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DEMYSTIFYING CLINICAL TRIALS ▸ Every year, thousands of clinical trials across the globe play an essential role in advancing our understanding of medical therapies. These trials are not merely regulatory requirements; they are crucial phases in the lifecycle of drug development, providing key insights into the efficacy and safety of prospective treatments. 💡But what's actually involved with a clinical trial? Discover more below about the vital role of clinical trials in healthcare innovation and how they pave the way for new treatments to reach those in need. The article explores questions and topics like: 🌐 What is a clinical trial? 🎯 Why are clinical trials important? 🌍 The global landscape of clinical trials and key areas of focus 🔄 The phases of clinical trials 🔗 The future of clinical trials including the impact of technology #ClinicalTrials #MedicalResearch #PatientCare #Innovation #Healthcare #Akesa #ClinicalTrialSupplies

🔍 #ClinicalTrialsDemystified 💉 Did you know? Every year, thousands of clinical trials worldwide are pivotal in advancing medical therapies! They're not just checkboxes; they're critical stages in drug development, offering invaluable insights into treatment effectiveness and safety. 💡 Curious about what goes into a clinical trial? Dive deeper into their indispensable role in healthcare innovation through this post and learn how they're paving the way for new treatments to reach those in need. #HealthcareInnovation #MedicalResearch 🌟

A 2023 Tufts Center for the Study of Drug Development (Tufts CSDD) survey among several hundred sponsor companies found that only 27% are routinely soliciting patient input into protocol design decisions. While stakeholders throughout the #clinicalresearch industry are well-intentioned in wanting to support #patientengagement, many factors are contributing to a high level of reluctance. Find out what these factors are: https://bit.ly/3Q4LEy2 #clinicaltrials

THREE (3) BENEFITS OF PARTICIPATING IN CLINICAL TRIALS. 1.     Finding Novel Treatments Clinical trials are essential in advancing medical discoveries from the researchers to the patients. The data collected during trials evaluate the effectiveness and safety of an investigational product, which determines if the product should be approved by the US Food and Drug Administration (FDA) or similar regulatory authorities for use by the public. Importantly, these trials will only happen with the participation of healthy volunteers or patients. In addition, you will have access to a first-class medical team that carefully monitors your progress and overall health. 2.     Get Help and Help Others by Saving Lives Participating in clinical trials is necessary to help prevent, diagnose, and find cures for diseases and illnesses. Your participation in clinical trials could contribute to the link between research and bringing life-saving therapies to patients. For example, if you have a genetic disease or illness, your participation could have an immense impact personally. You could also be helping sick people with similar genetic makeup to get novel treatment options. 3.     Get Treated by the Best Medical Practitioners Remember that whenever you actively participate in a clinical trial, your care is monitored by your doctor and highly-trained clinical research staff members. They look at every health parameter worth looking at, including labs, drugs, symptoms, and data collection processes, and carefully interrogate the impact on you, your care, and your outcome. They adhere to study protocols, ensuring lab testing and study procedures are executed with utmost precision and in line with standard guidelines for conducting research in humans. It takes a well-trained team of research professionals to keep a clinical trial running smoothly. At Bispharm Clinical, patient-centricity is our watchword. All our services are tailored to ensure you get the best out of your participation. #Bispharmclinical #Studyparticipant #Clinicaltrials #Patientrecuitment #Clinicalresearch #Clinicaltrialsitemanagement #SMO

Enhancing patient diversity in #ClinicalTrials has become a key priority in #DrugDevelopment. To learn more about the latest expectations for enhancing clinical trial diversity, we interviewed Rose Blackburne, MD, MBA, vice president and global head of general medicine and women’s health at the PPD Clinical Research Units business of Thermo Fisher Scientific. In the following interview, Dr. Blackburne discusses the latest #regulatory requirements around diversity in clinical trials, how the industry is responding and what actions will help enable further progress in clinical trial #HealthEquity in the years ahead: Clinical trial diversity: https://lnkd.in/ewPfDMFh #ClinicalDevelopment #pharma

Triall Insights 🔍 More than 75% of clinical trial protocols require at least one substantial amendment according to recent research by Tufts CSDD. Protocol amendments are highly disruptive to clinical operations and represent the largest cause of unexpected study delays and costs. To illustrate, biopharma companies spend an estimated $7-8 billion annually to implement these amendments of which 25% are considered to be ‘avoidable’. So what are key drivers? Common amendment drivers include: - Restrictive inclusion criteria - Excessive data collection - Logistical constraints Sponsors and CROs are now looking at historical data to inform their future study designs and prevent such design flaws, thereby avoiding amendments and boosting overall trial predictability. In this article, we unpack how #RWD and historical clinical trial data are used to enable a more 'data-informed' way of protocol development. We cover concrete examples of how data-informed decision-making can drive more adaptable, cost-efficient, and patient/site-centric studies. Keep on reading: https://lnkd.in/dnAnMaYs #clinicaltrials #clinicalresearch #DCTs #eClinical #datadriven #datainformed 

