clinical studies

International Clinical Trials Day: A chance to debate the future of innovation

Vanco Vlastimil (��ֳ� S.A.) — Fri, 19 May 2023 12:02:25 +0000

International Clinical Trials Day: A chance to debate the future of innovation

Iris Loew-Friedrich, Patient Value Development Solutions

Vanco Vlastimi… Fri 19/05/2023 - 14:02

Whilst markers like International Clinical Trials Day are an important moment to recognize our shared clinical challenges and opportunities, the reality is, these thoughts are never far from our mind. At ��ֳ�, one of our biggest drivers is our mission to enhance and evolve our clinical capabilities to bring life-changing innovations to our patients.

What International Clinical Trials Day does is allow us an opportunity to raise our heads above the everyday and take stock of our longer-term ambitions for clinical innovation. As a scientist, I relish the opportunity to look towards the future, and provide my insights on some of the most fundamental changes we’re striving towards, in and out of the lab.

The power of data

A key focus area is the evolution in our understanding of the power of data globally, increasing the types of data we can examine, from basic science to healthcare resource utilization information. The sharing of data could be understood as a universal drive to improve medical science. And whilst every citizen would feel a commitment to contribute data, companies, academia and government institutes would sign up to a global obligation to maximize the use of data in a responsible way for the benefit of all.

Patient experience prioritization

From the patient perspective, I see the way we design trials changing for the benefit of the participants, mirroring daily clinical practice as much as possible to ensure a diverse population can participate. Transitioning from everyday healthcare to participation in a clinical study will be seamless in the future and provide an identical experience so that clinical studies are fully integrated into care. Currently, only 5% of potentially eligible patients participate in clinical studies and this challenge is slowing down innovation. Integration of clinical studies into care will change this. Study protocols will be designed with patient needs and patient burden as the first consideration, with regulatory requirements and scientific curiosity following this priority. Patients should be able to participate from home, submitting results digitally with real-time communication and support to maximising efficiency and patient experience, and minimise the cost and carbon footprint of large-scale trials.

A truly virtualized approach

The increase of virtualized trials can further address clinical challenges, reducing the need for large patient enrolment. Artificial intelligence tools and data assets collected in one digital library could combine current patient data with historical information from earlier trials to enable robust testing with a limited cohort.

Safety-centric monitoring

Safety data could also be measured in a constant and standardized manner across the industry. Apps validated by independent scientific groups, approved by regulators and usable across all clinical studies could mean that all data related to a medicine and its control group are routed in real-time to an independent data monitoring committee. At pre-defined milestones, analyses could be performed and communicated to the clinical team and regulators, improving regulatory science and decision making.

A culture of collaboration

From a regulatory standpoint, I hope that a culture of partnership will continue, that interactions with regulatory agencies are frequent, collaborative, with transparent sharing of information, and joint evaluation of next steps.

With our industry and the world, we operate in constantly changing, there’s a healthy amount of educated speculation when we think about the future of clinical trials. But I have ultimate confidence that ��ֳ� will be at the forefront of the effort to evolve and improve the industry’s approach to innovation, for the benefit of the patients we serve.

Find out more about our passion for innovation here: Innovation is | ��ֳ�

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Human centred clinical trials driving increased participation

Chiara Vona — Wed, 19 Apr 2023 12:23:58 +0000

Human centred clinical trials driving increased participation

Lewis Millen, Global Clinical Science & Operations

Chiara Vona Wed 19/04/2023 - 14:23

At ��ֳ�, patients are at the center of everything we do. With that comes an understanding that patients are not only patients but are first and foremost human beings. That is why innovation, to me, means human centric health, and delivering human centred clinical trials as part of people’s health journey.

When it comes to clinical trials our vision is to educate, empower and enable all patients to actively participate. Traditionally, clinical trials were conducted in a clinical setting in 100% of cases. That is all changing, with a move towards hybrid clinical trials split between the clinic and the home, where possible, and putting human needs at the center of our clinical trials.

Many of the patients that we serve have complex conditions and our aim is to make clinical trial participation as easy as possible, enabling participants to continue with their day-to-day lives with minimal disruption. By combining participant-centred design with innovative technologies, we seek to increase flexibility and optionality. For example, on those days where patients need more flexibility, we endeavour to offer a home option.

For our solutions to be meaningful to each patient’s needs we must ensure that clinical trials are representative of the diverse communities that we serve, and cater to a diverse array of situations that are unique to each patient. That is why we are striving for optionality at every stage of drug development through to treatment. The increase in choice can expand the patient footprint throughout the clinical trial process and help empower more people from diverse communities, a diverse range of ages, a diversity of situations, and remote locations to participate in trials.

To make clinical trials a part of a human centric health journey, we must deliver a diverse set of options that enable all to participate.. To that end we are leveraging innovative technology to pilot and deploy remote patient-centric sampling and data capture solutions, such as PK blood sampling, non-invasive skin biopsies and imaging.

Innovative technological solutions are aiding the expansion of trials from the clinic into the home and placing patients’ needs at the heart of drug discovery to ensure that ��ֳ� solutions reach all communities and serve diverse human needs.

