Therapeutic innovation & regulatory science最新文献

{"title":"Incorporating Patient Input into the Target Product Profile.","authors":"Jean-Noel Talabardon, Janet E Church, Masanori Okuse, Michaela Dinboeck, Sheila Dickinson, Simon Messner, Michael Boisclair, Jean-Pierre Malkowski","doi":"10.1007/s43441-025-00783-1","DOIUrl":"10.1007/s43441-025-00783-1","url":null,"abstract":"<p><p>Target product profiles (TPP) are summaries of characteristics which drug developers expect to be necessary for a product to meet patients' needs, receive regulatory and payer approval, and differ from existing treatment options. As the experts on their own disease, patients bring invaluable perspectives to drug development, which cannot be obtained by other means. This communication reports on the development of a systematic guidance framework for a patient-focused, standardized TPP. The guidance was developed in a long-term iterative process, with crucial aspects reviewed and validated with the patient community. Five focus areas of a TPP were identified where patient perspectives are fundamental: target population, unmet need, dosage frequency and route of administration, efficacy endpoints, and acceptability of benefit/risk profile trade-offs. A guiding principle should be to incorporate patient perspectives in a systematic process starting as early as possible. A number of tools are available for obtaining patient perspectives, e.g., desk research, patient advisory boards/patient councils/online bulletin boards, focus groups with patients/caregivers, and/or in-depth interviews. When discussing the proposed process with patient representatives, they identified several key requirements for the interaction between R&D organizations and patient representatives. These include the use of clear language, respect for patients, engagement with patient experts, provision of adequate context and background information. We further discuss the relative importance of integrating patient perspectives into the different focus areas and touch upon the potential benefits to patient organizations from adapting these concepts and processes to enhance their voices in drug development.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"659-667"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of Composite Index in Psychiatry Clinical Trial.","authors":"Haiqi Zhang, Shein-Chung Chow","doi":"10.1007/s43441-025-00772-4","DOIUrl":"10.1007/s43441-025-00772-4","url":null,"abstract":"<p><p>In psychiatry clinical trials, a validated instrument (or questionnaire) which consists of a number of questions (or items) is often used for evaluation of the safety and efficacy of a test treatment under investigation. This approach based on rating scales for evaluation of safety and efficacy of a test treatment under study, however, has been criticized of being subjective. To overcome the problem, the use of a composite index which combines the subjective rating scales and objective functional magnetic resonance imaging is proposed. For this purpose, statistical methods for development of composite index are derived. The proposed composite index is evaluated both theoretically and via extensive clinical simulation studies.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"761-768"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials.","authors":"Hanke Zheng, Julie A Patterson, Jonathan D Campbell","doi":"10.1007/s43441-025-00774-2","DOIUrl":"10.1007/s43441-025-00774-2","url":null,"abstract":"<p><strong>Background: </strong>The Inflation Reduction Act's (IRA) Drug Price Negotiation Program (DPNP) may reduce incentives for industry investments in post-approval clinical development. We aimed to explore the IRA's impact on the initiation of industry-sponsored, post-approval clinical trials.</p><p><strong>Methods: </strong>Using Citeline's Trialtrove database (7/2014-8/2024), we conducted an interrupted time series analysis (ITSA) to estimate the IRA's impact on the initiation of industry-sponsored Phase I-III trials in previously approved drugs, excluding all vaccines and COVID-19 treatments. We conducted an additional ITSA to examine post-IRA changes in government-funded trials, hypothesized to be unaffected by the IRA, and sensitivity analyses to explore potential exogenous confounding factors. Finally, we explored differences in the IRA's impact on post-approval industry-sponsored clinical trial initiation in small versus large molecule drugs.</p><p><strong>Results: </strong>Following the IRA's passage, the average monthly number of industry-sponsored trials on post-approval drugs decreased by 38.4%. The ITSA indicated that the IRA's passage was associated with an immediate drop of 11.1 industry-sponsored trials (p-value < 0.05) and an additional decrease by 0.9 trials per month (p-value < 0.01). The IRA's passage was not statistically associated with changes in government-funded trial initiation. Sensitivity analyses supported ITSA findings. Initiation of post-approval industry-sponsored trials decreased by 47.3% and 32.9% for small and large molecule drugs, respectively.</p><p><strong>Conclusions: </strong>The IRA's passage was associated with reductions in industry-sponsored, but not government-funded, post-approval trials, with larger reductions for small molecule drugs. These findings provide early evidence supporting concerns around IRA-related reductions in incentives for post-approval clinical development.