Critical path activities in clinical trial setup and conduct: How to avoid bottlenecks and accelerate clinical trials.

Most clinical trials are delayed due to scientific and/or operational challenges. Any effort to minimize delays can generate value for patients and sponsors. This article reviews critical path process steps commonly identified by practitioners, such as during protocol development, site contracting, or patient recruitment. Commonly considered measures, such as adding more trial sites or countries, were contrasted with less frequented measures, such as evidence-based feasibility or real-world evidence analysis, to help validate assumptions before clinical trial initiation. In a broad analysis, we integrated a literature review with a practitioner survey into a framework to help decision makers on the most critical process steps when setting up or conducting clinical trials in order to bring critical treatments to patients faster.

Trends, challenges, and success factors in pharmaceutical portfolio management: Cognitive biases in decision-making and their mitigating measures.

Effective portfolio management is crucial for innovation and sustaining revenue in pharmaceutical companies. This article holistically reviews trends, challenges, and approaches to pharmaceutical portfolio management and focuses, in particular, on cognitive biases in portfolio decision-making. Portfolio managers strongly rely on external innovation and face increasing competitive pressure and portfolio complexity. The ability to address biases and make robust decisions remains a challenge. Portfolio management practitioners most commonly face confirmation bias, champion bias, or misaligned incentives, which they seek to mitigate through expert input, team diversity, and rewarding truth-seeking. Ultimately, highest-quality portfolio management decision-making could be enabled by three factors: high-quality data, structured review processes, and comprehensive mitigating measures against biases in decision-making.

There's an app for that, but nobody's using it: Insights on improving patient access and adherence to digital therapeutics in Germany.

Background: Mobile health applications and their subset digital therapeutics-defined as evidence-based software interventions to prevent, manage, or treat a medical condition-offer great potential to improve patient care. However, such solutions often struggle to reach widespread adoption. Objective: This study seeks to explore healthcare stakeholders' roles and potential for fostering patient access and adherence to evidence-based digital therapeutics and thereby improve health outcomes from the perspective of digital therapeutics developers and distributors. Methods: Semi-structured qualitative and semiquantitative interviews were conducted with 19 experts from developers and distributors of digital therapeutics in Germany to discuss their perceived relevance of different healthcare stakeholders and strategies in promoting patient access and adherence to digital therapeutics. Results: Healthcare professionals were found to have the greatest potential to promote both access and patient adherence to digital therapeutics, followed by health insurers, pharmaceutical companies, and patients themselves. In terms of patient access, healthcare professionals have potential due to their ability to prescribe digital therapeutics. Other stakeholders' potential stems from their capacity to influence healthcare professionals prescription decision. In terms of patient adherence, only healthcare professionals are of high relevance by onboarding patients and monitoring digital therapeutics use. Most healthcare stakeholders currently do not fully leverage their potential. Further educating healthcare professionals and simplifying processes for them, empowering patients to seek treatment with digital therapeutics, and designing digital therapeutics' product features for better adherence can help improve patient access and adherence. Conclusions: Established healthcare stakeholders and digital therapeutics developers both need to take action to improve patient access and adherence to digital therapeutics. Several macro-level changes can support these efforts, including broader information dissemination, improved financial incentives, simplified prescription and activation processes, and a wider adoption of blended care and pay-for-performance payment models.

Toward the institutionalization of quantum computing in pharmaceutical research.

Innovative pharmaceutical companies have started to explore quantum computing (QC). In this article, we provide a collective industry perspective from QC domain leaders at leading pharmaceutical companies. There are immediate nonfinancial benefits in engaging with QC, some likely financial returns in the short term in drug development, manufacturing, and supply chain, and potentially large scientific benefits in drug discovery long term. We discuss the required activities for institutionalizing QC: how to create an understanding of QC among researchers and management, which and how to deploy external resources, and how to identify the problems to be addressed with QC. If (and once) deployable, QC will likely have a similar trajectory to that of computer-aided drug design (CADD) and artificial intelligence (AI) during the 1990s and 2010s, respectively.

Perspective of German medical faculties on digitization in the healthcare sector and its influence on the curriculum.

