The Stanford Cancer Institute Early Drug Development program awarded for increasing clinical trial access
The Stanford Cancer Institute Early Drug Development (EDD) program brings in early-phase clinical trials so cancer patients can have access to innovative treatments that could provide a therapeutic benefit.
Recently, the EDD program was awarded an Integrated Strategic Plan (ISP) Star by Stanford Medicine for increasing clinical trial enrollment and access. In just a few years, the program has increased total visits at the Stanford Medicine Cancer Center by more than 200% and new patient visits by nearly 150%.
Feriel Buchholz, EDD’s clinical research manager at the Stanford Cancer Institute Clinical Trials Office, notes that clinical trials are inherently uncertain.
“We don’t always know whether in phase one if patients will benefit from treatment.”
Nevertheless, clinical trials are an important way for patients with cancer to have access to new drugs that are potential breakthroughs.
Sponsors, which can include pharmaceutical companies, the National Cancer Institute, or Stanford investigators, can contact Stanford about participating in a clinical trial. Once the trial is activated at Stanford, the EDD team lets Stanford oncologists and community doctors know about the new study, and they can refer patients to the EDD group to be considered for study participation.
Buchholz says, “We send monthly flyers advertising our new studies so that community doctors are aware of what’s available for their patients.”
Rochelle Reyes, lead advanced practice provider of clinical research at the Stanford Cancer Center, states, “We are so grateful for the continued collaboration from referring oncologists within Stanford's growing network and beyond. We strive to collaborate with each patient's primary oncologist to offer the best possible treatment for each patient, whether on a trial or not.”
To increase access and enrollment, the team created a new process focused on educating patients about clinical trials.
Reyes explains, “Patients face numerous barriers to enrollment on a clinical trial such as mistrust in human research, not knowing the process or intent of research, or not being offered trials. Some of these barriers we aim to overcome through a thoughtful prescreening process, sometimes over several visits. We seek to build trust with patients, provide transparency about the true inconveniences and clinical risks of trial participation, and provide information about specific trials.”
The EDD team bases every encounter with the patient on their unique goals of care.
Reyes clarifies, “We aren't looking singularly for trial candidates, but we present trials as options that may be a means towards their personal goals. The ultimate decision of whether a patient should pursue a trial is between the patient and their primary oncologist who knows them and their disease best.”
Buchholz points out that clinic visits have increased because they are willing to meet with patients initially to educate them and not necessarily to enroll them. The EDD team identifies one or more trials for the patient and helps the patient determine which is best based on the patient’s unique life and clinical circumstances.
She says, “They all make an informed decision on which one to go based on numerous factors including, for example, how many times they have to come to Stanford if they live far away. If the study requires them to come every two days, that might not really be something a patient would like to do. Then we’ll look for something where maybe the trial requires a visit every two or three weeks. So it really depends on the patient’s situation.”
Reyes notes that there are barriers to trials, as with healthcare in general, that the EDD program has not yet solved, such as the cost associated with more frequent and longer visits to the Stanford Cancer Center in Palo Alto. To lessen the patient’s burden, the EDD team can work with the trial’s sponsor to provide travel reimbursement.
During their initial discussion with the patient, the EDD team prescreens every referred patient for every trial in their portfolio and in the pipeline. This includes a comprehensive review of biomarker testing so patients have access to trials that are informed by precision oncology.
Reyes describes how this is important for patients to increase their treatment options as more cancer therapies are informed by precision medicine. Patients with potentially actionable biomarkers may be referred to the Stanford Molecular Tumor Board and other NCI-comprehensive cancer centers. They discuss any gaps in testing and either order tests directly or provide guidance to the referring team.
Buchholz says, “You have some clinical trials that develop drugs that pinpoint a certain mutation, and if we don’t know whether a patient has that mutation or not, that decreases their chances of finding the right clinical trial for them.”
The EDD program carefully curates their portfolio with the goal of having a trial option for every patient in need, although that is not always possible.
Reyes states, “As cohorts open and close, and slot availability varies, having a trial option isn't always possible, but that is why we ask our referring partners to ‘Take a Trials Time Out’ and refer often and early to EDD so we can lay the groundwork for eventual trial enrollment.”
Occasionally, they will reach out to the trial’s sponsor if they’ve noticed the trial’s eligibility criteria are too restrictive and preventing patients from enrolling. Buchholz notes that often sponsors agree to amend the protocol because they’ve noticed a lack of enrollment and are receptive to the EDD team’s input.
Of the EDD program’s next steps, Buchholz speaks positively about continued growth.
“We’re hoping to grow as a group and bring in more investigators and clinical research coordinators so that we could bring in more trials and provide more opportunities for patients to benefit from cutting-edge therapies.”
February 2024 by Katie Shumake
Left: Courtesy of Rochelle Reyes