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"781-789"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond Reimbursement Status: Availability of Advanced Therapy Medicinal Products Across the European Union.","authors":"Zora Čechová, Jana Kubátová, Adéla Bártová, Jakub Jamárik, Jiří Samek","doi":"10.1007/s43441-025-00769-z","DOIUrl":"10.1007/s43441-025-00769-z","url":null,"abstract":"<p><strong>Background: </strong>Advanced Therapy Medicinal Products (ATMPs) represent an innovative therapeutic approach with the potential to impact the treatment of rare diseases significantly. Although authorised centrally in the European Union, their market launch differs across Member States (MS). This study aimed to describe the ATMP market availability in MS and explore potential influencing factors, providing insights into specific barriers beyond pricing and reimbursement policies.</p><p><strong>Methods: </strong>ATMP availability was defined as the product launch in each MS. Data was collected through open governmental sources, databases, and communication with national competent authorities. Spearman's correlation coefficients were calculated to examine the relationship between ATMP availability and their characteristics (time since granting marketing authorisation, target patient population size, and cost).</p><p><strong>Results: </strong>We collected the availability data on 18 ATMPs from 23 EU MS. Market uptake varied significantly, with Germany (89%), France and Italy (61%) leading. Estonia and Latvia confirmed that no ATMP has been launched on their markets yet. Six ATMPs were available in more than one-third of the analysed MS. No significant correlation was observed between ATMP availability and analysed product characteristics except for time dependency for CAR T-cell therapies.</p><p><strong>Conclusion: </strong>Beyond pricing and reimbursement processes, the ATMP commercialisation in particular MS is influenced by the marketing authorisation holder's decision and capacity. ATMPs face product-specific challenges in achieving EU-wide availability, including complex manufacturing, distribution, and administration processes. To increase the accessibility of innovative ATMP-based treatments, implementing the cross-border access framework or individual ATMP production under the hospital exemption is essential, especially in underserved MS.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"728-736"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation.","authors":"Hillary S Andrews, Grace Collins, Bernat Navarro-Serer, Mark D Stewart, Jeff D Allen","doi":"10.1007/s43441-025-00799-7","DOIUrl":"10.1007/s43441-025-00799-7","url":null,"abstract":"<p><p>The U.S. Food and Drug Administration (FDA) recommends concurrent development of targeted therapies with an associated companion diagnostic (CDx) as the optimal approach to provide patient access to novel, safe, and effective treatments. However, CDx validation often relies on clinical samples from pivotal clinical trials for the drug, which can be challenging, particularly when there is limited sample availability. A review of Summary of Safety and Effectiveness Data (SSED) documents for CDx approved for non-small cell lung cancer (NSCLC) revealed that CDx for rare biomarkers often use alternative samples for validation. While the practice of using alternative samples for validation occurs, it is not always clear when these flexibilities are considered or how alternative samples should be used for validation. To address this, we propose the FDA establish guidance for the use of alternative sample sources for CDx validation, especially for rare biomarkers, to ensure timely and effective patient access to targeted therapies.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"676-679"},"PeriodicalIF":1.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools.","authors":"Marie Mc Carthy, Joseph C Cappelleri, Bill Byrom, Helen Doll, Junrui Di, Charmaine Demanuele, Joan Buenconsejo, Cheryl D Coon","doi":"10.1007/s43441-025-00794-y","DOIUrl":"10.1007/s43441-025-00794-y","url":null,"abstract":"<p><strong>Objectives: </strong>This paper seeks to identify some of the complexities associated with determining meaningful change for endpoints derived from digital health technologies (DHTs) and propose possible methodologies for this process. Ultimately, this is a call to action to consider appropriate methods and practices required to enable digital endpoints (DEs) to achieve their full potential as Drug Development Tools.</p><p><strong>Methods: </strong>Using the Food and Drug Administration (FDA) Patient-Focused Drug Development (PFDD) guidance documents as a framework, we explore the nuances and challenges that exist when determining meaningful change for DEs compared with traditional clinical outcome assessments (COAs).</p><p><strong>Results: </strong>There are unique characteristics associated with DEs that provide distinct challenges when determining meaningful change. This complexity spans the totality of meaningful change considerations, from ensuring that the DE itself is meaningful from the patient perspective to selecting appropriate anchors that enable determination of the magnitude of change that is meaningful for patients.