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Blog
Dec 16, 2020
How Teckro Enables a “Quality by Design” Approach to Clinical Trials
This is the second part in the Quality by Design blog series. In the first part of this blog series about Quality by Design, I wrote about how we have seen an increase in the uptake of new technologies by sponsors and clinical research organizations (CROs) to effectively manage clinical trial conduct during the pandemic. To address and adapt to the changing clinical trial management landscape, sponsors, site management organizations and CROs are maximizing their focus by utilizing a risk-based management approach and incorporating the Quality by Design (QbD) principles as outlined in ICH E6 R2. Incorporating these principles will help facilitate efficient and effective trial management. And, most importantly, it will ensure that the safety and well-being of patients is prioritized, as well as preserving overall data quality. There are numerous benefits to clinical trials from this targeted and systematic approach to continuously evaluating risks. Specifically more informed communication among stakeholders. At the end of the day, this approach helps all functional teams throughout the stages of the clinical trial, from patient recruitment, study start-up, study conduct, through to study closeout. And the right technology can help expedite the risk-based study management and monitoring process. Enter Teckro In my previous blog I discussed how risk-based thinking can be broken down into two main aspects: defining what is critical to success for the study and continuously assessing and managing the risks that could derail that success. Essentially, this requires early detection and visibility into the status of those risks so that sponsors and clinical trial teams can proactively mitigate any negatively trending delta  changes. While the concepts of early detection and visibility sound obvious, these are not new ideas. Metrics and key performance indicators have been around for quite some time now.  However, consider the fact that there still exists no way of seeing in real-time what sites are doing. Nor can sponsors or monitors see what documents site personnel are accessing to get them the right information quickly. Also consider the fact that there are numerous channels to communicate important study related updates, medically related questions, or clarifications for the study teams or medical monitors. The “old ways” still exist when it comes to inefficiencies. This includes the fact that sites are still using paper documents and protocols, that there are multiple communication pathways, and delayed responses to research staff questions due to study teams traveling or important information getting caught up in emails. These examples demonstrate that there is still room for improvement in the visibility and detectability sector of proactive trial management. Teckro’s digital engagement platform is perfectly positioned to help study teams facilitate the QbD and risk management principles previously mentioned. Teckro offers greater insight into the site behaviors, which could have a direct impact on study trial efficiencies and ultimately, trial outcomes. Quality by Design and the Teckro Digital Engagement Platform Let’s take a deeper dive into how Teckro’s unique features support risk-based monitoring and enable the QbD process: Teckro Search – Get the answer any time on any device As the protocol “in your pocket,” Teckro means that the latest trial instruction is always available for research personnel from their mobile device. This eliminates guesswork for research staff by putting the protocol within reach at the point of care. And it helps study teams manage risk because essential study information is readily accessible for those making key decisions, such as participant eligibility and toxicity management. Stakeholders access current clinical trial information instantly with Teckro Search. The word current is key because we always keep the right, approved version of the protocol for each site. This avoids the risk of protocol deviations or violations because site staff are following the wrong version of the protocol.   But this isn’t merely for the convenience of site staff. Sure, they get the benefit of anywhere, anytime access to the protocol and other study information. However, the benefits are far greater in that sponsors now have the visibility they truly need to understand at a site level what is happening with their trials. What sites are looking at the protocol is a good indication of engagement. And search trends are a critical early indicator of potential safety issues. Teckro Connect – Bypass multiple communication channels Teckro Connect allows site staff to directly access experts for immediate clarification or guidance. This takes the pressure off busy CRAs and means that staff on the ground can confirm the right course of action, making trials more efficient and improving patient safety. Real-time access to experts also helps time-pressured physicians. As the trusted advisors to patients, they are key to ensuring successful patient recruitment. By unblocking research sites, physicians can quickly and easily confirm decisions, for example patient eligibility. The combination of Teckro Search and Teckro Connect is powerful from a risk management perspective. It means site staff have not only the access to critical study information when and where they need it, they also have a direct line to ask further clarifying questions – all from their mobile phone. This means questions are answered at the point of care with a patient. Coming back to the QbD principle of continual review, now sponsors have visibility into site staff questions so they can spot trends and be proactive with issues.   