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Sites smothered by technology solutions

Sunday, May 1, 2016

Technology solutions help sponsors and CROs make better drug development decisions, streamline processes and reduce clinical trial costs. But for a majority of investigative sites, these same technologies get in the way of efficient operations and add to their already heavy workload.

CenterWatch analysis suggests that investigative sites are inundated with a growing number of technologies that rarely interact with each other. Only 9% of global investigative sites surveyed report that technology solutions provided by sponsors and CROs to conduct clinical studies meet their operating needs “very well.”

“In simple terms, the software wasn’t designed for us,” said Michael Koren, M.D., CEO of the Florida-based Jacksonville Center for Clinical Research and one of its principal investigators. “Software that would actually look at our workflow and respond to our needs would be useful. But in virtually every product I’ve seen, the investigator is an afterthought and not central to the design. The software isn’t focused on the way that physicians, coordinators and clinicians work. There is nothing about it that is investigator-friendly.”

In the CenterWatch analysis and interviews, investigators said technology systems provided by sponsors and CROs for clinical trials create duplicative work, since information from patient visits or laboratory tests must be transcribed from paper or electronic sources manually into study software. Sites also are responsible for a growing number of technologies that study volunteers are asked to use, such as electronic diaries and wearable devices. In addition, the proliferation of technologies requires sites to interact with a greater number of third-party vendors and complete burdensome training requirements.

Sites are adapting to the complex technology needs of sponsors and CROs at a time when industry leaders widely recognize the need to ease burdens on investigators conducting clinical trials, particularly as investigator turnover rates have been getting progressively worse. The CenterWatch study offers insights into the challenges investigators experience managing multiple software systems and provides opportunities to improve site involvement with technology moving forward.

“We have to change our processes to allow physicians to be successful in research,” said Jeff Kingsley, D.O., CEO of IACT Health, an integrated clinical research site network with nine locations in the Southeast. “We need to remove unnecessary burdens so there is a greater likelihood that doctors can become highly competent, experienced investigators.”
Incompatible technology overload

CenterWatch asked 252 global investigative sites about their technology use in a 2016 survey conducted online between January and March in collaboration with the Association of Clinical Research Professionals (ACRP).

Investigators reported that sponsors and CROs overload their sites with a wide array of technologies that typically don’t communicate with each other. Overall, sites used about 10 different software applications to manage clinical studies in 2015. Almost half (46%) of investigators said they believe sponsors and CROs require them to manage too many separate technologies.

“I am a proponent of these technologies. But the difficulty is the need to use so many different systems, which are hard to keep track of and don’t talk to each other,” said Jeremy Rigby, executive director of Advanced Clinical Research, which has locations in Utah and Idaho. “All of these systems work differently, have different login credentials and require training.”

The study found that the two systems most frequently used by respondents were electronic data capture (EDC) and electronic case report form (eCRF), which are both mature technologies used at more than 80% of investigative sites. This finding is consistent with other recent studies that show electronic data collection technologies have been widely adopted across the industry and are accepted as standard practice in a significant majority of phase III trials.

More than half of respondents also used interactive voice or web response systems, (IVRS/IWRS), clinical web portals, safety and adverse event reporting technology, clinical trial management system (CTMS) and electronic patient reported outcome (ePRO) systems. Other technologies employed less often include learning management system (LMS), electronic trial master file (eTMF), eSource and ePRO platforms that use a patient’s own smartphone or tablet. In addition, some sites are beginning to manage new electronic tools that study volunteers take home, including wearable devices and drug adherence sensors.

About a fourth (23%) of respondents said the various technology solutions available today are not meeting site operation needs and the rise in the number of eClinical technologies has created inefficiencies and productivity challenges for their sites.

“What used to be simple is now more complicated and for no good reason. It’s all in the name of using electronics,” said Richard Litov, Ph.D., director of Pedia Research, which has locations in Kentucky and Indiana. “CROs and sponsors are making our work more complicated, less efficient and more frustrating.”

Significantly, even though EDC was introduced more than a decade ago, investigators and study coordinators continue to record patient study-visit information on paper and then re-enter the source data into EDC and other electronic systems. Patient information stored in the site’s own clinical trials management system (CTMS) or electronic medical record (EMR) software is typically printed out and manually transcribed into clinical trial software systems. Since the various systems seldom have the ability to integrate, patient data often must be entered into several different electronic systems—such as EDC, IVRS/IWRS, ePRO or an investigator portal—for the same study.

“It’s surprising that better information and technology hasn’t been applied to clinical research sites,” said Koren. “We are so sophisticated in some ways, but we are still basically writing things down before we put them in the computer. Why?”

Similarly, electronic systems can complicate procedures for reviewing and signing-off on laboratory reports. Laboratory reports are sent to investigators for review either by fax, which requires sites to maintain fax machines and traditional landlines, or through internet portals. In either case, site staff typically need to manually enter information from the reports, along with evidence that they have been reviewed by the investigator, into EDC or other study software systems. Study coordinators also report that electronic systems require continual monitoring in order to locate copies of new laboratory reports, such as results from electrocardiogram (ECG) tests.

