Patient Co-Next

With so much general information about patient engagement now online, we refocus our newsletter content to cases of actual implementation in clinical trials and research to bring value to those seeking practical guidance. This means a bi-monthly newsletter moving forward, and in the September - October edition we highlight several examples of early patient engagement to shape research priorities in rare disease, respiratory infection, and kidney stone disease. Plus an example of how parent involvement in a pediatric stroke trial enabled better education, recruitment and retention. What is inspiring is that these were lead by patients, caregivers and clinicians - showing that patient engagement at the patient-physician interface is truly walking the talk! 🙌 www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #pfdd #clinicaldevelopment #PRO #QoL #DEI #diversity #precisionmedicine #PPI #raredisease #pediatric #children #adolescent #patientpreference #GLUT1 # #RSV #USD #kidneystone #stroke #recruitment #retention #patienteducation

Let's focus on under-represented groups in clinical trials, in the August Research Insights Newsletter! 👧🏻 How well have early phase #oncology clinical trials considered the quality of life and #administration needs of children and adolescents? Apparently it's improving, but there is more work to be done - especially since there was no evidence of patient involvement in the studies assessed. 🦓 Have you thought about how to apply #diversity, #equity, #inclusion, and #accessibility in rare disease clinical trials? Learn more in this review with case examples. www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #pfdd #clinicaldevelopment #PRO #QoL #DEI #diversity #cancergenomics #precisionmedicine #PPI #children #adolescent #cancer #oncology #raredisease #pediatric #patientpreference

How does the #FDA measure the implementation of their guidance documents? FDA guidance documents have played an important role in setting expectations for drug and device researchers, on improved patient centricity and representation in clinical trials (#PFDD, #DEI). With the recent release of the draft guidance document which has updated the 2022 draft on Diversity Plans from Underrepresented Racial and Ethnic Populations in Clinical Trials, and now expanded to the 2024 draft on Diversity Action Plans for all relevant Underrepresented Populations (including sex, age, and other). These are exciting times for patients and clinical research! We have recently shared a couple of examples of how the #implementation of patient engagement in clinical trials can be measured. How does the FDA measure the implementation of such guidance documents? Here is an example of how they assessed the use of Patient Experience Data (#PED) in Regulatory Decision-Making in 2021, after releasing draft guidance documents in 2017. Key insights and learnings from the 3-year cohort assessment of 120 'approved' New Drug Applications (NDAs), Biologics License Applications (BLAs), and efficacy supplements: 🌟 Different types of FDA applications vary in their need for PED 🌟 68% of FDA applications mentioned PED - 97% of which used Patient-reported Outcomes (PROs) or other Clinical Outcomes Assessments (COAs), 3% used Patient Preference Studies (PPS) 🌟 30% of approved product labeling mention PED, of which 53% were for products with priority review. Composition of type of PED here: 67% PROs, 25% other COAs, 6% natural history studies, 1% observational studies, 1% qualitative studies 🌟 Focus groups with 91 FDA staff, 29 BioPharma representatives, and 75 other Stakeholders (patients and caregivers, clinicians, and research, education, support, and advocacy organizations) identified these overarching perspectives: FDA - use of PED in reviews and decision-making is science-based and evolving, some use qualitative PED for background and context. Other Stakeholders - stated that they do not know how FDA uses PED in regulatory decision-making, and would like to better understand this. Recommendations have been made, with follow up assessments of PED use planned by the FDA in 2026 and 2031. It is encouraging to see such interest from regulators in assessing the progress influenced by their guidance documents! Link to the PED Assessment: https://lnkd.in/gs8DP9Q3 www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #pfdd #innovation #clinicaldevelopment #measurement #implementation #PRO #COA #DEI #diversity #PPI #PAIR #FDA #regulatoryaffairs