Innovation is at the center of everything our R&D colleagues do at ��ֳ�, but how we innovate is as unique as our employees. For this reason, we asked our researchers to share with you what innovation means to them. So, take a look at what they think innovation is on our dedicated ‘innovation is’ website here.

innovation

innovation R&D science clinical studies

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Hackathon Brings Together Diverse Talents for Digital Innovation

eCMSadmin — Fri, 19 Mar 2021 10:00:00 +0000

Hackathon Brings Together Diverse Talents for Digital Innovation

Stayce Murray, IT Digital Clinical Development

eCMSadmin Fri 19/03/2021 - 11:00

As part of our ongoing digital business transformation, we are evolving our clinical development operating model from a sequence of activities into an integrated digital technology and data-enabled process.

Each aspect from clinical study design, feasibility assessment, clinical site identification, patient recruitment, data collection, data analyses and reporting are included and open to future innovations. Several pieces are already undergoing major renovations through our End-to-End (E2E) Clinical Study Automation program; that aims to ensure quicker delivery of each study while simultaneously reducing costs and enhancing consistency and quality. This is being realized through an internally developed IT platform that will be used right from the clinical study design stage.

Digitalization is an enabler for us to collect and access data and information quickly allowing us to ask important questions, get the answers rapidly, so that we elevate and accelerate our contributions.

Empowered to bring this vision to reality and inspired by the momentum for more inclusive innovation, in February we called on the collective intelligence, curiosity and enthusiasm of our employees to participate in a hackathon. A sprint-like event where ��ֳ� programmers and experts from diverse backgrounds collaborated on a specific technical design challenge for the E2E Clinical Study Automation program.

The hackathon focused on improving the quality and efficiency of data analysis through automation. Seventeen multi-disciplinary teams with colleagues from 16 departments across ��ֳ� participated in the month-long event. In the end, holistic, innovative approaches to solve the problem statement were submitted by 70% of the teams; far exceeding internal expectations and external benchmarks. Participants shared their excitement and pride in seeing the diversity of teams, thoughts, and submissions for the hackathon.

Advancing our digital business transformation in a more end-to-end manner and utilizing our diverse talents in creative ways is a win-win for all: for functional transformations through synergies and knowledge sharing, for all employees through development and connectivity, for ��ֳ�’s sustainability and ultimately for the patients we serve together.

innovation

Hackathon End-to-End Clinical Study Automation E2E Clinical Study Automation clinical studies

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Delivering Patient Value Faster Than Ever

eCMSadmin — Thu, 04 Mar 2021 13:00:00 +0000

Delivering Patient Value Faster Than Ever

Elizabeth Manning, Patient Value Development Solutions

eCMSadmin Thu 04/03/2021 - 14:00

If the last year has shown us one thing, it’s the power of science to change the course of history. At the beating heart of the recent acceleration in medical advancement is clinical study design, and never have we needed this process to be more efficient, consistent and innovative.

At ��ֳ� we are transforming our entire clinical development process from a sequence of activities into a digitally (i.e. technology, and data-enabled), fully integrated process. All aspects of clinical development from clinical study design, feasibility assessment, clinical site identification, patient recruitment, data collection, data analyses and reporting are included and subject to major innovation.

A cornerstone is the End-to-End (E2E) Clinical Study Automation program which aims to ensure a more rapid delivery of each clinical study while simultaneously reducing cost and enhancing consistency and quality. This is being realized through an internally developed IT platform with data standards and digital clinical design contents (i.e. inputs for various study documents) as the foundation for interoperability and digitalization right from the clinical study design stage. The program will ultimately lead to better, faster and more consistent trial design, leading to more rapid delivery of differentiated solutions to patients.

Our Development Teams are currently working tirelessly to turn this ‘blue sky’ vision into industry leading reality. Our Clinical Metadata Repository (CMDR), established in August 2020, and the ongoing development of Augmented Study Concepts are helping us to transform manual, paper-based study design processes into digital content, all being realised through an internally developed IT platform. But this is an ambitious programme and we won’t stop there – we’ll continue to push the boundaries and look to grow the internal platform further.

This is a pivotal moment for ��ֳ� – we’re proud of what we’ve achieved so far, and excited about the road ahead and what this programme could mean for the future of clinical studies and, ultimately, for our patients.

If you’re interested in joining our Development Team at this exciting time, please take a look at our current career opportunities here.

innovation

End-to-End Clinical Study Automation E2E Clinical Study Automation clinical studies

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Research transparency adds value for patients

eCMSadmin — Fri, 31 Jan 2020 00:00:00 +0000

Research transparency adds value for patients

Chris Pfitzer, Global Clinical Science & Operations

eCMSadmin Fri 31/01/2020 - 01:00

��ֳ� strives to improve the lives of people with severe diseases. One way we can contribute to scientific understanding is to share information about our clinical and observational research.

We have developed a new policy setting out what, when, how and where we share information about our research with patients and the public. This will help patients to make informed decisions, while also supporting future clinical research.

We see this revamped policy as a win-win for patients and researchers. Patients and their caregivers will have access to more data than ever before. This can be used to make informed decisions about their healthcare options. It reflects a wider shift towards greater patient empowerment, helping people with severe diseases become active partners in managing their conditions.

��ֳ�’s new policy also supports scientific research. Sharing individual patient-level data, in a secure way, allows for better research decisions. This in turn translates into faster and improved insights. These results drive scientific discover. Ultimately this supports our shared goal of improving the lives of patients.

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Real-world evidence transparency patients clinical studies

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clinical studies

International Clinical Trials Day: A chance to debate the future of innovation

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Human centred clinical trials driving increased participation

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Hackathon Brings Together Diverse Talents for Digital Innovation

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Delivering Patient Value Faster Than Ever

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Research transparency adds value for patients

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