Clinical Trial Fundamentals

Breaking Update on Trial Equity: **U.S. Department of Labor has confirmed that patients are eligible to use the Family & Medical Leave Act (FMLA) while participating in a clinical trial, based upon a Request for Opinion received by the Foundation For Sarcoidosis Research (FSR)** Background: FSR's Ignore No More campaign gained deep insights among African American patients through surveys and focus groups to understand barriers to research participation. These insights revealed concerns related to time off from work and risk of impacts to pay, work assignment, and other benefits. There had been ambiguity among the research community (including site staff) as to whether FMLA would cover job-protected leave of absence to address time off to care for an individual’s or a family member’s serious health condition while in a trial. Outcome: A link to the full DOJ response is in the release link below, but calls out that: -> Employees who meet all other requirements of FMLA may access FMLA benefits for participation in clinical trials or the clinical trials of those for whom they serve in a caregiver role.  -> The term “treatment” includes clinical trials and treatments that may or may not be effective regardless of whether it is new, experimental, or a placebo.  -> As long as this is part of the support and management of a serious illness and is not an elective procedure such as plastic surgery, it does not matter that the patient’s participation is “voluntary”.  -> Employers may still require appropriate documentation before issuing access to the leave as laid out in the FMLA, but will not require that they indicate if they are on therapy or placebo, as this will not likely be revealed until after the time at which the requested leave time would expire.   -> Employers may only verify that an employee has serious health conditions requiring treatment by a provider when responding to the leave request.  Kudos and gratitude to mary, Tricha, and the dedicated team at the Foundation For Sarcoidosis Research -- great demonstration of starting with patient insights, identifying a root cause, and creating clarity that can help address equity in research. https://lnkd.in/eei-j5j6

A patient told me last week that the hardest part of considering a trial was not the science. It was opening the consent form. She used one word. Avalanche. That word stayed with me, because the industry rarely calls this what it is. We say "low motivation". We say "poor engagement". We say "screen failure". The person on the other side usually has a much more accurate word. Twenty pages of dense text written for regulators, ethics committees, and legal teams, handed to someone already managing a diagnosis, a job, a family, and a future they did not plan for. Then we ask why drop-off happens before week one. The problem is not motivation. The problem is the load. When the cognitive load is this high, hesitation is not a deficit. It is a reasonable response. Clarity is the design fix the industry keeps deferring. Plain-language summaries. Visual structure. Honest time and life expectations. Risk and benefit are written like a conversation, not a contract. This is not soft. It is operationally measurable. Studies that invest in clarity see fewer amendments, fewer screen failures, and stronger retention. The economics now match what patient advocates have been saying for years. Understanding comes first. Decisions follow. Our job is not to push harder. Our job is to make the path readable. Tomorrow I'm sharing the longer thought. #ClinicalTrials #InformedConsent #PatientVoice #HealthLiteracy #ClinicalResearch #PatientExperience

182 clinical trials testing 138 different Alzheimer's drugs are happening right now. And most patients have no idea they might qualify. Here's the uncomfortable truth about dementia drug development in 2025. We have more promising treatments in the pipeline than ever before. Drugs targeting tau pathology. Immunotherapies beyond amyloid. Cancer medications repurposed for neurodegeneration. Even gene therapy for high-risk genetic variants. But the vast majority of eligible patients never hear about these trials. The disconnect: Researchers desperately need participants. Trials fail not because drugs don't work, but because they can't recruit enough people. Patients desperately want treatments. Families ask me constantly about new therapies. They're willing to try anything. Yet enrollment in dementia clinical trials remains painfully slow. What's broken: Most trials require very early-stage disease. But most people get diagnosed late. By the time they find out they have dementia, they're already too advanced for the trials testing preventive treatments. Trials cluster at major academic centers. If you don't live near a research university, you probably don't know these studies exist. Eligibility criteria are restrictive. The patients who need treatment most are often excluded. Too many medications. Wrong subtype. Comorbid conditions. Doctors don't know about ongoing trials. I'm a dementia specialist and I struggle to keep track of what's recruiting. Primary care doctors have no chance. Here's what's particularly frustrating: Some of these drugs will work. We'll look back in 10 years and say "We had that treatment in 2025, but couldn't get enough people enrolled to prove it worked." The bottleneck isn't science. It's logistics. We need better trial awareness. Better enrollment systems. Broader eligibility criteria. More decentralized trials that come to patients instead of requiring travel. Right now, we're running the most robust drug development program in dementia history while most eligible patients never get the chance to participate. That's not just inefficient. It's ethically problematic. If you or someone you know has early cognitive changes, ask about clinical trials. Not because trials are guaranteed to help, but because participation accelerates progress for everyone. 💬 Have you tried to find clinical trials? What barriers did you hit? ♻️ Repost if clinical trial access should be easier 👉 Follow me (Reza Hosseini Ghomi, MD, MSE) for honest perspectives on dementia treatment