Which healthcare organisations are taking tangible steps to assess the opportunities and impact of patient engagement in research? Trusted medical and scientific institutions are leading the way! In the July edition of Patient Co-Next Research Insights, we share how groups such as the National Cancer Institute (NCI), the National Institutes for Healthcare and Research (NIHR), and the European Blood and Marrow Transplantation (EBMT) Society are paving the way for meaningful patient involvement in early trial design, PRO development and selection, and assessment of patient engagement impact in research. www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #pfdd #innovation #clinicaldevelopment #measurement #implementation #PRO #DEI #diversity #cancergenomics #precisionmedicine #dosefinding #PPI #PAIR #NCI #NIHR #EBMT

How do you measure implementation of patient-centric activities in a clinical trial? We share one way that we tried to gauge this, among an audience of industry, academia, healthcare organisations, and trial service providers who attended the Global Clinical Trials Connect 2024 conference. After reviewing what innovation in clinical trials means to patients, and outlining the 14 components of the 'Personalized Clinical Trials Framework' from #TransCelerate, we asked the audience which of these activities they have implemented in a clinical trial. Out of 46 respondents in the audience: 👩🎓 The highest activity implemented was providing patients education about the clinical trial (32). 💡📱The second highest activities implemented were creating general awareness about clinical trials, and enabling collection of digital data from patients during the trial (23). 🙏 Fewer had involved patients in providing input into the trial design or protocol (15). 🧓 The lowest activities were those providing patients with convenience - decentralised participation via direct delivery of therapies or alternative procedure locations, and flexibility in scheduling (7-9). There seems to be more work needed to 'walk the talk' in practice, when it comes to patient centricity in clinical trials. If trial sponsors also conducted a similar measure of their patient-centric activity implementation, we wonder what this would look like for different organisations? We welcome your thoughts and feedback! www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #pfdd #patientjourney #decentralizedclinicaltrials #directtopatients #personalizedclinicaltrials #patientretention #innovation #clinicaldevelopment #corvusglobalevents #measurement #implementation

Improve your knowledge and expertise in patient centricity in clinical trials! In the June 2024 Patient Co-Next Research Insights newsletter, we share: * A Pharma company’s experience with leveraging patient input into topics relevant to clinical trials * A comprehensive review of factors impacting D&I in oncology clinical trials * How patient insights can drive research priorities early on in a case study in long Covid patients * An EMA-funded review of the use of patient experience data across the medicines’ lifecycle www.patient-co-next.com #PAH #merck #diversity #inclusion #DandI #longCovid #COVID #EMA #patientexperiencedata #PED #oncology #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #pfdd #pharma #chemosensorydisorder #alzheimersdisease #livedexperience #PRO #patientpreferences

Going to #EHA Congress in Madrid? Take the opportunity to meet us on your arrival, before it all starts, to focus on #patientcentricity and #patientengagement in #clinicaltrials and #research. We are offering a drop-in at the Patient Co-Next XChange Hub to BRAINSTORM, DISCUSS, SHARE your ideas, thoughts or opinions on all things patient-centric! See the flyer below for more details 😊 www.patient-co-next.com

