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Applied Clinical Trials April 2021

Calyx has announced that Catalyst Clinical Research is entering into a partnership with Calyx to use Calyx’s Medical Imaging solution for their customers’ oncology trials.

The ACTIVATE Solutions for CRO Partners program is designed to provide alignment between Calyx and its CRO partners. By participating in the ACTIVATE CRO program, Catalyst aims to better meet the imaging needs of their clients and help accelerate oncology trial execution and data collection.

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Calyx Welcomes Catalyst to ACTIVATE Program

Science 37, Inc. and LifeSci Acquisition II Corp. have announced today that they have entered into a business combination agreement. Upon closing of the proposed transaction, the combined company will operate as Science 37 and is expected to be listed on the NASDAQ under the sticker symbol “SNCE”.

The transaction values Science 37 at a total enterprise value of approximately $1.05 billion and a fully distributed equity value of approximately $1.3 billion at signing, excluding any contingent consideration. The transaction also includes up to $125 million of additional contingent consideration to existing shareholders of Science 37 subject to the achievement of certain aftermarket stock price targets.

The transaction has been unanimously approved by each of LifeSci’s and Science 37’s Board of Directors. The proposed transaction is subject to the approval of LifeSci and Science 37 stockholders and the satisfaction or waiver of other customary conditions, including a registration statement being declared effective by the U.S. Securities and Exchange Commission and is expected to close in the third quarter of 2021.

Science 37 Merger with LifeSci Acquisition II Corp.

As pressure mounts on Capitol Hill to enact legislation designed to reduce federal outlays for prescription drugs, the drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic. In a surprise move, the Biden administration has announced support for waiving international protections on intellectual property (IP) under the World Trade Organization (WTO) to expand access to anti-COVID vaccines. US trade representative Katherine Tai stated that a limited waiver on IP protections for certain products would be negotiated by WTO to help end the worldwide pandemic and block the emergence of new viral variants.

Biopharma leaders countered that even with patent waivers, the new vaccines will be difficult for foreign manufacturers to produce quickly and safely (see note below). Instead, US and European manufacturers seek to maintain IP protections by ramping up vaccine donations and supplies of production materials for India and other countries with capable vaccine production facilities to increase local production. Moderna recently promised to send 500 million doses of its COVID vaccine to COVAX, the vaccine supply program for the World Health Organization (WHO), while Pfizer earlier donated $70 million in medicines to India to help treat the surge in coronovirus infections and deaths. Moderna had previously said that it would not enforce IP protections for its mRNA-based vaccine, but that has not led to new production overseas. And AstraZeneca and Johnson & Johnson already have licensed their vaccines to foreign manufacturers.

Industry’s main message is that patents drive biomedical innovation, which has been responsible this past year for remarkably fast action in developing new vaccines and treatments to combat COVID-19. Loss of IP protection would open the door to drug developers in China and Russia to tap confidential information held by western firms and would do little to help manufacturers in developing nations move into vaccine production.

Meanwhile, Congressional leaders are proposing legislation to drive down drug costs at home to finance expanded social and educational benefits under the Biden administration’s American Families Plan. So far, the White House appears willing for Congress to take the lead on the drug pricing debate, with President Biden omitting specific price reform provisions from this latest legislative package.

The main arguments for and against drug pricing proposals were aired at recent hearings before House Energy & Commerce and House Labor & Education subcommittees.

 Patient representatives, consumer advocates, financial analysts and leading academics made their cases for legislative proposals to shape drug development and patient care: Reformers claimed that costly therapies limit patient access to life-saving treatments, while heavy spending on medicines drives up health care costs for all. Industry analysts maintained that the free market for medicines in the US benefits all by supporting hefty investment in high-risk biomedical R&D. They argue that actual drug prices are tricky to assess; patient out-of-pocket costs are driven more by hospitals and insurance practices; and greatly expanding competition from Chinese and other subsidized manufacturers is challenging innovation in the US and Europe.

The lead House proposal, HR 3, seeks to authorize price negotiations for drugs reimbursed by Medicare Part D drug plans. While that move is strongly opposed by industry, there’s more bipartisan support for limits on annual drug price hikes, caps on out-of-pocket costs for patients, added price transparency, and revisions in drug reimbursement for treatments delivered in clinics under Medicare Part B.

Senate leaders also are looking to revise earlier pharma pricing measures to gain sufficient support from Republicans to move forward. Earlier legislative efforts by the Senate Finance Committee were blocked by the GOP leadership, and moderates could still shy away from proposals strongly opposed by industry and certain patient groups.

