The pressures of the pandemic have brought into sharp focus the need for greater innovation and modernisation across the pharmaceutical industry. This is especially the case when it comes to traditional clinical trials, which have often been marred by costly, inefficient and logistically demanding processes. But things are changing and new technologies are making decentralised trials increasingly possible. Carolina Rossi Wosiack, Managing Director of EMEA at digital consultancy CI&T, explores the benefits these new technologies and processes will have on the industry.
The delivery of new medicines to the marketplace is the lifeblood of the pharmaceutical industry and clinical trials are critical to demonstrate their safety and efficacy. Between 2021 and 2028, the global clinical trials market is expected to grow at 5.7 percent per year to reach an overall value of $69.5 billion by 2028. However, despite this, the clinical trials process is being held back by costly, inefficient and logistically demanding processes.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
Can’t attend live? No worries – register to receive the recording post-event.
Traditional trial models and practices are no longer sustainable for the industry, which is under more pressure than ever to deliver. The global coronavirus pandemic has brought into sharp focus the need for lightning speed R&D into vaccines and medical treatments. Not to mention the millions of dollars of investment at risk from patients being unable to visit healthcare facilities for their treatment. With the world expected to see more infectious disease outbreaks in the future, the industry needs a new and innovative approach – one that ensures patients have access to lifesaving medicines, irrespective of black swan events like the COVID-19 pandemic.
Decentralised trials, where the trial process is moved into the patients’ home, is an alternative which can alleviate some of the significant bottlenecks which occur in traditional trials. Moreover, they are gaining ground thanks to technologies such as artificial intelligence (AI), machine learning (ML) and cloud computing. So much so, that a recent study found 76 percent of researchers are now running decentralised trials due to the pandemic, with 38 percent indicating more than half are decentralised. Remote trials are becoming increasingly possible and this is leading to a renewed drive for patient centricity across the pharmaceutical industry.
Removing bottlenecks
Extensive paperwork and the amount of travel to and from clinical trial centres have traditionally hindered efforts to recruit volunteers. More recently, fears of attending appointments in a healthcare setting, where there is a perceived risk of being infected by COVID-19, has provided a huge setback. However, this is not just about the recruitment drive. Ensuring patients stay onboard and avoid poor protocol adherence is another major issue affecting the conclusiveness of many clinical trials.
Decentralised clinical trials can help alleviate some of these bottlenecks around patient uptake. They present a far more patient-centric approach, building convenience and flexibility into the process as the patient can undertake the trial from the comfort of home. There is no need for travel, nor the pressure to attend medical facilities – even for the initial paperwork, which can all be done through electronic consent. All of this empowers the patient to act. This means quicker, more accurate results, since greater convenience directly impacts compliance and adherence to protocol.
In addition, it can also drastically improve recruitment rates and, importantly, access a more diverse patient population, since the trial is no longer grounded to a specific healthcare facility. This diversification is crucial in helping ensure the safety and efficacy of treatments across the entire population.
All of this is critical to the success of clinical trials and subsequently the faster, cheaper development of effective and safe drugs to market.
A digital solution
There are clear benefits to decentralised clinical trials; however, it is unrealistic to think these will be the ‘norm’ in years to come. It is much more likely that there will be a hybrid approach; a mix of onsite patient and remote visits, using healthcare facilities closer to the patient’s home, such as when an MRI scan is necessary. However, the pandemic has accelerated acceptance by medical professionals that new remote monitoring technologies and devices can, and should, be used to safely conduct decentralised trials whenever possible.
Committing to using available technology in clinical trials could revolutionise the process. One area demonstrating great potential is wearable devices. Whether worn as a wrist strap or as an adhesive patch on the body, AI-embedded capabilities allow these devices to measure a patient’s heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data in real time.