This is an exciting move by Pfizer! Participants in Pfizer-sponsored clinical trials now have the unique opportunity to access their individual data approximately 12 months post-trial completion. Sharing data transparently is foundational to creating patient-centered trials. This initiative not only fosters patient empowerment but also contributes to the evolution of clinical trials into more patient-centric and responsive endeavours. Thoughts? #ClinicalTrials #PatientCentricity

'In addition, ABPI analysis of data compiled from research organisations around the UK showed a moderate increase of 15% in annual recruitment to industry clinical trials in the UK, up by 5,366 participants year on year to a total of 42,088 in 2022/23. However, annual recruitment to industry clinical trials in the UK still remains well below the 58,048 participants recruited in 2017/18. This means there are 16,000 fewer people in the UK participating in industry clinical trials in 2022/23 than just six years ago.' I am sure you have seen the positive report from ABPI. However, if you look at the actual recruitment figures, this data is not positive. While 42,088 patients may sound like a lot the reality is that many patients participate in more than 1 clinical trial because they have positive experience from their participation in research. This means that in real life this figure could be almost half (if we don't count same patient participating in another study). What I really hope to see in the future is an initiative that more patients are aware of clinical research and have access to new therapies. There is a lot to be done to achieve this! #clinicaltrials #patients

How to improve patient outcomes by decreasing the I/E criteria in clinical trials. Are pharmaceutical companies, sites and CROs addressing this?? 1. Simplify Eligibility Criteria: Streamline and simplify the inclusion/exclusion criteria in clinical trials to ensure broader access for patients. Eliminate unnecessary restrictions and focus on the core requirements that are essential for the study objectives, safety, and efficacy. 2. Expand Age and Comorbidity Inclusion: Broaden the age range and consider including patients with common comorbidities that are representative of the real-world population. This expansion will enhance the external validity of trial results and improve equal access to clinical trials for a wider patient population. 3. Embrace Real-World Evidence: Incorporate real-world evidence (RWE) into the trial design by leveraging electronic health records, patient registries, and observational studies. RWE can provide valuable insights into patient reported outcomes and help identify potential participants who may not meet traditional eligibility criteria but could still benefit from trial participation. 4. Enhance Patient-Centric Trial Design: Involve patient representatives and advocacy groups in the trial design process. Their input can help identify and modify criteria that may unintentionally exclude certain patient populations, promoting equal access and ensuring patient reported outcomes are meaningful and relevant. 5. Utilize Adaptive Trial Designs: Implement adaptive trial designs that allow for modifications in eligibility criteria based on accumulating data. This flexibility enables the inclusion of a broader patient population throughout the trial, leading to more representative patient reported outcomes. 6. Increase Diversity in Trial Recruitment: Actively promote diversity and inclusion in trial recruitment efforts. Collaborate with community organizations, healthcare providers, and patient support groups to reach underrepresented populations. This strategy will help address disparities and ensure equal access to clinical trials. #InclusionExclusionCriteria #EqualAccess #PatientReportedOutcomes #ClinicalTrialDelivery #RealWorldEvidence #PatientCentric

Including diversity in clinical studies has long been a topic of discussion within the medical community. The importance of this issue is further elaborated in a perspective published on NEJM Group. One notable example highlighting the impact of diversity on clinical accuracy involves the influence of skin color on the outputs of pulse oximetry, detailed in recent publications. Notably, the US FDA recently released a draft guidance titled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." This guidance aims to standardize study design, potentially aligning practices with new regulatory provisions. Some manufacturers have already incorporated these requirements into their operations, showcasing proactive measures in this area. The guidance outlines the format and content of Diversity Action Plans, emphasizing the need for sponsors to specify enrollment rationale and goals across various demographic factors. It also encourages a comprehensive approach to diversity beyond traditional categories, ensuring representation of the patient populations that may benefit from approved products. While the focus is currently on US markets, aligning these requirements internationally presents an intriguing challenge. Aligning epidemiologically with conditions treated by products across diverse markets adds further complexity to this goal. Furthermore, the guidance holds promise for digital health applications, ensuring efficacy and benefit alignment with user needs. For more information: - NEJM perspective: https://lnkd.in/ghRnRRKZ - FDA draft guidance details: https://lnkd.in/gR2kKEef - Pulse Oximetry discussion on NEJM: https://lnkd.in/gUBMTYZw - FDA Executive Summary for Pulse Oximetry Investigation: https://lnkd.in/ghRu2-H4 - Relevant report from Fierce Biotech: https://lnkd.in/gC3afHU9 - Relevant report from MedTech Dive: https://lnkd.in/gwjhZ6kz #clinicalstudy #clinicaltrial #clinicalevaluation #biomedicalengineering #Quality #Regulatoryaffairs #medicaldevices #digitalhealth #SaMD #SiMD #Medtech #Biotech #FDA #IVD #POC #clinicalevaluationstudy #standards #guidance #diversity #CRO #Research #PolicyRegulation #Planning #clinicalresearch #precisionmedicine #precisionhealth