De-risk your evidence generation process by quickly assessing the feasibility of your External Comparator Arm (ECA). Identifying potential gaps early saves both time and financial resources.

This 24-question check evaluates three critical domains:

• General Strategy (2 questions)

• Data Feasibility (13 questions)

• Design Feasibility (9 questions)

Is there evidence for the benefit of COVID vaccinations in todays’ times? Recent study provides answers!

A team of scientists including GIPAM colleagues used GER claims data from GWQ Service Plus to explore what the impact of COVID-19 seasonal vaccinations between 1 September and 30 November 2023 is in an observational period of 4 months. A total of 146,132 individuals (73,066 vaccinated / 73,066 not vaccinated, 1:1 propensity score matching) were compared. All-cause mortality was 25% lower among COVID-19-vaccinated individuals (HR: 0.76; 95% CI: 0.70–0.82). Direct and indirect healthcare costs were found to be lower as well. These real-world findings support continued implementation of national immunisation recommendations during the endemic phase of SARS-CoV-2 circulation.

📖عربي Arabic version of the unique ABQ questionnaire available!

In order to improve patients’ adherence to healthcare interventions such as long-term medication therapy in chronic diseases, there is one major challenge: Scientists as well as developers of adherence-promoting interventions and physicians need to know exactly WHY patients do not adhere with the interventions/prescriptions that were recommended to them.The ABQ is a unique and validated questionnaire to identify adherence barriers on a patient-level. It has now been validated in Arabic questionnaire:

The “GKV Financial Stabilization Act” (GKV-FinStG), introduced in November 2022, brought several changes to the German pricing system for drugs, including a novel discount on pre-selected combination therapies. From October 2023 onwards, German statutory health insurance funds (SHIs) are entitled to a discount of 20 percent of the manufacturers’ prices on outpatient drugs that are prescribed in combination with another drug (for new drugs regulated by AMNOG) as designated by the “Gemeinsamer Bundesausschuss” (G-BA; §35a (3) sentence 4 SGB V). The German government expected medium-term savings of approximately €185 million per year.

Despite progress in the detection and treatment of bladder cancer (BC), it remains one of the common cancer diagnoses. Updated estimates of its epidemiology and mortality are needed to better understand the BC burden in Germany. This research aims to estimate the incidence/prevalence of BC in Germany and to describe trends in mortality in the last eleven years.

OBJECTIVES: To describe recent trends in lung cancer incidence, staging, morphology, and survival outcomes in Germany using comprehensive population-based data from the German Centre for Cancer Registry Data (ZfKD).

METHODS: This retrospective analysis included all lung cancer cases diagnosed from 2020 to 2023 in individuals aged 18 years or older. Anonymized data were sourced from the ZfKD, which compiles mandatory cancer notifications across the German federal states. Variables analyzed included patient demographics, tumor characteristics (histological subtype, stage), and Kaplan-Meier-based survival estimates stratified by cancer subtype and stage.

RESULTS: A total of 222,366 lung cancer cases were recorded, with incidence per 100 adults of 0.081, 0.082, 0.081, and 0.077 in 2020, 2021, 2022, and 2023, respectively. Non-small cell lung cancer (NSCLC) accounted for 82.6% of cases, while small cell lung cancer (SCLC) made up 13.8%. NSCLC patients were older at diagnosis than those with SCLC (mean 70.2 vs. 68.5 years). Stage IV was the most common at diagnosis (41% in NSCLC, 59% in SCLC). Median survival was 12.8 months for NSCLC and 8.1 months for SCLC, dropping to 6.5 and 6.8 months, respectively, in stage IV disease. Adenocarcinoma was the most frequent NSCLC subtype (40.5%), followed by squamous cell carcinoma (15.7%).

CONCLUSION: Late-stage lung cancer diagnosis remains common and contributes to poor short-term survival. These findings underscore the need for earlier detection strategies and continued research into treatment pathways and outcomes.

OBJECTIVES: To investigate whether social desirability bias contributes to the paradox of older adults reporting high medication adherence despite a greater risk of non-adherence due to polypharmacy and comorbidities.

