Clinical trials

Discovery to design to delivery: how patients are helping us innovate

Vanco Vlastimil (��ֳ� S.A.) — Wed, 05 Apr 2023 09:44:16 +0000

Discovery to design to delivery: how patients are helping us innovate

Kate Trenam, Early Patient Engagement

Vanco Vlastimi… Wed 05/04/2023 - 11:44

Discovering and developing new medicines is a key part of what we do here at ��ֳ�. But we believe that a new medicine is only truly valuable and innovative if it’s meaningful to patients. It has to be a solution that patients really want, and which makes a genuine difference to their lives.

The creation of meaningful medicines at ��ֳ� doesn’t happen by luck or by chance, it happens because we work hard to implement partnerships with patients at all stages of the drug development process.

There is growing evidence that patients’ contributions during the very early stages of drug development can have a positive impact on research into new drugs. Because at this stage researchers are gaining an understanding of patient communities and their unmet needs, patient-friendly research approaches and identifying meaningful outcome measures for patients. Who better to inform these processes than the patients themselves?

At ��ֳ� we have developed a new end-to-end framework designed to ensure that patients and key stakeholders can provide input as early as possible into our research and development programs, as well as the entire drug lifecycle. At the clinical trial stage, we co-create protocols with patients / patient advocacy groups to help us assess protocol complexity and minimize the burden on patients.

Today, approximately 46% of our trials also have a Decentralized Clinical Trials (DCT) patient-centric component. DCTs help to make our clinical trials more accessible and easier to participate in for patients who may not be able to easily access a clinical trial in person, and they can help us to reach patients living in under-represented geographies.

In the area of Parkinson’s, we have joined forces with Parkinson’s UK, and the Parkinson's Foundation in the U.S., to establish a Patient Engagement Council for Parkinson’s Research (PECPR). The aim of the council is to ensure that patient insights are central to the overall strategy and activities across ��ֳ�’s Parkinson’s Disease research and early clinical development program. Through this collaborative partnership, the council aims to embed patient involvement in the earliest stages and throughout each step of ��ֳ�’s Parkinson’s drug development program.

At ��ֳ� we celebrate the fact that patients are increasingly active and empowered when it comes to decisions about their healthcare – they are no longer ‘customers’, but more ‘co-creators’ in the R&D process. We celebrate it because we hope that by closing the gap between scientists and patients, we can discover new ways to target the drivers of disease.

To learn more about how innovation drives everything we do visit Innovation is | ��ֳ�

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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforces

Vanco Vlastimil (��ֳ� S.A.) — Tue, 09 Aug 2022 15:30:57 +0000

Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforces

Zoma Foster, Patient Value Development Solutions

Vanco Vlastimi… Tue 09/08/2022 - 17:30

At ��ֳ�, our vision is to ensure participants in ��ֳ� clinical trials are reflective of the populations that will ultimately benefit from our new medicines. We look for opportunities to partner and collaborate with organizations that can support and drive initiatives that will seek and include diverse patients in ��ֳ� clinical trials. This commitment to external collaborations and bringing lessons learned back to ��ֳ� ensures we are connected to best practices in the industry. A recent example of this partnership occurred with Tufts Center for the Study of Drug Development.

��ֳ�, along with other peer pharmaceutical companies and Clinical Research Organizations (CROs), worked with Tufts Center for the Study of Drug Development to conduct a study to characterize and examine the relationship between investigative site personnel diversity and study participant diversity. The study concluded that a diverse clinical research workforce is associated with diversity among clinical trial volunteers. It also showed that diversity in the clinical research workforce still falls short of reflecting the diversity of the global patient population and identified key areas to support increased racial and ethnic representation among site staff.