🚨 The clinical research industry doesn’t have a recruitment problem. It has a courage problem. We have hundreds of vendors pouring billions into patient recruitment—AI, social ads, EMR mining, direct outreach, even skywriting—and yet, enrollment rates haven’t budged. Why? Because we refuse to: ❌ Fix protocol design. Instead, we create impossible inclusion/exclusion criteria that screen out 90%+ of potential participants. ❌ Fund sustained community engagement. Instead, we chase individual study enrollments instead of investing in long-term patient activation.  ❌ Pay patients fairly. Instead, we offer stipends that are taxed, penalizing participation while pharma and vendors rake in billions. ❌ Make trials patient-friendly. Instead, we overload study calendars with unnecessary visits and procedures, making it impossible for real people to participate. ❌ Acknowledge what we already know. Instead, we sit in echo chambers like this LinkedIn thread, talking about problems we’ve known about for decades. We don’t need more vendors. We need more leaders with guts. A few companies are actually doing the hard work. Think: Acclinate Mural Health Savvy Cooperative Heartbeat Clinical Research SGM Alliance Reflections Collective 🚀 Fixing enrollment isn’t about more vendors. It’s about fixing the system. 👇 In the carousel, I’ve broken down the biggest takeaways from the fiery discussion on Brad Hightower's post SCOPE post (link in comments) on why trials still struggle to enroll. (with select comments from Joe Dustin George T Mathew, MD, MBA, FACP Rafi Weisz Nelson Rutrick Terttu Haring Mark Evans Steve Wimmer Jennifer Howell MSN, RN, CPN) Now let’s talk about real solutions. Who else is actually moving the needle in clinical trial participation? Tag them in the comments. #ClinicalTrials #ClinicalResearch #PatientCentricity #HealthEquity #DecentralizedTrials #PatientActivation

Clinical trials aren’t only scientific experiments. They’re logistical ones, carried out in real lives. Enrollment is a moment. Participation is a lived experience that unfolds over time. It shows up as: • appointments that don’t align with work, school, or caregiving • side effects layered onto already full lives • transportation, childcare, and logistics that quietly compound • uncertainty that doesn’t resolve between visits None of this is abstract. It directly shapes who can participate and who can stay. I wrote this piece to explore what clinical trials actually ask of patients after enrollment: • why time and stability matter as much as willingness • how access narrows once studies are underway • what we miss when participation is treated as a single decision This isn’t about consent. It’s about sustainability. 🔗 Read here: https://lnkd.in/gUCWWAwY How can we better support the people who choose to participate; not just at enrollment, but all the way through?

🔇 Cell Therapy New Publication Alert 📉 CAR-T works in mantle cell lymphoma—but access remains the real bottleneck. A recent real-world analysis on eligibility, utilization, and barriers to CAR-T in relapsed/refractory mantle cell lymphoma (MCL) reinforces a critical industry truth: clinical efficacy alone does not translate into broad patient impact. 🔑 Key takeaways 👉 Eligibility erosion is real. A meaningful proportion of r/r MCL patients never make it to CAR-T due to rapid disease progression, declining performance status, or comorbidities—often before referral even occurs. 👉 Timing is everything. Delays related to referral, leukapheresis, manufacturing, and reimbursement materially reduce the number of patients who can ultimately receive therapy. 👉 Systemic barriers persist. Logistics, site capacity, payer friction, and geographic access continue to limit real-world utilization—despite FDA approvals and guideline inclusion. Strategic implication: ☝ CAR-T’s next chapter in MCL (and beyond) won’t be defined solely by better constructs—it will be shaped by earlier line use, faster manufacturing, decentralized care models, and complementary modalities that can bridge patients to treatment or serve those who will never be eligible. For developers, CDMOs, and health systems alike, the message is clear: The science is strong. The challenge now is execution. 👉 Innovation must extend beyond the cell—into workflow, access, and health-system design. Paper link https://lnkd.in/ddfZGQ72 #CellTherapy #CART #MantleCellLymphoma #RealWorldEvidence #OncologyStrategy #CGT #BiotechInsights #Nature #brexucabtagene autoleucel #Tecartus

