Rethinking Clinical Research – towards more inclusive, innovative, and sustainable patient-centered clinical trials developed in partnership with patients

Christine Kubiak, PharmD, PhD, EMBA

Klin Farmakol Farm. 2026;40(2):76  

Potentially inappropriate drugs in patients with chronic ischemic heart disease

Mária Kolesárová, Martina Dobrovičová, Dalibor Kolesár

Klin Farmakol Farm. 2026;40(2):77-86 | DOI: 10.36290/far.2026.003  

As a result of population aging, the rate of polymorbidity and the associated polypharmacy and polypragmasia are increasing. There is an increased risk of drug interactions, adverse effects, and the likelihood of inappropriate drug use in the elderly population. The aim of this retrospective study was to analyze the medication history of older adult patients with chronic ischemic heart disease (IHD) and to identify potentially inappropriate medications (PIMs). Data were collected over a one-month period from the prescription records of patients who were institutionalized in a social services home. PIMs were identified according to the current Beers...

Luna - a software tool for data transfer from admission note to medication chart

Marek Pecha

Klin Farmakol Farm. 2026;40(2):87-91 | DOI: 10.36290/far.2026.019  

The admission report is a fundamental document that a physician creates when admitting each patient for hospitalization. Manually transcribing data from the admission report into the medication chart (so-called "temperature chart") is time-consuming and represents a potential source of errors. Medication errors are among the most common adverse events in hospital care, and a significant proportion of them occur during the prescribing and refilling of medications, including incomplete or illegible prescriptions. The author presents a software tool called Luna, which automatically transfers key information from the admission report into a medication...

Clinical trials: The evolution of the traditional phase-based approach in contemporary clinical research

Lenka Součková, Veronika Kunešová, Adriána Papiež, Hana Blahynková

Klin Farmakol Farm. 2026;40(2):92-96 | DOI: 10.36290/far.2026.017  

Clinical trials represent a key component of the development of medicinal products and a fundamental source of evidence for evidence-based medicine. Traditionally, the clinical development of medicines has been described through four sequential phases of clinical trials (I-IV), reflecting the stepwise evaluation of safety, dosing, efficacy, and post-marketing surveillance after a medicinal product is introduced to the market. This model has long served as both a regulatory and educational framework for clinical research. However, in recent decades the clinical development of medicines has undergone significant changes. In practice, sub-phases of clinical...

Innovative clinical trial designs

Adriána Papiež, Lenka Součková, Jitka Rychlíčková

Klin Farmakol Farm. 2026;40(2):97-101 | DOI: 10.36290/far.2026.024  

Innovative clinical trial designs represent an important shift in the methodology of clinical research, reflecting the growing complexity of diseases, the development of personalized medicine, and the emergence of advanced therapy medicinal products. In addition to traditional randomized controlled trials, approaches such as adaptive designs, master protocols or single-arm studies are increasingly being used, enabling more flexible and targeted evaluation of new therapeutic interventions. They may accelerate the identification of effective therapies and improve the efficiency of resource utilization; however, they also introduce methodological and...

Inclusivity in clinical trials: barriers and their potentional solutions

Hana Kocourková, Jitka Rychlíčková

Klin Farmakol Farm. 2026;40(2):102-107 | DOI: 10.36290/far.2026.022  

Inclusivity in clinical research is an important prerequisite for obtaining relevant results applicable to routine clinical practice. Clinical research should therefore include partici­pants who accurately represent the target population across a range of characteristics. However, certain patient groups remain under-represented in clinical trials. The so called under-served populations often include older adults, ethnic minorities, patients with multiple comorbidities, and socioeconomically disadvantaged individuals. Their limited participation may be due to methodological and organizational barriers inherent in the study design. This review article...

Environmentální udržitelnost v klinickém výzkumu

Michaela Beníšková, Jitka Rychlíčková

Klin Farmakol Farm. 2026;40(2):108-111 | DOI: 10.36290/far.2026.021  

Skleníkové plyny zásadně ovlivňují globální klima. Sektor zdravotní péče představuje jeden z významných zdrojů emisí CO₂, v celosvětovém měřítku se řadí na páté místo. Klinický výzkum je jeho nedílnou součástí; přináší inovace, ale i další environmentální zátěž. Snaha minimalizovat uhlíkovou stopu proto prostupuje i do metodologie a designu klinických studií a klinického výzkumu jako celku. Prvky jako digitalizace a decentralizace klinických studií mohou přispět ke snižování environmentální zátěže. Stále jde ale spíše o předpoklad podložený omezenými daty. K dosažení udržitelnějších metodik je třeba cílenější kvantifikace a identifikace klíčových...