Background: The German healthcare sector is in the process of being disrupted by digitization. Universities are asked to reflect on the consequences and develop strategies to prepare their medical students for a digitalized health care sector. The current state of research does not systematically record the associated activities of individual medical faculties in Germany. Objective: This study was designed to survey the status-quo of how German medical faculties view the digitization progress and to what extend digital capability building is already integrated into the curricula. Methods: A questionnaire with three focus areas was developed: Firstly, the general view of the medical faculties on digitization; secondly, concrete measures to prepare students for digital change and thirdly, the overarching organizational and regulatory conditions. The data was collected through short, questionnaire-based telephone interviews among those responsible for the curriculum at their faculty. The datasets collected were anonymized and statistically evaluated. Results: 30 interviews were conducted. The majority of faculty representatives agreed that digitization will change the role of physicians (87% agreement). Changes caused by individual digitization trends were however viewed to be less likely, e.g., whether medical expertise will become less important due to digital assistance systems (20% agreement), whether physician positions will be replaced by robots and algorithms (7% agreement), or whether hierarchies in hospitals will flatten (13% agreement). Digitization was seen to be of major importance for medical studies (93% agreement). Associated content should be given a higher priority in the curriculum (87% agreement). Two-thirds of faculty representatives believed that overarching institutions such as politics and medical associations ought to have more concrete plans for implementing the digital transformation and that innovations should be implemented in practice faster. Conclusion: While most faculty representatives attach great importance to the digitization of the health care system for university education, various questions about structural teaching measures to prepare students for the digital change show that there is no uniform education of medical students for a digitized health care system. We were also able to show that most faculty representatives are dissatisfied with the regulatory and organizational conditions of digitization in the medical sector.

Physicians' Attitudes Toward Prescribable mHealth Apps and Implications for Adoption in Germany: Mixed Methods Study.

BACKGROUND: In October 2020, Germany became the first country, worldwide, to approve certain mobile health (mHealth) apps, referred to as DiGA (Digitale Gesundheitsanwendungen, in German, meaning digital health applications), for prescription with costs covered by standard statutory health insurance. Yet, this option has only been used to a limited extent so far. OBJECTIVE: The aim of this study was to investigate physicians' and psychotherapists' current attitudes toward mHealth apps, barriers to adoption, and potential remedies. METHODS: We conducted a two-stage sequential mixed methods study. In phase one, semistructured interviews were conducted with physicians and psychotherapists for questionnaire design. In phase two, an online survey was conducted among general practitioners, physicians, and psychotherapists. RESULTS: A total of 1308 survey responses by mostly outpatient-care general practitioners, physicians, and psychotherapists from across Germany who could prescribe DiGA were recorded, making this the largest study on mHealth prescriptions to date. A total of 62.1% (807/1299) of respondents supported the opportunity to prescribe DiGA. Improved adherence (997/1294, 77.0%), health literacy (842/1294, 65.1%), and disease management (783/1294, 60.5%) were most frequently seen as benefits of DiGA. However, only 30.3% (393/1299) of respondents planned to prescribe DiGA, varying greatly by medical specialty. Professionals are still facing substantial barriers, such as insufficient information (1135/1295, 87.6%), reimbursement for DiGA-related medical services (716/1299, 55.1%), medical evidence (712/1298, 54.9%), legal uncertainties (680/1299, 52.3%), and technological uncertainties (658/1299, 50.7%). To support professionals who are unsure of prescribing DiGA, extended information campaigns (1104/1297, 85.1%) as well as recommendations from medical associations (1041/1297, 80.3%) and medical colleagues (1024/1297, 79.0%) were seen as the most impactful remedies. CONCLUSIONS: To realize the benefits from DiGA through increased adoption, additional information sharing about DiGA from trusted bodies, reimbursement for DiGA-related medical services, and further medical evidence are recommended.

Quantum computing's potential for drug discovery: Early stage industry dynamics.

Quantum computing (QC) is expected to revolutionize drug research by performing tasks classical supercomputers are not capable of. However, practically useful quantum computation is not yet a reality, and thus it is still unclear when and whether QC will be capable of solving real-world issues in drug discovery. By identifying the QC-related activities of pharmaceutical companies, startups, and academia in the field of drug discovery and development, we show that QC has gained traction across all of these stakeholder groups, that there is focus on developing utilities related to lead optimization and compound screening, and that there is a need for collaboration in the highly dynamic QC ecosystem.