Activity in the eConsent sector has risen considerably during the past six months, with Medidata’s acquisition of electronic informed consent pioneer Mytrus and the entry of new market players, even though widespread industry adoption of the technology has appeared to have stalled.

Last month, WIRB-Copernicus Group (WCG) announced its acquisition of Patient Genesis’ ConsentNow eConsent technology and in April Quorum Review IRB released a new tool developed in-house called Q Consent, which integrates electronic consent with its IRB process. CRO and clinical trials software company Target Health recently added eConsent to its software offerings and CRF Health launched an updated version of its TrialConsent platform that can be integrated with existing eCOA solutions. In addition to Medidata’s acquisition of Mytrus earlier this year, last November technology company DrugDev, which was recently acquired by QuintilesIMS, bought a leading eConsent tool called SecureConsent.

Recent surveys, including a new CenterWatch poll of patient attitudes about clinical trial participation, show growing acceptance and plans for greater use of eConsent technology, which holds the promise of offering better patient comprehension of clinical trial protocols through use of interactive elements and the ability to reduce protocol deviations by automatically catching errors common to the informed consent process.

While significant barriers remain, the new investments and growing interest in the technology suggest eConsent adoption rates are at an inflection point with higher expected growth going forward. Tom Favillo, president and chief operating officer of Quorum Review IRB, predicts eConsent use in global studies will increase from its current level of 3% to 5% of global studies to at least 20% within the next three years. In a 2017 CRF Health State of eConsent report, which surveyed 146 professionals from sponsor companies, CROs and IRBs, one-fourth of respondents believe eConsent will be used in more than 75% of their organizations trials three years from now.

“Everyone feels that it may not have happened yet, but there is going to be an uptake and explosion of the use of this technology at some point in the future,” said Lindsay McNair, M.D., chief medical officer, WCG.

Slow adoption curve

Many clinical trial processes, including electronic data capture (EDC) and electronic reported outcomes/electronic clinical outcome assessments (ePRO/eCOA), have shifted to digital technologies during the past two decades. Yet the informed consent process largely remains paper-based. Given the increasing complexity of clinical studies and inefficiencies in the traditional processes, proponents of eConsent believe electronic consent tools, which could use interactive multimedia components, could improve patient understanding of the protocol, study efficiency and protocol compliance.

Yet the adoption curve has been slow. While there was a flurry of activity three or four years ago as major pharma companies began pilot projects with eConsent, widespread uptake of the technology in the marketplace has taken longer than originally anticipated. More than half of respondents surveyed by CRF Health this year reported eConsent has not been used in their organization and only 7% reported eConsent-use for nine or more studies. A joint study conducted in 2016 by the Drug Information Association (DIA) and the Tufts Center for the Study of Drug Development (CSDD) found that eConsent wasn’t among the top patient-centricity initiatives implemented at the 22 companies studied. In addition, very few sites have had experience with the tool. DrugDev’s 2016 site survey found only 27% of global sites have used eConsent.

“Early adopters are now thinking about how they could take eConsent into broader use. But still, mainstream pharma has not started to pilot programs,” said Rauha Tulkki-Wilke, vice president, Product and Service Management, CRF Health. “There are very few companies that are using eConsent in 100% of their studies today.”

One of the greatest challenges to  the adoption of eConsent has been convincing sponsor companies that it offers significant enough benefit to outweigh the additional burden and expense of implementing the new technology. It’s hard for senior managers to justify the high upfront costs, additional training and extended study start-up timelines required when the benefits, at least so far, have largely been incremental.

The 2017 CRF Health study of clinical research professionals representing 100 biotechnology, pharmaceutical, CRO and IRB organizations found that the perceived high cost and uncertain return on investment (ROI) have prevented many companies from becoming early adopters of eConsent. The study suggested that due to a lack of robust evidence, many respondents didn’t believe the ROI claims made about eConsent and that more evidence and education was needed to prove the true value of technology.

Since the technology is relatively new, research studies that reported improved patient comprehension in clinical trials that employ eConsent typically have had small sample sizes or have showed only limited improvement over paper consent processes. In a 2013 meta-analysis of clinical trials that included interventions for informed consent, researchers found that use of multimedia in the informed consent form didn’t necessarily improve comprehension since traditional paper informed consents have been generally effective in this area.

