scholarly journals Commentary on Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Real-World Evidence

2020 ◽  
Vol 55 (3) ◽  
pp. 229-231
Author(s):  
Mark A. Sutherlin
2016 ◽  
Vol 34 (10) ◽  
pp. 1039-1050 ◽  
Author(s):  
Bonny Parkinson ◽  
Rosalie Viney ◽  
Marion Haas ◽  
Stephen Goodall ◽  
Preeyaporn Srasuebkul ◽  
...  

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Andreas Straube ◽  
Philipp Stude ◽  
Charly Gaul ◽  
Katrin Schuh ◽  
Mirja Koch

Abstract Background Erenumab, the first-in-class fully human monoclonal antibody targeting the calcitonin gene-related peptide receptor, was shown to be efficacious and safe for the prophylactic treatment of migraine in adults in randomized clinical trials. Large-scale, real-world evidence in multi-centre settings is still needed to confirm these results. Erenumab patient profiles outside clinical trials and physicians’ treatment patterns, as well as data from patients treated in Germany, a severely impacted population, are not published yet. Methods TELESCOPE was a multi-centre survey gathering real-world data from 45 German headache centres between July 2019 and December 2019. The project consisted of two parts. In the first part, treating physicians shared their experiences on current erenumab treatment with regard to patient profiles, treatment patterns and treatment responses. In the second part, a retrospective chart review was conducted of 542 migraine patients treated with erenumab for at least three months. Treatment responses focused on various aspects of patients’ quality of life. Results The analysis of 542 patients’ charts revealed that three-month treatment with erenumab significantly reduced monthly headaches, migraine and acute medication days. Furthermore, headache intensity and frequency were reduced in over 75 % and accompanying aura in 35 % of patients. The clinical global impression scale revealed a general improvement in 91 % of patients. According to the treating physicians’ professional judgement, 83 % of patients responded to erenumab and 80 % were satisfied with the treatment. Physicians evaluated restricted quality of life, the number of monthly migraine days and previous, prophylactic treatments as the main components of the current patient profile for monoclonal antibody recipients. Based on the assessment of physicians, erenumab reduced migraine symptoms in 65 % and increased quality of life in more than 75 % of their patients. Conclusions TELESCOPE confirms positive treatment responses with erenumab shown in clinical trials in a real-world multi-centre setting. The results show consistently positive experiences of physicians utilizing erenumab in clinical practice and underline that therapy with this monoclonal antibody is effective in migraine patients, particular in those, who have failed several prophylactic therapies.


2021 ◽  
pp. 253-282
Author(s):  
Richard C. Zink ◽  
Melvin Munsaka ◽  
Birol Emir ◽  
Yong Ma ◽  
Judy X. Li ◽  
...  

Author(s):  
Jim Weatherall ◽  
Faisal M. Khan ◽  
Mishal Patel ◽  
Richard Dearden ◽  
Khader Shameer ◽  
...  

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 228-228 ◽  
Author(s):  
Lorie Ellis ◽  
Marie-Helene Lafeuille ◽  
Laurence Gozalo ◽  
Patrick Lefebvre ◽  
Elisabetta Malangone-Monaco ◽  
...  

228 Background: Little information exists regarding the sequences in which new mCRPC therapies with evidence of survival benefits are used. This study aims at describing the sequence of mCRPC medication use as observed in 3 healthcare datasets. Methods: Healthcare claims datasets (Dataset #1 and #2) and a community oncology electronic medical record (Dataset #3) were used to identify PC patients with ≥ 1 claim for a study drug (abiraterone acetate--AA, cabazitaxel--CAB, docetaxel – DOC, enzalutamide – ENZ, and sipuleucel T – SIP) occurring after 9/1/2012. The index date was the 1st study drug claim. Patients were excluded if a study drug claim occurred prior to 9/1/2012. Descriptive statistics summarized the proportion of patients receiving one vs. two or more lines of therapy. The prevalence of 1st line therapy and of 1st to 2nd-line sequences was analyzed. Results: Analysis of 3 unique datasets with > 5,900 PC patients revealed most patients received a single line of therapy. AA and DOC were the most common 1st line agents. The five most-prevalent 1st- to 2nd-line sequences identified in each database are shown in the table below. The most commonly observed 1st- to 2nd-line sequences were AA-ENZ, AA-DOC, and DOC-AA. Conclusions: Real world treatment selection for 5 mCRPC medications was consistent across 3 datasets. The majority of PC patients had a prescription/claim for a single agent. AA and DOC were the most commonly selected 1st line treatments. A 2nd-line agent was observed in 14-33% of patients. Similar patterns of 1st-2nd line sequences were observed between datasets. Further research is warranted with longer follow-up and consideration of other treatment interventions. [Table: see text]


2020 ◽  
Vol 26 (1) ◽  
pp. 5-9
Author(s):  
Monika Kozieł ◽  
Gregory Y. H. Lip ◽  
Tatjana S. Potpara

Real world registries of patients with atrial fi brillation (AF) have provided important evidence on contemporary AF management and adherence to guidelines in real-world patients across most of regions in Europe. While prospective randomized clinical trials are the ‘gold standard’ of evidence, we recognize that trials have specifi c inclusion/exclusion criteria and many groups of patients can be under-represented. Thus, real world evidence is needed to supplement and augment the evidence, especially for the under-represented patient groups (eg. the very elderly and frail, ethnic minorities, end stage renal failure, those in nursing homes, cognitive impairment, etc) that have been largely under-represented or excluded from clinical trials. The BALKAN-AF survey is the largest prospective, multicenter (a total of 49 centres), observational AF dataset from the Balkans, a European region inhabited by about 10% of the European population that has been under-represented in many prior clinical trials or registries. In BALKAN-AF, data regarding consecutive subjects with electrocardiographically documented non-valvular AF were collected in seven Balkan countries (Albania, Bosnia & Herzegovina, Bulgaria, Croatia, Montenegro, Romania and Serbia) by a cardiologist or an internal medicine specialist where cardiologist was not available. The Serbian Atrial Fibrillation Association created and conducted the BALKAN-AF survey (performed from December 2014 to February 2015).


2021 ◽  
Author(s):  
Qian Li ◽  
Hansi Zhang ◽  
Zhaoyi Chen ◽  
Yi Guo ◽  
Thomas George ◽  
...  

Recently, there is a growing interest in using real-world data (RWD) to generate real-world evidence (RWE) that complements clinical trials. Nevertheless, to quantify the treatment effects, it is important to develop meaningful RWD-based endpoints. In cancer trials, two real-world endpoints are particularly of interest: real-world overall survival (rwOS) and real-world time to next treatment (rwTTNT). In this work, we identified ways to calculate these real-world endpoints with structured EHR data, and validated these endpoints against the gold-standard measurements of these endpoints derived from linked EHR and TR data. In addition, we also examined and reported the data quality issues especially the inconsistency between the EHR and TR data. Using survival model, our result showed that patients (1) without subsequent chemotherapy or (2) with subsequent chemotherapy and longer rwTTNT, would have longer rwOS, showing the validity of using rwTTNT as a real-world surrogate marker for measuring cancer endpoints.


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