed.
Phase 2 trials can be randomised trials which means patients will be put into different groups at random.
These trials compares the new treatment to the current available treatments. This trial is done to see which treatment works better, how it affects quality of life, etc. This phase needs many patients to show the differences.
The last phase is when the treatment has been shown to work and has been licensed (approved). This phase is to see how well the treatment works when used widely and any long-term risks.
Ethics and consent
Ethics and consent of trials are imperative. They ensure the safety of the patient and that decisions made are unbiased. Consent is vitally important to ensure the patient understands the study and any potential risks (if any).
Consent is normally in writing and the patient is counselled regarding the trial or study and is given the opportunity to ask any questions before giving consent.
MEET OUR EXPERT – Kyara Bergstrom
Kyara Bergstrom is the head of research at Netcare Breast Care Centre. She is also the COO of the Pink Parasol Project (www.pinkparasol.co.za), a website-based directory listing conventional and complementary therapists and practitioners.