Meanwhile, Democrats disagree on how the administration should use the savings generated by drug price reductions. Moderates look for added revenues to strengthen coverage under the Affordable Care Act and to bolster biomedical research and drug oversight. Progressive reformers, however, want to use the gains to expand Medicare and Medicaid as next steps towards a universal health care system.

Up until now, the White House had signaled that it wants to avoid a major confrontation with the biopharmaceutical industry, which has earned plaudits for record development and production of critical COVID vaccines and therapies. President Biden recently signed into law two bills designed to enhance approval of new generic drugs and to encourage prescribing of biosimilars, and other more targeted reform measures may gain support if broader pricing measures fall off.

At the same time, financial reports reveal huge increases in revenues and profits for the makers of pandemic vaccines and therapies. Pfizer recently predicted $26 billion in COVID-19 vaccine sales this year, likely its biggest source of revenue. Analysts also are documenting a broad increase in global spending on drugs and vaccines last year, and the rise is projected to continue. A WTO resolution waiving IP protections only for COVID-19 vaccines in itself is unlikely to erode sales for existing products, as it is expected to take weeks or months to negotiate. The larger danger is that it could set a precedent for similar action on treatments for other critical diseases and further encourage political attacks on pharma operations and profits.

Note: the complexities of mRNA-based vaccine production are clearly illustrated by the New York Times article on Pfizer’s vaccine process: see 

How Pfizer Makes Its Covid-19 Vaccine - The New York Times (nytimes.com)

https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver

https://energycommerce.house.gov/committee-activity/hearings/hearing-on-negotiating-a-better-deal-legislation-to-lower-the-cost-of?mc_cid=68505cc519&mc_eid=d758d51698

https://edlabor.house.gov/hearings/lower-drug-costs-now-expanding-access-to-affordable-health-care?mc_cid=68505cc519&mc_eid=d758d51698

The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.

Pharma Prices & Patents Under Attack

The COVID-19 pandemic has added significant risk for pharmaceutical and medical device clinical trials by confounding important safety endpoints. Adjudication of clinical events plays a crucial role in ensuring life-improving therapies are developed and brought to market safely, but adjudication programs can be arduous and costly if not managed properly. Today, trial sponsors must be more diligent than ever in their adjudication pursuits while simultaneously grappling with dramatic landscape and procedural shifts caused by the pandemic.

COVID adds complexity to managing clinical event data

An effective adjudication program, regardless of where it is or who is leading it, depends on how clinical event data is managed. However, there is no one-size-fits-all approach. A widely accepted academic or industry standard pertaining to a Clinical Event Committee (CEC) simply doesn’t exist and there is very little regulatory guidance for trial sponsors. Additionally, some event adjudication is still conducted on paper, which in addition to being extremely time-consuming is error-prone and expensive, creating significant resource burdens for organizations.

These challenges often manifest in clinical trials in the form of incomplete source documents or documents containing unredacted patient health information (PHI), putting sponsors at risk for noncompliance with EU GDPR, HIPAA and other privacy regulations. Problems can also arise from delayed reviews by CEC members or poor visibility into the status of event queries or other performance metrics.

The COVID-19 pandemic has exacerbated these challenges by constraining clinical sites, clinical investigators, and trial participants. This disruption has significantly impacted clinical trial operations—interfering with patient enrollment and recruitment, efficient source data collection, protocol adherence and delivery, outcome reporting and regulatory compliance.

Technology paves the way for a new approach

As with many areas of clinical research, innovative new technologies—when combined with deep scientific and medical expertise—can help address these challenges and increase efficiency, data quality and compliance, particularly amid a global pandemic when in-person collaboration and timely problem resolution isn’t always possible.

Compared to paper-based processes and trying to manage complex committee worklists through emails and spreadsheets, web-based adjudication platforms offer many advantages in this new era of remote work. A single, centralized location for everything from source document collection to review, along with AI-enabled redaction capabilities and local translation services, make even the most complex trials manageable from anywhere in the world. Once these benefits are fully realized by trial management teams a return to traditional methods is highly unlikely. Specific advantages enabled by technology that trial sponsors would be wise to embrace moving forward include:

 utilizing a single, centralized cloud-based platform allows adjudication committee members located anywhere around the world to review clinical event dossiers securely and efficiently, in real time. Adjudicators appreciate that no third-party software is required to access the platform—all they need is simple internet access. This can reduce the time to complete event reviews and mitigate risk for delays. Adjudicators also benefit from integrated display of source documents and images, automated committee worklists, the ability to generate queries within the system directly to trial sites and proactive reminders and alerts.

