In-depth: Study results highlight the growing momentum towards more real-time and technology-enabled clinical trials in the pharmaceutical industry and facilitates increased enrollment of female patients.

eConsent could significantly boost female participation in clinical trials, according to new real-world outcomes from a US-based women’s health study. Enhanced eConsent technology from Medable, implemented in a trial run by Icon plc, achieved “remarkable enrollment goals”, according to Alison Holland, Medable’s Chief Customer Officer.

Data showed that over 85 percent of trial participants opted to use the enhanced eConsent technology. Promisingly, 18 sites achieved 100 percent adoption, while the top-enrolling site achieved 91 percent adoption.

These findings are notable given that the trial protocol required patients to be regularly assessed across 13 points.

Women remain underrepresented in clinical trials, largely driven by poor levels of enrollment by this patient population. Eligibility is also a major contributing factor.

Remote electronic consent is particularly beneficial to driving female participation due to increased time constraints for women and mothers juggling family care responsibilities”

Alison Holland, Chief Customer Officer, Medable

 

Medable’s Alison Holland continued: “Remote electronic consent is particularly beneficial to driving female participation due to increased time constraints for women and mothers juggling family care responsibilities”.

What is eConsent?

Obtaining a patient’s consent for their participation in clinical trials and research has traditionally been conducted through paper-based forms. Electronic consent (eConsent) provides a digital, paper-free option that is sustainable and reduces administrative burden and costs for researchers, meanwhile freeing up time for both patients and staff.

If high registration levels—as seen in the menopause-focused study—are replicated at scale in different trials and indications, drug developers will be better informed about how pharmaceuticals effect females.

Why this matters

Peri-menopause and menopause is a growing area of interest in clinical research, particularly around how drugs can affect women during these final stages of their reproductive life. Outcomes from the study that utilised enhanced eConsent technology therefore offers timely insight on improving female participation.

Increasing female enrollment could accelerate drug development timelines by giving scientists a better understanding of the safety and efficacy of medicines across different patient populations.

Ultimately, eConsent is a core tool in the decentralisation of clinical trials, a key area of innovation within the sector. Not only do technology-enabled and real-time clinical trials facilitate stronger patient adherence to complex protocol requirements, leveraging tools such as eConsent in trials could help streamline adoption of AI in the pharmaceutical industry.

Key insights

  • · Over 85 percent of female patients in the study consented electronically
  • · A total of 18 sites achieved 100 percent eConsent adoption among participants
  • · Study outcomes illustrate benefit of eConsent as a tool for increasing female participation in clinical trials
  • · Digitally-led approach lays foundation for increased patient adherence to complex protocol requirements.

Medable’s Total Consent platform, implemented in ICON’s women’s health study, enhances bulk processing and digital consent by providing AI-powered PDFs, which the firm has shown, “reduces deployment time from 5-14 days to less than three days”.

Similar initiatives are being integrated across the industry, including the US Food and Drug Administration (FDA). In May, the agency proposed a pilot programme to assess how AI-enabled technologies can enhance the efficiency and quality of decision-making in early phase clinical trials. As such, considering digitally-led options such as eConsent in clinical research positions adoptees of this approach in a prime position ahead of future regulatory requirements.

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