Teckro Engage – Proactive outreach Teckro Engage delivers relevant, timely updates to the right people at the right time. While Teckro Connect is a way for site staff to request help, Teckro Engage is the means by which study teams can delivered targeted messages with relevant updates or essential guidance. Busy monitors and research staff are alerted and can see all of their important study updates in one place through Teckro, rather than wading through emails. From a risk management perspective, having this message history all in one place ensures a seamless chain of communication across study team members so there is a record of messages and when they were sent. The other benefit of Teckro Engage is that study teams can track whether their messages are opened. We all know that even with the best intentions, emails can slip past us and pile up in our inbox. The Teckro Engage dashboard means study team members don’t have to guess whether their messages are being received. Teckro Survey – Drive study improvements Teckro Survey is a web-based tool that makes it quick and easy for study teams to get direct feedback from research staff and monitors on the ground. Risk can be managed with targeted surveys capturing time sensitive site feedback. Study design can be improved by capturing the input from research sites. This way, performance can be improved upon and the site viewpoint included when it comes to determining the feasibility of the next phase of a trial. Just like with Teckro Engage, study team members have a dashboard to track open and response rates to their surveys. Again, this takes the guesswork out of whether the message is received. Now, study team members have ways between Teckro Engage and Teckro Survey to be super targeted on the messages they want to send and the feedback they collect for continual improvement and risk-based monitoring. A 21st Century Approach to Clinical Trials Risk-based study management requires that all study stakeholders take responsibility in order for the trial to be successful.  Teckro’s digital engagement platform helps to enable sponsors and clinical research teams  “bake in” quality principles from study award through to study closeout. By evaluating, managing, revising and communicating risks often and defining what is critical to success up front, study teams can expect improved study-related efficiencies, reductions in protocol deviations, and improved communications with study teams and site staff.  Adopting new technologies to meet the new requirements for study management and monitoring doesn’t  have to be overly complicated.  Optimizing clinical trials using Teckro can help pave the path forward for clinical teams and bring clinical trials firmly into the 21st century.
Blog
Dec 03, 2020
How Quality by Design Can Help Pave the Path Forward for Clinical Trials in a Post-COVID World
This is the first part in a Quality by Design blog series, exploring the key principles of quality by design. One of the major barriers facing clinical trials is poor trial design, which can lead to incomplete data sets, an expensive trial process, and ultimately contribute to a trial’s failure. This is why drug developers and CROs are focusing on risk-based monitoring, utilizing the quality by design principles as outlined in ICH E6 R2, a 2016 update to the Good Clinical Practice Guidelines. ICH E6 R2 Quality by Design Principles The revisions in the amendment mainly affect sponsors, stipulating a more proactive approach to study design, risk management and study monitoring. Currently sponsors conduct multi-site international clinical trials, but repeating trials in different markets to comply with different regulations is inefficient and leads to delays in delivering new drugs to patients. By “baking” quality into the process, trials can be continually monitored to achieve optimization; this standardization leads to greater efficiency. We’ve all seen just how much the world has changed over the last six months. The pandemic has upended our way of life and many trials have been cancelled or delayed. The benefits of improving trial design cannot be overstated! First things first, let’s look at the main reasons for low quality trials: Inadequate staff training Lack of protocol clarity leading to poor understanding of what is required Lack of management supervision or quality control of required tasks during the study Reduced quality control over collection and recording of study data Problems with patient recruitment, enrollment and retention Enter Quality by Design Clinical trial quality relies on having an investigational plan with solid objectives and outcome measures. Quality by Design (QbD) emphasizes building quality into the process from the beginning. Initially introduced in the early 1990s, the approach focuses on identifying Critical to Quality (CTQ) key data and trial processes. By understanding the factors that are CTQ, risks can be managed effectively. QbD allows for risk and knowledge-based decisions and continuous improvement. It is a systematic approach to development that starts with predefined objectives and emphasizes product and process understanding and control, based on sound science and quality risk management. Risk-based thinking can be broken down into two main aspects: Defining what is critical to success. What matters most? Patient safety and data reliability are crucial. Managing the elements of the clinical trial.  It is vital to continually evaluate, control, communicate, review and report risks. So, how can we ensure success when combining these two concepts?  Study set-up is key. Setting the team up for success begins with identifying what is critical to succeed along with processes that have an impact on patient safety and data reliability.  