My husband Otis W. is in remission from multiple myeloma after CAR-T therapy at MD Anderson. God's grace and mercy! 🙏🏽 But even with my DNP training and years in pharma, we were blindsided by side effects that weren't mentioned during informed consent. Hand tremors. Specific infections. Psychological changes. When these happened, we had no warning because they were considered "rare." But rare according to whose data? Black Americans are twice as likely to develop multiple myeloma as White Americans. Yet we represent only 5-8% of clinical trial participants for the treatments that get FDA approval. When your safety data doesn't include the populations with highest disease burden, you don't actually know what's rare for us. I've sat on both sides of this table. As a caregiver watching my Superman go through a complex treatment with incomplete information. As a former Field Medical Director who launched products and worked on Pfizer's Global Health Disparities COVID-19 Paxlovid Workgroup. And as a Family Nurse Practitioner and someone with a Master's in Bioethics and Medical Humanities, who understands that informed consent should actually be informed. So let me tell you what we faced and what so many families continue to face: Trial eligibility criteria often exclude patients with naturally lower neutrophil counts. Benign ethnic neutropenia is more common in Black patients. These are normal variations, not sickness indicators, and they disqualify people from studies. https://lnkd.in/eryKnzHb. Trial sites are concentrated at academic medical centers requiring significant travel, time off work, and out-of-pocket costs. If you have to take three buses to get to your trial visit, access has been designed out of the equation. Historical mistrust is real and earned. But instead of building trust through community partnerships before trials launch, we often just note the mistrust and move on. Medical Affairs teams can do something about this. We can advocate internally for trial site placement in accessible communities. Push for eligibility criteria that don't inadvertently exclude based on racial phenotypes. Partner with community organizations before enrollment fails. Ensure consent processes address outcomes that may present differently in populations that weren't adequately studied. Breakthrough treatments only work if safety data includes the people who need them most. We can't do this alone and the work is not done. ♥️ If you're in Medical Affairs thinking about how to redesign trial access in your therapeutic area, let's connect. We need each other for this. #clinicaltrialdiversity #multiplemyeloma #healthequity #patientadvocacy #DNPsofColor #nursesinpharma

I’ve lived with multiple disabilities and chronic illnesses my entire life. What I didn’t fully realize until recently is how often people like me are left out of the research that shapes our care. A recent study from the Waisman Center highlights a persistent problem: individuals with disabilities continue to be excluded — intentionally and unintentionally — from health research. Read more: https://lnkd.in/gjABab4k This isn’t niche. According to the CDC, 1 in 4 U.S. adults has a disability. And 76% of U.S. adults live with at least one chronic illness, many of which can be disabling. Yet those of with disabilities are routinely excluded through restrictive eligibility criteria, inaccessible sites, rigid protocols, and assumptions about complexity. Those exclusions shape the evidence base itself. For me, that’s personal. I’ve navigated care where: - Treatments weren’t tested for how my body responds - Guidelines didn’t reflect my lived experience - Trial outcomes didn’t measure what matters in daily life Exclusion from research isn’t just about participation — it determines who gets counted in the science driving policy and standards of care. Too often, accessibility is treated as an afterthought. Formal accessibility audits of clinical sites and study operations should be standard practice — not a special request. That includes reviewing physical access, transportation barriers, digital platforms, communication formats, consent processes, and study workflows before participants ever encounter them. Inclusion requires operational change. We need: - Study designs that anticipate and accommodate disability - Accessible consent and materials - Inclusive recruitment pathways - Disabled people involved as advisors and co-researchers - Proactive accessibility audits Health research that excludes disabled people is limited research. And limited research leads to limited care. Disability is not an exception. It is part of the population. #HealthEquity #DisabilityInclusion #InclusiveResearch #ClinicalResearch #ChronicIllness #PublicHealth