We had a busy week at the Global Clinical Trials Connect 2024 (#Corvus) and the 16th Clinical Trials Strategic Summit (#AgileFalcon), as panellists, speakers, and active participants. At GCTC 2024, Sophie Wintrich was on the day 1 panel to discuss "The Future of Patient-Centricity in Clinical Trials" and on day 2 was joined by Pauline Frank to co-present their perspective on implementation and innovation with the "Personalized Clinical Trials Framework" (from #Transcelerate). Key learnings from this stimulating meeting from a patient-centricity perspective: 💡 #ChatGPT lists #patientcentricity as a pillar of innovation for future clinical trials, but we question why this is considered innovation and not already part of how clinical trials are run? The PCTF provides tangible actions towards implementing patient centricity in a trial. 👨⚕️ There is an exciting array of new ways to identify patients for trial recruitment and identifying trends for successful trials, using #AI, #NLP and #ML - but the human touch and understanding the "why" behind the data remains important to truly meet patient needs. 🛑 Let's stop using the term #patientretention, and replace it with "patient persistence" as the latter implies partnership and efforts to pull together in the same direction. 💁♀️ #Platformtrials are currently not well supported by the #pharmaceuticalindustry and more driven by patient and medical organizations, but these trials can provide business value as well as delivering research, societal and healthcare systems value. Importantly, they provide more treatment options for patients than standard trial designs. 🌏 #RWE can play a key role in patient-centric trial designs, potentially replacing control / placebo arms with real-world data. At the 16th CTSS, Pauline Frank moderated a panel of experts - Dr. Andriy K., Elizabeth Eagling-Vose, MBA, Shaantanu Donde, Cornelia Baumgartner- Diolaiuti, Dr Sumeet Ambarkhane, MD - in a discussion about "Optimizing Clinical Development" through Medical Affairs integration. It became an interesting debate with the audience, especially since smaller Biotech companies often don't have Medical Affairs resources. The value of Medical Affairs to bring insights from external stakeholders to enable robust #evidencegeneration and to enable #patientengagement, were seen as some of the value which Medical Affairs could bring to clinical teams👍. A big THANK YOU to the organizers, co-presenters, co-panellists, and the curious audience! www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #patientjourney #transcelerate #decentralizedclinicaltrials #directtopatient #personalizedclinicaltrials #AI #patientretention #innovation #platformtrials #clinicaldevelopment #medicalaffairs #healthcaresystems #RWE

Although the International Clinical Trials Day 2024 theme is dedicated to “recognising and championing clinical research professionals” as “The Trailblazers Among Us”, it is important not to forget the patients and other professionals involved. Firstly, THANK YOU to the clinical trial patients who have contributed to advancing medicine, and to the patient advocates and experts who represent the voice of the patient to improve clinical trials outcomes. We would also like to spotlight clinical trial supply professionals who we engaged with at last week's Clinical Trial Supply Forum in Brussels, to share our insights on implementation of patient engagement in clinical trials. We took away key learnings from this group of professionals: 🔎 Their focus on ensuring trial therapies reach trial sites or direct-to-patients on time and within quality specifications, is admirable - one example shared of a radiotherapy with 7 days activity that required -80C storage, supplied successfully from Vienna (Austria) to a trial in Sydney (Australia)! 💡 They proactively seek solutions to manage issues of waste in trials, currently a mind-boggling 50% of unused therapies (many end up getting destroyed) - one example shared of innovation in e-labels 🙍♀️ Patient recruitment forecasting is often inaccurate due to multiple reasons, and have a flow on impact. Improvement is required, and critical stakeholders (like clinical trial supply and patient advocates/experts) should be involved at trial and protocol design stage to minimise issues 🌎 Environmental impact and sustainability are important issues for trials, and clinical trial supply has a key role to play Finally, we would like to acknowledge Carol Jarvis, the patient speaker at the Forum who is a world-renowned musician and Hodgkin's Lymphoma survivor. Her inspiring story elevates the importance of striving to conduct better clinical trials for patients. Thank you to Nikki Kandola and the PharmaIQ for a great event! www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #patientjourney #clinicaltrialsupply #decentralisedclinicaltrials #directtopatient #dct #dtp #clinicaltrialsupplyforum #pharmaIQ #caroljarvis #clinicaltrialsday

We believe that insights from research in patient engagement is key to improving the knowledge and expertise of the clinical trial community in applying patient centricity. Access the 1st Patient Co-Next Research Insights newsletter below! We share findings from studies on engagement with diverse and developing communities to improve their research knowledge, and a systematic review on patient and public involvement (PPI) reporting in patient safety research. We would love to get your feedback about the insights shared 😊 www.patient-co-next.com #patientengagement #patientcentricity #patientadvocacy #clinicaltrials #research #drugdevelopment #patientinsights #patientrecruitment #clinicaloperations #pfmd #diversity #inclusion #communityengagement #GPP2 #PPI #insights #parkinsonsdisease #urinaryincontinence