Pharmaceutical Medicine最新文献

Clinical experts are embracing the use of social media platforms for medical education, outreach, data sharing, and content dissemination within the medical community. In this interview, Dr. Khoi Than, a specialist in minimally invasive spinal surgery explains his role as a content creator and curator on social media platforms and describes how he uses surgical videos and opinion polls to educate and explore decision making behind surgical interventions. Dr. Than shares neurosurgery and spinal surgery techniques in the USA and internationally with trainees using interactivity and images to engage his followers. He believes that the ability to share operative techniques and research findings widely and instantly at the click of a button offers substantial benefits for patients. In this interview, Dr. Than reflects on how he engages with peers, students, and patients, how digital opinion leaders are making research more accessible, how social media has affected virtual conferences, and what advantages digital opinion leaders have over traditional key opinion leaders.

Aggregate safety assessment involves evaluation of the totality of safety data to characterize the emerging safety profile of a product. The Drug Information Association-American Statistical Association Interdisciplinary Safety Evaluation scientific working group recently published an approach to developing an Aggregate Safety Assessment Plan (ASAP). Creation of an ASAP facilitates a consistent approach to safety data collection and analysis across studies and minimizes important missing data at the time of regulatory submission. A critical aspect of the ASAP is identification of the Safety Topics of Interest (STOI). The STOI, as defined in the ASAP, comprises adverse events (AEs), which have the potential to impact the benefit: risk profile of a product and typically require specialized data collection or analyses. While there are clear benefits to developing an ASAP for a drug development program, multiple concerns may be encountered with implementation. This article uses the examples of two STOIs to demonstrate the benefits and efficiencies gained with implementation of the ASAP in safety planning as well as in optimally characterizing the emerging safety profile of a product.

Background: Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African continent, this is partly due to capacity limitations of National Regulatory Authorities (NRAs). One important approach to address this issue is work sharing and regulatory reliance. Therefore, the aim of this study of regulatory authorities on the African continent was to identify which risk-based approaches are being used as well as their foreseen role in the future.

Methods: The study employed a questionnaire to identify which risk-based models are used for the regulatory approval of medicines and to determine which frameworks are in place to enable a risk-based approach, as well as to provide insight into the future direction for risk-based models. The questionnaire was sent electronically to 26 NRAs in the African Continent.

Results: Twenty-one authorities (80%) completed the questionnaire. Work sharing was the most commonly used model, followed closely by unilaterial reliance, information sharing, and collaborative review. These methods were perceived to be an effective and efficient use of resources, enabling faster medicine availability for patients. The unilateral reliance approach by the authorities included abridged (85%), verification (70%) and recognition (50%) models for a range of products. However, challenges included a lack of guidelines to undertake a reliance review together with resource constraints, while access to assessment reports was the most common barrier to using a unilateral reliance model.

Conclusions: Many authorities in Africa have adopted a risk-based approach to medicines registration and created work sharing, unilateral reliance pathways and regionalisation models to facilitate the availability of medicines. The authorities believe that in future, assessment routes should move from stand-alone reviews to risk-based models. However, this study indicated that there would be challenges to implement this approach in practice, which would include improving resource capacity and the number of expert reviewers as well as implementing electronic tracking systems.

Suicide is a serious and growing public health concern yet randomized controlled trials (RCTs) that inform pharmacologic treatment remain limited. We emphasize the overall need for such trials and review the literature to highlight examples of trials that have aimed to study patients at elevated risk of suicide. We discuss key examples of existing psychotropic medication trials as well as psychotherapy intervention studies that can yield important design insights. Medications that have been studied in individuals at risk for suicide include lithium, clozapine, zolpidem, prazosin, ketamine, esketamine, and aripiprazole. While important design challenges should be considered-RCTs to study suicide are feasible and much needed. Issues such as overall trial design, patient-selection criteria, and the scales/tools used to assess suicidality are discussed.