 promotes ease when uploading and redacting required source documents for an adjudication trial. Automatic email reminders when source documents are coming due for upload saves valuable time versus staff having to manually look in a system to see what is due or overdue.

 automatically highlight and redact PHI directly within the platform, and many feature build-in translation and human quality control, lessening the site burden and reducing query issuances for non-compliance.

 enable researchers to electronically manage the complete source document submission and safety endpoint review paradigm which often vary by country or region. This is an important element because trial workflows can be extremely complex and made up of dozens of steps, of which many are highly specific follow-ups.

 offer sponsors and permitted users online access to view, in real-time, the case review status, data receipt and processing, query status and site performance metrics. The sponsor may also be able to schedule and run reports of charter-defined endpoints. These reports can then be used by CRAs, CRCs and site managers to monitor their performance and ensure compliance with the protocol.

 through built-in e-signatures, audit trails, and cloud backups provide security, protection, and audit trail transparency while giving adjudicators ready access to the required information on every clinical event type.

 eliminates any custom programming required to model a custom adjudication process which is traditionally extremely costly for sponsors. The ability to work with sponsors to configure the system based on their unique needs and workflow can be game-changing from a cost and process perspective.

Well-known dissatisfaction with paper and other traditional clinical adjudication processes is unlikely to be tolerated much longer given the availability of these kinds of tools. In today’s world, it is critical that best-in-class, custom research tools are at the fingertips of trial sponsors, CROs and CECs to advance the clinical trial process more effectively than ever before. Performing clinical adjudication via a web-based platform minimizes the risks presented by COVID-19 by alleviating the well-known strain on the various stakeholders, empowering them to finally complete their workflow efficiently, safely, remotely, and securely.

, is the Chief Innovation Officer at Bioclinica

There's no one-size-fits-all approach during the COVID-19 pandemic 

Transforming Clinical Event Adjudication in the Era of COVID-19

Calyx has announced the availability of Calyx RIM v7.0 for its Regulatory Information Management (RIM) system. The RIM v7.0 release represents the first update that uses Microsoft’s cloud-based, Azure native technology.

Among other features, Calyx RIM v7.0 includes analytics through Microsoft’s Power BI, and Azure Files—a scalable architecture that enables fully managed file sharing in the cloud.

Calyx Releases RIM 7.0

In December 2020, more than 230 clinical trial sites, sponsors, and contract research organizations completed Florence Healthcare’s State of Clinical Trial Technology Industry survey

 about how clinical operations technology changed in 2020 and how they expected it to evolve in 2021. As we quickly approach the mid-year mark of 2021, it’s clear that the responses revealed several significant trends that are as impactful and true today as they were at the end of 2020. 

These trends will continue to shape the industry in the future. Sponsors, CROs, sites and technology providers should understand them in order to run safer and more efficient clinical trials—and perhaps even discover more treatments and cures.

Increased use of technology at clinical trial sites

In the survey, 47% of clinical trial sites and 36% of sponsors said they increased their spending on technology in 2020. When asked why they invested more heavily in tech, 64% of sites and 71% of sponsors and CROs said it was because of the need for remote work during the COVID-19 pandemic.

When non-patient-facing personnel began to work remotely, many sponsors and clinical trial sites discovered that essential documents weren’t available online. A handful of employees had to rush to find, scan and upload paper study documents, slowing down trials. In some instances, sites were completely closed and there were significant delays in being able to access critical documents. Given these experiences, it’s not surprising that 87% of sponsors claim they invested in technology to eliminate paper records.

Clinical operations software is used for more than storing study documents. 76% of sponsors said they conducted most of their clinical trial monitoring remotely in 2020, while only 18% of monitoring took place remotely in 2019. Though this dramatic spike was caused by the pandemic, most sponsors, CROs, and clinical trial sites expect the trend to continue. In fact, 83% of sponsors and 80% of sites believe most clinical trial monitoring will be remote by 2023. With remote monitoring becoming more mainstream, choosing a secure, compliant software service or confirming that current services are compliant will be a priority for many sites in the next three years.