This requires a rigorous review of the protocol by cross-functional teams. In addition, it's vital that key critical to quality indicators are developed with the appropriate thresholds identified as early as possible.  De-risking the protocol incorporates the quality by design philosophy and ensures risk is managed proactively.  Continuously review the study. Once the risks have been identified and CTQ indicators with thresholds have been established, the process needs to be managed. Utilizing the QbD approach requires a continuous review of the study throughout the study lifecycle. PDCA Cycle Method One method of doing this is by using the four-step management method used in business - PLAN, DO, CHECK, ACT – or PDCA cycle method. PDCA is an iterative four-stage approach to improve processes, products and services in order to resolve problems. It was originally developed by renowned management consultant Dr. William Edwards Deming in the 1950s. His focus was on identifying what caused products to fail to meet customer expectations and predicting the results of an improvement effort, by constantly comparing results to revise the theory. This very practical approach is used today to help businesses develop hypotheses about what needs to change and test them in a continuous feedback loop. Let’s take a closer look at how the PDCA cycle can be used to improve QbD in clinical trials:
Blog
Apr 01, 2020
Taking a Risk-Based Strategy Further: It’s Time to Rethink Clinical Trial Monitoring
There probably isn’t a person on this planet that isn’t closely watching the current coronavirus (COVID-19) pandemic. Like everyone, I am concerned with the health of my family, our employees, our customers, and generally the people of the world impacted by this virus. But it is in the face of such adversity that we need to ask how we can adapt for whatever uncertainty the future holds. If anything is certain, it is that there will be circumstances that will disrupt business as usual. Disruption happens. Businesses need to be prepared for these disruptions and many have business continuity strategies currently in place. But, who could have predicted a global pandemic which has impacted every business sector and supply chain? Answer: No one. Clinical trials are vital for evaluating and advancing medical and patient care. Today’s current situation is impacting how these clinical trials can continue operating safely and efficiently. Functions impacted include – but are not limited to – supply chain, patient safety, data integrity, patient retention, investigational product management, clinical trial monitoring and trial management in general. All areas in clinical trial management have been impacted but specific to clinical trial monitoring, the current model must be modified to ensure that the clinical trials can continue to operate. Specifically, clinical trial monitoring must be adapted to ensure a risk-based strategy is implemented to manage all study-related risks but also to ensure that patient safety is addressed and that data integrity is maintained. Here are a few observations in the current clinical trial monitoring model that need to be reconsidered in light of our current situation: Clinical trial monitoring is primarily based on physical movement of people. CRAs are moving from site to site. You only need a few flight disruptions and cancellations to cause issues. And now, CRAs are likely not able to perform site visits due the coronavirus restrictions. It can be retrospective and reactive. CRAs can only be at one place at a time. As a result, there is no real-time detection of site related issues. It might not be until the next site visit weeks later that potential risks are identified. It can separate research staff and critical medical/scientific knowledge. In most instances, the CRAs are the intermediaries between research staff and trial management and medical monitors. This “switchboard” means providing study related answers can take precious time that no one can afford. In the current environment, quick and real-time communication is essential to ensure continuity of care. It is dependent on paper. This requires that site staff physically refer to the regulatory binder for protocol-specific information. How will regulatory documents be accessed for verification if CRAs or site staff are not physically located on site? Specifically related to the protocol for quick reference, how will sites be ensured that they are utilizing the most current version available? In consideration of the current circumstances and to bring us forward in confronting the current monitoring limitations, it is time to rethink the approach to monitoring and bring it into the 21st Century. We can help. Here are some targeted solutions that I think can realistically improve the effectiveness of monitoring and address the inevitability of disruptions that will happen in the future: Rely less on face-to-face interactions. Utilizing a risk-based approach, CRAs will only be on-site to address any critical milestones and will have more time and bandwidth to assess critical to quality endpoints in-house rather than onsite. Streamline communication with research sites. CRAs and clinical trial management should have a proactive, simple and streamlined way to provide real-time updates rather than generic or passive means (e.g. in person visits, email, newsletters, etc.). This includes proactive information on study updates as well as answers to time sensitive questions. Measure the impact of the communication. Hope isn’t a strategy. When it comes to knowing whether study-related information has been effectively delivered and received and being actioned by the target audience, there is no room for guessing whether the PI or study coordinator got the message. Respond quickly to data that shows potential risk to the study. With less physical travel, CRAs can review data remotely in real time and respond to