How data is crucial to the relaunch of the Cancer Moonshot
In this article, Ben Hargreaves takes a look at the renewed effort to tackle deaths from cancer in the US through the Cancer Moonshot. Central to the initiative is the aim to gather data from willing participants that can provide greater insights into cancer development and treatment over time.
The Cancer Moonshot was officially launched in 2016 by the passage of the 21st Century Cures Act through US Congress. The Moonshot was started with three aims: to accelerate scientific discovery in cancer, foster greater collaboration between stakeholders, and to improve the sharing of cancer data. During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI).
In February of this year, it was announced that, under President Joe Biden, the White House would renew leadership efforts on the Moonshot. As part of the relaunch, a goal was set to reduce the death rate from cancer by at least 50% over the next 25 years.
The new stage of the Moonshot has been established on the contribution and the role that US citizens can play in this effort. In particular, the US government suggested that people getting back to cancer screenings missed due to the pandemic, quitting smoking, and participating in research could all play a vital role. A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research.
Building a bank
The Biobank was launched in 2020, with an initial aim of enrolling at least 1,000 patients with locally advanced or metastatic solid tumours and haematologic malignancies undergoing standard of care therapy. The objective is to gather patient biospecimens longitudinally to understand how patients react to treatments and how cancer develops over time. Participants can also receive tumour biomarker testing that may help offer them different treatment options.
Individuals who choose to be involved in the project are asked to donate tissue and blood samples during regularly scheduled procedures and doctor visits. The biospecimens and associated health data will then be made available to cancer scientists, potentially offering the opportunity to discover new treatments.
However, one of the early challenges that faced the Biobank on being set up was the difficulty in managing the volume of data that would be produced. Another hurdle would be to create resources on a public-facing website for consent forms and access to biomarker reports, which would also need to be engaging and easy to navigate.
A recent research paper on the Moonshot effort, published in Nature, stated, “Many powerful datasets are not being fully utilized due to challenges in data storage, accessibility, and processing. These datasets are critical as a means to identify how molecular information affects clinical outcomes.” The author of the study noted that researchers from anywhere in the world can now request access to the growing dataset that is being generated by the Biobank effort.
Up in the clouds
The companies tasked with supporting the data needs of the Biobank are Medidata and Theradex Oncology, alongside the NCI. The trio are charged with helping to enrol patients across more than 100 clinical sites in the US, with the purpose of engaging and educating study volunteers on the process, collecting the patient information accurately and securely, and enrolling patients onto the project itself.
Medidata has provided its Patient Cloud and Rave solutions to the Biobank, which includes eConsent and Rave EDC (electronic data capture). The eConsent platform is a regulatory-compliant electronic consent system for clinical trials and the Rave EDC is a secure system for clinical trial site, patient, and lab data capture and management.
Walt Lee, director of client services for Medidata, spoke to pharmaphorum about the solutions it is providing to the Biobank, where he explained how the two services work in conjunction with one another: “Medidata eConsent automates the patient enrolment process and onboards patients directly into Rave Electronic Data Capture (EDC), improving overall consent tracking management, reducing informed consent errors, and easing the administrative burden for sites and study teams.”
“It also enhances the patient experience with easy-to-understand clinical trial information, such as a video about the Biobank study, as well as informed consent documents for electronic signature,” he continued.
Facilitating patient understanding and consent
Informed consent is crucial to recruiting the patient to the study. This means that Medidata was tasked with ensuring that patients could accurately understand the objectives of the project and their rights as a patient. This was delivered through a patient-centric video about the Biobank study presented to the patient on an iPad, Lee explained.
Once the video is presented, the patient is asked to take a knowledge check to ensure that they have fully understood the consent process. Informed consent and HIPAA (Health Insurance Portability and Accountability Act privacy law) documents are also presented to the patient alongside the video, where they are able to tag sections of the documents for follow-up discussions with the investigator or clinician before signing them. The entire process takes place in the physician’s office, alongside a clinician. According to Lee, all of the content created for the eConsent part of the process was worked on alongside the Biobank team.
Further than providing consent, Lee explained that additional data can be generated from the process: “eConsent ensures consistent patient registration and consistent delivery of messaging about the trial and consent process directly to the patient. The technology provides the sponsor and investigators with objective metrics related to their patients’ consent, such as time spent watching the video or reviewing the informed consent documents, and their performance on knowledge tests.”
Due to the fact that the registration and consent data flow directly into Medidata’s Rave EDC solution, data entry is streamlined and transcription errors are eliminated. The end goal for these types of solution is to ease the burden of enrolment on patients, clinicians and the trial investigators. In the case of Biobank, this could mean a higher number of patients enrolled onto the initiative, and to potentially help to bring Cancer Moonshot’s aims of vastly reducing the number of deaths from disease closer to reality.