Concerns about the use of clinical trial software

Although many clinical trial sites and sponsors had already begun to embrace technology for electronic recordkeeping and remote monitoring before the pandemic, the significant uptick in technology use last year came with its own set of challenges. Some sites had to adopt software quickly to participate in COVID studies or to allow remote work. With less time to evaluate vendors, sites and sponsors risked using software that didn’t integrate well with their existing processes or that didn’t meet all security and compliance regulations. As the COVID-19 pandemic ends, and FDA inspections return to a normal cadence, compliance could quickly become a concern for some organizations.

To ensure compliance in the future, sites and sponsors need to select software providers that can learn about and comply with varied global regulations and protocols. Further, the survey suggests that post-COVID, sponsors and sites will move away from last-minute or emergency software vendors and instead choose vendors that are intimately familiar with life sciences, clinical trials, and FDA, GDPR, and HIPAA regulations.

Close attention to choosing the right clinical trial technology in 2021 and beyond

90% of clinical trial sites in the survey invested in technology to increase their chances of being chosen for a study, as sponsors prefer sites with secure, compliant electronic records. Clinical trial software can save time, minimize mistakes and handoffs, make it easier for sponsors to oversee all of the sites they’re working with, and even encourage patient participation by allowing participants to conduct some study activities remotely.

However, the wrong technology can cost clinical trial sites time and money, result in low user adoption, and limit which workflows can be integrated. In a worst-case scenario, the software may have to be removed and replaced. Therefore, in 2021 and beyond, sites and sponsors will search for software that 1. Is worth the investment, 2. Makes sense to all users in the clinical trial ecosystem (including participants), and 3. Accommodates a variety of workflows.

68% of sites worry about their budget to buy technology, and purchasing the wrong software can make it difficult to convince your team to invest in technology in the future. Software vendors with a site-first mindset can help determine which software features the site needs to support a strong ROI. 

In the future, clinical trial technology will need to focus on proven site and user adoption. 48% of sites worry about integrations when incorporating new software, and 40% have concerns about transitioning to new technology. On the employee side, it helps to choose a software provider who offers thorough training during the implementation stage and excellent customer support afterward. Sites and sponsors will also need to consider participant interactions, choosing software that is user-friendly so that trial participants don’t find electronic processes more overwhelming than paper ones.

In 2021, many clinical trial sites look forward to adding functionality to their electronic Investigator Site File (eISF) platforms. 65% of sponsors and sites surveyed plan to have a purpose-built eISF platform with additional workflows layered on top of it. 47% of those sites want to use electronic consent forms, while 37% want to use technology to manage source data. Clinical trial technology providers will need to offer varied workflows as part of a single software to remain competitive.

Moving forward in the clinical trial technology industry

2020 dramatically changed the landscape for clinical trial technology, with many sponsors and sites rushing to adopt software to support decentralized trial processes with remote monitoring and electronic recordkeeping. In 2021 and beyond, sponsors, CROs, and trial sites will continue to embrace technology but will do so more carefully, considering concerns about compliance, workflow, budget, and adoption. The clinical trial technology industry will need to adjust accordingly and offer well-regulated, versatile, and user-friendly software that CROs, sponsors, and sites can effectively leverage for years to come.

 is the Director of Innovation for Florence Healthcare

https://florencehc.com/downloads/2021-state-of-clinical-trial-technology-industry-report/

Findings from Florence Healthcare’s State of Clinical Trial Technology Industry survey about how clinical operations technology changed in 2020 and how they expected it to evolve throughout this year.

The State of the Clinical Trial Site Technology Industry: Examining Key Trends

Medidata, a Dassault Systèmes company, has announced the launch of Medidata Adjudicate, a clinical endpoint adjudication system, fully integrated with the Medidata Clinical Cloud.

A single solution that follows all clinical events from beginning to final outcome, Medidata Adjudicate is designed to support investigator sites, contract research organizations (CROs), adjudicators, physicians, data managers, Clinical Event Committees (CECs), and sponsors who collect, manage, organize, adjudicate, and submit clinical endpoint data by providing:

Full visibility into all trial events and status; real-time visibility is critical to ensure clinical events are moving through the adjudication process efficiently, and that sponsors and CROs have real time access to events

Flexible reporting that allows users to monitor turnaround times and performance

Self-service configuration that allows customers to perform their own trial builds.

Medidata Launches Clinical Endpoint Adjudication System

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

There is some powerful support for personalized and precision medicine in the 'Porto declaration on cancer research' that was opened for signature on May 3

 in the Portuguese city famed for its more traditional approaches to a sensation of well-being. The occasion was the EU Cancer Research Summit, where the accent was on developing a network of well-distributed and interconnected high-quality infrastructures for translational research, clinical and prevention trials, and outcomes research.