critical data points that are negatively trending and represent a risk to the study. In this model, we can further improve the quality of the trials and better protect patient safety. Have immediate access to the current protocol any time. Research staff and CRAs always need access to the right version of the protocol at their fingertips. This isn’t always practical or efficient with paper or PDFs in a portal. But real-time access to the right version at the right time is vital. Out of any crisis, there is an opportunity to reflect on how we can better prepare for the future. We’ve seen how important it is to continually evaluate new ways of operating in light of this current situation. With the management of clinical trials, there are numerous strategies to be considered. Specific to monitoring clinical trials, it’s time to rethink the current model. Fortunately, with the smart use of technology, it is not out of reach to make changes in how clinical trials are monitored and we are well-positioned to rise up and meet the challenges imposed by COVID-19 and its impact to the management of clinical trials. What do you think about modernizing clinical trial monitoring? Please send me your thoughts at connectwithandrea@teckro.com
Blog
Jan 28, 2020
Overcoming Fear of the Unknown: The Path to Virtual Clinical Trials
Recently, I attended a seminar on virtual clinical trials. I know, I know…another seminar to enlighten us on what’s new, upcoming, and trending. With benefits like reduced costs and saved time, virtual clinical trials seem appealing. So, why aren’t sponsor companies and clinical research organizations (CROs) running to implement them? Those of us who have worked in the pharma industry for quite some time understand that while new technology might sound promising, there are real challenges with its implementation. If we are being honest about why virtual clinical trials are not being implemented as quickly as you would expect, the truth – at least in part — is fear of the unknown. Let’s face it, trying to change years of clinical trial conduct is like turning the Titanic on a dime. Process changes, organizational mindset, regulatory requirements, data privacy concerns, and impacts on other internal systems are just a few reasons why virtual clinical trials haven’t taken off. So how do we challenge our current system and take that first step into this unknown space – or at the very least, dip our toes into the big scary pond that is virtual clinical trials? The bigger question in my mind is, can we as an industry afford not to? We only need to take a look at the current state of clinical research trials to see how broken they are. With an approximate 30% patient drop-out rate and 50% of sites not recruiting as per schedule, it’s clear we need to tackle the root causes for continuous trial delays. There is also a lack of trial diversity. Specifically, the women, elderly and individuals in rural populations who are woefully underrepresented. Throw in some additional barriers like patient mistrust making recruitment more difficult, and it’s not hard to see that we have a real problem. Given these glaring statistics, we need to ask how can virtual clinical trials improve the current state of the industry? There are instances where some are already dipping into the virtual clinical trial space, especially in late-phase trials. But we need a push to take the ultimate plunge within the Phase I-III space. That push is coming directly from the patients, and their voices are getting understandably louder. Let’s discuss removing these barriers to get into the virtual clinical trial game. Here are a few checklist suggestions to start the discussion: Take a holistic approach. Whatever technology is being considered must be harmonized across all devices. As an example, the smartphone plays an essential role. It can be used for patient engagement, medical reminders, phone/telemedicine options, patient eDiary, and follow-ups. Consider what data you need. An app alone can only solve one part of the problem. Data needs to be enabled within the app, which means the level of information captured is crucial. As an example, capture only what is vital for an endpoint of the study ­­– any additional information will complicate the study by requiring additional regulatory hurdles, incurring data reliability issues, data overload or resistance from patients and healthcare providers. Fit into the everyday life of the user. Technology should not be a burden for the patient or healthcare professional. For example, instead of having to manually track and enter data could the patient use a wearable device that would automatically and easily capture the required information? Plan for changes. Another consideration is to evaluate what would happen if there is a change in the technology itself. If there are routine software changes, will the data remain viable? Consider how this will be managed. Factor in compliance. Finally, compliance is key! Consider compliance with actually wearing the device or using the technology. Again, this needs to fit seamlessly into their day to day life. The good news is that sponsors and CROs don’t have to go it alone. There are existing resources out there that can offer assistance for evaluating new technology. And the FDA has existing guidance to help ensure the appropriate regulations are being followed. We are on the cusp of transforming how we conduct clinical trials. Yes, there are regulations and challenges, but even the FDA is on board and encouraging greater adoption of clinical tools. Our collective job now is to take the leap and be the innovative change agents that move the industry forward. Do you have any suggestions on how to improve industry adoption for modern technology like virtual clinical trials? Please email me at connectwithandrea@teckro.com.