Patient and Public Involvement in clinical research: from regulatory requirements to partnerships with patients

Hana Blahynková, Lenka Součková, Adriána Papiež

Klin Farmakol Farm. 2026;40(2):112-115 | DOI: 10.36290/far.2026.025  

In recent years, clinical research has increasingly focused on the systematic involvement of patients and the public (Patient and Public Involvement, PPI), with patients no longer viewed merely as study participants but also as active partners contributing to research planning. This approach enhances the relevance of research questions, improves the feasibility of studies, and increases the applicability of their results in clinical practice. The principles of patient involvement are reflected in modern methodological and regulatory frameworks, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human...

Proton pump inhibitors: rational prescribing and long-term safety in children

Jana Tomanová, Petra Rozsívalová, Rita Halašová, Josef Malý, Jan Melek

Klin Farmakol Farm. 2026;40(2):116-123 | DOI: 10.36290/far.2026.009  

Proton pump inhibitors (PPIs) are among the most commonly prescribed drugs in paediatrics, with their prescription rates having significantly increased in recent years. Although effective for indications such as gastroesophageal reflux disease, peptic ulcers, or eosinophilic esophagitis, concerns remain regarding their safety, dosing, and frequent off-label use, especially in infants and newborns. This article provides a comprehensive overview of the pharmacological properties of PPIs in the pediatric population, focusing on the specifics of pharmacokinetics and pharmacodynamics in different age groups. It considers the influence of CYP2C19 genetic...

Specifics of corticosteroid administration in patients with central nervous system diseases with a focus on neurointensive care

Lucie Sauerová

Klin Farmakol Farm. 2026;40(2):124-128 | DOI: 10.36290/far.2026.008  

Corticosteroids (CST) play a key role in the treatment of oncological, infectious, and autoimmune diseases of the central nervous system (CNS). CST reduces inflammatory processes and is used mainly to reduce brain edema and intracranial pressure, thereby significantly improving the quality of life of patients. They are also administered as substitution therapy in the context of a functional deficit of the pituitary gland or hypo­thalamus. Administration is not indicated universally in all patients. Before use, we should evaluate the risk/benefit, i. e., the severity of the clinical manifestations of the disease and the risk of adverse effects, and...

The role of glucocorticoids in endocrinology

Pavel Cee, Jan Drugda, Filip Gabalec

Klin Farmakol Farm. 2026;40(2):129-133 | DOI: 10.36290/far.2026.007  

Glucocorticoids represent a fundamental group of hormones that play a key role in the regulation of metabolism, immune response, and adaptation to stress. Their widespread use in medicine is based on potent anti-inflammatory and immunosuppressive effects; however, long-term therapy is associated with the risk of serious adverse effects. This article focuses on hypercortisolism, both in the form of endogenous Cushing's syndrome and the more frequent exogenous form related to long-term glucocorticoid administration. Clinical manifestations, diagnostic procedures, and current therapeutic options including surgical, pharmacological, and radiotherapeutic...

Over-the-counter products, SARMs and dietary supplements as hidden causes of male hypogonadism and subfertility: a clinical overview and practical management

Marek Broul, Aneta Hujová, Kateřina Langmaierová

Klin Farmakol Farm. 2026;40(2):134-138 | DOI: 10.36290/far.2026.004  

Objective: To summarize clinically relevant exposures to over-the-counter (OTC) products and dietary supplements that may cause secondary hypogonadism and impaired male fertility, and to propose a pragmatic diagnostic and management pathway relevant to Czech clinical practice. Methods: Narrative review with targeted searches of MEDLINE/PubMed, Embase and the Cochrane Library (2000-2025), complemented by regulatory sources (FDA, WADA) and Czech resources on dietary supplement oversight and nutrivigilance. Results: Selective androgen receptor modulators (SARMs) carry the highest risk of suppressing the hypothalamic-pituitary-gonadal axis and remain prohibited...