In the field of clinical research, the therapeutic area of oncology in particular is facing a substantial patient recruitment challenge. At present, roughly 15,000 oncology trials are actively recruiting (Longtaal Clinical Trials Landscape Dashboard; www.clinicaltrials.gov), while participation rates have been estimated at a mere 3%-8% of possible candidates, with even smaller numbers in minority and geriatric populations (Institute of Medicine [US] Forum on Drug Discovery, Development, and Translation, 2010). Low enrolment rates threaten more than just the success of individual clinical trials: they may also hinder treatment advances and corresponding benefits to outcomes (Unger et al., 2016).
Improving cancer care for patients in all aspects is the most important outcome promised by trials, but the fact is that any success stories happen in defiance of competition for patients among oncology researchers and of barriers of protocol feasibility and patient eligibility.
Technological innovations offer new ways to overcome recruitment barriers
Along with the fact that patients themselves have little awareness of existing opportunities, this all results in the reality that recruitment is often a labor- and time-intensive process. Fortunately, technological innovations are starting to offer new ways to overcome historical oncology recruitment barriers and disrupt the status quo. One example of technology coming to meet this need is the evaluation of live EMR data, which allows the combination of advanced clinical trial design with the possibility of assessing the occurrence of specific patient attributes at a site level. This would help accelerate recruitment by identifying trial-eligible patients at the time of diagnosis. Most recruitment workflows applicable today rely strongly on oncologists’ thorough knowledge of their patient base and their awareness of active clinical trials. Patients, however, are not always tracked as potentially eligible for a clinical trial until after they have failed first-line therapy.
On the industry side, the decision on which site to contact and thus to make potential patients aware of a new clinical trial traditionally follows the path from strategy leads at headquarters to regional affiliates, and then on to site managers at the local level, where the start-up and feasibility teams begin to determine ―or to pre-select― the clinical sites that might be eligible to participate. The final selection is based on a variety of factors, including, but not limited to, historical performance data, overall patient counts, specialization, and the assessment of historical claims data, if available. At this point, it is important to mention that, in the case of Germany, over half of cancer patients are not treated in university hospitals or teaching hospitals following initial diagnosis, but rather visit specialized regional clinics which might not necessarily make it onto the initial roster of potentially eligible sites.
With the increasing progress toward precision medicine, however, more comprehensive clinical diagnostics are often required to qualify patients for certain trials. Specialists may need to obtain additional tumor samples or biomarkers from patients and oncologists will need subsequently to rely on the diagnostic teams for new analyses or ancillary reviews.
Timing is crucial
This approach is not only cumbersome for the oncologists’ and pathologists’ case flows, but it can also delay entry into active treatment protocols and may have an emotional impact on patients, owing to treatment delays. Timing is clearly of the essence in cancer trial recruitment. Principal investigators, clinical research coordinators, and other research staff are facing minimal time windows within which to work, not only owing to the complexity of diagnosing patients with specific inclusion/ exclusion criteria, but also because it is often challenging to obtain even baseline information in a consolidated fashion. In essence, clinical sites need to find patients who have appropriate tumor types and who are at the right stage of treatment within various lines of therapy.
Moreover, protocol eligibility factors may require patients who are refractory to a certain drug class and/ or in relapse. This forces physicians and coordinators to identify potential candidates after they have failed one therapy, but before they are starting another course of treatment, in contrast to proactive identification and tracking of patients who are in certain lines of therapy earlier on. The sooner oncology trial candidates can be identified after a diagnosis, the faster researchers, providers, and ―most importantly patients can achieve better outcomes. From a site management perspective, contract research organizations (CROs) typically see that 15% to 20% of sites under-recruit or do not recruit at all. A large portion of this percentage is caused by the inability to identify the right patients at the right time and to approach them about participating in trials. Easing cumbersome workflows increases the likelihood that patients will be identified for relevant trials, alleviating the frustration of enrolling few recruits after completing months of upfront preparation (Howland & Bowen, 2019).
By adopting an online feasibility tool, pharmaceutical companies and contract research organizations can reduce the costs and effort devoted to e-mailing . feasibility questionnaires, attending to follow-up reminders, and waiting to receive completed questionnaires.
Manual tracking and analysis of feasibility responses will be eliminated, and the availability of feasibility status update reports and dashboards will benefit study management teams seeking to keep up with all the activities tied to global trials (Clinical Researcher, 2017). Researchers and sponsors also benefit from the condensed timelines through technology-supported trial designs. Fasttrack enrolment can help alleviate delays that cost as much as US$8.0 million per day (Howland & Bowen, 2019).
In addition, the sooner patients are enrolled in a study, the more efficacy and safety data can be collected. For researchers and patients, the timely awareness of clinical research as a care option allows for earlier and more informed decision-making. Every increase in cancer study participation, small or large, represents new possibilities of saving lives. Traditional challenges associated with oncology trial recruitment ―low enrolment rates amidst stiff competition― can be overcome. Identifying and tracking trial eligible patients driven by live EMR data is a new mechanism to help get the best care for patients.
• Clinical Researcher. 2017. Accelerating Study Start-Up: The Key to Avoiding Trial Delays.
• Howland, C. Meghann and T. J. Bowen. 2019. Accelerating Oncology Trial Recruitment by Identifying Patients at Diagnosis. Clinical Researcher, June 2019 (Volume 33, Issue 6).
• Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities. 6, Clinical Trials in Cancer.
• Unger, J. M., E. Cook, E. Tai, and A. Bleyer. 2016. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book 36:185-98
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