Community Engagement Program

Our Community Engagement Partner Program is one approach ��ֳ� is taking to address these findings. We aim to collaborate directly with health professionals and their local communities to listen to the community’s needs, answer questions related to clinical research, and educate about clinical trials within the community. Our goal is to create direct collaboration between health professionals and their local communities through a range of initiatives, such as:

Listening to the needs of the community
Answering questions related to clinical research
Educating about clinical trials within the community
Engaging proactively in activities such as walks, health fairs, public forums, and educational seminars
Providing information to patients about clinical trials in their area in an easy-to-understand format

We anticipate the outcomes of these initiatives will:

Improve awareness of the importance of diversity in clinical trials (including HCP/Staff education and training)
Develop and foster long-term relationships with local communities and patient support groups/advocacy initiatives
Establish a footprint in the diversity landscape to improve awareness and access to ��ֳ� clinical programs
Increase the number of referral centers for ��ֳ� clinical programs
Increase the number of diverse investigators identified and referred to ��ֳ� for clinical trials
Increase the number of diverse patients participating in ��ֳ� clinical trials

Partnering for Greater Impact

��ֳ� recently worked with industry leaders as a member company of TransCelerate to launch their Sponsor Toolkit Program for Diversity, Equity and Inclusion of Participants in Clinical Trials. In addition, ��ֳ� is a proud member of PhRMA who just launched Equitable Breakthroughs in Medicine Development to further innovation and collaboration, bringing together diverse communities, patients, providers, health partners, community organizations and academic institutions to pilot a network of sustainable, connected, community-based trial sites.

Although as an industry, we still have work to do, through partnerships and initiatives such as these, we are building on a strong foundation to promote inclusion of underrepresented patients in clinical trials.

Contributors: Zoma Foster (Tufts Study); Nicole Tillery (TransCelerate Toolkit); Iris Loew-Friedrich (��ֳ� DE&I Executive Sponsor)

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Clinical trials Community Engagement Program Clinical research Tufts Center for the Study of Drug Development Diversity equity and inclusion

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Capturing real-world data and evidence in clinical trials

Vanco Vlastimil (��ֳ� S.A.) — Wed, 20 Jul 2022 06:00:00 +0000

Capturing real-world data and evidence in clinical trials

Emily Lewis, Digital Care Transformation Neurology

Vanco Vlastimi… Wed 20/07/2022 - 08:00

At ��ֳ�, we see the many benefits of integrating technology in all aspects of our business to amplify the power of scientific innovation and to improve patient care.

In the second ��ֳ� Digital Health Roundtable (June 2022) an expert panel discussed how clinical research, and the data we use within it, can be more reflective of the real-world settings in which patients live, so that providers can better close gaps in care and improve patient outcomes.

The expert speaker panel included: Ying Lu, PhD (Professor of Biomedical Data Science, Stanford University), Jeremy Rassen, Sc.D (Co-Founder and President, Aetion, Inc.), Dorothee Bartels, PhD (Global Head of RWE and Digital Sciences, ��ֳ�), Devin Gilliam, Head of Clinical Trials (Datavant).

For decades the best practices of clinical research involved rigidly designed, prospective randomized controlled trials (RCTs). While that remains the case in many scenarios, these kinds of trials collected data under ideal conditions and did not always reflect the routine clinical practice settings they are meant to inform. Over the last decade, as real-world data methodology advances and related regulatory guidance has matured it has allowed us to generate the evidence needed for strategy and decision making within development itself.

The expert panel discuss the need to further develop a common language, standards, structure and process, and global best practices around these new evidence generation frameworks to meet this rapidly advancing world.

Watch the roundtable to find out more: https://youtu.be/tYfym1U1vD4.

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Digital Health Digital Care Transformation Real-world data Clinical trials

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Piloting wearable sensor technologies for clinical trials

Vandenbruaene Nathalie — Mon, 30 May 2022 11:17:28 +0000

Piloting wearable sensor technologies for clinical trials

Isabela Niculae, Global Clinical Sciences and Operations Innovation

Vandenbruaene … Mon 30/05/2022 - 13:17

Measuring vital signs is a critical part of any clinical trial; it helps us to characterize diseases and the effect of our therapies. Wearable sensors have the potential to help us capture vital signs data more efficiently and with much more detail. Automating the remote collection of vital signs data in clinical studies promises to bring a wealth of benefits for patients, sites, study teams and project teams.

