Background: Out-of-pocket (OOP) costs pose a significant barrier to participating in cancer clinical trials (CCTs). Financial reimbursement programs (FRPs) that reduce the burden of OOP costs can support participation in CCTs if the information is readily available to participants at the time of enrollment. Prior studies have shown the importance and impact of FRPs, but despite improvements, significant barriers still remain. Objective: This study was designed to explore the feasibility and acceptability of automated texts designed to offer, screen, and enroll CCT participants in an FRP for OOP travel and lodging-related clinical trial costs. Methods: This study used a mixed methods approach. Eligible participants were those who consented to participate in a breast, leukemia, or chimeric antigen receptor T cell (CAR-T) trial at the Abramson Cancer Center of the University of Pennsylvania, a National Cancer Institute comprehensive cancer center. Quantitative data were collected through engagement metrics, including text response rates and enrollment rates, as well as patient-reported satisfaction scores. Qualitative data were derived from semistructured interviews. Program enrollment rates were used to determine feasibility, whereas the engagement metrics were used to measure the acceptability of the program. Semistructured interviews were conducted with a subsample of patients who responded to at least one of the FRP texts and agreed to be interviewed to determine the barriers to and facilitators of enrolling in the Improving Patient Access to Cancer Clinical Trials (IMPACT) program via text, perceived advantages and disadvantages of the text messaging program compared to a phone call, and overall feedback on the acceptability of the automated text messaging program. Results: Quantitative data, including engagement with texts, FRP eligibility screening, and enrollment rates, were collected from all participants who successfully received a text (n=51), and qualitative data were collected from a subsample of participants who agreed to participate in a semistructured interview (n=28) about the text-based program. Participants’ mean age was 58 (SD 12) years, approximately 65% (n=33) of participants were female, 21% (n=11) of participants were Black, and 4% (n=2) of participants were Hispanic or Latino. There was high engagement with texts (n=49, 96.1%) and a high screening rate for FRP eligibility (n=33, 64.7%). Of those who successfully screened, 26 (51%) screened via text. We also saw high overall FRP enrollment rates of those who completed the texts (n=16 of 24 eligible, 66.7%) and high satisfaction (Net Promoter Score=51). The text-based platform streamlined the enrollment process, allowing one-third of patients to complete enrollment independently, without assistance from the FRP coordinator. Reported facilitators for completion of the text conversation included support from the coordinator and introduction of the FRP by CCT teams. Barriers were a lack of communication from CCT teams, patient skepticism about the legitimacy of the texts, and limited program information via text. Conclusions: Despite the small sample size and single study site, these findings suggest that automated text messaging can be an effective, low-cost, and scalable strategy to increase awareness and streamline enrollment in FRPs.
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Autistic- and attention-deficit/hyperactivity disorder-like traits: differential associations with burnout, depression and anxiety, and empathy among Japanese junior residents
IntroductionBurnout, depression, and anxiety are major concerns among physicians because they affect individual well-being, patient care, and healthcare systems. Neurodevelopmental traits, including autistic-like traits (ALTs) and attention-deficit/hyperactivity disorder (ADHD)-like traits (ADHLTs), may increase vulnerability to psychological distress. However, little is known about how these traits relate to burnout, depression and anxiety, and empathy among junior residents.MethodsIn this cross-sectional study, 148 junior residents from two teaching hospitals in Japan completed validated measures of ALTs (21-item Japanese version of the Autism-Spectrum Quotient), ADHLTs (Adult ADHD Self-Report Scale Screener), burnout (Maslach Burnout Inventory), depression and anxiety (Hospital Anxiety and Depression Scale), physician–patient empathy (Jefferson Scale of Physician Empathy), and psychological flexibility and inflexibility processes (Valuing Questionnaire, Cognitive Fusion Questionnaire-7, and Work-related Acceptance and Action Questionnaire). Associations were examined using multivariable logistic and linear regression analyses. Exploratory statistical mediation analyses using structural equation modeling examined indirect associations through psychological flexibility and inflexibility processes.ResultsThe prevalence of ALTs and ADHLTs was 23.6% for each trait. ALTs were associated with lower personal accomplishment, a burnout dimension; higher depression and anxiety; and lower physician–patient empathy. ADHLTs were associated with greater emotional exhaustion, another burnout dimension. In exploratory statistical mediation analyses, progress toward values, a core process of psychological flexibility, showed a significant indirect association between ALTs and personal accomplishment, and the direct association was attenuated and no longer statistically significant after including the process variables. Significant indirect associations through progress toward values were also observed for the associations of ALT with depression and anxiety and empathy. Cognitive fusion, a core process of psychological inflexibility, showed a significant indirect association between ADHLTs and emotional exhaustion. Overall, neurodevelopmental traits were associated with distinct patterns of psychological functioning, suggesting variability in both vulnerability and adaptive processes.DiscussionNeurodevelopmental traits such as ALTs and ADHLTs were significantly associated with burnout dimensions, depression and anxiety, and physician–patient empathy among junior residents. Psychological flexibility and inflexibility processes, particularly progress toward values and cognitive fusion, may be relevant to these associations. Process-based support strategies may warrant further investigation for residents with elevated neurodevelopmental traits.Clinical trial registrationhttps://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R00005, identifier UMIN000046897.
