Clinical Trials Day

Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

Vanco Vlastimil (��ֳ� S.A.) — Wed, 24 May 2023 14:34:52 +0000

Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

Marie Teil, Women of Childbearing Age Mission

Vanco Vlastimi… Wed 24/05/2023 - 16:34

This year’s Clinical Trials Day (May 20^th) serves as a timely reminder that much still needs to be done to make clinical trials more inclusive, particularly for pregnant and breastfeeding women.

I am proud to have presented at Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2023, discussing strategic approaches in pregnancy and pediatrics alongside Dr Solange Corriol-Rohou, Senior Director of Regulatory Affairs and Policy at AstraZeneca, and Corinne de Vries, Head of Translational Sciences at European Medicines Agency.

Today, although 70% of pregnant women take at least one prescription drug during pregnancy, only about 5% of drugs have been properly monitored, tested and include label data to inform use during pregnancy and breastfeeding. This reflects a widespread tendency not to include pregnant and breastfeeding women in clinical trials – often driven by public attitudes about risk, as well as outdated approaches to research.

Due to the lack of inclusion of pregnant and breastfeeding women in clinical research, women around the world continue to be subjected to misinformation and misconceptions. The global clinical trial community needs more discussions like the one we had at RAPS Euro Convergence 2023, seeking to drive actions that ensure women have access to timely information about the safe and efficacious use of medicines.

New efforts are urgently needed to change the mindset when it comes to benefit-risk considerations. We should stop focusing solely on the risks to the unborn baby and consider the benefits to the mother of being treated – as well, of course, as the consequences to both the mother and baby of not being treated.

There is a clinical and ethical imperative to generate more and better standardized data, informing decision-making on medication use during pregnancy and breastfeeding. Such a change can only be achieved through collective action from all relevant stakeholders.

At ��ֳ�, we remain committed to addressing such health disparities and closing gaps in clinical trial diversity. No woman should ever have to choose between managing her health and starting a family. So, this May 20^th, let’s rally together and call for better representation of pregnant and breastfeeding women in clinical trials.

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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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Clinical Trial Day: Honoring our Clinical Researchers

eCMSadmin — Thu, 20 May 2021 09:00:00 +0000

Clinical Trial Day: Honoring our Clinical Researchers

Becky Malone, Patient Value Development Solutions

eCMSadmin Thu 20/05/2021 - 11:00

At ��ֳ�, we are committed to discovering and providing innovative solutions that address significant unmet needs for people with severe chronic diseases. Because the diseases we tackle are serious, and every patient has a unique journey, our goal is to enable them to live their best life, whatever that is for them. Our people are at the heart of that goal, with their diverse strengths and talent they enable us to fulfill our ambitious goals by driving innovation and providing differentiated solutions.

International Clinical Trials Day began in 2005 to commemorate the day James Lind started the first clinical trial on May 20, 1747. This year, on May 20, 2021, we will celebrate and raise awareness by honoring some of our clinical research professionals across the globe and the work they do to improve patient care. Read below to learn more!

Standardization is an integral element to automating the clinical trial design and study build process. Organizations such as ��ֳ� are looking to leverage technology solutions to effectively define, manage and integrate the metadata processes. But what are the driving factors, challenges and important considerations for those looking to modernize their approach to clinical trial design and study builds? Stayce Murray, Head of IT Digital Clinical Development, partnered with Formedix to explore these considerations and discuss the role of metadata standardization in an end-to-end clinical study environment. View the full session here.

��ֳ� was one of the member companies instrumental in advancing this industry-leading TransCelerate initiative, established to maximize the value of clinical data collected in the control arms of clinical trials by enabling the responsible sharing of patient-level data from completed studies while safeguarding patient privacy. Read more in the Pulse On Progress (pg. 9) from TransCelerate where a vision to increase potential value in a post COVID-19 world is described.

Innovation is a driver in the acceleration and impact of our research and development. For patients that includes advancing adaptations in decentralized clinical trials (DCT) and ��ֳ� was recently highlighted in the Clinical Leader online magazine for use of DCT studies during the pandemic. Tero Laulajainen, Head of GCSO, was interviewed on how our digital transformation helped to manage the impact of the pandemic on clinical trials. Advancing the use of decentralized trials allowed us to mitigate the impact of the pandemic on our clinical studies allowing a more patient centric experience. In addition, he joined peers at Janssen, Mallinckrodt Pharmaceuticals, PPD and Medable to discuss best practices, techniques for using technology to improve patient centricity, and ways to implement remote Electronic Clinical Outcome Assessment (eCOA) and DCTs in a non-disjointed way. View the entire session here.

The pandemic continues to have a profound impact on people around the world, putting pressure on our health systems and disrupting all our daily lives. But it has also showcased human ingenuity, and the significance of R&D in overcoming societal threats and the importance of looking beyond just tomorrow as it pertains to developing solutions for patients. Imagine a future where a patient or physician can find, learn about and participate in clinical research similar to the way we interact with our own financial services companies – through apps and sophisticated yet simple technology solutions. Enter digital transformation and blockchain solutions! Alongside industry peers such as GSK, Novartis, and Bristol-Myers Squibb, Disa Lee Choun, Head of GCSO Innovation, moderated this exciting forum on “Creating a More Seamless Front-End and Back-End to Future-Proof and Advance Digital Transformation in Pharma”. View the full session here.

We continue to collaborate with innovative external partners. We have joined with Stanford Medicine for rapid exploration of clinical datasets to identify defined patient phenotypes and clusters. Stanford, with its unique access to scientific and medical excellence alongside significant patient data, will considerably expand our range of available approaches to better understand patients.

To enable rapid investigation of new patient populations where our solutions could impact, we have worked with Quantum Black. Together the ��ֳ� and Quantum Black team have brought together diverse datasets and used advanced analytics to enable prioritization of potential new opportunities for our pipeline programs.

These are just a few examples of how ��ֳ� and our researchers are working to ensure we remain at the forefront of a rapidly changing external environment. Thank you to all our clinical research colleagues for the leadership, resilience, and passion you bring each and every day to create value for people living with severe disease.

Check out ‘Our Science’ page to learn more and follow our continued external partnering and collaboration on Twitter, LinkedIn and Facebook!

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Clinical Trials Day R&D Our Science Digital Transformation

Comment:

Posted by Sumantoke Bagchi, 27 May 2021

Thanks for enriching us with the info

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Clinical Trials Day

Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

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

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Clinical Trial Day: Honoring our Clinical Researchers

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