Designing Patient-Friendly Trials for Site Performance

A telling sign of progress is how the language we use to describe processes, people and relationships changes. When it comes to clinical trials, one of the most noteworthy shifts in the words we use is how subjects have become patients.

Lindsay Singler, Patty McAdams, Gina Uhlenbrauck, Kirk Jernigan and Julie Schulman at Applied Clinical Trials note how, in the past, subjects “had research performed on them.” These days, clinical trials treat patients as key partners in the research.

Patients contribute across “the spectrum of clinical development, including in the design and planning of research protocols, selection of outcomes and endpoints, development of recruitment and retention strategies, and dissemination of research results,” the group writes.

Trial researchers now understand the value of patients’ perspectives and experiences in helping identify gaps in knowledge.

As such, trial researchers have begun to design studies to be much more in line with the patients’ needs and those of their caregivers.

While this is the goal, and indeed an emerging trend, the writers suggest this patient-centric approach is still in its infancy. They suggest that trial researchers should focus on making trials more patient-friendly and suggest applying different relationship models, depending on the requirements of the trial. These include:

  • Patients to be invited as advisory board members
  • Patients to sit on the steering committee
  • Patients to act as co-investigators

One of the most important reasons for patient-centric trials is to make it easier for people to participate.

Below is how forward-thinking clinical trial directors are doing that.

Barriers to Trial Recruitment

Ease of participation has not always been straightforward. Consider that as many as 60 percent of oncology trials fail to enrol more than a single patient, according to Covance. However, a trial sponsor will fork out an estimated $50,000 for a site start-up. That totals an approximate $2 billion lost between 2006 and 2010 from non-performing sites.

Judy Stone at Forbes says the “biggest barrier in recruitment” is not with the setup of trials, but from a “lack of encouragement or support from the attending physician.”

This comes from physicians’ lack of awareness of clinical trials and a lack of time to discuss options with patients, Stone suggests. “Many are also concerned about lack of control—it is critical that the trial physician communicate regularly with the primary physician,” she continues.

Another reason for poor recruitment is that, often, patients think they will get a placebo and might be reluctant to participate because of this. Alternatively, they might assume, sometimes incorrectly, that a trial drug is superior to an existing treatment with which they’re familiar.

Stone stresses the importance for trial sponsors and researchers, as well as primary physicians, to dispel any patient misconceptions and manage their expectations.

Patient Enrollment Can Be Problematic

Even if there is a glut of patients waiting to be recruited, it can still be difficult to complete the process.

Therefore, trial sponsors need to minimize “all the hoops we make people jump through to get involved and remain in a clinical study,” says Tony Averbeck, vice president of business development at SubjectWell.

Instead, Averbeck notes the importance of enhancing the patient experience. The starting point is making access to trials simple. “What we found is that, any time you can remove participation burdens, you see an increase in willingness to enroll,” Averbeck explains. “Having homecare visits as an option in a study makes our job in recruiting easier because it lowers the patient burden and increases geographic reach.”


Online Communities Provide Understanding

While trial researchers may not have the resources to build their own online forums, there are communities that already exist that they could use to their advantage. Researchers could direct interested participants to these communities to help them grow confidence and answer queries about ways clinical trials are conducted.

Kathryn Burn is head of partnerships and research at Smart Patients, an online community for patients and families affected by serious illness. She notes how patients have expressed a need for a patient-friendly search engine for clinical trials. That is how her company was born.

Now, the search engine enables patients to curate and build Top 10 lists of clinical trials. They can further rate, compare and discuss trials.

Early Engagement With Patients Improves Trials

Once patients are enrolled in trials, it’s essential that communication is initiated early on and maintained throughout the trial.

Jean McCoy and Pam Garfield at Clinical Leader advise researchers to engage with patients as early as possible, as this can put the trial on a smoother and more cost-efficient path.

Among the pair’s findings:

  • 97 percent of patients regarded it as important that pharma companies include consumer input when designing trials.
  • 83 percent value the chance to review details and offer opinions.
  • 34 percent cite transport, site location or scheduling conflicts as barriers to participation.

