Jorge López Sancho’s Post

Are you patient INTEGRATED or just patient centred? I had an incredible time at Patients As Partners in Clinical Research Community News EU 2024. It was great to meet so many passionate people and hear the work they’re doing to advocate for patients in pharma. My main takeaway was that it’s not enough to be patient-centric. The patient perspective should be heard and acknowledged at each step of design and delivery. This is the key to producing meaningful work and outcomes. What can this look like? 1. Sending regular emails to research participants to update them on progress and share relevant news/ insights 2. Having internal patient boards that you consult on a regular, longitudinal basis 3. Have a mindset to give and not take from patients. Patients are people first and we must always remember that! Above all, we must remember to ‘mind the gap’, in the words of Xoli Belgrave . Consider barriers to participation, particularly those from under-served groups. #patientsaspartnerseu24 #patientvoice #patientadvocacy

Thank you to the Duke Clinical Research Institute for the opportunity to speak at the recent Think Tank on the State of Clinical Research and Care Delivery. I appreciate the chance to engage with colleagues and leaders from the FDA, CMS, and beyond. During the session, I emphasized several critical points, which resonated with issues raised by those from the regulatory and reimbursement communities: - High-quality Evidence: Creating a package of evidence that meets the requirement of different regulatory agencies to demonstrate the safety, efficacy and quality of investigational medicines. - Patient-Centric Design: Designing trials with patients and with their needs in mind, including flexible schedules and digital health technologies for remote participation. - Community Collaboration: Partnering with advocacy groups and healthcare providers to raise awareness and address barriers to participation. - Diversity and Inclusion: Implementing strategies to enhance diversity in trial enrolment and ensure representation across diverse populations. Key question: how can we move science through to new medicines that make a meaningful difference for those living with chronic conditions across the world more quickly and less expensively - while maintaining confidence in safety? Lots of great discussion today! #EvidenceGeneration #ClinicalInnovation #DigitalHealth #RCT #RWE

Clinical trials wouldn't exist without patients. They bravely take on the challenge of testing new treatments, paving the way for medical advancements. They're not just participants; they're collaborators in the quest for better healthcare. Here are 10 ways to put patients first: 1. Host patient focus groups to get real-world insights and concerns. 2. Conduct live protocol simulations to understand the participant experience. 3. Collaborate with patient advocacy organizations for outreach and support. 4. Analyze real-world data to personalize the trial design and understand diverse patient populations. 5. Include clear information on location, inclusion/exclusion criteria, and study details on the recruitment website. 6. Implement a digital pre-screener form so patients can quickly assess if they pre-qualify. 7. Establish early personal interactions with patients to build trust and address concerns. 8. Minimize obstacles like travel requirements, overly strict eligibility criteria, and accessibility issues. 9.  Maintain a clear and consistent line of communication throughout the entire trial process. 10. Reduce administrative burdens on research sites so teams can focus on patient care and personalized interaction. By putting patients at the heart of clinical trials, we can create a more streamlined, informative, and ultimately, successful research experience for everyone involved! #ClinicalTrials #PatientCentricResearch #ClinicalResearch

Brief Summary “This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.”

5 things you should know about clinical trials 1. Clinical trials are tests where doctors study new medicines or treatments by working with people. They do this to find answers to important health questions. 2. You choose to join a trial - it's never forced. If you start and then change your mind, you can stop at any time. 3. Sometimes, clinical trials need people who aren't sick to help. This lets doctors compare results between healthy people and those with illnesses. 4. Keeping you safe is very important. Researchers have to follow strict rules and safety guidelines set by the government to protect everyone in the trial. 5. Before you decide to join, the researchers will explain everything about the study to you. This is called "informed consent" - it means you understand what will happen before you agree to take part. Want to know if a clinical trial could be a good fit for you? Here's what to do: 1. Have a chat with your doctor about it. 2. Look for trials near you by visiting www.clinicaltrials.gov. 3. For more information:   - Watch some helpful videos https://lnkd.in/gCNbxJBe   - Find a list of questions you can ask the researchers You can get both of these at https://lnkd.in/gXMXFWkN. These steps can help you learn more and decide if joining a clinical trial is right for you.

