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What Is Clinical Research?

All research on humans is referred to as clinical research (healthy or sick people). To provide improved patient care, it focuses on enhancing illness understanding, creating diagnostic tools, and developing new treatments or medical equipment. It is highly well-defined and adheres to a strict study procedure, and it can only be carried out under specific circumstances. Clinical research is a branch of medicine that examines the safety and efficacy of drugs, equipment, diagnostics, and treatment regimens designed for human consumption. Clinical studies are used to accomplish this. Clinical trials are tests or observations conducted to answer specific issues, such as whether a new therapy or gadget is safe and helpful to patients (Kazdin, 2016). Clinical trials are lengthy, meticulous processes that might take years to complete from start to finish. Clinical trials involving drugs and technologies begin in the laboratory and may include animal testing. In case, a new treatment appears to be promising, it may be put to human testing in the form of a clinical study. Although trial participation is a personal choice, some patients with cancer or any other detrimental diseases want to participate because they desire accessibility to the most cutting-edge medicines being researched by researchers that may not be available elsewhere. Many people appreciate knowing that they will be regularly monitored by a study team and that they may be helping to develop breast cancer treatment in the future (Ioannidis, 2016).

What Is the Difference Between an Observational Clinical Research Study and a Clinical Trial?

Observational studies have a lot of usefulness because they are easier to complete and less expensive to run than clinical trials. When recruiting a significant number of patients for a long-term, placebo-controlled trial is challenging, as it often is with orphan diseases, databases like FOS (Fabry Outcome Survey) come in handy since they provide a big volume of patient data over a long period of time. Furthermore, the inclusion criteria are frequently broader, and the range of coexisting illnesses, disease severity, and concurrent treatments is generally broader. As a result, results from database research are frequently extended more broadly to the entire community (Bosdriesz et al., 2020).

A clinical trial is a human research study that aims to answer specific questions concerning novel therapeutics, vaccinations, or diagnostic procedures, as well as new ways to use existing treatments. After researchers have tested speculative novel medicines or procedures in the lab and on animals, the most promising ones are pushed into human clinical trials. Clinical trials are divided into several stages. During a study, researchers learn more about the prospective treatment, its risks, and how well it could or might not work, as well as factors of quality of life (Coates et al., 2018).

Role of Statistics in Clinical Trials

Clinical and statistical reasoning are both necessary for medical advancement. Clinical researchers must generalise from a small number of cases to a large number of cases, combining empirical evidence with theory. Empirical knowledge is derived from observations and data in both medical and statistical sciences. The foundations of medical thought are proven biology and assumptions. Mathematical and probabilistic models are used to derive statistical theory. One of the pillars of evidence-based clinical practise is biostatistical analysis, which is essential for conducting new clinical research. It assesses and applies existing research findings to new studies with precision. The demand for sophisticated biostatistics is growing by the day, with just about 10% of novel compounds reaching the market. Because it improves submission quality, it shortens schedules, lowers costs, and lowers risks (Patterson & Jones, 2017). Different important statistical methods are being used at all stages of the drug development process. During clinical research, biostatistics also helps to minimise fraud and unintended errors. Data fabrication, or making up data values, or falsification, or modifying data values, are both examples of fraud. According to the recorded examples, it entails cheating on the inclusion criteria to allow ineligible people to participate in the trial. Furthermore, by creating data, the relevant data for such incorrect inclusions is not lost. Biostatistics strategies are used in clinical studies to account for sources of variability in patients' reaction to treatment. It also enables researchers to make excellent conclusions in times of ambiguity by drawing logical and exact inferences from the collected data. It allows for the collection, analysis, presentation, and interpretation of data in a variety of fields like epidemiology, clinical trials, genetics of population (McDermid, 2021).

What Are Examples of Clinical Research?

People agree to explore novel medicines under strict supervision in therapeutic clinical trials to help doctors find the best treatments with the fewest negative effects. A therapeutic clinical trial may investigate a new treatment that has showed promise in laboratory studies, animal studies, or earlier clinical trials. It could also be used to evaluate new combinations of existing medicines, new types of surgery or radiation therapy, or novel treatment methods, such as dosage, timing, or delivery method (by mouth vs. through an IV, for example). Basket and umbrella trials are newer forms of therapeutic studies that are used to test new medicines in people who have tumours with similar gene mutations or biomarkers. Basket studies, also known as bucket trials, are clinical trials that enroll people with various tumours who share the same gene mutation or biomarker. People with the same type of cancer — such as breast cancer — but distinct gene mutations or biomarkers that may have a role in the cancer's development are enrolled in umbrella studies. Non-therapeutic clinical trials look into ways to improve cancer detection and diagnosis, prevent the disease from forming or recurring, reduce side effects, and improve the quality of life of cancer patients (Piantadosi, 2017).

How Many Phases Are in Clinical Trial?

Clinical trials for new medicines are separated into stages, which are referred to as phases. Early phase trials may examine whether or not a medicine is safe, as well as the side effects it creates. Later-stage trials are designed to see if a new treatment is superior to established treatments. Clinical trials are divided into three phases: phase 1, phase 2, and phase 3. The earliest phase studies are phase 1, and the most recent phase trials are phase 3. Some trials have a phase 0 stage, and some phase 4 trials are conducted after a medicine has been approved (Piantadosi, 2017).

References

Bosdriesz, J. R., Stel, V. S., van Diepen, M., Meuleman, Y., Dekker, F. W., Zoccali, C., & Jager, K. J. (2020). Evidence‐based medicine—When observational studies are better than randomized controlled trials. Nephrology, 25(10), 737-743.

Coates, L. C., Tillett, W., Shaddick, G., Pincus, T., Kavanaugh, A., & Helliwell, P. S. (2018). Value of the routine assessment of patient index data 3 in patients with psoriatic arthritis: results from a tight‐control clinical trial and an observational cohort. Arthritis care & research, 70(8), 1198-1205.

Ioannidis, J. P. (2016). Why most clinical research is not useful. PLoS medicine, 13(6), e1002049.

Kazdin, A. E. (2016). Methodological issues and strategies in clinical research. American Psychological Association.

McDermid, R. (2021). Statistics in clinical trials. Anaesthesia & Intensive Care Medicine.

Patterson, S., & Jones, B. (2017). Bioequivalence and statistics in clinical pharmacology. Chapman and Hall/CRC.

Piantadosi, S. (2017). Clinical trials: a methodologic perspective. John Wiley & Sons.