Digitally Enabled Oncology Research: A Breakthrough for Patient Inclusion

    ESMO Open recently published a study titled “Unlocking digitally enabled research in oncology: the time is now.” According to the study, the progress in oncology therapeutics, screening, and supportive care has substantially increased the survival rates among cancer patients over the last five decades. The groundbreaking advancements in the oncology clinical trial have played a key role in this process. They’ve served as the cornerstone for translating research outcomes into tangible patient benefits.

    However, conducting clinical trials is an expensive and sometimes exclusionary process.

    During the forecast period between 2015-2017, the median evaluated cost of oncology pivotal trials was $31.7 million (interquartile range = $17.0-$60.4 million). Per-patient costs for phase III trials have seen a drastic increase since 1996. Moreover, the arduous and lengthy process of traditional clinical trials further adds to this cost and concentrates trials in a set number of provisioned cancer centres. 

    According to the study, the workflow for conducting traditional oncology trials is non-inclusive. That leads to a low recruitment rate (as low as less than 10%). Furthermore, most clinical trials fail to bridge the diversity gap in a clinical trial. They fail to enrol more patients from ethnic minorities or socioeconomic groups, elderly patients, or patients living in remote areas. 

    Racial and ethnic populations in the USA are often burdened with specific diseases. However, they are usually not well represented in clinical studies, as stated by the FDA. Black and Hispanic minorities, for example, represent 13.4% and 18.5% of all cancer patients in the USA. According to recent analyses of cancer therapeutic trials, their trial participation rate is only 4%–6% and 3%– 6%, respectively. Low enrollment of minorities reduces the generalisability of trial outcomes whilst also representing a discrepancy in access to high-end healthcare. 

    All these contributing factors only jeopardise the research outcome, severely affecting the effectiveness of the cancer therapeutics being rolled out to the market.

    The study emphasised increasing the use of digital technologies in clinical cancer research to address these challenges. 

    According to the study, compared to traditional trials, oncology clinical trials that embrace digital technologies and take a fully decentralised and digitised pathway see a drastic uptick in accuracy and patient recruitment and retention rates. Highlighting the consequential and far-reaching benefits of digitising oncology clinical trials, the study states, “Digital technology can simplify trial procedures, expedite and enhance data collection, promote a global and more equal reach, and foster patient empowerment and participation.” 

    Democratising patient screening, enrollment, patient consent, and follow-ups can significantly reduce patient burden and drop-out rate, thus expediting the trial process. For example, AI-enabled tools, leveraging machine learning (ML) and natural language processing (NLP), can significantly streamline the patient eligibility determination process compared to traditional pre-screening methods. 

    For example, manual eligibility screening of 90 participants for three trials took 110 minutes. Meanwhile, AI-assisted eligibility screening of the same participants for the same trials took only 24 minutes. That’s a drop of 21.82% in the time burden of eligibility assessments. Again, AI-enabled models hold the potential to drive inclusion in trials by refining the patient selection criteria. Citing research by Gustave Roussy, the ESMO Open study stated that an NPL model, fed into electronic medical records (EMRs), can reduce the patient screening failure rate in oncology clinical trials from 39.8% to 12.8%.

    The study also stresses the importance of deploying high-end DCT platforms in escalating clinical trials. In fact, ObvioHealth, a leading VRO in oncology clinical trials, has marked DCT platforms offering eConsent and ePRO as key enablers of reducing site burden and augmenting data accuracy. According to a study, clinical trials that deploy eConsent platforms exhibit a lower error (0.32%) and higher completion rates compared to the traditional consent process (7%).

    The study also states that implementing digital tools, such as biosensors and electronic patient-reported outcomes (ePROs), helps streamline the process of collecting clinical data as well as patient-generated health data (PGHD). Furthermore, these tools ensure data quality and better patient compliance. That leads to in-depth insights into a patient’s health, treatment impacts, quality of life, and toxicities. 

    To illustrate the point, ePRO-based clinical trials exhibit a compliance rate of about 90% to 97%—much higher than that of paper-based trials, which is at only around 30%. 

    Deploying decentralised and hybrid models in clinical trials can significantly bridge geographical and demographic gaps by enabling underrepresented populations to participate in trials remotely. 

    The potential for digitally enabled clinical trials in oncology is tremendous. However, deploying fully decentralised and digitally enabled trials comes with some challenges. 

    For example, ensuring protected data storage and transmission is critical in oncology clinical trials. Identity protocols and encryption processes are central to safeguarding patient data, the study stresses. 

    Again, the study emphasises the importance of developing robust regulatory frameworks to ensure DCT models are designed to be more patient-oriented. 

    Finally, the initial cost of implementing and operating a digitally-enabled fully decentralised clinical research may seem high. However, the data quality, accuracy, and cost-reduction it eventually offers justifies the initial investment. By speeding up the trial closure process, digitally enabled research hastens the roll-out of life-saving/improving therapeutics to the market. 

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