How sites and sponsors can collaborate for a smooth site feasibility process
The site feasibility process is broken. The average clinical trial coordinator spends 264 hours a year completing feasibility questionnaires for sponsors. Yet 80% of clinical trial sites still don’t complete patient enrollment on time, and 11% of sites selected for a study never enroll a single patient.
In addition to being inefficient and inaccurate, site feasibility is often repetitive. Sites fill out nearly identical information not only for multiple sponsors, but often for multiple studies from the same sponsor.
So how can we make feasibility less time-consuming and repetitive for sites and less inaccurate for sponsors? These strategies could help:
- Help sponsors and sites collaborate on the site feasibility process
- Use data to project patient enrollment more accurately
- Create a unified site feasibility platform that sites and sponsors can access
In this article, we’ll break down what sites and sponsors need from site feasibility and how a unified site-sponsor platform can address these needs and improve collaboration.
What sponsors and CROs need from the feasibility process
Copenhagen University Hospital surveyed sponsors and Contract Research Organizations (CROs) about what they look for during site selection:
- 84% of sponsors and CROs said patient recruitment was their number one priority
- 75% would work with an inexperienced trial site if that site had the right patient population
- 88% would rather reach their enrollment goals 10% faster than cut their costs by 20%
So for sponsors and CROs, patient recruitment is by far the most important part of feasibility. They need an accurate estimate of:
- How many patients at each site could meet the requirements of the trial
- How many of those patients might enroll
And sponsors have good reason to worry about recruitment. 70% of clinical trials experience delays because of low enrollment, and 80% of sites don’t reach their enrollment goals. These delays can cost sponsors an estimated $37K per day.
How technology can help with projecting patient enrollment
Technology can help solve the problem of inaccurate recruitment estimates.
- Sites can use data from their EHR to create more accurate enrollment projections
- Sponsors can expand the sites they reach out to for studies
Sites need software that analyzes their EHR data and helps them share the anonymized data with sponsors and CROs. This requires a site feasibility platform that’s integrated with the EHR: a type of technology many vendors are working on, but none have perfected yet.
Sponsors can also expand the sites they reach out to for studies. While many sponsors like to work with sites they know well, it doesn’t make sense to return to the same sites over and over if they don’t have the right patient population for a specific trial.
A collaborative site feasibility platform can help sponsors search for sites that have the patients they need, even if they haven’t worked with those sites before. Sites can upload their patient data into the platform once and let multiple sponsors view it to see if the site has the right population for a particular study.
A collaborative site feasibility platform can help sponsors find not only patients with specific medical conditions but also patients who are diverse in age, race, and gender. Diverse recruitment is now a requirement from the FDA, as well as the right moral choice, so making recruitment inclusive is more important than ever before.
Expanding trials to more sites, especially frontier sites like pharmacies, clinics, and doctors’ offices, gives more patients the opportunity to participate in clinical trials. This speeds up patient recruitment and ensures clinical trials engage participants who reflect the diversity of the patient population.
What sites need from the feasibility process
For sites, the main problem with feasibility is time-consuming, repetitive work. Clinical Research Coordinators (CRCs) spend an average of 264 hours per year completing feasibility assessments.
Those time costs would be justified if CRCs felt their time was being well-used: but many don’t. CRCs report that they often have to answer the same questions across multiple feasibility surveys. Some even report answering the same questions for sponsors they’ve already worked with.
As one site leader stated to Applied Clinical Trials, “We are still constantly asked, ‘Do you have a freezer?’ We get this question even from companies we’ve done many clinical trials for.”
Multiple organizations have tried to address the problem of repetitive work. For example, the American Society of Cancer Oncology (ASCO) Task Force suggests:
- Implementing a uniform feasibility process across sites and sponsors
- Minimizing and standardizing questions
- Leveraging technology to centralize feasibility assessments
While the clinical trial industry embraces these ideas, sponsors, sites, and CROs have had trouble agreeing on a unified technology platform–which makes it difficult to have a unified feasibility process or set of questions.
A unified site feasibility platform
The ASCO Task Force, the Clinical Trials Transformation Initiative (CTTI), the National Cancer Institute Clinical Trials Working Group, and many other organizations agree a shared feasibility platform is needed. The problem is finding one that works.
To benefit sites, a feasibility platform must:
- Be easy-to-use
- Allow sites to upload basic information once and update it as needed
- Offer flexibility to both sites and sponsors
- Give sites information on sponsors and their studies
When we talked to sites at our innovation summit, they said ease-of-use was where many feasibility platforms have failed in the past. Too many platforms aren’t intuitive for site staff and overcomplicate simple processes like uploading documents.
So what makes a feasibility platform easier to use?
- Standardized set of questions
- Areas for sites to add common information, like their address, contact information, and equipment
- Ability for sponsors to add study-specific questions
In other words, the industry needs a feasibility platform that’s more like the Common Application for college admissions. Students enter their basic information, like their name, GPA and extracurriculars, once for many colleges to view. But if the schools have a specific essay question they want the student to answer, the university can still send it to applicants.
The Common App works because it saves students from wasting their time on repetitive questions and lets them focus on the ones relevant to an individual school. It also benefits the university, which doesn’t have to waste time developing a full individual application.
Similarly, a good feasibility platform will let sites waste less time on repetitive questions and sponsors waste less time creating standard surveys. Sites and sponsors can then focus on study-specific questions.
Sponsor and site collaboration
Many feasibility platforms ask sites or investigators to share their information with sponsors. But the platform should also ask sponsors or CROs to share information about themselves and their studies with sites.
After receiving the study protocol, many major sites do an internal evaluation of whether they have the right staff, patients, and equipment for a particular study.
Sites also consider:
- Whether the study is likely to benefit their patients
- Any potential regulatory challenges
- Study timelines and current capacity
- Whether the study design is patient-centric
So while it’s important to create a feasibility platform where sites can upload their information, it’s equally important to create a feasibility platform where sites and sponsors can communicate.
Sponsors should be able to reach out to sites that might be a good fit for a study, send them protocols, and answer any questions the site may have about whether a study is right for them.
A better site feasibility process
To improve the site feasibility process, we need to listen to sponsors’ desire to improve patient recruitment estimates and sites’ desire to make the process more efficient and less repetitive.
A feasibility platform that’s integrated with the EHR can help sites create more accurate recruitment projections and share anonymized data with sponsors. Sponsors can also search a unified platform to find new sites that have the patients a study needs.
Equally importantly, a unified feasibility platform can make the feasibility process faster and less painful for sites by allowing them to input basic information only once. They can then answer supplemental questions for each study on an as-needed basis.
But all of these ideas will only work if sites and sponsors have a unified site feasibility platform they love to use. To learn more about the future of site feasibility, check out the recording of our Innovation Summit on inclusive study start-up.
And if you’d like to be part of the conversation on new innovations in clinical trials, subscribe to our newsletter to be notified next time we host an Innovation Summit.
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