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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.