Clinical trials are essential for medical innovation, our most reliable pathway to developing potential innovative therapies that treat disease — and, in many cases, save lives. For patients, participating in a clinical trial often means early access to potential life-changing therapies.
However, for decades, many people who could benefit from clinical trials haven’t been able to participate. Most trials have been conducted at large academic medical centers in urban areas, requiring patients to travel long distances, take time off work and arrange childcare. These demands have unintentionally limited participation to people with the financial means and flexibility to overcome these barriers.
New approaches to conducting clinical trials are changing this dynamic and allowing more people to participate. By bringing studies directly into communities, we’re beginning to remove long-standing obstacles and make participation more convenient and accessible to everyone. These community-based trials are expanding access for people who have traditionally been left out. Here’s how they can work:
- Local patient advocacy groups and community-based healthcare providers are helping spread the word about available trials, acting as trusted voices in the local towns and suburbs they serve.
- Local healthcare providers are supporting routine trial visits and providing patient health information to study leaders, reducing the need for patients to make so many trips to distant medical centers.
- Digital health tools allow patients to share key study data — like blood pressure, cholesterol or blood glucose levels — from the comfort of their homes, eliminating unnecessary clinic trips.
Together, these innovations are modernizing the clinical trial landscape with the promise of better patient access, more rapid enrollment and faster completion. At the same time, advances in trial design and analytics have led to new ways to reduce the size of placebo groups and shortening trial durations — further maximizing patient benefit.
So why aren’t these modern trials available in every community? Because today’s regulations haven’t caught up with today’s science. Many federal rules governing clinical trials were written for a different era, before these innovative tools were available. We’re working with regulators, policymakers, researchers, and patient advocates to update these outdated frameworks. Everyone, regardless of income or zip code, should have the chance to participate in a clinical trial.
Meet our fictional patients Maria, Joe, and Sam, who are each exploring the possibility of participating in a clinical trial to access a potential new treatment option. But as barriers mount, their opportunity to participate slips away. Watch our short, animated video that illustrates the challenges Lilly is working to address through its modernization efforts and see how Congress and the FDA can continue to help make clinical trials more accessible and representative for patients like them.
To find a trial for you or a loved one, please visit the Lilly Trials (US) website.
[00:00–00:09]
[A flat, warmly illustrated animation opens in a domestic kitchen rendered in soft pinks and muted greens. Maria — a woman with short dark hair and red lips, wearing a bright red long-sleeve top — stands behind a kitchen island with her arms loosely crossed, holding a dark smartphone. A steaming green coffee mug sits on the counter. Behind her: teal-green cabinets, open shelving with jars, a gas stovetop, and a window looking onto a sunny day with clouds and green hedges. The scene is calm and inviting.]
Narrator: Maria is living with a medical condition that affects her daily life. When her doctor calls to tell her about a clinical trial for a potential new treatment, she feels encouraged—until she learns the trial site is two hours away.
[00:10–00:19]
[The screen splits into two panels. On the left, a bold red background displays animated white text, building phrase by phrase. On the right, a simplified illustrated map of Indiana appears in light gray with white state borders. A red map pin marks the clinical trial site in the north; a blue circular home icon marks the patient's location in the south. A winding, red-dotted route connects them, emphasizing the long distance required.]
[Text appears on screen: Clinical trials can offer hope - but are often out of reach.]
Narrator: She wants to participate, but obstacles quickly add up.
[00:20–00:29]
[The camera zooms tightly in on Maria. Just the top of her head and wide, upward-gazing eyes are visible, conveying worry and distraction. Thought bubbles materialize around her, each containing an illustrated icon representing a different barrier: a clock (lost work time), a baby pacifier (childcare), a car with a dollar sign (transportation costs), and a medical symbol (managing her illness). A baby crib rail is faintly visible in the background.]
Narrator: She works full-time at a manufacturing plant, where taking time off means lost pay. She also worries about childcare, transportation, and managing her illness.
[00:30–00:39]
[The frame splits into three equal illustrated panels, all rendered in desaturated, muted gray tones, signaling lack of access and inequality:
Left panel: Maria in her kitchen, arms crossed, in grayscale. It’s no longer vibrant.
Center panel: Joe, a bearded white man in denim overalls, is hunched over in a green agricultural field, a grain silo visible in the distance. He represents rural patients far from trial sites.
Right panel: Sam, a bald, older Black man wearing glasses and a light pink sweater, is standing in profile in a modern living room, looking down at a smartphone. A potted plant and a blue sofa are behind him.]
Narrator: Maria isn't alone. Patients across the country face similar barriers.
Joe has no reliable transportation to reach the trial site.
Sam needs care close to home, but the nearest research hospital is hours away.
[00:40–00:49]
[Animated map. A full-screen, softly textured map of the continental United States fills the frame in dusty rose and pale pink. State lines are drawn in faint white. The vast geography communicates the scale of the access problem. Patients are spread across the country, far from the handful of existing trial sites. No markers appear yet; the empty map itself conveys isolation.]
