Exploration of early food effect study of innovative drugs based on physiologically-based pharmacokinetic absorption model / 中国临床药理学与治疗学

Since the impact of food on innovative drugs exposure will increase the risk of evaluation failures for safety and effectiveness, food effect study is routinely completed before multiple ascending dose (MAD) trials for innovative drugs. The prediction performance of physiologically-based pharmacokinetic absorption model (absorption PBPK model) in the application of food effect prediction has improved, we proposed a new strategy to explore food effect based on the absorption PBPK model. Based on the accurate prediction by absorption PBPK model, the food effect studies for qualified innovative drugs would be nested in MAD clinical trials to intend replacing the early independent food effect study. That would be promising to reduce costs and time for drug development, and also to provide the template for early food effect study in China.

The role of modeling and simulation in pediatric clinical trials / 国际药学研究杂志

Children’ s ability to dispose of drugs and the efficacy/safety of drugs for children differ from those adults as children are in the process of growth and development. In general,medication for children in a certain age group should be supported by clinical trial data from the corresponding pediatric population. However,compared with clinical trials in adults,children’s clinical trials have many challenges such as the ethical limitation and the difficulty in enrolling subjects. As a result,the use of drugs for children is often not formally approved by the drug regulatory authori- ties. At present,researchers tend to apply modeling and simulation to clinical trials,and conduct prospective studies be- fore the clinical use of drug to predict the optimal dosage regimen for children of different ages. In particular,there have been several successful cases in determining the optimal sample size for clinical trials based on the optimal design theory, optimizing sampling time point using the prior information from modeling,and processing sparse data by the Bayesian principle. This paper summarizes the role of modeling and simulation in pediatric clinical trials by reviewing previously reported clinical trial literature.

The problem of medicating women like the men: conceptual discussion of menstrual cycle-dependent psychopharmacology

While hormonal changes during the ovulatory cycles affect multiple body systems, medical management, including medication dosing remains largely uniform between the sexes. Little is known about sex-specific pharmacology in women. Although hormonal fluctuations of the normal menstruating process alters women's physiology and brain biochemistry, medication dosing does not consider such cyclical changes. Using schizophrenia as an example, this paper illustrates how a woman's clinical symptoms can change throughout the ovulatory cycle, leading to fluctuations in medication responses. Effects of sex steroids on the brain, clinical pharmacology are discussed. Effective medication dose may be different at different phases of the menstrual cycle. Further research is needed to better understand optimal treatment strategies in reproductive women; we present a potential clinical trial design for examining optimal medication dosing strategies for conditions that have menstruation related clinical fluctuations.

Discussion on Clinical Trial Design of Artificial Hip Prosthesis / 中国医疗器械杂志

Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.

Función de la estadística en el contexto de los ensayos clínicos / Role of statistics in the clinical trials

La complejidad y los elevados costos que se asocian al desarrollo de medicamentos han impuesto la búsqueda de estrategias más eficientes que combinen reducción de tiempo con calidad de investigación. La metodología estadística tiene una función fundamental en este proceso. En el presente trabajo se realiza una revisión bibliográfica de la función de la estadística en las investigaciones terapéuticas, cuyos objetivos consisten en describir cómo interviene la estadística en los ensayos clínicos y exponer algunos avances y retos que enfrenta el bioestadístico en el contexto actual del desarrollo de estos estudios. Se describe el proceso estadístico dentro del ensayo clínico desde un punto de vista práctico, exigencias regulatorias y disposición documental. Se exponen algunos temas metodológicos específicos y técnicas estadísticas desarrolladas con aplicaciones en estos estudios. En conclusión, la metodología estadística en los ensayos clínicos ha experimentado un desarrollo creciente en los últimos años. Las investigaciones proponen el uso de diseños flexibles que dinamizan los estudios y métodos de análisis más sensibles. Las entidades regulatorias establecen guías en estos temas que orientan para la presentación armonizada de ensayos clínicos ante diversas situaciones. La aplicación de técnicas estadísticas más sensibles y el uso de la tecnología que sustenta estos avances es un tema en desarrollo y con creciente presencia en la literatura de ensayos clínicos

The complexity and high costs associated to the development of drugs have brought about the search for more efficient strategies combining time saving and research quality. The statistical methodology plays a fundamental role in this process. The present paper made a literature review of the role of statistics in therapeutic research. The objectives were to describe how statistics participate in the clinical trials and to present some advances attained as well as the challenges met by the biostatician in the present context of development of these studies. The statistical process was described in the clinical trial from the practical viewpoint, including regulatory demands and documentary availability. Some specific methodological topics as well as application-developed statistical techniques were presented. It was concluded that the statistical methodology in clinical trials has experienced growing development in the last few years. The research suggested the use of flexible designs that would speed up the most sensitive studies and methods of analysis. The regulatory bodies set guidelines that give instructions for the harmonized presentation of clinical trials under various circumstances. The application of more sensitive statistical techniques and the use of technologies supporting these advances is a subject that is increasingly dealt with by the scientific literature on clinical trials

The Role of Stereotactic Ablative Radiotherapy for Early-Stage and Oligometastatic Non-small Cell Lung Cancer: Evidence for Changing Paradigms / Journal of the Korean Cancer Association, 대한암학회지

A compelling body of non-randomized evidence has established stereotactic ablative lung radiotherapy (SABR) as a standard of care for medically inoperable patients with peripheral early-stage non-small cell lung cancer (NSCLC). This convenient outpatient therapy, which is typically delivered in 3-8 fractions, is also well tolerated by elderly and frail patients, makes efficient use of resources and is feasible using standard commercial equipment. The introduction of lung SABR into large populations has led to an increased utilization of radiotherapy, a reduction in the proportion of untreated patients and an increase in overall survival. In selected patients, the same ablative technology can now achieve durable local control of NSCLC metastases in a variety of common locations including the adrenal glands, bone, brain, and liver. At the same time as this, advances in prognostic molecular markers and targeted systemic therapies mean that there is now a subgroup of patients with stage IV NSCLC and a median survival of around 2 years. This creates opportunities for new trials that incorporate SABR and patient-specific systemic strategies. This selective mini-review focuses on the emerging role of SABR in patients with early-stage and oligometastatic NSCLC.

How to Design a Clinical Trial for Spinal Cord Injury / 中国康复理论与实践

@#The most rigorous and valid spinal cord injury(SCI)clinical trials would be a prospective,double-blind,randomly,control one.The design and conduct of SCI clinical trials should meet appropriate standards to make it of efficacy and safety,trustworthy,and in the best interests of subjects.