Heru’s Post

🌍⚕️ Clinical Outcome Assessments (COAs) play a vital role in clinical trials, ensuring accurate measurement of patient outcomes. However, the process of localizing COAs can often lead to costly and time-consuming revisions. Discover effective strategies to avoid COA source revisions and minimize their impact on translation in our article: https://ow.ly/oBN450SOSPR #COA #Translation #ClinicalResearch #l10n #clinicaltrials

🌍⚕️ Clinical Outcome Assessments (COAs) play a vital role in clinical trials, ensuring accurate measurement of patient outcomes. However, the process of localizing COAs can often lead to costly and time-consuming revisions. Discover effective strategies to avoid COA source revisions and minimize their impact on translation in our article: https://ow.ly/oBN450SOSPR #COA #Translation #ClinicalResearch #l10n #clinicaltrials

🌍⚕️ Clinical Outcome Assessments (COAs) play a vital role in clinical trials, ensuring accurate measurement of patient outcomes. However, the process of localizing COAs can often lead to costly and time-consuming revisions. Discover effective strategies to avoid COA source revisions and minimize their impact on translation in our article: https://ow.ly/oBN450SOSPR #COA #Translation #ClinicalResearch #l10n #clinicaltrials

 I’m excited to share the publication of a significant case report titled "Preanalytical Challenges in Tacrolimus Monitoring" in the APFCB eNEWS 2024, Issue 2. In this report, we address the frequent preanalytical challenges we encounter in Tacrolimus monitoring, as well as the complaints from both patients and clinicians. Often, the cause of unexpectedly high or low Tacrolimus levels, despite normal dosing, can be attributed to seemingly simple factors such as diarrhea in the patient or the use of concurrent medications. This highlights the critical importance of understanding these preanalytical factors to ensure accurate monitoring and optimal patient outcomes. Santosh Pradhan samyak Diagnostic

We specialize in providing custom solutions and recommending the best data collection methods for both standard and unique clinical trial circumstances. Learn more about the novel ediary solution we developed to ensure successful data collection in a hemophilia clinical trial: https://lnkd.in/eVW28bzC #clinicaltrial

🚀 58.1% of the studies adopted Quality Tolerance Limits in 2023! 💡 You want to gain more insights about industry trends, then I advise you to read the following Applied Clinical Trials Magazine article: https://lnkd.in/eXiA63yB CluePoints #RBQM

The use of patient preference information for endpoint selection, quantitative benefit-risk assessment, HTA or shared decision making has been discussed extensively. However, patients' voices matter in so many decisions along the product life cycle, including the clinical study design. Patient-focussed drug development should not only be about outcome selection and interpretation, but also about the entire evidence generation process. Deciding on whether or not to take part in a clinical trial can be challenging with many pros and cons to weigh. Evidera's StudyGage tool is a nice example of this thinking. It uses dedicated preference information to compare alternative trial designs while carefully controlling for potentially complex heterogeneity in preferences. A lot of thinking, testing and validation work went into this with tons and tons of brain power from people like Kevin Marsh, Caitlin Thomas and Nicolas KRUCIEN. Let's make evidence generation patient-centric. Please send me a message if you are interested in learning more.

👉 Diagnostic devices 👈 are absolutely critical to provision of care. But they pose specific challenges from a regulatory approval perspective. Why? One reason is the problem of demonstrating accuracy. Diagnostic devices need to be supported by data showing they are accurate - but in comparison to what? And what does 'accurate' actually mean? Let's consider some possibilities. 1) The 'gold standard' method One way of showing accuracy is by demonstrating that a device offers an outcome that is non-different to a 'gold standard' widely held to represent the 'correct answer'. This would require both devices to be used on the same patient sample, followed by a comparison of readings. This is a strong method but is not without its difficulties: there may be no universal agreement on a 'gold standard' method and, sometimes, the subject device itself might be held to be that standard. 2) The inter-observer method This method requires two or more observers / clinicians to use the test device on the same patient sample at different points in time. Results obtained from different observers are then compared. This method is useful for when no gold standard is available, but can be influenced by variances in the technique of the observers. 3) The 'two arms' method. Where applicable, two specimens of the same device could conduct simultaneous readings on both arms / legs / eyes etc of subjects. These values then enable a direct comparison. This method can be limited by pathology impacting one side of a subject. 4) The intra-observer method. Perhaps the most simple approach - this involves the same observer conducting two or more readings on the same patient sample. Results are then compared for consistency. Choosing which method to use is a key decision, often influenced by data available on similar devices. But don't leave it until the last minute - ensuring your device is supported by the data it needs is vital to gaining certification. What other methods can be used? Comment below if you have any further thoughts! #mantrasystems #diagnosticdevices #medicaldevices #clinicalevidence

Start 2025 by rethinking patient dropout rates in your clinical trials. Every participant who discontinues the study drug or deviates from the protocol diminishes the study's statistical power and credibility. Introducing SPUR, a unique adherence solution that delivers personalized behavioral diagnosis and intervention plans tailored to each participant. SPUR encompasses the key determinants of patient beliefs, attitudes, and behaviors: Social, Psychological, Usage, and Rational factors, customized for every individual. By completing a simple electronic questionnaire, participants receive immediate feedback through the SPUR analysis. Research investigators gain insights into participant profiles, predicting adherence risks, identifying drivers of non-adherence, and offering personalized communication strategies to enhance engagement. Clinical Ink, in an exclusive collaboration with Observia, presents SPUR as a game changing clinical trial adherence solution.

Pharmacogenomic testing can guide prescribing decisions to improve therapeutic effectiveness and prevent adverse drug reactions. Studies have shown that PGx can significantly improve patient health benefits, from more effective health treatment, fewer adverse drug events (ADE), reduction in hospital visits, and mortality. This presentation is focused on describing the basic concepts of Pharmacogenomics and its application in real life patient care situations.