80% of sponsors and contract research organizations (CROs) expect study initiation, recruitment, consent, source data collection and monitoring to be predominantly digital by 2023.
Many CROs have kept up with this trend by adopting decentralized trials that combine digital technology with in-person visits.
What is Contract Research Organization
For example, IQVIA has more than 80 decentralized clinical trials in 40 countries as of 2020. Another major CRO, ICON, found that most of their patients preferred hybrid clinical trials over fully virtual or fully localized ones.
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What can we take away from this? CROs must work closely with research sites to maintain the standard of care and connection that patients are accustomed to. But CROs must also embrace technology if they want to stay competitive.
With the help of well-designed clinical trial software, CROs can improve recruitment, retention and data collection. But to see these benefits, you also need to know what technology to look for.
Read on to learn how you can use remote access, consent and monitoring technology to improve the patient experience and save time and money on clinical trials.
Why the industry needs CROs who can use technology
Clinical trials in the U.S. cost the pharmaceutical industry about $7 billion a year and often take up to 10 years for a drug to pass all four phases of testing.
Contract research organizations save sponsors millions of dollars by speeding up drug development timelines. But more importantly, it will ensure that patients waiting for life-changing treatment receive it faster.
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Many clinical trials encounter costly delays due to difficulties in recruitment, retention and data collection. Although digital technology alone cannot solve all of these problems, it can help with each of them. Here is the procedure:
Technology increases participant recruitment
80% of clinical trials are delayed due to recruitment difficulties and up to 50% of trial sites enroll one or fewer participants. The cost of these recruitment delays can range from $600,000 to $8 million per day, and all that lost money can leave sponsors frustrated with their CROs.
However, technology can help CROs by engaging more sites in recruitment and helping those sites find participants. First, digital technology increases the number of research sites that CROs can work with.
Can’t find the participants you need near you? Remote site access technology platforms allow your CRO to work with locations across the country or even the world. These software systems give you instant access to documents and site data so you can connect with any research site with suitable patients.
But digital technologies can also help individual websites gain subscribers faster. Participants often respond better to patient-centered studies, studies that take their comfort and preferences into account.
A patient-centered study can use patient engagement technology such as telehealth phone calls, electronic consent forms, and smartphone apps to keep participants engaged and save them multiple trips to the clinic.
These features also help increase recruitment. Patient-centered phase II and III trials took an average of four months to recruit 100 participants, while standard phase II and III trials took an average of seven months to recruit the same number of people. This means your CRO could accelerate your recruiting schedule by 43% just by using patient engagement technology.
Software can improve patient retention
Once sites accept patients, they often struggle to retain those patients. The average dropout rate from clinical trials is between 14% and 30%. This high abandonment rate hurts CROs’ chances of winning trials from sponsors.
But technology offers a potential solution. 83% of patients say they want regular digital reminders from doctors or nurses about taking medications or scheduling appointments, and 91% of patients say they would like digital updates from their loved one’s care team.
Digital technology allows research sites to screen participants more frequently and efficiently, which can reduce dropout rates and increase patient satisfaction. By embracing patient engagement technology, CROs are proving to sponsors that they can conduct hybrid studies that put patients’ needs first.
Wearable devices improve data collection and analysis
Remote technologies, such as wearable devices and smartphone apps, can collect data from participants when they shop, exercise, or work, not just when they are at the research site. This gives researchers the opportunity to compare how a treatment works in the real world with how it works in the clinic.
For example, one study used wearable devices to analyze the chest wall vibrations of heart failure patients. Wearable devices automatically transmitted this data to research sites, so data was collected in real time and more likely to be accurate.
Real-time data collection also helps researchers identify adverse events more quickly and keeps participants safe. CROs can use their ability to provide accurate data and protect participants to win trials from sponsors.
So, the main benefits of using technology include:
- Increase patient recruitment by adding more sites
- Improving patient retention through participant engagement
- Improving data collection by incorporating real-time data
They need CRO technology
In our 2021 State of the Industry survey, 87% of funders said they are investing in technology as they plan to eliminate paper processes. CROs must become digital contract research organizations to continue working with digital-only sponsors.
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But many software programs don’t work well with clinical trial regulations or workflows. As technology becomes more mainstream, CROs will need to choose efficient and compliant software systems to stand out from the crowd. Here are a few types of technology you should look into:
Platforms for remote web access
CROs need to look for software that allows them to view research sites’ documents and data and share documents with their sites. 71% of funders and CROs now say the ability to work remotely is a key factor when choosing a technology.
Historically, CROs have relied on portals or email to share documents with their sites. Each research site had to store their documents locally and then upload them to the site’s portal. If a document needed to be updated, the CRO would have to email the site, request an update, and wait for the new document to be uploaded.
Electronic Investigator Site Files (eISF) with remote site access can streamline document and data sharing. Sites control their eISF and can store all their documents and data in it. However, they can also give their CRO access to specific documents.
Digital contract research organization
With remote access to documents and site data, a digital contract research organization can conduct remote monitoring visits. 76% of sponsors performed most or all of their monitoring remotely in 2020, and 83% of sponsors expect most of their monitoring to be remote by 2023.
This means that in order to win sponsor business, CROs must demonstrate that they can monitor remotely. However, 30% of sponsors are concerned that all their sites will not adopt the technology to enable remote monitoring. It is important to look for clinical trial technology that is designed for and controlled by the sites.
Research sites and CROs also need remote monitoring technology, where employees can leave notes for site staff to let them know when documents need to be updated. Once the site has made the required changes, the CRO will immediately see the latest version of the document.
Patient-centered technology
CROs need to make clinical trials more patient-centered to improve recruitment and retention—but that means finding the right patient-centered technology.
Some CROs have chosen to adopt mobile apps for data collection and informed consent (Learn more about the key components of eConsent here.) These apps allow participants to visit the website less frequently. Other CROs have opted for text message programs that remind participants when they have appointments or need to take their medications.
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When selecting patient-centered technology, CROs must listen to participants as well as physicians, caregivers, and patient advocacy groups. Which technology will help participants the most depends on whether patients are already coping with the disease, how tech-savvy they are, and whether they have regular access to phones or computers.
How CROs can prepare for the future of research
CROs need to embrace efficient and compliant technology to keep up. By incorporating remote workplace access and patient engagement technologies into your daily workflows, you can offer sponsors powerful patient acquisition, participant retention, and data collection capabilities.
Interested in becoming a digital contract research organization? Check out webisite http://vial.com/cro/. Total Clinical Trial Management and Aperio Clinical Outcomes. These experts discuss what technology they adopted during 2020, what software was most valuable to them, and what technology they see CROs using in the future.