Top 5 Challenges of Running Esophageal Cancer Clinical Trials

With over 550,000 new cases diagnosed each year, esophageal cancer is the seventh most common type of cancer worldwide. The overall 5-year survival rate is about 20%, but that number changes to 46%, 26%, and 5% depending on whether the growth is localized to the esophagus, if it has become regional, or spread distantly, respectively. With these relatively low survival statistics, esophageal cancer clinical trials are especially important for providing more treatment options to patients who are non-responsive to first-line therapies.

Studying new treatments in oncology isn’t without its challenges, but the first step to overcoming them is awareness. Read on to learn about the top 5 challenges sponsors face when running esophageal cancer clinical trials and how to overcome them.

1 | Improving Study Accessibility

Investigational drug research into diseases as prevalent as esophageal cancer will often be conducted at large-scale academic medical institutions located in major cities. However, these sites will have difficulty reaching eligible patients who live in more rural or medically underserved areas. Sponsors can improve the accessibility of their esophageal cancer clinical trials with three key strategies:

  • Launch multi-platform social media campaigns to reach a greater pool of potential candidates;
  • Create engaging promotional study materials to be shared with a large network of oncologists and gastroenterologists; and
  • Offer reasonable travel compensation to aid interested individuals who do not have the means to attend visits at distant locations

2 | Finding Experienced Investigators for Esophageal Cancer Clinical Trials

Oncology clinical trials will often span multiple research centers across different participating countries. This does improve the heterogeneity of the overall study population, but it also presents sponsors with the challenge of maintaining consistency between each site. Especially in specialized indications like esophageal cancers, the qualified investigator chosen by sponsors should have sufficient disease experiences to safely care for their clinical trial patients. Finding the right sites can be done with a careful and detailed selection process that is started early on with a focus on staff capabilities. Additionally, digital trial software can also be implemented to remotely share important clinical research resources with smaller clinical sites, for whom such training opportunities may not be as accessible.

3 | Implementing Modern Technology

It wasn’t too long ago that physical stacks of source documents, regulatory paperwork, and clinical assessments were an inevitable part of running any clinical trial. However, today’s sponsors have the benefit of enlisting the help of innovative, tech-enabled contract research organizations (CRO) to streamline different parts of the trial management process. Digital trial master files (eTMF), clinical trial management systems (CTMS), and real-time integrated electronic data capture (EDC) systems can go a long way in keeping all important documents well-organized for esophageal cancer clinical trials.

We are still in a transition period between the world of paper and technology. However, advancing data-sharing technology can help further standardize global regulatory guidelines to reduce the time spent on inefficient, paper-based data management practices. Products like Vial CRO’s eSource, EDC, and ePRO technology help reduce the burden of redundant data collection, while streamlining communication between sites and sponsors.

4 | Accommodating Disease Burdens

Recruitment challenges are inevitable in any study, but they’re especially prevalent in esophageal cancer clinical trials and other oncology studies because the target population is inherently very ill. Aside from investigational treatments, cancer patients also undergo intensive procedures like chemotherapy or tumor imaging as part of their standard of care. Immunocompromised individuals like this don’t have the physical capacity to attend frequent in-person visits because it presents the risk of worsening their illness. This is where modern technology is even more valuable for sponsors because it makes remote patient data collection possible with electronic patient-reported outcomes (ePRO) and informed consent forms (eConsent) software. These accommodations make clinical trial participation more feasible for esophageal cancer patients who may have disabilities, are elderly, or have significant disease progression.

5 | Defining the Eligibility Criteria

Esophageal cancer most commonly presents as esophageal squamous cell carcinoma (ESCC), but can also be found in the form of esophageal adenocarcinoma (EAC). Both ESCC and EAC are accompanied by the challenge of early on-set screening before patients become symptomatic, after which the 5-year survival rate dips unfavorably. Sponsors must design their eligibility criteria to account for the fact that most esophageal cancer patients are already in advanced stages by the time they pursue clinical trial options. Otherwise, potential candidates may be too severe to be considered eligible for treatment.

Vial Oncology CRO

Although oncology sponsors face the difficult task of successfully running trials on esophageal cancer, these top 5 challenges can be overcome with early preparation and collaboration. Vial is a next-generation CRO partner that offers expert executive teams specializing in oncology, gastroenterology, and more. Connect with a team member today to learn how our products can help streamline your next clinical trial!

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