METHODS: We analyzed cross-sectional data from 308 anonymized adults with atrial fibrillation (AF), surveyed via online panels in the UK and the US, and during outpatient visits at a specialized stroke center in a German hospital. Patients suffering from AF and undertaking long-term treatment were included independently of the type, treatment, or duration of the disease. Participants completed the Adherence Assessment Questionnaire (AAQ), a validated self-report instrument that includes a two-item social desirability scale. Binomial logistic regression was used to estimate associations between age, social desirability, and their interaction with self-reported non-adherence, adjusting for gender, country, and number of medications. Sensitivity analyses using ordinal and linear regression models, as well as moderation estimates, were conducted to assess robustness.

RESULTS: The sample had a mean age of 67.0 years (SD: 13.2), and 33.8% were female. Increasing age and higher social desirability scores were associated with lower odds of reporting non-adherence (OR = 0.97, 95% CI: 0.94-0.99, p = .009 and OR = 0.80, 95% CI: 0.64-1.00, p = .051, respectively). The age-by-social desirability interaction was marginal in the binomial model (OR = 0.98, 95% CI: 0.96-1.00, p = .105), but significant in ordinal (p < .001) and linear (p = .002) regressions. Older adults with higher social desirability scores were especially likely to report better adherence. The moderation analysis (p = .016) confirmed that social desirability bias strengthened the association between age and adherence. No country-level differences were observed.

CONCLUSION: The apparent increase in self-reported adherence with age may reflect response bias rather than true behavioral differences. The tendency of socially desirable response behavior should be considered when interpreting self-reported adherence data.

External control arms (ECAs) are used to generate comparative evidence (e.g., effectiveness) when only a single-arm trial has been conducted during the drug development process. However, key stakeholders often face substantial delays in determining the feasibility of an ECA; a responsive tool could streamline this process in a structured, rigorous manner.

A structured tool to help teams plan and assess medical chart review studies with the rigour needed for HTA, regulatory, or publication use.
It highlights key design and operational considerations—bringing common pitfalls into focus before study initiation.

This checklist is designed to support high-quality, regulation-aligned ITC submissions for EU Joint Clinical Assessment.
It helps teams identify and address key reporting requirements early reducing the risk of delays or rejected assessments.

Analysis of real-world data from Swedish National Registers (2017–2021) and a German insurance claims database (2018–2021) to assess characteristics and dosing patterns in PsA and axSpA patients initiating b/tsDMARDs. Included: 9414 PsA and 7763 axSpA patients in Sweden; 2045 PsA and 1756 axSpA patients in Germany. Despite alignment with European treatment guidelines, treatment patterns differed notably between countries. Further analysis comparing outcomes is warranted to determine real-world effectiveness of divergent approaches.

Stay aligned with EU JCA requirements for systematic literature reviews. This checklist covers areas like defining PICOs, selecting relevant comparators, documenting search strategies, and planning meta-analyses.

The choice of data when starting an RWE study is critical. Each option—whether administrative claims, electronic medical records, registries, or surveys—offers unique strengths and limitations. Selecting the right one depends on your research objectives and the nuances of the healthcare system where the data originates.

The European Health Technology Assessment (EU-HTA) aims to harmonise HTA across Europe, enhancing efficiency and reducing duplication of work for national authorities. This paper explores key components of the EU-HTA framework, challenges, future perspectives, and implications for pharmaceutical companies, primarily concentrating on drug evaluation over medical devices

Scientific evidence needs might differ substantially between the different stakeholders, but they also vary between countries due to different philosophies in the assessment of healthcare interventions. This requires early Global Evidence Generation planning. This paper deals with the process of developing an Evidence Generation Plan (EGP).

Systematic literature review to identify real-world studies reporting NST or attrition rates in la/mUC from 2017–2022 (including data reported since 2015). Of 2439 publications screened, 29 reported NST rates, ranging from 40–74% in eight European-based studies, 14–60% in 12 US-based studies, and 9–63% in nine studies in other locations (meta-analysis estimate, 39%). Factors associated with NST or no second-line therapy included older age, female sex, poor performance status, poor renal function and distant metastases.