Demonstrating the ROI of eConsent has also been difficult because the true costs of paper processes are often not well-known. While eConsent could save monitoring time, since documents are managed electronically, and there are potential savings if the tool can reduce protocol deviations, those types of benefits are difficult to quantify. Similarly, better patient comprehension of study requirements could help reduce participant drop-out rates, which could have a significant impact on study cost and data quality, but the cost associated with that outcome would be difficult to measure.

“You are going to have more of a qualitative ROI than a quantitative ROI for eConsent, at least initially,” said Cassandra Smith, associate director, Investigator & Patient Engagement at Janssen Research & Development and a leader within the TransCelerate eConsent Initiative. “You may have a reduction in audit findings around missing pages in the informed consent or using the wrong version of a consent document. But they are more qualitative measures as opposed to hard-core cost measures.”

Another major barrier to faster adoption has been the global regulatory environment.

In December, the FDA issued guidance on the use of eConsent in clinical research that addressed many of the compliance concerns raised by industry and was generally seen as promoting the advancement of eConsent in clinical trials. Uncertainty remains, however, about shifting regulations internationally, especially in Europe, related to the validity of electronic signatures, use of mobile health applications and the security of cloud-based technology. Countries have different standards for privacy, data storage and the ethics requirements around consent.

“The biggest organizational resistance factors are mostly centered around compliance concerns and security and privacy concerns, said said Mitchell Parrish, vice president of legal and regulatory affairs at Kinetiq, the technology and consulting division of Quorum Review IRB, and Quorum’s general counsel.

eConsent adoption has also been stalled within sponsor companies due to organizational challenges. Multiple business units within CROs or sponsors may want to pursue eConsent technology, such as the clinical operations group, procurement, the legal team or an innovations department, but often there isn’t one individual or group leading the effort, which increases the difficulty in terms of adoption. Internal teams generally don’t know who needs to be included in discussions about the decision to adopt eConsent or its potential impact on operations. In addition, since eConsent tools capture patient privacy information, additional audits and legal reviews are needed within an organization before its use in a study.

“We’re in an interesting environment for pharmaceutical companies today. They’ve gone through a lot of consolidation in the past few years and that always makes it harder for them to move to new tools,” said Quorum Review’s Favillo. “We have people who are very excited about looking at the tool and sharing it with others in their company. But it’s hard for even them to identify who within their company has been identified as the person who could say yes.”

Many sponsors also are reluctant to add another technology platform into site study management, along with the training and process adaptations that involves, when investigators already report feeling overwhelmed by a myriad of different technologies that aren’t integrated.

“Companies are worried about introducing different technologies to sites at the same time they are introducing electronic patient reported outcomes and other types of technology. They may feel that one more technology is just too much to add,” said WCG’s McNair.

Some investigators also have expressed concerns that their patients, particularly those who are elderly, would feel more comfortable with a paper consent form than one on a mobile device.

“Even though everyone is more technology-literate now, the older population may or may not feel comfortable with the process. It is totally different than signing for a credit card purchase on a device and getting a receipt,” said Phillip D. Toth, M.D., president, CEO and owner of Midwest Institute for Clinical Research in Indianapolis, Indiana. “eConsent is more of a benefit for the industry. It helps industry check off another box to track compliance of the site, but this does not put the patient’s needs first. The patient should be the main focus of the consent process.”

Adoption rates advancing

eConsent vendors report beginning to see a shift in market opportunities with new customers requesting product demonstrations and exploring the possibility of using eConsent in studies both in the U.S. and abroad. In particular, Eric Delente, president, Patient Solutions, DrugDev, a QuintilesIMS Company, reported an uptick in interest from companies in Asia Pacific and the EU and said many of DrugDev’s demonstration requests are from clinical operations groups and upper management looking for enterprise kinds of solutions in contrast to teams that previously looked to pilot the technology on smaller projects. Medidata has also seen an increase in sponsor companies that have already piloted eConsent solutions beginning to more aggressively expand its use across their portfolios.

“We have several top 10 pharma clients that are saying they want to do 100 to 200 studies in eConsent next year. Three or four years out, they want to be doing everything with eConsent,” said Anthony Costello, vice president, Mobile Health, Medidata Solutions, and former chief executive officer of Mytrus.

In addition, while a few major CROs have either acquired or built their own eConsent products, others have already identified eConsent partners or are running processes to choose them.

Recent studies indicate eConsent use in clinical trials has earned greater acceptance from organizations, investigative sites and patients.