“When we have to get ECG reports for a study, the ECG system doesn’t communicate with us via email to let us know there is a new report,” said Krissy Stewart, a study coordinator at Pedia Research. “We have to constantly log in to the system to see if they have the report. We are supposed to sign off on these ECGs within a week, but it’s hard to keep up when you have 12 subjects and you need to get a new report for each one.”

Further, investigators have indicated the need to transcribe source documents and patient information into various electronic mediums duplicates effort and increases the chance of transcription errors.

“I can say categorically that the electronic case report form is much more work than the paper one,” said Phillip Toth, M.D., president, CEO and owner of Midwest Institute for Clinical Research, a dedicated clinical trials site in Indianapolis, Indiana. “But that is from the site’s perspective. From the sponsor’s perspective, they love it because they immediately begin to crunch numbers, see trends and get their data faster. We are not going to be able to go backward. So we just have to live with it. It’s the way of life.”

David Morin, M.D., director of clinical research at Tennessee-based Holston Medical Group, added, “We still live in a paper world, by and large, and I don’t think that will change any time soon in research.”

Top challenges: Passwords and training

Each sponsor or CRO chooses what technology systems will be used for a particular study, which means that investigative sites must manage software from multiple vendors in each technology category. Even in the EDC space, which has consolidated during the past 10 years, some investigative sites report to using up to 10 different EDC platforms.

“If you want to conduct clinical trials, this is what you’ve got to do,” said Toth, whose site conducts about 20 studies at a time. “You don’t have a choice. It’s not a matter of companies asking our opinions about how to make things better.  Nobody does that. They use whatever system they choose and we just have to follow.”

These numerous technology systems and internet portals each require a unique username and password, which typically must be changed every three months for security reasons. Nearly three-fourths (74%) of study respondents identified keeping track of multiple usernames and passwords as a top technology challenge. High-volume sites routinely maintain login information for at least 40 or 50 systems. Each site creates its own method for managing passwords; some record them in notebooks, while others use password-protected software. Some large sites have dedicated staff resources to oversee lists of study passwords and change them when needed.

“I can understand that you need portals for drug accountability, subject data and labs or ECGs. But there should be a way they could be combined so it minimizes how many times I have to log in to something. There are many different logins needed just to get a full idea of a patient visit,” said Brandy Paul, a study coordinator at Pedia Research.

The increase in eClinical technologies also requires investigators to work with more vendors than in the past, which adds complexity and inefficiency to site operations. Several investigators told CenterWatch that they routinely receive email messages about critical study requirements from unknown third-party vendors that fail to mention the name of the study or the company they are referencing. One investigator reported receiving an email from an unfamiliar vendor about the need to log in to an investigator portal for information about safety reports; the message ended up in a spam folder and the investigator never saw the report. A sponsor audit was triggered, which found the vendor at fault.

IACT Health’s Kingsley said his company has conducted trials where the site had to ask the sponsor for a budget re-negotiation because the vendors picked for various technologies were difficult to work with, had cumbersome interfaces or recorded data incorrectly.

“We have done trials where running the protocol wasn’t the hard part. Managing all of the vendors or dealing with bad vendors was the big barrier,” said Kingsley, whose network conducts 130 active trials a year across its nine sites. “We have spent a tremendous number of human hours behind the scene to try and fix vendor errors.”

Investigators also expressed frustration over technology training requirements. A total of 39% of respondents indicated that too much training for technologies was required. In addition, 95% of respondents said training across protocols was repetitive since sponsor companies and CROs typically don’t accept prior training on a particular system. For some widely used software systems, such as Medidata’s Rave, investigators report they might be required to repeat the same training up to 12 times a year.

Sites indicated the technologies with the most extensive training requirements include eSource, ePRO, eCRF and EDC; systems that require lower levels of training include IVRT/IWRT, adverse event reporting software and investigator web portals.

“Training is hugely burdensome. Today, almost no one will accept prior training,” said Kinglsey. “It’s a waste in our industry. It’s wasting our time and it’s increasing the cost of research for no good benefit.”

Low marks for ePRO reliability

Investigative sites gave the most established technologies, including EDC and IVRS, the highest ratings for meeting their technology needs. Medidata and Oracle were the top-mentioned EDC vendors for overall quality and ease of use, with 45% of sites rating both company’s EDC systems as “very reliable.” Investigators ranked IVRS/IWRS systems, which are typically used to register and randomize patients, as the most reliable and easiest to use technology in terms of performing its intended function.

“The IVRS is always easier than other systems because there is less you have to do. You have a site number, a user number and a password, so there is not much interaction with it,” said Toth. “The electronic case report forms can be daunting. Even though the system might be easy to navigate, the sponsor may insert extra sets of questions and drop-down boxes that can complicate your life.”

ePRO technologies, which include electronic patient diaries, received among the lowest marks for reliability. Only 15% of sites said ePRO technology was “very reliable.” In interviews, sites reported particular problems with ePRO when they are given outdated hardware or software; some sponsors, for example, still use PalmPilot handheld devices first adapted about 20 years ago for patient diaries. With older technologies, the hardware and software itself can be slow, which means it takes longer for study coordinators to register a new account for patients. Site staff members also must teach patients how to use unfamiliar devices and resolve problems.

