The use of multimedia, including videos, animations, or interactive graphics in clinical trials is growing. Although its impact on the success of clinical trials is not yet fully understood, studies have shown that it can improve participant engagement, comprehension, and retention of study information.
Healthcare reimbursement is starting to use patient-reported outcomes as proof that a drug or treatment improves the quality of life enough to warrant the cost.
CROs face growing pressure to differentiate themselves. Myths about sponsor expectations and priorities surrounding eClinical technology can cause CROs to lose bids.
When engaging CROs, sponsors are increasingly prioritizing performance excellence and replicable operating standards.
Protocol amendments are inevitable, but choosing the right RTSM partner can help you navigate study changes with speed and agility.
Medrio, a global leader in eClinical software and services used in decentralized, hybrid, and traditional clinical trials, is pleased to announce it received a Silver Award at the 2022 Davey Awards for its “Build It Better: ePRO Accreditation Program.”
With increasing regulatory requirements for the inclusion of patient-reported outcomes in study data, maintaining the status quo in PRO collection can have costly consequences.
Participant education is a critical part of informed consent and one that is easy to improve by leveraging established patient education best practices. Medrio CEO Nicole Latimer discusses some of the most successful approaches she has seen in her career:
Does your CRO or sponsor have a policy around IP numbering in clinical trials? If not, they could be putting your clinical trial at risk.
San Francisco, CA (August 19, 2022) — Medrio, a global leader in eClinical software and services used in decentralized, hybrid, and traditional clinical trials, has successfully completed a System and Organization Controls (SOC) 2 Type 2 examination. The independent third-party report attests to the controls at Medrio regarding the security, availability, and confidentiality of its eClinical technology and solutions.
Smart IP Packaging Helps Clinical Trials Avoid Supply Chain Hurdles to Study Startup Ian Davison, Ph.D. Neuroscience, Medrio’s In-house RTSM Subject Matter Expert Packaging decisions may seem benign, but they can have a direct impact on whether a clinical trial experiences supply chain issues. The ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. Employing your randomization software for clinical trials vendors’ expertise early prevents these issues from becoming problems and can expose surprising efficiencies. Facing a myriad of deadlines and deliverables, time- and resource-crunched study leaders maintain a delicate balance around how tasks should be prioritized, day-by-day or minute-by-minute, in the race against the clock to FPI (first participant in). Often this means that critical decisions about the core technologies that will enable the study are deferred until just months (or even weeks) before FPI, and why not? Past practice has shown that with the right vendor, the Randomization and Trial Supply Management (RTSM) system can be refined until days before go-live. But this approach is short-sighted. Triaging other decisions and projects over RTSM activities may seem obvious since it enables the study team to prioritize milestones that require a longer-lead time. In fact, often the product is already packaged, labeled, and sitting in the warehouse by the time the RTSM software decision is made. However, when it comes to RTSM software, there are multiple advantages to engaging a vendor up to a year in advance of study start to ensure that the supply chain and clinical operations are operating in tandem. Packaging and labeling decisions made in advance of platform selection may have inadvertently “designed out” critical opportunities to enhance supply management, clinical operations, and participant safety, to say nothing of basic efficiencies. When leveraged early, the right RTSM vendor can answer several critical IP packaging decisions and streamline clinical trial startup. How are the kits packaged and labeled? Some studies will create a participant pack for the participant’s full participation in the study. For example, if the participant is scheduled to complete 10 visits to the site during the trial, the participant pack is produced with enough product for the full 10 visits and, potentially, labeled with the participant’s unique identification number. As each visit occurs, the site takes a kit from that participant’s participant pack. At the surface, this intuitively seems like an efficient and organized way to manage the supply inventory, but consider what happens if that participant withdraws or is removed from the study after two of the 10 visits. Suddenly the site is holding eight wasted kits because they are in a box that is already dedicated to that participant. Similarly, what if – despite best intentions and care – a kit becomes damaged during the study, leaving that participant without a full cycle? In this instance, the easy decision may be to open another box to take a replacement kit, but suddenly 20 kits are tied to one participant because one kit was broken. Consider the financial implications of this waste. If the product cost is $1,000 per participant pack and there are 10 kits in the box, there’s $10,000 sitting in a box, with limited visibility into what has happened to it. How many kits can fit in a box? The question of how many kits can fit in a box is an important metric. Consider this: what if you only fit eight in a box but set the shipment at nine? This means you’ll need to split the kits into two boxes and have all the inefficiencies associated with tracking two shippers and two temperature logs. And be careful – which kits are in with which temperature logger? Experienced RTSM vendors have the foresight to consider these types of scenarios and can work with you to create harmonized kit and shipment designs. This ultimately reduces not only the cost of shipping but the associated environmental and sustainability impacts as well. How many kits can the site store safely? It’s also important to consider not only how many products can fit in a box but the size of the box. Sites and pharmacies nearly always have limitations on the space they can dedicate to kits. For example, you may be able to put one hundred blister packs of paracetamol (acetaminophen) on a shelf. However, if your products are the size of a shoebox, most pharmacies won’t have the space to hold the same inventory of one hundred. The concern around site storage capacity becomes even greater for products that need to be held at an ultra-low temperature or for controlled substances with security concerns, like opioids. With space at a premium, sites need to consider how much space they have in their -80 freezer. Most sites don’t have the capacity to hold one hundred kits in storage. Additionally, many pharmacies have regulations limiting opioid quantities because of the risk of having a controlled substance in a pharmacy, such as theft. How can I make the best use of my limited IP resources? Eventually, kits that have been packaged, labeled, and stored will need to be distributed to study participants. This provides yet another opportunity for sponsors to enhance trial supply management efficiencies by partnering with the right RTSM vendor. Based on the chosen packaging design, an RTSM can be used to build allocation rules and automate the process of distributing kits based on parameters set by the user. For example, the user may choose to manage supply using a reorder-point method, demand drive, or just-in-time strategy. There may be different sources at different stages in the trial (from pharmacy at visit one, then direct-to-participant subsequently). All of these can be supported by the RTSM, ensuring that the correct IP is always available when and where it’s needed and that there are no missed participant visits or other disruptions to study continuity. Realizing the benefits of fully-optimized RTSM While most studies employ some kind of RTSM solution,
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. Also Read: ePRO vs Paper Strategies in Clinical Trials The Impact of Replacing Paper Processes Speed 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. Scalability 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. Flexibility 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. Enhance Compliance 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. References
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