Historically, clinical trials have been concentrated at cancer centers or academic medical centers (AMCs) in major cities. These sites understand the regulatory and compliance requirements of clinical trials and can provide exceptional patient care. But they’re overworked.
The clinical trial industry is expected to see 5.8% annual growth every year from 2022-2030. Yet many sites already have anywhere from 30-70 trials in their backlog, largely because of staffing shortages.
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Andrea Bastek Andrea Bastek is the Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research with more than 8,000 study sites across 30 countries connected. She has extensive experience in the clinical trials space for medical devices, including deep collaboration with sites to drive processes that ensure successful […]
These major sites also aren’t accessible to all patients. Often, only patients who live nearby or can afford to travel are able to join trials at AMCs. This is why community-based clinical trials are growing in popularity.
Community-based clinical trials that engage local sites can help overworked coordinating centers keep up with the pace of clinical trials and reach more patients. But community sites often lack clinical trial experience. So how can we ensure they have the regulatory oversight and technology they need to succeed?
After more than 15 years in the clinical trial space, I’ve seen successful and unsuccessful attempts to engage community sites. But with the right strategies in place, I believe community-based trials can be efficient, compliant, and accessible.
Coordinating centers working with community sites
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Community or “frontier” sites include locations like:
- Local physicians’ offices
- Pharmacies
- Community health clinics
- Labs
Most sponsors see the potential of working with these sites to reach patients. But frontier sites often don’t have experienced investigators, research staff, or regulatory staff, which can raise questions about data quality and compliance.
This is why sponsors and coordinating centers may want to examine the processes that already exist for multicenter trials. Academic medical centers like Stanford, the University of Michigan, Johns Hopkins, and the University of Rochester already have coordinating centers that can help run multicenter trials, but historically they have focused on smaller, investigator-initiated, or grant-funded studies.
Sponsors can explore using some of the same tactics multicenter trials have used in the past to bring in frontier sites. This might mean:
- Working with inexperienced community sites directly to help them grow
- Partnering with site management organizations (SMOs) that are experienced in helping smaller sites
- Collaborating with an experienced coordinating center that can guide frontier sites through running a trial
These strategies may require re-examining mindsets and strategies–but all of them can help make trials more accessible.
Experienced PIs and regulatory staff sharing their knowledge
When experienced coordinating centers or SMOs work with frontier sites, their focus will be on supporting those sites through complex protocol requirements and how they can leverage expanded geographic access to maximize enrollment.
Expanding geographic access and using frontier sites means bringing new principal investigators, including diverse PIs, into trials. While this is an exciting advantage, those new PIs will need support. 49% of PIs participate in just one trial, and if they lack support from sponsors, CROs, coordinating centers, or SMOs, more PIs could fall victim to this turnover.
Experienced PIs at coordinating centers or within site networks can serve as mentors to new PIs. Coordinating centers or SMOs can also provide assistance with study contracts, budget negotiations, and regulatory documents so site staff can focus on patient visits.
These strategies reduce the barrier to entry for new frontier site PIs, allowing them to fulfill their role in a trial and offer patients the accessibility of frontier sites.
Professional regulatory staff working with community sites
Like experienced Principal Investigators, experienced regulatory staff can also play a vital role in helping frontier sites. For example, they can use remote technology to consistently access, review, and provide feedback on documents from frontier sites.
They can then identify missing or out-of-date regulatory documents and help frontier sites complete them, so frontier sites can focus on working with patients.
Clinical research professionals can also help community site staff understand complex clinical trial regulations, like 21 CFR Part 11 and ICH GCP.
Technology itself can even help with this process, if vendors are careful to keep their software compliant. Less-experienced sites can benefit from built-in features like:
- Audit trails that automatically track changes to documents
- eSignatures that follow Part 11 guidelines
- Tools to redact Protected Health Information (PHI)
Clinical research involves dozens of regulations and complex requirements. The staff at pharmacies, labs, and doctors’ offices can’t become experts immediately. But with the help of built-in compliance features and experienced regulatory staff, even new-to-research staff can avoid compliance errors in their trials.
Patient accessibility in clinical trials
Too often, clinical trials populations don’t accurately reflect the patients who will ultimately use a treatment. The FDA specifically notes that Black, Indigenous, Asian and Latinx patients are often underrepresented in clinical trials, and older patients often face underrepresentation as well.
Bringing trials to frontier or community sites won’t solve the industry’s diversity problems singlehandedly. But community sites can make trials accessible to a wider range of people.
Clinical trials that take place entirely at academic medical centers aren’t accessible to many people, including:
- People who work hourly or multiple jobs
- People who use public transportation
- People who are caregivers
People with strict work shifts can’t afford to take hours off for in-person appointments, and traveling across town for quick check-ins puts a heavy burden on people who don’t have a car, rely on public transit, or have to pay for childcare. This means that fully in-person, site-based clinical trials often inadvertently exclude low-income patients.
When patients can travel to a pharmacy or doctor’s office in their own neighborhood, they can reach the site on foot or using public transit. They also have to take less time off work and request childcare less often.
In many cases, community-based trials are more accessible for patients with chronic illnesses or disabilities as well. In one study of patients with chronic illnesses, 42% of respondents said they didn’t join trials because of the inconvenience of travel.
Having to travel was the most common reason patients gave for avoiding trials, even above concerns about side effects (30%) and getting a placebo (23%). By moving trials to pharmacies or doctors’ offices near patients’ homes, we can cut down on the travel needed to participate in a study.
This strategy has already yielded dividends in the past. For example, the SPRINT blood pressure trial engaged 19 coordinating centers and 102 community sites. The trial successfully recruited 15,000 participants, more than their 9,000-participant goal, and 50% of those patients were people of color.
Building community-based trials that work
Successes like the SPRINT trial prove that community-based trials can remain compliant and efficient while also being more inclusive for patients. But bringing in community and frontier sites requires the help of coordinating centers, SMOs or new innovative models, experienced regulatory staff, and remote software. With a combination of these factors, we can bring clinical trials to more neighborhoods and more patients who need them.
Photo: gmast3r, Getty Images
Andrea Bastek is the Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research with more than 8,000 study sites across 30 countries connected. She has extensive experience in the clinical trials space for medical devices, including deep collaboration with sites to drive processes that ensure successful study participation. She is committed to finding workflow efficiencies that improve clinical trial execution. She holds a Ph.D. in Biomedical Engineering from the Georgia Institute of Technology.
