Clinical trials may be expensive and slow, but according to Advarra's SVP of Site/Sponsor Innovation Christine Senn, PhD, we're on the precipice of change. One area that could accelerate trial execution (and reduce burden) is improving trial feasibility – the process by which a sponsor or CRO identifies trial sites. The current process is broken and those fractures have downstream effects that negatively impact every stakeholder. After all, burden leads to burnout, which directly impacts trial efficacy and patient experience. In a recent piece for The Medicine Maker, Christine shares eight uncomplicated dos and don'ts for improving feasibility. Read the full article here for more insights from Christine: https://lnkd.in/gKXZhNCj #ClinicalResearch #ClinicalTrials #HealthcareInnovation
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Last chance to register! Gain insights from industry experts on how standardized patient experience measurement forms a valuable novel dataset for retention and KPIs based on the democratic voice of the patient in real-time. Register now using the link below and join Archana Sah MS (Pharm.), PMP, Jesse Hoffman, Scott Schliebner, Carole Stockmeier, and Kristopher Morgan for an informative session on the Standardized Measurement of Patient Experience in Clinical Trials. Don't miss out on this opportunity to stay ahead of the curve in patient-centered clinical research! Register: https://lnkd.in/ePeF_W9W #PatientExperience #ClinicalTrials #standardization
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SporeData's post on Bayesian adaptive designs in clinical trials underscores the importance of adaptive designs in improving the efficiency and ethical aspects of clinical research. Adaptive designs offer a flexible alternative to traditional fixed designs, allowing for modifications based on interim results without compromising the study's integrity. This methodology can lead to more effective and safer clinical trials, emphasizing patient safety and resource optimization. #BayesianAdaptiveDesigns #ClinicalTrialsInnovation #EfficientResearch #HealthcareDataScience #PatientSafetyEnhancement #collaboratewithsporedata
This post showcases the advantages of #Bayesian adaptive designs in clinical trials, emphasizing their efficiency in reducing sample size and study duration, and enhancing patient safety through early stopping for futility. Drawing from the OSCAR trial case study, the post contrasts traditional trial methodologies with Bayesian adaptive approaches, highlighting the flexibility and efficiency of the latter. For a deeper understanding, refer to the original paper: https://lnkd.in/deKYU-dv. This comparison underscores the potential of Bayesian adaptive designs to streamline clinical research, making it a valuable read for professionals in the field. At SporeData Inc., our team possesses specialized expertise in designing Bayesian adaptive trials, offering tailored solutions that enhance the efficiency and effectiveness of clinical research. To learn more about Bayesian adaptive designs and how you can use them for your research, please contact SporeData Inc. Ricardo Pietrobon Lucas Teixeira Aline Machiavelli #BayesianAdaptiveDesigns #ClinicalTrialsInnovation #EfficientResearch #HealthcareDataScience #PatientSafetyEnhancement #collaboratewithsporedata
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This post showcases the advantages of #Bayesian adaptive designs in clinical trials, emphasizing their efficiency in reducing sample size and study duration, and enhancing patient safety through early stopping for futility. Drawing from the OSCAR trial case study, the post contrasts traditional trial methodologies with Bayesian adaptive approaches, highlighting the flexibility and efficiency of the latter. For a deeper understanding, refer to the original paper: https://lnkd.in/deKYU-dv. This comparison underscores the potential of Bayesian adaptive designs to streamline clinical research, making it a valuable read for professionals in the field. At SporeData Inc., our team possesses specialized expertise in designing Bayesian adaptive trials, offering tailored solutions that enhance the efficiency and effectiveness of clinical research. To learn more about Bayesian adaptive designs and how you can use them for your research, please contact SporeData Inc. Ricardo Pietrobon Lucas Teixeira Aline Machiavelli #BayesianAdaptiveDesigns #ClinicalTrialsInnovation #EfficientResearch #HealthcareDataScience #PatientSafetyEnhancement #collaboratewithsporedata
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Did you know Clinical Trials Day is this 20th May? In recognition of this day, join us for a special webinar hosted by PharmaTimes and featuring our founder, Mark Doyle. This webinar will delve into the evolution of clinical trials and highlight the pivotal role of patient-centricity in their development and deployment. Don’t miss this insightful discussion. Register on the PharmaTimes website below: https://ow.ly/ny5F50RiumG #ClinicalTrialsDay #PFDD #Webinar