</p><p><strong>Conclusions: </strong>With increased adoption of DHTs in clinical trials, their specific use is evolving, as evidenced by their being referred to as DHT-passive monitoring COAs in the FDA drug development tool (DDT) qualification program. However, the determination of meaningful change for these DEs can be more nuanced and challenging than for traditional COAs. Merely adapting existing approaches for traditional COAs does not readily support DEs derived from continuous datasets collected over long periods. New methods and approaches are required, and this can only be realised by working together, to ensure that the value and limitations of various methodologies as they relate to DEs can be refined.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"668-675"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Value of Integrated Evidence Approaches in Drug Development.","authors":"Joseph A DiMasi, Melvin Skip Olson, Zachary Smith, Kenneth A Getz, Gorana Capkun","doi":"10.1007/s43441-025-00778-y","DOIUrl":"10.1007/s43441-025-00778-y","url":null,"abstract":"<p><strong>Background: </strong>The use of Integrated Evidence Plans (IEPs) by the pharmaceutical industry has expanded in recent years with the aim of optimizing healthcare and patient outcomes. The evidence base of IEPs goes beyond traditional randomized controlled trials to provide holistic evidence suitable for all stakeholders and allows for consideration of different packages in different regions. However, this approach to drug development is not systematically adopted by all sponsors because of perceived uncertainty in its investment value.</p><p><strong>Methods: </strong>We introduce the concept of value drivers to which we apply an expected net present value (eNPV) model of the cash flows for drug development and commercialization. The approach is outlined for two, typical, hypothetical lifecycle management IEPs. The measure of IEP value is defined as the increment in eNPV that occurs when IE programs are employed in comparison to when they are not.</p><p><strong>Results: </strong>We found substantial value for IEPs. One example incorporated a plan to conduct an observational study that could be used as a basis for approval in lieu of a classical phase II trial for a supplemental indication. In the other example, increased adoption of the new treatment leads to a highly positive increment in eNPV based on the critical evidence generated in a phase IIIb study.</p><p><strong>Conclusions: </strong>Use of value drivers and eNPV-based value models when planning for IEPs can provide objective guidance for project teams. The value can be estimated through formal economic analysis that considers planned timelines, R&D costs, estimates of the likelihood of regulatory approval, patient access and clinical adoption if development is successful.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"808-816"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today?","authors":"Neil Bertelsen, Elisabeth Oehrlein, Bronwyn Lewis, Tiffany Westrich-Robertson, Jim Elliott, Tom Willgoss, Nidhi Swarup, Ify Sargeant, Oishika Panda, Maria M Marano, Hayley Chapman, Nicholas Brooke","doi":"10.1007/s43441-025-00770-6","DOIUrl":"10.1007/s43441-025-00770-6","url":null,"abstract":"<p><strong>Background: </strong>As healthcare stakeholders aim to support patient-centered care, patients play an increasingly important role in pharmaceutical and medical technology development and healthcare decision-making. Patient engagement (PE), patient experience data (PED), and meaningful integration of PE to enrich PED have been evolving rapidly. This landscape review focuses on emerging PE/PED practices and guidelines in 2023.</p><p><strong>Methods: </strong>References published between January-December 2023 on the use of PE and PED from health technology assessment (HTA) and regulatory bodies in different countries, three peer-reviewed journals, and referred resources from collaborators were analyzed. These references were compared with those in our previous publication (August 2021-January 2023, 17-month period).</p><p><strong>Results: </strong>Overall, 28 references from HTA/regulatory bodies, 26 from peer-reviewed articles, and 17 referred resources were identified. Eight references on PE and PED integration (PE + PED) were identified in 2023 from HTA/regulatory bodies, compared with none in the previous 17-month analysis. Emerging trends on the role of PE, PED, and real-world evidence in HTA/regulatory deliberations, transparency and geographic variations in the use of such evidence and practices, and gaps thereof have been highlighted.</p><p><strong>Conclusions: </strong>The increase in PE, PED, and PE + PED references worldwide in 2023 versus the prior 17-month analysis suggests accelerated adoption of PE + PED practices. However, a need remains for comprehensive, actionable guidance on best practices for use of PE and PED for harmonization and incorporation into HTA/regulatory processes. Patient input-essential for evidence-based decision-making-provides valuable insights that enhance care quality, treatment relevance and effectiveness, and builds trust and sustainability.