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International Clinical Trials

Capture the Data

Among the latest technological developments in the clinical research sector, adoption rates are higher for electronic data capture (EDC), electronic source documentation (eSource) and eClinical integration, as the goal has become to capture 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. They are also being driven by the FDA embracing new technology, and a willingness to dialogue with experts on how to best channel this revolution in order to advance clinical research.

Latest Technologies

The following is a run-down of the tools available on the market today:

EDC
The move from conducting clinical trials on paper to 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 recent report, the healthcare cloud computing market is expected to expand 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 information creates 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 pharmaceutical companies and their CROs. Utilising cloud infrastructure scales quickly and streamlines data processing, improving quality and allowing for a simple, unified experience.

A 2013 report by Industry Standard Research shows that just two EDC providers supported over 50% of clinical studies utilising EDC. The adoption of EDC versus paper has increased each year by 15%, indicating that the demand for EDC is growing at an explosive rate (3). In the last 10 years, the industry has seen a dramatic shift away from paper. While only 24% of studies conducted in 2005 used EDC, 75% of clinical trials in 2012 were likely to employ it. As such, at the end of 2015, five EDC suppliers covered 50% of the market share. The same report also outlines EDC as becoming the standard practice, with approximately 88% of Phase 3 studies initiating use of this technology.

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

eSource
Two years ago, in an effort to move away from paper inefficiencies, the FDA issued its final guidance on electronic source data in clinical investigations. In these guidelines, 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.

One way for eSource 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 electronic medical record (EMR). The FDA does not regulate EMRs; therefore, they are not subject to 21 CFR Part 11 requirements. Collected data can be entered directly into electronic case report forms (eCRFs), on the condition that they meet 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 must have access to verify the data in the EMR (5).

Electronically collected data can be kept on- or offsite. Onsite storage can present many logistical challenges, such as data corruption or loss, standard operating procedures, software validation plan, restricted access and many more. 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 Good Clinical Practice non-compliant.

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 electronic trial master file (eTMF). Currently, only about 54% of TMFs are electronicbased (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 programme, before updating paper documents from older studies.

RBM
The latest trends indicate that sponsors are more comfortable than ever in outsourcing source data verification and monitoring visits to CROs. However, they now prefer to insource clinical operations and data management in order to have more real time control over the study, and mitigate any fallouts as they happen.

Experts point out that as more companies employ RBM, clinical trial teams should differentiate between clinical data supporting safety, efficacy and protocol endpoints, performance, and general study management (7). The value of RBM would not be leveraged if all data were otherwise treated equally instead of being classified.

eConsent
There are several eSignature and electronic informed consent (eConsent) systems currently available on the market. In addition, organisations such as Apple are also entering the medical research market, with apps and wearable technology. For example, Apple's ResearchKit has a module for building electronic consent forms.

About 66% of the top 50 pharma companies are either already using eConsent, or planning to in the near future. The percentage is even higher among the top 25 businesses on the list – 88% of them have already implemented eConsent. Each of the top 10 organisations has also put eConsent initiatives in place (8).

ePRO
In a recent Tufts survey examining 22 sponsors and CROs, 18 reported having adopted electronic patient-reported outcome (ePRO) methods, which resulted in increased data quality, patient compliance and efficient data collection. 61% of the surveyed companies indicated they began using ePRO in the last five years; 28% in the last 10 years; and 11% over 10 years ago (9). Experts believe the increased emphasis placed on patient-reported outcomes, and the push for technology adoption in clinical trials, has resulted in a significant growth in ePRO utilisation. While the Tufts survey points out there has been an overwhelming increase in ePRO usage in the oncology field, the main drawback cited has been the cost of employing ePRO as compared to paper.

Yet it has long been known that ePRO improves the quality of patient-reported data over paper systems or diaries; patients, being human, often do not write down their notes as they should each day or in a timely manner. Not only can ePRO systems remind patients to record their notes, but it can also track whether they have created all their entries at once just prior to the next site visit, as is often the case in the paper world (also known as the parking lot syndrome). ePRO adoption is likely to continue as more companies see its value for post-marketing trials, as well as its benefits and expanding capabilities as new vendors add new systems each year.

eClinical
CROs are quickly realising that in order to remain competitive, they need their IT infrastructure to accommodate an influx of clinical data that would be well-organised and easily accessible from a central repository.

