With trial delays costing potentially $600,000 to 8 million per day, pharmaceutical and biotech companies, as well as CROs have begun innovating through digitalization.

Regulatory bodies have helped paved the way for digitalization, including the FDA’s latest guidance in June, which allowed for innovations and adaptations that were successful throughout the lockdown to be implemented for use outside of the pandemic.

Are digitalization trends for small and mid-sized pharma?

Pharmaceutical and biotech companies are also using digitalization across more of their operations – as well as CROs of every size, and small pharmaceutical companies too.

“Today, small pharma companies are overwhelmingly driving innovation, accounting for 63% of all new prescription drug approvals over the past five years,” according to an article in Pharma Voice.

These are a selection of digital trends that are shaping Outpatient Clinical Trials in 2021.

Trend #1 eConsent

eConsent is the use of electronic methods to request, confirm and document informed consent.

The U.S. Food and Drug Administration (FDA) and the U.S. Office for Human Research Protections (OHRP) has supported eConsent in clinical trials since 2016, in a guidance document which states that “electronic processes to obtain informed consent may use an interactive interface, which may facilitate the subject’s ability to retain and comprehend the information.”

A recent 2019 Industry eConsent Survey states that the key drivers were “improved patient comprehension, efficiencies through digitization, improved patient retention, and reduced regulatory risk and audit findings. The top drivers identified were similar between biopharmaceutical company respondents and CROs.”

Even prior to the pandemic there was an increasing trend to utilize eConsent within biopharmaceutical companies and CROs, which has only grown more substantially since Covid-19.

Trend #2 Electronic Health Records (eHRS)

Electronic Health Records (eHRS) are a digital version of a patient’s paper health chart. Used from everything from targeting to recruitment to screening and more, eHRS utilization is on the rise.

This is likely due to the impact it has on recruitment. According to the Journal of Biomedical Informatics, eHRS supports clinical research by reducing redundant data capture, supporting hypothesis testing, evaluating the feasibility of trials, and helping to screen populations. Linking eHRS in clinical trials has also been shown to increase patient recruitment.

This trend is supported by market findings. According to an Electronic Health Records Market 2021 Industry Report published on February 7th 2021, “the global Electronic Health Records (EHR) market size is projected to reach USD 28680 million by 2026, from USD 24170 million in 2020, at a CAGR (Compounded Annual Growth Rate) of 2.9% during 2021-2026.”


Trend #3 Electronic Trial Master File (eTMF)

Electronic trial master file (eTMF) systems utilize hardware and software to manage clinical trial data. Benefits in clinical trials include saving time, cost-effectiveness and an increased visibility to repair and discover document errors. It is also helping with recruitment, as patients can opt to be contacted for trials that are relevant to their medical conditions.

“The electronic trial master file (eTMF) market was valued at US$ 938.32 million in 2019 and is expected to grow at a CAGR of 16.5% from 2019 to 2027 to reach US$ 3,155.64 million by 2027,” according to an article in Industry today. “

“These solutions help the pharmaceutical and biotechnology to organize the data of drug development appropriately, avoiding the regulatory risk of missing files during audits. The rising R&D budgets and advantages offered by eTMF are thus expected to be responsible for the growth of the pharmaceutical and biotechnology companies segment over the coming years.”

The trend towards eTMF is largely attributed to an increase in government funding, the decentralization of trials fueled by Covid-19, and the acceptance of eTMF within the clinical trial industry.

Trend #4 Wearables

The use of wearables in clinical trials continues to rise. Wearables, or ‘wearable technology’ are smart electronic devices worn close to the skin that collect data digitally and automatically.

Wearables offer remote data capture over longer time periods, providing more detailed, granular data. This aligns with decentralized trials and can improve patient safety while reducing the burden of traveling to sites. The ease of use makes wearables patient-centric, which improves recruitment and patient retention.

According to Clinical Leader “As of February 2020, clinicaltrials.gov shows that approximately 460 wearables studies are underway, and according to Kaiser Associates and Intel, 70 percent of clinical trials will incorporate sensors by 2025.”

The IQVIA Clinical Development Trends Impact Assessment supports this, listing remote data capture as one of the top 8 trends in trial productivity.

Trend #5 AI tools: machine learning and natural language processing.

AI tools are being used to improve recruitment in clinical trials by integrating information gleaned from wearables, Electronic Health Records (HER) and medical devices into ‘matches,’ which are then recommended to doctors and patients. This can take place via the wearable technology or at the clinical consultation.

In terms of retention, according to an article in Clinical Leader, “the application of AI to rich patient data presents the opportunity to track the patient’s compliance with the clinical trial’s adherence criteria. The data can be presented to clinical trial administrators, which allows them to notify the patient of retention risks and take predictive and preventive measures as opposed to reactive management.”

Digitalization- the path towards decentralization.

A June survey by GlobalData revealed that 67% of health experts “plan to use decentralized clinical trials in the near future due to Covid-19”. Many of these companies were already in the process of the transition- but this process has been expedited by the largest healthcare crisis that clinical trials have faced yet. This is not just a challenge, but an enormous opportunity.