The last point is important. Early engagement can help trial organizers design a more patient-friendly trial by foregoing unnecessary tests, resulting in fewer trips and less travel time for patients.

“Something as simple as arranging for a car service to assist with transportation might make all the difference in keeping a patient enrolled,” they advise.

Their other ways of engaging patients to design better trials include:

  • Co-creation workshops that connect patients, clinical investigators, clinical coordinators and the internal clinical development staff to discuss the trial
  • Electing a patient advisor for the study team as the main point of contact for patients
  • Patient councils comprising a “selected and trained group of patients and caregivers” for ongoing feedback

Patient-Friendly Trials Rely On Building Trusting Relationships

Engagement is important because it can save costs, but it also builds trust. This is especially so when researchers are able to connect patients to previous study participants.

When able to access communities of peers to share and seek information, patients feel more confident about the process.

Cheryl Lubbert at Clinical Leader says this “creates an untapped opportunity for clinical development teams to have patients help other patients decide whether to participate in a clinical trial.”

However, Lubbert notes that only a small fraction of trial participants find out about trials from another patient.​

To make trials more patient-friendly, researchers should use existing and former patients to create a recommendation network for prospective patients. This can take the form of patient advocacy groups or ambassadors programs.

The Importance of a Trial Site

Of course, a trial can do all of the above right but fail with their trial site.

Jeff Zucker, SVP at Worldwide Clinical Trials, says that with the “trend towards patient-centric trials … sites and investigators are being somewhat forgotten in the process.”

He calls for a re-engagement so that while technology continues to play a role in building relationships with patients and providing ease of access to trials, there is still value in face-to-face interactions.

The trial site can play such a crucial role in maximizing these interpersonal connections. After all, an “engaged site can serve as a key advocate at every level,” Zucker asserts.

This means CROs and sponsors need to make it simple and pleasant for trial sites to work with them. Zucker provides a few strategies to improve site performance:

  • Manage site relationship processes through “early engagement with site leaders” to set up a mutual confidential disclosure agreement (CDA) to facilitate the flow of information.
  • Agree to high-level processes such as how the sponsor/CRO will seek a site’s input, how the site will become a preferred choice for the sponsor and how escalation will be handled.
  • Increase interaction between sponsor and CRO through regular meetings and communication.
  • Deliver site benefits with all parties planning together to avoid any surprises during trial operations.
  • Engage physicians to “seek advice on clinical excellence … [and] learn about the latest developments and create opportunities to information share.”
  • Communicate with purpose and set clear expectations and goals.

Assess Risk Of Trial Sites

Ashok Ghone at Applied Clinical Trials also emphasizes the value of the trial site. But Ghone argues that site performance depends on “patient recruitment, data quality, patient safety and protocol compliance,” as these could impact the timelines and budgets of trials.

To overcome these risks, Ghone advises trial sponsors and researchers to make use of analytical technology and e-clinical tools to make managing site performance more efficient and to provide better oversight.

Additionally, Ghone suggests:

  • Identifying and assessing the sites for any risks
  • Identifying data sources and points to compile a risk report

Integrate Trial Sites and Study Processes

So, trial researchers have a site that is highly operational, with strong teams and engaged patients. But what next?

Robert Dannfeld at Applied Clinical Trials warns that study processes and the workflows of trial sites need to be compatible and integratable. While this is not an easy task, “study teams must be able to integrate the study processes into their daily routines.”

Not only is this a wise “investment in the success of a clinical study,” but it also encourages trial sponsors to conduct a feasibility analysis to determine whether a site is suitable.

“Only by analyzing the study protocol and a thorough feasibility analysis one can make realistic statements on which study sites are appropriate for the study,” Dannfeld argues.

Trial researchers need to engage patients early on in the recruitment and enrolment process. The aim of making participation in trials as easy and comforting as possible can result in reduced costs as well as more confident and willing patients.

Of course, there is a lot to get right, but communicating regularly to empower patients, as well as making trial sites compatible with the study’s aims, will help ensure researchers run effective and insightful trials.

Images by: Tomwang/©123RF Stock Photo, Alexraths/©123RF Stock Photo, dolgachov/©123RF Stock Photo

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