Challenges and future directions for multiple sclerosis after the 2024 McDonald diagnostic criteria
Nature Medicine, Published online: 09 July 2026; doi:10.1038/s41591-026-04490-8
The 2024 revision of the McDonald diagnostic criteria is an important step toward earlier and more inclusive diagnosis of multiple sclerosis. Realizing its full potential will require continued refinement of biomarkers, disease stratification and clinical trial approaches.
When the real world becomes the trial
Nature Medicine, Published online: 09 July 2026; doi:10.1038/s41591-026-04484-6
Once confined to post-market surveillance, real-world evidence is now being used to emulate trials, guide approvals and even run studies in real time, forcing a rethink of what constitutes a clinical trial.
Dissociation and PTSD in women with a history of childhood sexual abuse: a pilot examination of a specialized inpatient unit
BackgroundWorldwide, there are relatively few specialized inpatient units dedicated to women with histories of childhood sexual abuse (CSA) and comorbid psychiatric disorders. This pilot study examined dissociation and PTSD among women admitted to such a specialized integrative inpatient unit in Israel. We conduct an in-depth analysis of the role of dissociation in these women’s clinical picture, as well as in their treatment response.MethodsThe study included two phases. Phase 1 used a cross-sectional design to assess the complex inter-relationships between PTSD and various facets of dissociation in women with CSA histories admitted to a specialized inpatient unit (N = 108). Phase 2 focused on a sub-sample of participants (N = 28) who completed the inpatient program and completed admission and discharge assessments. Measures included the PTSD Checklist for DSM-5 (PCL-5) and the Dissociative Experiences Scale (DES-II).ResultsIn Phase 1, dissociative symptoms were positively correlated with overall PTSD severity and all PTSD symptom clusters, with the dissociative sub-measure of Absorption showing the strongest associations. In Phase 2, PTSD symptoms significantly decreased following treatment. In line with phase 1, reductions in Absorption were associated with improvements in overall PTSD severity and specifically in Hyperarousal symptoms.ConclusionsFindings from this pilot study indicate the therapeutic potential of a specialized integrated inpatient unit for women with CSA histories. Importantly, our results indicate that dissociation should be regarded as a major therapeutic target, most notably patients’ tendency for maladaptive absorption. These preliminary results should be expanded upon in larger, controlled clinical trials, further elucidating the role of dissociation and other mechanisms of change in similar units.
Local PBMC Isolation Enables Four-Hour Processing in San Diego
Fast, local cryopreservation is a consistent bottleneck for autologous cell therapy developers, even in major cell and gene therapy hubs. For the peripheral blood mononuclear cells (PBMCs) that form the foundation of immunotherapies, vaccine development and autologous therapies, every hour between leukapheresis collection and cryopreservation can degrade cell viability and functional integrity.
OrganaBio’s new PBMC isolation facility in San Diego removes that bottleneck for one of the three major cell and gene therapy hubs in the world. The opening of the new PBMC processing and cryopreservation laboratory at Excellos Labs (which OrganaBio acquired in May) makes it possible to isolate and cryopreserve PBMCs within three to four hours of collection, rather than losing time and quality by shipping live material across the country.
“The quality you lock in at cryopreservation is the quality the developer gets back months later,” Justin Irizarry, CEO, OrganaBio, tells GEN. “Get the first few hours right and you have protected everything downstream. Having that processing happen locally is what makes the few-hour window realistic rather than aspirational.”