Even when sites are given newer smartphones or tablets for recording patient-reported outcomes, study coordinators need to troubleshoot and manage systems when the devices don’t work properly or there are data collection problems. In the CenterWatch survey, about a quarter of investigators gave ePRO technologies low marks for the quality of help desks.

“Overall, there are a lot of benefits to technologies. Of course it doesn’t come without its inconvenience and hassles,” said Rigby. “But I think the industry is moving in the right direction in that regard. The systems are becoming more and more intuitive, easier to use and more robust. Where we usually run into the most problems is when we are stuck using old technologies that are cumbersome and don’t work well.”

Investigative sites also need to dedicate space for storing ePRO devices. For each trial, sponsors send their own tablets, smartphones and other devices, along with docking stations and cords, for patients to record diary information. Sites often set aside separate rooms to store the boxes of ePRO devices they must keep track of for their clinical studies.

“We have to put codes on them because there might be three different vendors on three different trials that use the same device. I have to make sure that I don’t accidently send one vendor’s device to a different vendor,” said Kingsley.

Addressing site technology needs

As many of the eClinical solution providers continue to develop point-based solutions that overwhelm sites, the CenterWatch analysis suggests that organizations need to re-think their top-down approach to technology adoption and take the needs of investigative sites into account. In particular, investigators would like technology systems that are interoperable and understand their workflow. More than a quarter (28%) of study respondents indicated that the industry should adopt a common technology platform. Sites also want sponsors and CROs to reduce redundant training requirements.

“A big problem is that CROs and the sponsors do not talk to the sites and get input from them about how to create a system or communicate better. They are one-sided about how do it and then require everybody to do it their way. That is not very efficient,” said Pedia Research’s Litov.

A few of the larger EDC vendors have begun to integrate technologies, including randomization, supply management or adverse event reporting capabilities, into their systems. As the eClinical space continues to consolidate with large companies buying smaller vendors, the industry could see more integration of systems in the future. Medidata, for example, just acquired medical imaging sharing company Intelemage and plans to integrate Intelemage’s technology into its Service as a Solution (SaaS) platform.

Interest in eSource is gaining momentum since the FDA issued a guidance in 2013 encouraging its use. With eSource, data obtained during a study visit can be entered directly into a tablet, which eliminates the need for duplicate data entry into EDC systems.

“This is a dramatic departure from the way that current clinical systems are built. Most clinical systems being used today are built around the needs of sponsors and statisticians to review the data for a statistical analysis, not around the workflow of the site with the patient in the room,” said Ed Seguine, CEO of Clinical Ink, which has developed an eSource platform called SureSource. “Sites deserve a better clinical trial experience, but they are used to dealing with the complex and convoluted process that we have right now. They just accept it.”

Other new technologies are being designed specifically to help sites manage clinical trial operations more efficiently. Regulatory compliance software has come onto the market recently to help sites keep regulatory binders up-to-date. Study respondents also invest in their own clinical trial management systems, Institutional Review Board/ethics committee filing software, electronic medical records systems and payroll/finance software to help manage site operations.

Companies are developing technology solutions specifically designed to meet site needs. Holston Medical Group’s Morin and his colleague Karen Gilbert, for example, formed a company called Trike to develop software that can help manage clinical trial complexity at the site level. The analytic tool, called SiteOptex, quantifies study complexity and evaluates its impact on productivity. The tool can be used to prevent over-allocating workload for study coordinators, which Morin said could potentially be disruptive to the clinical trial process and result in errors or staff burnout. Since SiteOptex will be used by site managers, it won’t add a burden on study coordinators.

“The goal is to optimize the ability of the coordinators to see patients, enroll patients in studies and not have an operational workload that restricts their ability to enroll,” said Morin. “Sites also can use the information to determine the health of their site. Do they have enough coordinators? Are they doing too many studies? Are they efficient?”

Looking ahead

“The way different systems are set up for EMR and other processes, we still live in the Tower of Babel. We are not going to be able to connect all of these disparate systems were we can have a streamline process that allows physician practices to utilize their EMR and have that data flow seamlessly into research,” said Morin. “In order for software systems to talk to each other, the data has to be normalized. I don’t think that will happen anytime soon.”

The adoption of new technologies will continue as sponsors and CROs look for greater efficiencies in drug development processes. eSource solutions that allow investigators to capture patient data during study visits are expected to gain wider acceptance, particularly as they can connect to CTMS and other technologies, yet the ability to integrate the various systems used at sites will occur on a more limited basis due to insufficient use of data standards.

 

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’s of Science degree from the Columbia University Graduate School of Journalism. Email karyn.korieth@centerwatch.com.

Annick Anderson has been conducting market research since 1998 in both the health care and consumer packaged goods industries.  Annick holds a Master’s of Business Administration from the Boston University Graduate School of Management. Email annick.anderson@centerwatch.com.

This article was reprinted from Volume 23, Issue 05, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>

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