The Importance of Site Selection in Oncology Trials: Finding Your Perfect Glass Slipper
From experience, matching the right sites for a clinical trial can sometimes feel like searching for Cinderella the day after the ball.
This is true for clinical trials in general, but becomes even more real when faced with the complex protocols and specialized needs of an early-phase oncology trial. Identifying the right clinical sites is paramount to ensure FPI, efficient patient enrollment, adherence to protocols, data efficacy and the overall integrity of the study. Site selection just isn’t something you can do half-baked. But how do you do it “right”?
Oncology Trials’ Biggest Challenge: Slow Patient Enrollment
To better understand why you must be strategic about site selection, we need to take a look at one of the largest universal barriers to oncology trial start-up: patient enrollment. Poor patient enrollment in an early-phase trial can disrupt trial timelines, delay drug approval, postpone or prevent a needed treatment for a cancer patient, and even lead to trial cancellation. Early Phase oncology trials are highly specialized. They’re not phase 3 studies testing an already more widely-used drug, with a lower barrier to entry and higher levels of established trust.
Patients have to meet stringent eligibility criteria, overcome complicated psychological reservations, and, finally, actually make it to the trial site in a consistent way! Let’s take a closer look at these factors.
Stringent Eligibility Criteria
Early Phase oncology trials often have narrow eligibility criteria for patient enrollment. This is done to create a more analogous and defined population, ensure that the dosing is safe and that the drug is efficacious, and minimize the risks that the potential side effects of the drug may pose. Of course, this is all with the goal of providing potentially life saving or life extending treatments to cancer patients.
Finally, in cancer research, many variables—such as the type and stage of cancer, previous treatments, and overall health—can affect how a patient responds to therapy. Stringent criteria help reduce these variations, making it easier to interpret the results of the trial data and determine whether the new treatment is effective. Unfortunately, while critical for the trials’ integrity, these stringent parameters can limit your pool of eligible participants.
Patient Reluctance
Cancer is abominably difficult to experience for the patient and their loved ones: mentally, physically, and emotionally. A cancer patient considering participation in a trial may be juggling a million different warring thoughts and feelings that make commitment to a trial the opposite of a straightforward decision. Concerns about side effects, distrusting of past and present inequalities in treatment, or skepticism towards experimental treatments, can play a role in patient reluctance – as can general existential overwhelm. Remember, your potential participants are people.
Limited Access
A patient may meet all eligibility criteria and even be excited to participate, but face geographical, economic, medical insurance and transportation barriers. The reputation, location and accessibility features of your site thus play a huge role in encouraging enrollment and consistent participation.
Which Variables Are In My Control?
The points discussed above are sometimes unavoidable. As a PI, research nurse, study coordinator and, or experienced research personnel, you can’t control how a patient is feeling, ignore the strict requirements necessary for your study’s integrity, or magically move your site around. However, there are some variables that are in your control.
Overly complex protocols and inadequate recruitment strategies – especially ones that also don’t take into account diversity and underserved patient populations – can limit participation. Critically, site limitations – including the competing trial landscape, location, infrastructure, PK “draw” hours, patient centricity, staff experience, and more – can be a game changer in the time it takes to get your patients recruited and your trial up and running.
Understanding Site Selection for Early Phase Oncology Clinical Trials
Early Phase oncology trials present unique challenges that necessitate a tailored approach to site selection. Factors such as the complexity of the study protocol, cancer treatments, the need for specialized equipment, and the requirement for experienced personnel distinguish these trials from others. Choosing sites equipped to handle these demands is crucial for the seamless execution of your study.
How Are Early Phase Oncology Clinical Trials Different?
As discussed, early phase oncology trials often involve:
Complex Protocols: Detailed treatment regimens and monitoring procedures.
Specialized Equipment: Advanced imaging and laboratory facilities.
Extensive assessments and labs: Long infusion times and full or intensive PKs with vital signs.
Experienced Staff: Personnel trained in oncology care and research methodologies.
Not all clinical sites are suitable for early phase oncology trials! You’re faced with an undeniable fact: knowing your site's capabilities, strengths, weaknesses and potential patient enrollment challenges is essential if you want to pick the right one.
Selecting Your Ideal Site
Site selection doesn’t have to feel out of reach. Why? Well, you’ve just found your fairy godmother.
At Winniedel, we work every day to position new biotech and biopharma sponsors and researchers with a diverse, global network of cancer centers available to be your next clinical trial site. We focus on SSU for Early Phase (FIH-2b) oncology trials, while also providing productive site sourcing “temp checks” to gauge site interest in your trial and/or asset.
We know from experience that excellence in the study start-up phase will position a study’s sustainability, efficacy, outcomes, and follow-up for scientific robustness and diagnostic success.
We offer:
Access to the Global Oncology Site Universe: Our global network will be at your fingertips; we offer you access to 200+ clinical trial sites, a therapeutically aligned KOL network, and agile full-service CRO partners for all activities after SSU.
Expert planning and in-house implementation: At Winniedel, we provide “white glove” services that accelerate SSU and results throughout the lifecycle of your study. Our proven effective SSU methodology, entrenched global site and KOL relationships, produce a collaborative and efficient approach to study start-ups.
Cost-effective collaboration: Our established non-traditional, full-service CRO partnerships provide a direct, less expensive, and dependable channel for meeting your study needs after SSU.
Our mission is to remove the site selection barriers your team faces so that the vitally important cancer research that needs to be done reaches the patients who need it most.
Get in touch with us today to learn more about how Winniedel can launch your study start-up efficiently and sustainably while facilitating efficiency, reducing costs, and removing the revolving door of change orders,
100% transparency and NO BULL throughout the lifecycle of your study!