⌚𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬 𝐚𝐫𝐞𝐧’𝐭 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬. 𝐓𝐡𝐞𝐲’𝐫𝐞 𝐬𝐲𝐬𝐭𝐞𝐦𝐬. And systems rarely fail in the conference room - they fail at the handoff. That handoff is where scientific fidelity meets operational truth. When those two don’t match, you don’t get a small delay. You get an alignment gap that quietly wrecks timelines, budgets, and sometimes the dataset itself. In the current biotech reset, there’s no margin for brittle design. With life-science VC funding down 15% and first-time financings plummeting from $2.6B to $900M, the penalty for protocols that can’t survive the clinic is no longer tolerable. The friction between scientific fidelity (aka "the data we want") and operational truth (what’s actually feasible) is costing us everything. 𝐂𝐨𝐧𝐬𝐢𝐝𝐞𝐫 𝐭𝐡𝐞 𝐭𝐫𝐚𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 "𝐕𝐢𝐬𝐢𝐭 𝐒𝐜𝐡𝐞𝐝𝐮𝐥𝐞 𝐓𝐫𝐚𝐩" 𝘚𝘤𝘪𝘦𝘯𝘤𝘦: “We need 14 visits in 12 weeks to capture every pharmacokinetic nuance.” 𝘙𝘦𝘢𝘭𝘪𝘵𝘺: “Site turnover is hovering above 30%. The remaining staff are drowning.” 𝘖𝘶𝘵𝘤𝘰𝘮𝘦: the patient - who, usually, has a job and a life - drops out by visit six, and you trade perfect data for no usable data. 𝐎𝐫 𝐭𝐡𝐞 "𝐈𝐧𝐜𝐥𝐮𝐬𝐢𝐨𝐧 𝐓𝐫𝐚𝐩" 𝘚𝘤𝘪𝘦𝘯𝘤𝘦: "Exclude everyone with [minor condition] to keep the population pure." 𝘙𝘦𝘢𝘭𝘪𝘵𝘺: "That rules out 60% of the people who actually walk into the clinic." 𝘖𝘶𝘵𝘤𝘰𝘮𝘦: The trial is excluded by design. In fact, 37% of under-enrolled trials fail specifically due to this protocol complexity. This isn't just annoying. It’s an engineered failure. ➡️The Daily Burn: Direct operational costs range from $40k to $55k per day as sites struggle to activate. ➡️The Amendment Tax: When we have to fix these predictable flaws, a single protocol amendment costs between $141k and $2M - and adds a 3-month delay. ➡️The Rescue Tax: If the trial needs a full mid-study rescue, the burn spikes to $235k–$1.6M per day. The human cost is worse. CRCs - our industry's ultimate firefighters - burn out trying to force a rigid protocol into a fluid reality. We need a better strategy. We need 𝐬𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐚𝐥 𝐛𝐚𝐥𝐚𝐧𝐜𝐞. Think of a suspension bridge. A rigid bridge snaps in high winds. A bridge designed to sway - to flex with the forces of nature - stands. We need protocols with calculated flex. ✔️Flexible visit windows. ✔️Decentralized options. ✔️Realistic inclusion criteria that bend without breaking the scientific integrity. 𝐖𝐞 𝐝𝐨𝐧'𝐭 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐝𝐮𝐦𝐛 𝐝𝐨𝐰𝐧 𝐭𝐡𝐞 𝐬𝐜𝐢𝐞𝐧𝐜𝐞. 𝐖𝐞 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫 𝐢𝐭 𝐟𝐨𝐫 𝐬𝐮𝐫𝐯𝐢𝐯𝐚𝐥 𝐢𝐧 𝐭𝐡𝐞 𝐰𝐢𝐥𝐝. The future isn’t “decentralized vs traditional.” It’s protocols engineered to flex without breaking - built for the clinic we actually have, not the clinic we wish we had. 👇If you’ve run trials, what’s the most “scientifically pure” requirement you’ve seen that wrecked your operations? ♻️ Repost to help your network level up their clinical trial game.

𝟭𝟯𝟭 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗚𝗿𝗼𝘂𝗽𝘀 𝗨𝗻𝗶𝘁𝗲 𝘁𝗼 𝗦𝗺𝗮𝘀𝗵 𝘁𝗵𝗲 #𝟭 𝗕𝗮𝗿𝗿𝗶𝗲𝗿 𝘁𝗼 𝗧𝗿𝗶𝗮𝗹 𝗣𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝘁𝗶𝗼𝗻: 𝗠𝗼𝗻𝗲𝘆. 131 healthcare groups just threw their weight behind the Clinical Trial Modernization Act. And it could be the biggest boost to patient access we’ve seen in years. - Backers include ACS CAN, National Health Council, NAMI, and the Association of Black Cardiologists. - Bill provisions: sponsors can cover copays, travel, lodging, childcare, and digital health tools for remote trials. - Support won’t jeopardize Medicaid or safety-net eligibility—up to $2,000 is exempt. Here’s the problem this solves: patients—especially cancer patients in rural or low-income households—are about 30% less likely to enroll in trials. Not because of science. Because of gas money, hotel costs, and lost wages. If passed, this bill could diversify trial enrollment, accelerate oncology innovation, and finally ease the access gap that has plagued research for decades. Clinical trial sponsors, CROs, and biopharma leaders should be paying close attention. The question is—will Washington move fast enough to match the urgency patients live with every day?