This repository should handle the integration, reporting, management, visualisation and analysis of all clinical data. For example, an integrated system comprised of custom clinical trial management systems (CTMS), pharmacovigilance, EDC and a Clinical Data Interchange Standards Consortium (CDISC) compliant data warehouse enables the timely analysis of research data. Traditional integration between EDC, CTMS, clinical data repositories and statistical analysis systems may require a lot of manual data transformation. While many sponsors can afford to transcribe data in the right format before sending it to their CROs, smaller companies still struggle to prepare their data for FDA submission.

That is why integration is crucial for both clinical trial sponsors and CROs to exchange data during all trial phases. Big Pharma reportedly spends close to $200 million annually for data transfer – but new trends are emerging to combat the old ways of not transferring data until all collection is done. More and more trials are now conducted with the data moving earlier during the study. This method allows managers to spot and ferret out potential problems, thus saving time and money. Another trend is following the CDISC’s Clinical Data Acquisition Standards and Harmonisation (CDASH) data standards for collection fields. This means companies do not have to restructure their data in the drug-approval process. CROs must also adopt data aggregation formats, such as the standard data tabulation model.

Incoming Change


Last December, the FDA published a landmark package of guidances, specifications and other documents governing electronic submissions. These have the force of law, which ` in effect will make the use of CDISC standards mandatory in the US and Japan by December 2016 (10). They also establish the framework for the requirement of standardised study data in submissions, and cover most aspects of submission data and documentation.

The new mandate increases pressure on CROs and sponsors to conform. In addition, the FDA is also considering updating the CDASH standards, which would also have a significant impact on current study processes.

A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its Precision Medicine Initiative in 2015. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 budget will be allocated to pioneer this patient-powered research, and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients (11). The funding will be spread out between the National Institutes of Health, the FDA and the Office of the National Coordinator for Health Information Technology (11).

Electronic Landscape


Although late to the game when compared to other industries, the clinical trial sector is now embracing IT at a much greater pace. New and improved software applications and systems are being deployed at increasingly higher rates, with sponsors and CROs adopting EDC, ePRO, CTMS, eTMF and other systems faster than ever – as the benefits have been proven to far exceed the expense, and the FDA and other regulatory bodies are mandating electronic data submissions. Usage of these applications and systems will continue to improve the quality of data being collected, reduce the overall costs of clinical trials, and speed new drugs and products to patients.

References

1. Visit: www.marketsandmarkets.com/market-reports/cloudcomputing- healthcare-market-347.html
2. Visit: www.transparencymarketresearch.com/pressrelease/ e-clinical-solution-software-market.htm
3. Visit: www.isrreports.com/reports/edc-and-ecoaepro-marketdynamics- and-service-provider-performance-2015
4. Visit: www.clinicalink.com/assets/ICTNOV2015.pdf
5. Visit: www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ ucm328691.pdf
6. Visit: www.cuttingedgeinfo.com/research/clinical-development/ trial-master-file
7. Visit: www.appliedclinicaltrialsonline.com/changes-rbm-trendsinterview- former-fda-compliance-officer
8. Visit: www.healthit.gov/sites/default/files/privacy-security/ecm_ finalreport_forrelease62415.pdf
9. Visit: http://csdd.tufts.edu/files/uploads/Tufts_ePRO_Summary_ Results.pdf
10. Visit: www.fda.gov/downloads/drugs/ucm433492.pdf 11. Visit: www.whitehouse.gov/precision-medicine

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Marc Desgrousilliers joined ClinCapture in 2010, bringing with him over 20 years' experience in software and engineering. He has worked with both startups and large international companies throughout the Silicon Valley, including VERITAS and Microsoft. At ClinCapture, Marc is responsible for evaluating emerging technologies suitable for the biotechnology industry, developing corporate IT, ensuring industry regulatory compliance and creating clinical systems and infrastructure for sponsors.

Eric Morrie
is currently Director of Product Operations at ClinCapture, managing customer support, professional services and product roadmap. Prior to joining the company, he worked at Wincere – a bay area consulting company and CRO – providing systems consulting and managing clinical and statistical programming. Eric holds a BS in Engineering Science and a Master’s in Business Administration from the University of Rochester, US, and has worked in the healthcare, pharmaceutical, and medical device industries for over 20 years.

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