Narrator: For patients like Maria, Joe, and Sam, community-based research could be life-changing by bringing trials closer to communities where patients live, work, and play.
[00:50–00:59]
[The U.S. map reappears, now animated with illustrated bubbles popping up across the country, each showing a neighborhood pharmacy or community clinic. Three bubbles are fully colored and labeled with patient names and house icons:
"Sam" — upper-left (Mountain West region), next to a brick home illustration.
"Joe" — center of the map (Midwest), next to a classic red-roofed house.
"Maria" — right-center (Southeast/Mid-Atlantic), next to a similar home.
Additional gray bubbles show existing clinical or hospital sites nearby. The map now looks connected rather than empty. Research is coming to the patients.]
[Text appears on screen: Community-based research helps bring clinical trials closer to patients' everyday lives.]
Narrator: Local physicians can conduct routine visits, reducing travel time.
[01:00–01:09]
[Sam is shown seated in his living room, now in full color, looking at an open laptop. On the laptop screen, a split video call is displayed: on the left, Sam smiles in a light pink button-down shirt; on the right, a woman with short black bangs and a white medical coat (his clinical coordinator or doctor) smile back. A blue speech bubble with stylized text lines appears above the laptop screen, indicating an active conversation. The setting is warm and modern.]
Narrator: Digital health tools allow patients to check in remotely and perform other trial-related requirements.
[01:10–01:19]
[Another three-panel split screen appears, now rendered in vibrant full color, signaling hope and possibility:
Left panel: Maria stands smiling beside a Black female physician in a white coat, holding a stethoscope and a tablet. A clock on the wall behind them adds a sense of urgency. Setting: a clinical office.
Center panel: Joe, now in full color and wearing overalls and a beret, stands smiling confidently in front of a community clinic marked with a red cross. His posture is open and relaxed.
Right panel: The laptop video call scene returns. Sam and his clinical coordinator are in cheerful conversation via telehealth.]
Narrator: Community-based research makes participation possible without significantly disrupting daily routines.
Study investigators still oversee trials, protecting patient safety, patient rights, and data integrity.
Community-based research is more accessible, inclusive, and reflective of real-world patient experiences. Unfortunately, outdated federal regulations stand in the way of them reaching their full potential.
[01:20–01:29]
[A full-screen flat illustration of the United States Capitol Building fills the frame against a bright blue sky dotted with white fluffy clouds. The iconic white dome, columned facade, red-brick staircases, flanking green trees, and a small American flag at the dome's center are rendered in clean, simplified detail. The image is calm and authoritative, establishing the setting for a legislative call to action.]
Narrator: Congress can take action to make clinical trials more accessible.
[01:30–01:39]
[A bold red banner animates across the screen against a background of the Capitol building and fanned-out illustrated legislative documents. Large white sans-serif text builds dynamically: CONGRESS can take action to make clinical trials more accessible.]
Narrator: That means:
[01:40–01:49]
[An official-looking animated document slides in from the left, bearing a circular Capitol Building seal at the top. The document is styled like a legislative bill, with horizontal placeholder lines beneath each heading. Two legislative actions are revealed in sequence on separate pages: Align FDA regulations to empower local HCPs to participate in clinical research and Clarify investigator oversight requirements]
Narrator: Aligning FDA regulations to empower local healthcare professionals to participate in clinical research.
Clarifying investigator oversight requirements for local providers and third-party vendors.
[01:50–01:59]
[The legislative document continues flipping to a new page, still positioned in front of the Capitol building. The text is large, bold, and centered on the page in a classic serif font: Encourage broader adoption of Digital Health Technologies (DHTs)]
Narrator: Encouraging broader use of digital health technologies through a standardized validation plan.
[02:00–02:09]
[The animated bill continues revealing two final legislative asks — each on its own page, shown in front of the Capitol. The document pages carry the same official seal and bill format: Remove financial barriers that limit patient participation and Establish safe harbor protections for sponsors to reimburse participants]
Narrator: Removing financial barriers that hinder patient participation.
And establishing safe harbor protections so sponsors can reimburse participants and pay for incurred costs without legal risk.
[02:10–02:29]
[The video returns to our three characters — Maria, Joe, and Sam — now shown together in a vibrant split-screen, each in their own environment. They appear confident, smiling, and engaged in daily activities while still participating in their clinical trials. The color palette is warm and full, a visual contrast to the muted, gray tones seen earlier. The final frame fades to the Lilly corporate logo on a clean white background.]
Narrator: Those actions can ensure more patients, like Maria, Joe, Sam, and even you, can access clinical trials and help drive the next generation of medicine.
Reference
Kidwell et al. Application of Bayesian methods to accelerate rare disease drug development: scopes and hurdles. Orphanet Journal of Rare Diseases. (2022) 17:186. https://doi.org/10.1186/s13023-022-02342-5