The San Diego lab reports an average PBMC viability of “around 99.1% and recovery above 2.9 million cells per milliliter, with consistency from batch to batch,” Irizarry says. He credits those statistics to rapid time to cryopreservation, validated standard operating procedures “including sponsor-specific protocols,” personnel trained in each of those procedures, and a single quality system for each of OrganaBio’s sites. That combination ensures consistency across batches and sites, so “a sample processed in San Diego is indistinguishable from one processed in Miami,” he emphasizes.
In contrast, one German study comparing cells cryopreserved within six hours or 20 hours of collection notes a higher percentage of apoptotic natural killer (NK) cells associated with the longer hold time. Specifically, after 20 hours, 41% of the cells were apoptotic versus 24% for those preserved within six hours of collection. Robustness also declined with the longer hold times.
Robust local sourcing for PBMCs is a strategic advantage for San Diego’s clinical-stage biotherapeutic developers. In addition to gaining higher-quality starting materials, they can expect to benefit from tighter manufacturing timelines and less supply chain risk. Local processing reduces the inherent risk associated with cold-chain and transportation variables, while enhancing redundancy provided by OrganaBio’s West Coast sites in San Diego, Irvine, and San Francisco Bay, and its East Coast headquarters in Miami.
OrganaBio expects continued growth, “including clinical trial services, manufacturing services, and product manufacturing,” Irizarry says. The company is onboarding new customers and programs and deepening relationships with existing customers. “We also will evaluate opportunities to expand into additional markets for clinical trial services, particularly where there is strong population growth, good ethnic and racial diversity, and a lack of professionalized PBMC isolation services in the market.”
The post Local PBMC Isolation Enables Four-Hour Processing in San Diego appeared first on GEN – Genetic Engineering and Biotechnology News.
<![CDATA[PP-01 targets CB-1 recovery and dopamine balance, aiming to ease cannabis withdrawal and boost abstinence as a fast-tracked phase 3 trial advances.]]>
<![CDATA[Phase 3 data show COMP360 psilocybin delivers rapid, lasting relief in treatment-resistant depression; FDA filing advances toward 2027 launch.]]>
Lower limb rehabilitation in chronic incomplete SCI: a randomized controlled trial protocol comparing combined TMS-tSCS neuromodulation vs. tSCS alone
BackgroundSpinal cord injury (SCI) affects 15.4 million people worldwide, with a substantial proportion of incomplete SCI patients remaining non-ambulatory, highlighting the importance of motor function recovery and mobility in rehabilitation. While transcutaneous spinal cord stimulation (tSCS) has emerged as a promising non-invasive neuromodulation technique for enhancing motor recovery, the therapeutic potential of combining tSCS with transcranial magnetic stimulation (TMS) remains largely unexplored. This combination may leverage the complementary mechanisms of supraspinal and spinal neuromodulation to enhance corticospinal tract plasticity and functional motor outcomes.ObjectiveTo evaluate the efficacy and safety of combined TMS-tSCS intervention compared to tSCS alone for improving lower extremity motor function in individuals with chronic incomplete spinal cord injury.MethodsThis prospective, randomized, controlled, assessor-blinded clinical trial will enroll 60 participants with chronic (>12 months post-injury) incomplete spinal cord injury (AIS C or D) aged 18–65 years from Alexandra Hospital, Singapore. Participants will be randomized 1:1 to receive either combined TMS-tSCS (intervention group) or tSCS with sham TMS (control group) for 16 weeks (32 sessions). The primary outcome is change in Lower Extremity Motor Score (LEMS) from baseline to 16 weeks. Secondary outcomes include walking speed (10-Meter Walk Test), functional independence (Spinal Cord Independence Measure-III), spasticity (Modified Ashworth Scale), electromyography of the lower limb muscles and neurophysiological measures of corticospinal excitability.Expected outcomesWe hypothesize that combined TMS-tSCS will yield superior improvements in LEMS (≥2 points greater improvement) compared to tSCS alone, with enhanced corticospinal tract plasticity as evidenced by neurophysiological measures.Clinical trial registrationClinicalTrials.gov, identifier: NCT07595497.
Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial
Nature Medicine, Published online: 07 July 2026; doi:10.1038/s41591-026-04472-w
A first-in-human, partially randomized and placebo-controlled phase I trial examined the safety, tolerability, pharmacokinetics and antiviral activity of the bispecific 10E8.4/iMab broadly neutralizing monoclonal antibody in people living with or without HIV, and found it was safe and well tolerated at different dose levels and routes of administration.