Before I explore these benefits, let’s take a look at how ��ֳ�’s Global Clinical Sciences and Operations (GCSO) Innovation has been working in this area as part of the Technology Transformation Implementation program.

Wearable sensor technologies: Walking in participants’ shoes
The development of wearable sensors has reached a stage where non-intrusive products can measure clinical dimensions continuously and in the real world with sufficient robustness. And GCSO Innovation has been piloting two wearable sensor solutions to explore how they can help us measure vital signs more effectively in our clinical trials.

The pilot engaged our colleagues across the organization in the innovation process, asking them to ‘walk a mile’ in patients’ shoes. An amazing eighty volunteered to take part, of which 24 were selected to wear each of the two devices for seven days.

Putting themselves in the place of a clinical trial participant, our colleagues reported on the comfort and usability of the devices.

New opportunities for medicines development
The COVID pandemic meant GCSO Innovation had to conduct the pilot virtually, which ultimately helped it learn about the potential for these devices in Decentralised Clinical Trials. With its final analysis complete and findings reported, GCSO Innovation concluded that “Devices capable of continuous data capture provide new opportunities for medicines development, and we were able to see a greater magnitude of granularity for physiological data”.

The report also revealed some important insights that ��ֳ� gleaned into operating clinical trials virtually and collecting continuous clinical trial data. Firstly, during the pilot, we learned that operating remotely presents new challenges to working with clinical trial participants. We are now considering how best to fully support participants in a virtual environment as we journey towards truly patient-centric clinical trials.

We also learned of some additional factors that we need to consider when we capture continuous data. These include device recharging times, loss of connectivity between the device and phone, how participants use or are challenged by these devices over time and their general comfort with these solutions.

Human beings are complex
But one of the most important things that we learned was that measuring physiological data continuously in a real-world setting presents a large degree of variability in measurements. That variability isn’t down to the underlying state of the participant but could instead be due to their extrinsic environment and activities of daily living.

In other words, human beings are complex creatures. The data that we continuously collect as participants go about their daily lives looks completely different from the data we capture in the controlled environment of hospitals during our clinical trials. We, therefore, need to understand what this complexity looks like and when measurement variations may naturally occur before we can maximize our use of these new tools.

Armed with this information, ��ֳ� study teams are now exploring how best to use wearable sensors in studies to benefit patients.

Rapidly advancing knowledge for the benefit of all
This pilot sandboxed GCSO Innovation’s investigation into our use of their innovative solutions. Sandboxing allows the team to gain timely, cost-effective feedback to rapidly advance their knowledge on how we can use wearable sensors effectively. Moreover, it also de-risks those innovations before we introduce them into our clinical trials.

Ultimately, I hope to see more pilots like this in the not too distant future. Trialing innovations in this way is a win-win for everybody. It benefits our patients and healthcare professionals by accelerating innovations. It benefits study teams and project teams by allowing them to capture continuous data in real-world settings. And it benefits ��ֳ� and our small and medium-sized enterprise (SME) partners by making us a better partner in the innovation ecosystems.

Moreover, ��ֳ� is looking to establish true partnerships at every step of the pharma value chain. Our new patient-centered framework, for instance, provides our colleagues in all business functions with a tangible roadmap on how to create a mutually beneficial, truly inclusive pharma. Find out more in the interview of our Chief Medical Officer Iris Loew Friedrich in a pharmaphorum article on "Engagement to partnership: The changing face of patient involvement".

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Clinical trials wearable sensors wearable technology Global Clinical Sciences and Operations GCSO

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Clinical trials

Discovery to design to delivery: how patients are helping us innovate

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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforces

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Capturing real-world data and evidence in clinical trials

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Piloting wearable sensor technologies for clinical trials

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