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"737-752"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Benchmarking Medical Information Services Beyond the Unsolicited Requests: A phactMI Benchmarking Survey.","authors":"Michael J DeLuca, Rena Rai, Kirtida Pandya, Lillian Chavez, Prachee Satpute, Michael Rocco, Parul Shah, Jen Multari, Michael Cuozzo, Evelyn R Hermes-DeSantis","doi":"10.1007/s43441-025-00787-x","DOIUrl":"10.1007/s43441-025-00787-x","url":null,"abstract":"<p><strong>Objective: </strong>Medical Information has a strategic role that extends beyond inquiry management. The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey of 35 US pharmaceutical companies was conducted to describe the current landscape and future opportunities of other services Medical Information could provide.</p><p><strong>Methods: </strong>In July 2023, an electronic survey containing 57 closed and open-ended questions was distributed to phactMI member companies. The survey questions addressed demographics, medical review, development of materials, training, patient services, insights, and awareness.</p><p><strong>Results: </strong>Medical Information is a significant contributor to the medical review of promotional healthcare provider materials (51%), patient materials (52%), and non-promotional medical materials (45%). Medical Information ensures the accuracy of medical information, fact checks and validates claim accuracy. Fifty percent of the respondents are responsible for reviewing and/or contributing to Medical Affairs material for Field Medical. Additionally, Medical Information trains both Field Medical and Sales teams on the Medical Information function, and to a lesser extent, disease state information. The majority (75%) of Medical Information Departments offer patient information. The vast majority (85%) produce and identify insights. Medical Directors, Field Medical, and Scientific Communications/ Publications often receive shared insights. Fewer individuals integrate insights with Field Medical and Medical Directors. Since 2018, Medical Information activities have seen a rise in advisory board presentations, insights reporting, publications, competitive intelligence, disease state education, surveillance, pathway submission, and labelling activities. Building awareness is still an important aspect of Medical Information and most focus on the development of their Medical Information website.</p><p><strong>Conclusion: </strong>The essential roles and activities of Medical Information Departments support products at every stage. Medical Information participates with multiple functions in evaluating medical materials and there is a growing trend of including Medical Information in the development and review of Medical Affairs materials. Medical Information has expanded its participation in pathway submissions, publications, and labeling activities. This benchmark for Medical Information can provide a potential best practice template for activities. For the future, the three areas to prioritize are: increasing the strategic value and KPIs of Medical Information, integrating and overseeing AI technology in the insights process, and improving internal visibility.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"848-858"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Awareness and Attitudes Regarding Adverse Drug Events and Reporting in South Africa.","authors":"Nokukhanya Ncube, Martha S Lubbe, Hanlie Steyn, Nkengafac V Motaze","doi":"10.1007/s43441-025-00795-x","DOIUrl":"10.1007/s43441-025-00795-x","url":null,"abstract":"<p><strong>Background: </strong>Reporting of adverse drug events (ADEs), by consumers enhances medication-related risk surveillance, public awareness, and understanding of medicine safety. The aim of this study was to explore adults' awareness of ADEs, attitudes towards reporting and perceptions of their role in reporting ADEs in South Africa.</p><p><strong>Method: </strong>We conducted a cross-sectional, analytical study in which adults residing in South Africa completed an online questionnaire. The data collected was analysed using both descriptive and inferential statistics.</p><p><strong>Results: </strong>We received responses from 350 participants. Most participants (86.2%, n = 302; N = 350) reported having heard about ADEs and the majority of participants (94.4%, n = 301; N = 319) indicated that reporting of ADEs was important. The Med Safety App was not widely known (17.3%, n = 58; N = 336) while the South African Health Products Regulatory Authority (SAHPRA) was relatively well known (77.4%, n = 260; N = 336). Healthcare providers only educated 55.7% (n = 180; N = 323) of the participants about ADEs and only 50.5% (n = 163; N = 323) of the participants asked their healthcare providers about ADEs. Awareness regarding ADEs was significantly higher (p < 0.001) among healthcare professionals (HCPs) compared to non-healthcare professionals (non-HCP).</p><p><strong>Conclusion: </strong>Most participants were aware of ADEs and agreed it was important to report ADEs although reporting tools, such as the Med Safety App, were not well known. We recommend awareness campaigns on reporting processes because this could improve consumer reporting of ADEs in South Africa.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"882-891"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144038820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}