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Feasibility studies are crucial in ensuring that clinical trial designs are realistic and achievable within set constraints of time, budget, and real-world logistics. Challenges arise when trial criteria become increasingly narrow, making participant recruitment and retention more difficult, especially for complex studies with specialized requirements and dispersed patient populations. By conducting thorough analyses early in the process, incorporating real-world data, and prioritizing patient-centric approaches, feasibility studies not only optimize trial operations and costs but also expedite the delivery of therapies to those in need. Lokavant CEO Rohit Nambisan sat down with Applied Clinical Trials Magazine to discuss structuring feasibility studies and how they can make running a trial more efficient. 👉 Read the article or listen in here! https://lnkd.in/dv494zbY #ClinicalTrials #Feasibility #PatientCare #RWD
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Bringing new treatments to life: At Alliance Clinical, we have proven expertise in a broad range of therapeutic areas to help accelerate your studies. Find out what makes us different: https://lnkd.in/ghzHNtbc #ClinicalResearch #ClinicalStudies #ClinicalTrials
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Consider the fact that over 90% of all evidence generated is RWE but the impact of this evidence in establishing the additional benefit of a product to patients is perhaps less than 5%. This is perhaps starkly illustrated in rare diseases, and complex medtech with small dispersed populations and the ability to evidence additional clinical benefit is hampered in traditional trial designs. Our recent work on a successful medtech product launch drew up on our years of experience of evidence generation programs to deliver: 1. Careful alignment of business goals balancing early data of clinical benefit to market access realities and patient needs. 2. Early planning of the evidence generation pipeline and underlying strategy. 3. Including pragmatic studies with external control arms and adaptive trial design approaches Keith Needham Grace Macalino David Gregory #Evidencegenerationstrategy #RWE #scientificstudies #thisisBakertilly
MedTech company launches digital health platform with help of effective clinical study design
bakertilly.com
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#Decentralized #clinicaltrials can allow more patients to benefit from #investigationaltherapies and help break down barriers to equitable trial participation. This is particularly crucial for #raredisease trials given the small patient populations and often very limited therapeutic options outside of clinical trials. FDA has taken important steps to support the adoption of decentralized trials, in particular during and after the pandemic, but real and perceived logistical, regulatory, administrative, and workforce challenges continue to hamper adoption. Great new article from the Clinical Trials Transformation Initiative (CTTI) on the topic today!
DYK? Incorporating decentralized approaches into clinical trials has the potential for improved accessibility and diversity, as well as lower burden for patients and caregivers. Despite the widespread support for decentralization, real and perceived challenges remain. Learn more about the barriers limiting wider implementation of decentralized elements in clinical trials and how trial designers can overcome them in #CTTI’s newest article published in the Journal of Therapeutic Innovation & Regulatory Science. https://bit.ly/3PQPZVw
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This Clinical Trials Transformation Initiative (CTTI) article showcases some of the great work they are doing in exploring perceived barriers to decentralising aspects of clinical trial delivery. There are real benefits to adopting more flexible delivery methods, particularly in increasing the diversity and representativeness of clinical trial populations. Which raises the question - what do we need to do to make it easier to use flexible delivery methods in Australian clinical research? CT:IQ is seeking to develop practical answers to this question in a new project. We are looking forward to meeting in person with current CT:IQ members in Melbourne in May to explore impactful ways we can make flexible trial delivery methods easier. If you are interested in this question, and/or are excited spend a day with Lisa Eckstein, Gudrun Wells, and some amazing Australian clinical trial thought leaders, why not become a member and come along? #CTTI #decentralisedtrials #clinicaltrialinnovation
DYK? Incorporating decentralized approaches into clinical trials has the potential for improved accessibility and diversity, as well as lower burden for patients and caregivers. Despite the widespread support for decentralization, real and perceived challenges remain. Learn more about the barriers limiting wider implementation of decentralized elements in clinical trials and how trial designers can overcome them in #CTTI’s newest article published in the Journal of Therapeutic Innovation & Regulatory Science. https://bit.ly/3PQPZVw
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Are you interested in enhancing glucose #datacollection in your clinical trial? Discover how IQVIA Connected Devices can accelerate clinical development, reduce patient burden and deliver a more complete view of glucose data, helping drive clinical research forward: https://bit.ly/4aVBurr #datacollection
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