As the old saying goes, two heads are better than one. Four heads? Now, that's a party! A huge thank you to Katherine Cornish, PhD, PMP, Lori Abrams, Dr. Christopher Gantz and Maya Zlatanova! If you missed out on this awesomely insightful webinar, there is no need to panic 😎; you can watch it now, too! 👇 Find it in the comments. Meanwhile, some of the things we talked about: 👉 Defining patient diversity and the importance of inclusion in clinical trials 👉 Exploring patient diversity differences between the USA and Europe 👉 The central role of sites in reaching diverse populations 👉 Strategies to support sites in becoming diversity-ready 👉 Building relationships with the community 👉 Patient advocacy groups and their role in empowering sites 👉 Collaboration between CROs, sponsors, and vendors 👉 Protocol development with the patient in mind 👉 Identifying visible and invisible barriers to trial participation ...yep, quite an insightful and rich conversation it was. Don't miss out! It's just an hour long and packed with goodies. 💡 #decentralizedclinicaltrials, #dcts, #clinicaltrials, #clinicalresearch, #patientfeasibility, #patients, #patientsfirst, #healthcare, #healthtech, #healthcaretrends, #pharma, #biotech, #cro

Exciting times for clinical research! 🎉 The FDA has finally released detailed guidance on Diversity Action Plans for certain clinical studies. This landmark move aims to ensure that clinical trials better reflect the diverse populations who will use medical products. The new guidelines emphasize: 🌎 Broadening eligibility criteria to include more diverse demographic and non-demographic groups. 🌎 Encouraging the use of digital health technologies to reduce participant burden. 🌎 Early engagement with patient advocacy groups to design more inclusive trials. These steps are crucial for addressing health disparities and ensuring that medical products are safe and effective for everyone. We are thrilled to see this alignment with our mission to foster inclusivity in clinical research. Our main solution for achieving these diversity requirements is Latin America, a region with over 660 million people, offering rich demographic diversity and a unique opportunity to enhance the inclusivity of clinical trials. Together, we can make clinical trials a true reflection of the global community we serve! Let’s celebrate this progress and continue our collective efforts to improve health outcomes for all. 🚀 Read more about the FDA's guidance: https://lnkd.in/eT5AhNTP #DiversityInClinicalTrials #HealthEquity #ClinicalResearch #FDA #LatinAmerica #ClinicalTrials

Transparency is an important factor in clinical research, and this extends to informed consent documentation. In 2019, the so-called revised Common Rule in the US required certain clinical trials with federal funding to publicly post their consent forms within a given timeframe. But has this made a difference to transparency? According to a cross-sectional study of over 10,000 trials, it has. Prior to the revised Common Rule, only 2.7% of trials shared consent forms on ClinicalTrials.gov; this rose to 30.5% after it was effective. https://buff.ly/3LIgRop #ClinicalTrials #ClinicalResearch #Transparency #PatientConsent

🌍Happy International Clinical Trials Day!🌍 Today, we're celebrating the amazing impact of #clinical trials around the world! These #trials are key to discovering new #treatments and bringing hope to #patients everywhere. 👏 Big Thanks To: - Patients and Volunteers: Your bravery and participation make all the difference. - Researchers and Scientists: Your hard work and innovation drive progress. - Healthcare Professionals: Your care and expertise make these trials possible. - Regulatory Bodies: Your oversight ensures everything is safe and ethical. 📈 Looking Ahead: Let’s keep supporting and investing in clinical trials globally to keep finding life-changing breakthroughs. #InternationalClinicalTrialsDay #MedicalResearch #GlobalHealth #HealthcareHeroes

The fact that 80% of clinical trials are delayed due to recruitment issues is a well-known statistic, but also something that needs to be drastically improved. I agree that it is important to involve patients more in the design phase of a clinical trial and also allocate the necessary resources for patient recruitment in a clinical trial to reduce the 80% figure.