In particular, it recommends action across three specific areas of research: translational, clinical, and outcomes. European-wide deployment of high-quality infrastructure could achieve a 10-year cancer-specific survival for 75% of patients diagnosed in EU member states by 2030—a literally vital contribution in the face of an expected increase of cases in EU from the current 3.5 million to more than 4.3 million by 2035.

With successful proof of principle clinical/prevention trials, translation will continue by means of clinical research to achieve effective healthcare system implementation, at the same time reducing the timespan from scientific discovery to patient benefit, says the declaration. But complex and advanced infrastructures are required to make the bridge to healthcare from basic/preclinical research and clinical and prevention research, building on inventions and innovations from basic/preclinical research to directly impact therapeutic and prevention research. The use of molecular and digital pathology for stratifying patients for systemic treatment with anticancer agents is increasing and liquid biopsies are being implemented as a complementary diagnostic/monitoring tool, and infrastructure support is also increasing in complexity for radiation and surgical therapy, imaging, and immunotherapy. But consortia of advanced cancer care centres are required to make the necessary links.

Infrastructures for clinical and prevention trials can take 'proof-of-concept’ studies as a starting point for further clinical and prevention research, with a practice-changing aim, including the assessment of its utility in healthcare or prevention, patients and individuals at risk, cure and survival, and health-related quality of life. But it will require well-developed clinical trial structures, and advanced diagnostic methods such as state-of-the-art molecular pathology, omics technologies, and pharmacology, as well as innovative imaging, to stratify patients are crucial.

Prevention will depend on infrastructures that include strong epidemiology closely connected to basic research, data acquisition capacity, and advanced computational capabilities, Appropriate funding mechanisms are needed to stimulate these activities and guarantee sustainability, including for proof-of-concept trials initiated by academic investigators, says the declaration.

Infrastructures for outcomes research will make it possible to deliver on the assessment of clinical utility, cost-effectiveness, accessibility, sustainability, and prioritization. Outcomes research in therapeutics must address all aspects of the clinical pathway, including treatment optimization, side effects of treatments, long-term follow-up with assessment of health-related quality of life, rehabilitation, and survivorship, as well as attention to social and economic aspects, and should be a collaborative effort between clinicians, researchers, and epidemiologists.

"Precision oncology isn't only about what is new. It's also about making better use of what we already have," Denis Lacombe, director general of the European Organisation for Research into and Treatment of Cancer, told the Porto conference to launch the declaration. He cited EORTC's SPECTA infrastructure for access to personalized medicine clinical research programs as an example of a successful quality assured clinical trial’s structure, arguing in favour of harmonisation of technical requirements to support multinational collaborations in next-generation clinical trials. "Current regulatory and research approaches leave many areas of treatment knowledge under addressed," he said, pointing to issues of dosage, sequence, combination, or possibilities of de-escalation.

He insisted that society will have to develop the means to generate datasets aiming at documenting the optimal treatment for cancer patients though the integration of clinical research, free of commercial interest in the process of access to treatments, and to inform healthcare systems. This means that for optimized treatments in healthcare, society must re-engineer new models of partnership between commercial and non-commercial research in the continuum of clinical science, regulatory science, and into health technology assessment. Public health priorities will need to command upstream research, to focus innovation where needed, and avoid multiplication of redundant agents of the same class.

While the needs were great, not everything needed creating de novo, he argued, "Europe should build on existing solutions and infrastructures which deliver, optimizing competences and avoiding duplication."

The EU Cancer Research Summit sparked powerful support for personalized and precision medicine across three specific areas of research: translational, clinical, and outcomes.

Exploiting Research Infrastructures for Personalized Medicine in Europe

AIXIAL has announced the acquisition of UK headquartered CMED Group by ALTEN EUROPE. CMED is a technology led CRO that specializes in full-service oncology, immuno-oncology, cell therapy and rare diseases, and provision of data and analytic services. CMED also has a technology division that is the developer of encapsia, a clinical data suite purpose designed to support traditional, decentral, virtual and hybrid clinical trials.

AIXIAL Group continues to build a global presence in size and scale with over 1,000 employees across the United States and Europe.

CMED Group joins AIXIAL

Industry has learned through experience that electronic technology to collect clinical outcome assessments (eCOAs) can enhance the patient experience, increase site satisfaction, facilitate regulatory compliance, gather more reliable data, and save time in the process.

