Top eClinical Trends in 2016 (1/2)

12 February, 2016, by ClinCaptureTeam

Glenn Keet is ClinCapture’s former CEO. He has worked in healthcare IT for over two and a half decades, and most recently was responsible for Business Development on the Optum Health Care Cloud, focusing on developing the ecosystem of providers, developers and consumers. Mr. Keet became part of Optum via the acquisition of Axolotl Corp., where he was President. He co-founded Axolotl in early 1995. Prior to his role as President, Mr. Keet was EVP over Sales and Marketing, responsible for all HIE sales to states, RHIOs and hospitals. Glenn Keet has previously held the role of VP of Business Development, and also has served as VP of Professional Services. He was the company’s Product Manager until 2001.

Clinical research is well on its way to transforming its paper-driven model to an all-things-electronic format. This paper focuses on the top eClinical trends in 2015 and 2016. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring.

Among the latest developments- adoption rates are higher for EDC, eSource, and eClinical integration, as the goal has become capturing real-time data as a continuous stream. These trends are partially the result of the prevalence of high-tech devices, sensors and wearables now entering the clinical trial industry.  Trends are also being driven by FDA embracing technology, and willingness to dialogue with experts on how to best channel this revolution in order to advance clinical research.

Higher EDC Adoption

The move from conducting clinical trials on paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality and regulatory compliance and reduce costs. This trend has grown because of the need to share real-time data and facilitate strategic decision making based on study progress.

According to a newly released report, the healthcare cloud computing market is expected to grow from $3.73 billion in 2015 to $9.48 billion in 2020 [1]. The eClinical solutions market, including cloud-based solutions, is projected to grow an average of 14% per year through 2020, reaching an estimated $6.52 billion, up from $3 billion in 2014 [2].

Incorporating different sources of data generates data management challenges, which is why cloud solutions are quickly gaining popularity. Cloud-based technology brings efficiency and cost-effectiveness to managing clinical data, and works for both pharma companies and their CROs. Utilizing cloud infrastructure scales quickly and streamlines data processing, improving quality and allowing for a simple, unified experience.

According to a recent report by Industry Standard Research (ISR), in 2013 just two suppliers accounted for more than 50% of EDC services. By end of 2015, the top five EDC suppliers cover 50% of the market share, which shows that the market for EDC software and services is growing [3]. The same report also shows that EDC has become standard practice with approximately 88% of Phase 3 clinical trials initiating use of the technology.

However, as recent Clinical Ink research points out, volumes of paper still delay clinical trials due to reliance on 100% source document verification (SDV). Risk-based monitoring (RBM) is also advancing at a high pace while sponsors and study teams don’t have the right eClinical solutions to generate real-time data [4]. This explains the emergence of the next trend on our list- electronic source documentation (eSource).

eSource on the Rise

Two years ago, in an effort to move away from paper inefficiencies, the U.S. Food and Drug Administration (FDA) issued its final guidance on Electronic Source Data in Clinical Investigations. In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.

According to the Food and Drug Administration (FDA) eSource Guidance of 2013: “Electronic source data are data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation” [5]. In other words, this is data that is entered directly into a digital format without having to first record it on paper and then transfer it to an electronic data capture solution.

A valuable collection point of eSource is a patient’s electronic health record (EHR, also referred to as EMR), which are typically created and maintained by the patient’s primary and treating physician(s).  EHRs have been rising in utilization worldwide, and particularly in the U.S. over the past 5 years because of monetary incentives put in place to adopt their usage. In fact, CMS and Medicaid will soon be inflicting penalties on providers who fail to demonstrate “meaningful use” of an EHR.

Yet investigators have liked the flexibility and versatility of pen and paper, and they can perceive computerized systems as a drain on their productivity. The Internet is not always easily accessible from the clinical sites, especially overseas. This is why new data capture solutions that are built on smart tablets can address these two hurdles. Tablet applications can be designed to “look and feel” just like paper, but they offer the efficiency of an electronic document, even when collected offline. Unlike case report forms (CRFs), which only capture the data necessary for analysis, eSource documents meets the broader need of providing affirmative documentary evidence related to a subject case history and site audit, and typically also allow for notes and ad-hoc comments.

Other benefits of eSource documents include increase in clinical data quality through validation checks and the removal of unnecessary duplication of data, as well as the reduction of monitor site visits by eliminating source document verification (SDV) and enabling remote document review. However, despite the many benefits, e-sourced documents can still be a challenge from a GCP compliance perspective.

One way for e-source solutions to comply with regulations and guidelines is to make the first data recording on paper or keep the source data in the clinical investigator’s control by entering it in an EMR. The FDA doesn’t regulate EMRs, therefore they are not subject to 21 CFR Part 11 requirements. Collected data can be entered into eCRFs directly on the condition that it meets all regulations. If the clinical data is transferred to an eCRF from an EMR, then that EMR is considered the source. The FDA has made it clear that clinical trial monitors and auditors should have access to verify the data in the EMR [5].

Electronically collected data can be kept on or off-site. On-site storage can present many logistical challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. Data not stored locally should be under the control of the investigator in order for it to be compliant. Thin-client architecture, which delivers e-sourced data straight into a CRO’s or sponsor’s remote server, can sometimes be GCP non-compliant.

Among its many benefits, eSourcing helps control fraud as it is far more difficult to fabricate electronic records compared to paper ones.  For this reason and others, the FDA has made substantial efforts in supporting the use of electronic data solutions in the past couple of years.

 Record Adoption of eTMF

A 2015 report by Cutting Edge Information shows that adoption of electronic documentation management and control systems is expected to reach 88% by 2020. These systems are commonly known as eTMF (electronic trial master file) in the clinical trial industry.  Currently, only about 54% of TMFs are electronic-based [6]. The report also indicates that updating paper documents to an electronic platform is more time-consuming than building new TMFs in an electronic system. To overcome the challenges associated with eTMF platforms, many surveyed teams reported executing eTMF strategies in waves. For example, teams may start by building new TMFs into an electronic system as part of a paperless pilot program, before updating paper documents from older studies.

Another recent study done by an eTMF provider also claims a sudden drastic spike in eTMF adoption. The Veeva 2015 Paperless TMF Study (Veeva is the provider of Vault eTMF) surveyed 50 international CROs and found that 38% use eTMF applications in comparison to 21% just one year ago—a 17 percentage point increase, striking especially for a market that traditionally moves more gradually. The same report also claims that, as compared to 2014, greater numbers of CROs now exchange TMF documents with sponsors via eTMF applications (36% today, up from 24%), and are much less reliant on paper (46%, down from 65%).

By Glenn Keet, former CEO at ClinCapture
And Eric Morrie, Director of Product Operations at ClinCapture

Sources:

[1] Healthcare Cloud Computing Market worth $9.48 Billion by 2020

[2] E-Clinical Solution Software Market to Exhibit 13.8% CAGR owing to Increasing Clinical Trials

[3] EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)

[4] At the Source

[5] Electronic Source Data in Clinical Investigations

[6] Refine Trial File Management Processes to Ensure Timely Submissions and Better Prepare for Regulatory Audits

[7] New survey reveals eTMF adoption has hit the tipping point

[8] Changes in RBM Trends: Interview with Former FDA Compliance Officer

[9] Providing Submissions in Electronic Format