A series of surveys conducted by Quorum show the likelihood of organizational resistance to eConsent adoption has dropped over the past 18 months from 60% to 38% at sponsor companies, CROs, institutions and sites. The surveys also found that the willingness of respondents, which included senior level executives from sponsors and CROs, to recommend and advocate for eConsent remained at high levels over the span of a year.

In CRF Health’s 2017 eConsent survey, a total of 45% of respondents estimated eConsent would be used on at least 20% of their companies’ studies within two years. In addition, the DIA-Tufts joint study found that eConsent was the top patient-centric initiative planned among half of the companies surveyed.

Studies also show many investigators believe eConsent could benefit site operations. DrugDev’s 2016 global site survey, which queried 418 sites worldwide on site-facing technology adoption, found that at least 50% agreed that eConsent would decrease site burden and be easier to use than a paper version by offering improved version control, a better dialogue with patients and better patient comprehension. In a follow-up survey to CRF Health’s 2017 eConsent survey, where 105 site staff members were asked about their opinions about the consent process, almost two-thirds of respondents thought eConsent would allow them to consent more participants into a trial.

Similarly, a 2017 CenterWatch survey of patient attitudes about clinical trial participation found that respondents indicated a preference for using an electronic informed consent process and a significant majority found eConsent tools user-friendly and helpful in understanding their involvement in clinical trial participation. The results are consistent with those captured in other studies on patient attitudes and satisfaction rates. Results of a multi-country pilot study of eConsent technology released last year by Janssen R&D, for example, found 69% of sites reported eConsent was a helpful tool for improving patient engagement during the consenting process and 38% said that it improved patients’ desire to enroll or stay on the trial.

“It’s early days for eConsent, but we are witnessing rapid change right now,” said CRF Health’s Tulkki-Wilke.

TransCelerate BioPharma’s eConsent Initiative, which has researched and documented best practices and global regulatory attitudes about eConsent use, is also expected to help drive more rapid adoption and create a common approach for electronic consenting of patients globally. In October, the organization will release its TransCelerate eConsent Implementation Guidance and Toolkit, which was created in collaboration with key stakeholder groups, to outline what sponsor companies should consider as they develop and operationalize eConsent strategies within their organizations, such as the need to measure key performance indicators or certain metrics that will help the value statements.

“The materials we have created are going to be helpful for companies to start the discussion about implementation of eConsent and give them some ways in which eConsent may be positioned and actually rolled out within a company,” said Janssen R&D’s Smith. “Each of the member companies are at different stages and phases of adoption and implementation within their companies. By coming together under TransCelerate, we can move the needle a lot faster and try to get some traction and some leverage in the industry.”

The eConsent Initiative also conducted a global survey to collect information from sponsors, CROs and eConsent vendors about their experience conducting global pilot programs with eConsent and determine where eConsent already has been submitted to IRBs or ethics committees. The data will be used to inform internal discussions at member companies about study planning. In addition, Medidata and other firms that offer electronic consent have approached international regulators to learn about their concerns with eConsent technology, how they can be addressed and whether some type of product development could help improve the chances of regulatory approval.

DrugDev’s Delente said adoption rates could also accelerate going forward as some of the larger, longer studies where eConsent tools are being deployed will be completed in the next 10 to 12 months and could potentially provide more tangible results to support the benefits of eConsent.

“These are two- or three-year-long studies and that’s when we are going to start to see the actual data come back about whether these studies seem to have better retention rates. We will start to see a larger number of patients who were consented electronically and see if there are meaningful results,” said Delente.

Costs will also start to come down as companies that have piloted eConsent begin to scale the technology across their portfolio. Product prices have begun to drop as new market entrants have developed more integrated, streamlined offerings for lower costs and other companies have built tools that allow sponsors and CROs to manage their own eConsent processes without vendor involvement.

“Although cost is not the main barrier for adoption, as deployments get larger the price per consent will come down,” said DrugDev’s Delente. “Another aspect will be moving toward more of a self-service model. Now the electronic informed consent process involves the whole authoring, quality control and review process that happens for paper documents. That number of steps is repeated when we digitize that paper document. Moving toward a process where everything happens within the system adds a lot of benefit. Lower cost, broader adoption and increased benefit are the key factors that are broadening adoption.”

