The publish or perish culture surrounding clinical trials is influenced by politics, economics, and sociocultural factors, all either nourishing the research landscape or creating the equivalent of a hurricane. But while these overarching obstacles loom large in pharmaceutical company boardrooms, frontline investigators are grappling with other, more immediate, pitfalls impacting the volume and diversity of data coming out of clinical trials.
Low enrollment, lack of diversity, and limited research sites currently rank as the top impediments to robust data. However, one innovative company is enabling trial sponsors to pre-emptively stave off Food and Drug Administration (FDA) rejections and limited efficacy by providing a foundational element for what could be the antidote: utilizing community-based research sites.
By connecting sponsors with smaller community trial sites, Inato is paving the way for greater enrollment diversity and amping up the data flowing out of clinical trials.
To provide some perspective, clinical trials take an average of eight years between initial testing to product approval, with only one in six gaining full FDA approval. A retrospective review of all FDA submissions between 2000 and 2012 showed that nearly 16% of rejected studies could have salvaged their research had they enrolled a larger, diversified population sample.
Given that nearly 95% of the population is excluded from study participation solely because they live too far away from academic testing centers, the consistent lack of diversity is not surprising. A whopping 70% of all clinical trials worldwide occur at just 5% of research sites, which primarily draw patients from populations within 40 miles of trial sites. In terms of inclusivity, racial diversity is a significant issue. For example, FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Trials Snapshots Summary Report found that just 6% of trial enrollees were Asian. Further, 75% of the patients enrolled in industry-sponsored clinical trials in academic medical centers and community hospitals are white.
The diversity problem goes beyond race, however. Consider that only 8% of cancer patients enroll in cancer trials, and less than 2% of cardiovascular disease trials reported any female sex-specific cardiovascular risk factors. Racial, gender, demographic, and geographic limitations drive up costs, dampen external validity, prolong timelines, and limit the generalizability of findings to the population at large.
Decentralized trials, which depend less on traditional research facilities and specialist intermediaries for data collection and instead leverage virtual tools (e.g., telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, home delivery of study drugs and materials), are often held up as the solution to the diversity problem. However, direct involvement and care of a physician is still crucial – particularly with complex trials. Engaging community-based sites overcomes this limitation, allowing patients to seek treatment close to home while receiving necessary support.
By enabling the participation of community-based research sites, companies like Inato are helping to improve representative data collection on a global scale and, in some cases, salvage existing trials that are struggling with enrollment. As a part of a patient-centric approach to clinical trials, community research sites bring access to patients worldwide, including those populations who have historically lacked access to clinical research.
Inato advances inclusion through its Marketplace platform, which reinvents the partnership model between sponsors and sites by reliably matching sites and clinical trials worldwide, opening access to a broader range of sites, and expanding the patient pool. Since June 2020, the company has built a network of over 1,500 community research centers in 40 countries to enroll patients in more than 70 disease areas.
Showcasing the success of this model is a global healthcare company that, due to the pandemic, faced delays in its trial timelines, fewer patients participating in trials, and the rising need to enroll patients quickly as more trials were taking off. Within their portfolio, an increasingly challenging disease area was multiple sclerosis (MS), for which several trials were running simultaneously. These included trials for Relapsing MS (RMS) – a historically arduous recruitment and enrollment area. The sponsor decided to post the trials to Inato’s Marketplace platform, allowing sites the opportunity to self-identify which trials worked best with their patient population and availability. The working relationship between Inato and the sites also enabled the trial sponsor to have a comprehensive view of each sites’ capabilities, ultimately selecting several to successfully participate in multiple MS trials.
For populations that are typically harder to recruit for, like RMS, Inato works closely with community sites to identify those with access to qualifying patients. In this case, the extensive process of pre-identifying patients that met trial criteria allowed one community-based center from Inato’s network to achieve the US First Patient In (FPI) in the RMS Phase II trial. In all, over 70 patients were identified for the RMS trials alone, with one site screening two patients within the first week of activation for a Phase III study.
For the global trial sponsor, Inato’s approach to bridging the gap between sites and sponsors translated into the successful launch of eight studies across several disease areas and nine countries. Using Inato’s Verified Commitment, the sponsor’s team could ensure the trials will meet enrollment goals before they begin screening and receive verified patient commitments from nearly 250 patients across these eight trials.
That organization has since expanded its relationship with Inato to include asthma and chronic obstructive pulmonary disease (COPD). It is a strong business case for the power of expanding clinical trial opportunities to often-underutilized community sites, which sets the stage for employing an inclusive research model.
The reality is that traditional clinical trials face more obstacles than ever due to rapidly evolving political, economic, and socio-cultural shifts that are exacerbating existing data and enrollment diversity challenges. By enabling access to the personalized care of community-based doctors, Inato optimizes the advantages of patient-centric trials. Its online marketplace platforms connect large sponsors with diverse community sites and provide those smaller sites with valuable enrollment support, leading to broader population representation and the benefits that come with it.
Increasing diversity, inclusivity, and reach in clinical trials through companies like Inato is emerging as the antidote to publish or perish.