Ala Taji Heravi
- Ethics in Clinical Research
- Meta-analysis and systematic reviews
- Health Systems, Economic Evaluations, Quality of Life
- Health and Medical Research Impacts
- Biomedical Ethics and Regulation
- SARS-CoV-2 and COVID-19 Research
- COVID-19 Clinical Research Studies
- Pharmaceutical industry and healthcare
- Statistical Methods in Clinical Trials
- Health, Environment, Cognitive Aging
- Pain Management and Placebo Effect
- Cancer Treatment and Pharmacology
- scientometrics and bibliometrics research
- Animal Virus Infections Studies
- Heparin-Induced Thrombocytopenia and Thrombosis
- Viral gastroenteritis research and epidemiology
- Data-Driven Disease Surveillance
- Colorectal Cancer Treatments and Studies
- Sepsis Diagnosis and Treatment
- Long-Term Effects of COVID-19
University Hospital of Basel
2020-2024
University of Basel
2020-2024
Swiss Tropical and Public Health Institute
2020-2022
Careers Europe
2021
Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, 44% remained unpublished at a median 12 years follow-up. aimed to assess decade later (1) whether rates completion publication have increased; (2) the extent which nonpublished RCTs can be identified in trial registries; (3) association reporting quality protocols premature discontinuation or nonpublication RCTs. Methods findings included 326 RCT...
The emergence of big data science presents a unique opportunity to improve public-health research practices. Because working with is inherently complex, must be clear and transparent avoid reproducibility issues positively impact population health. Timely implementation solution-focused approaches critical as new sources methods take root in research, including urban public health digital epidemiology. This commentary highlights methodological analytic that can reduce waste the replicability...
Abstract Extension of the COVERALL (COrona VaccinE tRiAL pLatform) randomized trial showed noninferiority in antibody response third dose Moderna mRNA-1273 vaccine (95.3% [95% confidence interval {CI}, 91.9%–98.7%]) compared to Pfizer-BioNTech BNT162b2 (98.1% CI, 95.9%–100.0%]) individuals with different levels immunosuppression (difference, −2.8% −6.8% 1.3%]).
Abstract Background Whether there is sufficient capacity and capability for the successful conduct delivery of a clinical trial should be assessed by several stakeholders according to transparent evidence-based criteria during planning. For this openly shared, user-tested, validated tools are necessary. Therefore, we systematically examined public availability content checklists which assess study-level feasibility in planning phase trials. Methods In our scoping review searched Medline,...
To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle exercise programmes) in comparison with regulated to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement.We conducted a repeated cross-sectional investigation random sample RCT approved 2012 (n = 257) or 2016 292) by research ethics committees Switzerland,...
Abstract Background Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, credibility results randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory medical journals, systematic reviewers, other stakeholders rely on appraise the conduct reporting RCTs. In response evidence poor protocol quality, Standard Protocol Items: Recommendations for Interventional Trials...
Objectives Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence low reporting quality RCT led to publication Standard Protocol Items: Recommendations Interventional Trials (SPIRIT) checklist in 2013. We aimed examine from three countries before after SPIRIT checklist. Design Repeated cross sectional study. Setting Swiss, German Canadian research ethics committees (RECs). Participants approved by RECs 2012 (n=257) 2016 (n=292). Primary...
Availability of randomized controlled trial (RCT) protocols is essential for the interpretation results and research transparency.In this study, we determined availability RCT approved in Switzerland, Canada, Germany, United Kingdom 2012. For these RCTs, searched PubMed, Google Scholar, Scopus, registries publicly available corresponding full-text publications results. We proportion RCTs with (1) protocols, (2) citing protocol, (3) providing a link to protocol. A multivariable logistic...
After basic immunization with 2 mRNA SARS-CoV-2 vaccine doses, only a small proportion of patients who are severely immunocompromised generate sufficient antibody response. Hence, we assessed the additional benefit third in different levels immunosuppression. In this observational extension COVERALL trial (Corona Vaccine Trial Platform), recruited from Swiss HIV Cohort Study and Transplant (ie, lung kidney transplant recipients). We collected blood samples before 8 weeks after vaccination...
ObjectivesTo systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), from where they are obtained, and hurdles that exist obtaining them.Study Design SettingPubMed was searched for recently published noncommercial, placebo-controlled drug trials. Corresponding authors were invited to participate an online survey.ResultsFrom 423 eligible articles, 109 (26%) corresponding (partially) participated. Twenty-one 102 (21%) reported not matching...
Background: The evidence from randomized trials on remdesivir for hospitalized patients with coronavirus disease 2019 (COVID-19) is conflicting. We conducted a systematic review and individual patient data meta-analysis (IPDMA) to assess the benefits harms of compared placebo or usual care in whether treatment effects differed prespecified subgroups.Methods: systematically searched electronic databases registries through April 11th 2022. primary outcome was all-cause mortality at day 28....
Background Conducting high quality investigator-initiated trials (IITs) is challenging and costly. The costs of investigational medicinal products (IMPs) in IITs the role hospital pharmacies planning are unclear. We conducted a mixed-methods study to compare planned actual IMPs Swiss IITs, examine potential reasons for differences, gather stakeholder views about services IITs. Methods included all with IMP from Basel pharmacy invoiced between January 2014 June 2020 (n = 24). documented trial...
Abstract Objective: The registration of clinical trials is required by law in Switzerland. We investigated (1) the proportion pro- and retrospectively registered trials, (2) availability results for ethically approved trial protocols, (3) factors associated with increased registration, (4) reasons non-registration. Design Setting: included all mandatory prospective which were ethics committee Northwestern Central Switzerland between January 1, 2016, December 31, 2020. Methods: extracted...