Strategic advantages of acquisitions

Many companies are positioning themselves to take advantage of the market as eConsent starts to take hold by integrating their solutions into existing technologies that many sponsors and CROs already use within clinical trials, such as cCOA platforms or clinical trial management (CTMS) systems, which can help advance adoption of the technology and reduce burdens that would result with the use of a separate system.

“I think in the next five or six years it will become a normal process. Why would you ever do informed consent on paper when you can do it electronically? It just needs to have that transformational change where people get over not understanding it and realize that it’s just as easy, if not easier, than paper and so much better,” said DrugDev’s Delente.

Medidata has been investing heavily in patient engagement tools during the past few years and acquired Mytrus to strengthen its patient cloud platform, which includes a patient reported outcomes (ePRO) mobile app along with capabilities to gather patient data from wearables and biosensors. The Mytrus acquisition was part of Medidata’s strategic vision to build an industry-leading cloud platform that unifies the many different products needed to support a clinical trial. Integrating Mytrus’ Enroll into its clinical cloud platform, for example, could allow sites to use one platform to electronically consent a patient and then have that patient automatically created and randomized within the EDC system.

“We are seeing more and more customers looking for an integrated platform. Some large companies want to choose best-of-breed providers, but there is more of a trend toward the larger, fully enabled platforms over the last year-and-a-half or two years,” said Medidata’s Costello. “The vendor landscape is changing fast. As we move into the world of apps being built like crazy and wearable devices coming onto the market by the dozens every year, the idea that sponsors are going to be able to pick best-of-breed vendors and best-of-breed apps is not as tenable as it used to be.”

For Quorum Review’s IRB-integrated eConsent tool, sites can use the same portal to submit IRB documents and manage the electronic informed consent. Quorum’s product also allows organizations to use existing consent forms and processes, which avoids the need for companies to form new teams or processes to use eConsent technology, and can turn an approved paper consent document into an electronic version within about 72 hours. Quorum has also begun working with other parties to integrate its eConsent documents with CTMS systems.

Similarly, DrugDev integrated its eConsent tool into a suite of technologies that support site operations, including site selection and startup, investigator payments and clinical operations. The new version of CRF Health’s eConsent platform can be fully integrated with an existing eCOA solution or delivered as a stand-alone product, and Target Health added its electronic informed consent product to its software system, which allows management of direct data entry capture, risk-based monitoring, randomization, drug supply management, serious adverse events management and reports monitoring at one website.

While eConsent is expected to become a key aspect of clinical research going forward, the technology won’t be isolated to the informed consent process. Demand for eConsent solutions in biosampling, both as part of clinical trials or for samples donated directly to biobanks, has risen sharply. With DrugDev’s technology, the consent form and sample kit used for a biosample can be identified by scanning a barcode or RFID code. Some providers, such as Patient Genesis, which has become part of WCG, have focused efforts on both sponsor companies and healthcare organizations, hospitals, surgi-centers and medical practices that perform procedures requiring consent.

“There are fantastic opportunities for use in clinical care. Procedure consents would work beautifully in electronic format,” said WCG’s McNair. “For a patient who needed a liver biopsy, for example, instead of the doctor handing them a paper form, the patient could be given a tablet with a five-minute video on it about what it was like to have a liver biopsy and what could be expected from the procedure. That would be tremendously more helpful to patients, more informative and better prepare them for what they will be going through than somebody giving them a quick explanation and a piece of paper to sign. Maybe as institutions start to move in that direction, it could help to push the research field in that direction as well.”

Looking ahead

Most organizations have eConsent on their strategic agenda and expect it will eventually become a key capability in clinical trials. While there are signs that the marketplace has reached a turning point, as activity has begun to pick up in recent months, actual adoption rates may grow at a slow pace until the industry sees greater consistency in global regulatory support for the technology and organizations can be convinced that the cost of implementing eConsent will outweigh the benefits.

“Informed consent is such an important part of a clinical trial. It’s very heavily regulated and very strictly audited,” said CRF Health’s Tulkki-Wilke. “Every sponsor wants to make sure that it’s done correctly. It’s a big step for them to reach the level of confidence where they can utilize an eConsent solution and can be confident that the eConsent process is done correctly. It would be easier if it was a less crucial step in the process. But it’s a very critical step. You need to get that right.” 

 

Karyn Korieth has been covering the clinical trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master of Science degree from the Columbia University Graduate School of Journalism. Email karyn.korieth@centerwatch.com.

This article was reprinted from Volume 24, Issue 09, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>