There is no ‘one-size-fits-all’ approach to decentralised clinical trials and different digital strategies can map out different technologies. That being said, an ecosystem of technologies will often be necessary to support these trials. Video calling and electronic reminders, for example, can improve patient compliance in trials – prompting participants to take their medication at the right time, to log down developments in their electronic diary and to stay mindful of when to attend remote check-ins. Ultimately, the move to digital can help to improve patient morale and adherence during the process, resulting in more accurate data and faster drug development.
Joining up the dots with data
Clinical trial success depends on capturing interoperable quality data and combining it with findings from all stages of medical research. To be able to submit to regulatory agencies, it is imperative you can show detailed evidence of the benefits new treatments have on patients, as well as any potential side effects.
However, generating valid evidence requires Herculean coordination from the industry and also from physicians and patients. Terabytes (or more) of data, including the number of patient drop outs, adverse reactions, frequency and nature of data collection and hours travelled to a site are just some of the complex data that typically needs to be tracked, logged and analysed.
Much of this work tends to be outsourced to clinical research organisations (CROs) who provide this service. Moreover, in the past companies tended to build digital solutions that best suit their purpose and that do not necessarily work with already established healthcare systems. This makes the present industry model over-complex and beset with organisation-specific dogma. To make matters more complicated, there is no universal standard for medical devices. Regulatory guidelines differ across geographies and this means, for example, that any device measuring heart rate or respiration rate requires calibration and a sophisticated degree of understanding. Taken together, there is a major challenge for the industry when it comes to effectively managing the different platforms and data sources – all while ensuring patient data is high quality, safe and secure.
Remote monitoring and decentralised trials can do much to remedy this, through the collection of real-world data and evidence. These provide an assessment over the lifetime of a trial; capturing more data, more continuously and in the context of lifestyle and health habits. With the use of various different technologies, decentralised trials can collect more data from patients than at traditional site-based clinical studies. Since these technologies deliver data straight from the source, they also reduce the need for additional data verification. This not only helps speed up, but also reduces the cost of clinical trials.
The armoury for modernisation
The pressures of the pandemic have brought into sharp focus the need for greater innovation between pharmaceutical companies. We have already seen this materialise in the unprecedented speed of vaccine development. Moving forward, decentralised clinical trials offer an effective shield against major disruption.
As the industry looks to modernise, the move towards decentralising clinical trials will play a pivotal part in this new flexibility and resilience. With patient centricity built into the process, you can remove significant bottlenecks – from better recruitment and engagement levels, to more accurate monitoring of data. This means better results and better results mean effective treatments reaching the market faster.
About the author
Carolina Rossi Wosiack is the Managing Director of EMEA at CI&T, a leader in driving digital transformation for global brands. For over 20 years, CI&T has been a trusted partner in helping Fortune 1000 companies drive growth and continuous innovation across business, people and technology.
Carolina is a seasoned digital executive with nearly 20 years of experience in innovative processes, people and products, combining strategic and analytic insights and various strategy methods across design thinking, growth strategies and agility. She has applied her expertise on a global scale across several industries in Europe, Brazil, the US and LATAM, ranging from pharmaceuticals to consumer goods, banking and telecommunications. Carolina has helped leading companies such as Roche, Sanofi, Johnson & Johnson and Ericsson to prepare and adjust their business for rapid adaptation in the digital world.
With the growing need for accelerated drug development, traditional site-centric clinical trial models have evolved to handle consumer requirements during unforeseen events. According to recent data published by the GlobalData Pharma Intelligence Center, decentralized or remote clinical trials have successfully brought research closer to the patients, with an overall increase of 1.3% of all trials in 2011 to 2.5% in 2020.
The decentralized model has several advantages over the traditional, centralised model of clinical trials.
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.
With the growing need for accelerated drug development, traditional site-centric clinical trial models have evolved to handle consumer requirements during unforeseen events. According to recent data published by the GlobalData Pharma Intelligence Center, decentralized or remote clinical trials have successfully brought research closer to the patients, with an overall increase of 1.3% of all trials in 2011 to 2.5% in 2020.
The decentralized model has several advantages over the traditional, centralised model of clinical trials.