Multiple components factor into the assessment of combination safety risks when two or more novel individual products are used in combination in clinical trials. These include, but are not limited to, biology, biochemistry, pharmacology, class effects, and preclinical and clinical findings (such as adverse drug reactions, drug target and mechanism of action, target expression, signaling, and drug-drug interactions). This paper presents a science-based methodology framework for the assessment of combination safety risks when two or more investigational products are used in clinical trials. The aim of this methodology framework is to improve prediction of the risks, to enable the appropriate safety risk mitigation and management to be put in place for the combination, and the development of the project combination safety strategy.

The approach to patient engagement (PE) in drug development has changed rapidly due to many factors, including the complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients, the desire to show 'value add' of PE, and the pandemic-related changes to how clinical trials are run, e.g., decentralised studies. In parallel, there have been changes in technology-assisted ways of running clinical trials, capturing patient health outcomes and preferences, an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability. Organisations are beginning to monitor PE activities and outcomes more effectively to learn and inform future PE strategies. As a result, these factors are facilitating the incorporation of patients' lived experience, preferences and needs into the design and running of clinical trials more than ever before. In this paper, the authors reflect upon these last few years, the emerging trends and their drivers, and where we may expect PE in clinical research to progress in the near future.

The incidence of cardiovascular diseases has significantly increased with the expansion of the industrialization of societies, which is notably linked to lifestyle changes and an unhealthy diet. Hence, determining the healthiest diet habits and supplements seems to be an appropriate way to decrease the global burden of cardiovascular diseases. Currently, caffeine, one of the most widely consumed compounds in the world, has emerged with some promising results in the treatment of numerous pathophysiological conditions of cardiovascular diseases. A literature search was conducted in PubMed, Scopus, Science Direct, Google Scholar, and Web of Science databases for the relevant articles regarding the pharmacology, preclinical, and clinical studies on the potential effects of caffeine on cardiovascular diseases. While caffeine could improve cardiovascular outcomes through several mechanisms of action, the literature review revealed controversial clinical effects of caffeine on blood pressure, cardiac arrhythmias, acute coronary syndrome, stable angina, and heart failure. In the case of dyslipidemia, coffee consumption increased total cholesterol, triglyceride, and low-density lipoprotein. Taken together, the existence of multiple confounding factors in the caffeine studies has resulted in inconclusive data interpretation. Further well-designed studies with adequate control of the confounding factors are warranted to draw a clear conclusion on the cardiovascular efficacy and safety of caffeine.

Customer experience (CX) is essential in any business. In the pharmaceutical industry, the Medical Information Contact Center is a customer-facing unit that provides evidence-based, scientifically balanced information to healthcare professionals and patients in response to unsolicited inquiries. The purpose of this paper is to provide analysis and guidance for designing and measuring interactions in the Medical Information Contact Center to facilitate the delivery of a superior and continuously improving CX. Surveys were conducted to establish current trends in CX among a diverse group of CX professionals and members of phactMI, a non-profit collaboration of Medical Information leaders from the pharmaceutical industry. The top three observations from the CX professionals survey centered on establishing a clear CX strategy, use of technology, and frequency of sharing results. Three potential areas for improvement focus on CX strategy, measurements of CX, and sharing of results. An analysis of quality monitoring results of customer interactions in the pharmaceutical industry from Centerfirst, a contact center quality monitoring service provider, was also reviewed. This analysis found a positive correlation between CX and three agent skills: taking the lead, empathy, and strong compliance skills. Based on these results, a CX guide was developed and specifically tailored for the pharmaceutical industry. This tool may be used to help identify, assess, and possibly improve CX.

An ongoing and increasing shift is occurring in ways in which the healthcare community (healthcare providers, patients, biopharma) disseminates and consumes information. Adoption of digital technologies, accelerated by the virtual environment created by the COVID-19 pandemic, are leading to new and innovative ways in which medical and scientific information and data are communicated. Digital technologies have largely enabled these approaches and led to an explosive increase in availability of information. This article describes considerations in how the healthcare community, and Medical Affairs organizations in biopharma, can effectively harness these channels to communicate effectively, and incorporate changes in behaviors and approaches to redefine what medical information and data look like.