It’s 2022—the world is embracing digitalization on a mass scale, yet 76% of healthcare organizations admit to printing their consent forms on paper. Why does the clinical trials industry continue to think that paper forms are sufficiently safe and equipped to handle their patients’ most sensitive data?
The Real Cost of Paper in Your Trials
Tracking the true cost of paper in your trials can be a difficult feat. Despite the advancements of clinical trial technology and growing guidance / acceptance from regulators for collecting electronic clinical data, a surprising amount of paper continues to exist (and it’s costing you more than just financially).
The money and resources spent on storing and archiving paper documents, along with the cost of printing and mailing CRFs (case report forms), is not only expensive, but also a time suck. When using paper to collect data, you’re creating a margin of error that doesn’t need to exist. The time and money used to correct those errors—such as misread handwritten data and the need for double data entry—are easy to avoid.
Not only is paper costing you time and money, it’s costing you patients. Consent forms are notoriously difficult and confusing for patients to navigate. The confusion from consent forms alone causes almost 30% of patients to opt out of clinical trials, costing you and your sponsors money. When a patient withdraws from a study, not only does it cost the sponsor three times as much to recruit a new patient, it also costs them the time to enroll new patients and the time invested in those lost.
Paper requires double data entry, tracking of CRFs and queries, in-house data quality assurances, and management of the paper itself. Imagine the time and money saved by digitizing the process. That means fewer site visits, resulting in less time and money spent on travel. Switching to an eClinical solution relieves your data management team of the tedious tasks of managing paper and gives them the time to do their job more efficiently.
Making the transition from paper to digital can be intimidating. But when you look at what paper is costing you; time, money, and patients, the solution becomes clear: it’s time to embrace digital.
The Impact of Replacing Paper Processes
When you integrate digital solutions into your trial, you can expect to save time. Using a digital solution, like electronic patient-reported outcomes (ePRO), eliminates the human error of paper diaries and removes the need for manual data validation. Patients are encouraged to enter their data directly into a web-based portal — accessible on their preferred device — in an on or offline setting and have that information automatically provided to their study team. When it’s time to submit their information, a reminder or trigger form alerts the patient to make sure they don’t miss an entry. Sites are then quickly notified of adverse events or missing data, enabling a swifter response and minimizing the possibility of trial delays or data errors. This translates to more accurate, trusted data that sites, sponsors, and CROs can use to proactively manage their trial timelines.
As of 2021, McKinsey still estimated that 70% of clinical trial participants lived more than 2 hours from the nearest trial site.1 Trials that rely heavily on paper-based processes are limiting their long-term scalability because they are reinforcing the geographic barriers that preclude patients from clinical research. Considering that oncology and rare disease trials are the largest growing therapeutic area2 for clinical research, it’s especially important to remove geographic, physical, and financial barriers that these patient populations are especially prone to experiencing.
Electronic consent (eConsent), ePRO, telehealth are helping sites replace paper processes to reach wider and more diverse patient populations and scale their studies for success. Standardizing workflows also helps increase consistency across teams and sites so your processes can scale with your needs.
In some cases, paper is simply unavailable. Certain patient populations — like elderly or lower socioeconomic classes — lack access or skill to maneuver electronic workflows.
With flexible eConsent and ePRO solutions, teams can streamline electronic data collection using their connected eClinical suite, but also support offline data entry and paper consent forms with ease. Instead of choosing one strict method of data collection, find a solution with the capacity and flexibility to support both.
Going digital allows you to protect your patients personal information with encryption and permissions that meet the global compliance regulations. Due to COVID-19, the FDA and European Medicines Agency were pushed to clarify their guidelines surrounding telemedicine, creating a clearer path for sponsors than there previously had been.3
Staying on top of regulatory changes can be a burden, but with a digital solution that continually performs in depth analysis of regulations around the world and ensures that their solutions are compliant, you can trust that your data is compliant. Patients also find comfort in knowing that your digital solutions are consistently updated to comply with regulations and it saves you time and money.4
Reduce and Replace Paper Using the Right eClinical Solutions
Despite living in the digital age, there is still a need for paper. But clinical teams should be looking to reduce their paper processes and embrace digital solutions wherever possible.
The transition from paper to digital can be overwhelming, but Medrio is here to help. Not only do we have the experience and proven results, we can meet you at the level of digitization that’s right for you.