 Further, regulators are encouraging electronic instead of paper-based data collection.

To derive the greatest benefits from this technology, several crucial elements must work together to create a strong foundation for sponsor success:

Involve all key stakeholders in the early stages

Carefully consider data NEEDS versus “nice-to-haves”

Take advantage of your solution provider’s experience

Rely on configurable platforms not customized solutions

The first two elements will be addressed in this article and the last four elements in Thoughtful Design in eCOA Development: Part 2.

Involve all key stakeholders from the start

It cannot be emphasized enough how important it is to include all your key stakeholders in the earliest stages of designing and implementing eCOA solutions for a clinical trial. This includes, but may not be limited to, your solution provider, study team, medical advisors, data management, and biostatistics. From the start, it is important for your stakeholders to collaborate and come to agreement on how eCOA technology will be used to achieve protocol objectives. This stakeholder engagement ensures everyone is clear about the scope, measurement modalities, the eCOA data being collected, start and end timelines, milestones, and how to minimize risks.

Team members who join the development team late in the process may attempt to change functionality or design after timelines and budgets are set, creating disagreements and delays through the design, development, and validation process.

Last minute changes during user acceptance testing (UAT) can negatively impact the timeline because of revised scope and increase the costs.

These changes can also increase risk as they were not incorporated into initial design and testing scenarios.

Benefits of early and inclusive collaboration

The team can make design and implementation decisions based on collective knowledge and experience to create a better user experience for patients, sites, and sponsors.

Ensures stakeholders are aware of key decisions and how those decisions will impact the study throughout its lifecycle.

Ensures the eCOA technology, data collection specifications, data transfer requirements, and data reconciliation processes can be supported by your organization’s procedures, systems, and data collection platforms.

Although it may take more time and resources at the start of the study to work collaboratively with all the stakeholders, the benefits of a well-defined and reliable eCOA solution may far outweigh that additional time upfront and, ultimately, save you time and resources throughout the life of that study.

Just because we CAN capture a specific piece of data through eCOA does not always mean we should. Our natural interest as scientists is to explore as many research questions as possible. The result of this curiosity has led to trials with numerous endpoints, many of which are collected, not as primary or secondary, but rather to answer exploratory questions. Further, the temptation with a convenient technology that presents new ways to interact with sites and patients is to use it to capture as much data as possible for multiple purposes. Instead, we recommend the following:

Collect data at only those necessary timepoints

Limit the time required for data collection at any given timepoint

Requiring patients to complete lengthy questionnaires at multiple timepoints can be an unreasonable burden and may negatively impact engagement, compliance, and retention. A more successful strategy is to resist the temptation to include too many endpoints and collect only those data needed to answer the most important research questions.

NOTE: Thoughtful Design in eCOA Development: Part 1 addresses two elements necessary in 

that helps sponsors derive the greatest benefits from eCOA technology. Thoughtful Design in eCOA Development: Part 2 will address implementing best practices in design, taking advantage of your solution provider’s experience, relying on configurable platforms not customized solutions, and focusing on user experience (UX).

Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ, 2002;324(7347):1193-1194.

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Ganser AL, Raymond SA, Pearson JD. Data Quality and Power in Clinical Trials: A Comparison of ePRO and paper in a randomized clinical trial. In: Byrom B, Tiplady B, eds. ePRO: Electronic Solutions for Patient-Reported Data. Surrey, England: Gower; 2010:49.

Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W. Capturing patient-reported outcome (PRO) data electronically: the past, present, and promise of ePRO measurement in clinical trials. Patient, 2015;8(4):301-309.

U.S. Food and Drug Administration. Guidance for industry—Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. Available from 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims

U.S. Food and Drug Administration. Guidance for industry: electronic source data in clinical investigations. September 2013. Available from 

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf

Critical Path Institute ePRO Consortium. Best Practices for Electronic Implementation of Patient-Reported Outcome Response Scale Options. Available from 

https://c-path.org/wp-content/uploads/2014/05/BestPracticesForElectronicImplementationOfPROResponseScaleOptions.pdf

Critical Path institute ePRO Consortium. Best Practices for Migrating Existing Patient-Reported Outcome Instruments to a New Data Collection Mode. Available from: 

https://c-path.org//wp-content/uploads/2014/05/BestPracticesForMigratingExistingPROInstrumentstoaNewDataCollectionMode.pdf

To derive the greatest benefits from eCOA technology, several elements must work together to create a strong foundation for sponsor success.

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Applied Clinical Trials April 2021