Confronting Trial Site Payment Challenges

The issue of site payments in clinical trials is marked by several factors that have been aggravated in recent years, causing compelling challenges that need an innovative solution. These challenges include:

• Increased Competition Among Sites: A 2023 Bain and Company report shows 53% of sites surveyed reported having insufficient bandwidth to run trials. This statistic is a sharp increase compared with pre-COVID-19 levels of 15% and 47% at the pandemic’s peak. Competition for trial sites is fierce, and high rates of inflation and attrition lead to financial inconsistencies and confusion in many areas. The existence of legacy payment solutions and decentralized trial models force many sites to make tough trade-offs and turn down trial opportunities.
• Geographic Complexity: Conducting trials across diverse physical locations compounds the geographic challenge, as a Tufts Center for the Study of Drug Development 2023 impact report cites a 39% rise in the mean number of countries per Phase III clinical trial, and 41% and 25% increases in investigative sites for Phase II and Phase III trials, respectively. This expansion in geographic reach introduces logistical hurdles, regulatory variations and cultural differences researchers must navigate. The need to comply with different legal frameworks and manage multiple currencies adds complexity, leading to inconsistencies and confusion.
• Evolving Environmental Factors: The continuously evolving clinical trial environment introduces additional complexities to site payments. Elements such as direct-to-patient trials and splitting payments between sites and decentralized clinical trials (DCT) vendors have made trial protocols increasingly intricate. These changes necessitate new payment structures and coordination, often leading to incorrect payments and hampering internal and site reporting capabilities.
• Concerning Economic Conditions: Difficult economic conditions prompt sites to request additional budget items, impacting site payment schedules and cash flow for CROs and sponsors. Legacy payment solutions are faltering, as they were not built to address these diverse site payment challenges, and the decentralized trial model leads to further inconsistencies. These factors burden study team members with administrative tasks and necessitate careful navigation.
• Global Challenges: Dynamic economic and political landscapes across countries outside of the U.S. also introduce significant payment challenges. Regions like Canada, EMEA, APAC and LATAM represent complex scenarios involving multiple payees, variable payment distribution and performance-based payments. Inconsistent levels of economic development and legal systems lead to potential fraud and currency control complications. Fluctuating domestic affairs, political and social unrest and governmental structural shifts directly impact site relationships and payment capabilities.

To mitigate these challenges, sponsors must streamline payment processes, enhance transparency, and enable accurate and timely compensation. Features like the systematic alignment of protocol structure, data reconciliation, and automation are vital.

Reimagining Site Payment Handling

Reimagining site payment methods is vital to meet the demands of accuracy, efficiency and transparency. Integrating a clinical trial payment solution that leverages technology and innovative approaches would:

1.      Increase Payment Efficiency

A tech-enabled clinical trial payment solution would ensure accurate, timely compensation by systematically aligning protocol structure with payable visit triggers. This alignment, coupled with features like EDC import, data reconciliation and payment calculation, would streamline processes and increase efficiencies.

Automation would be further improved through an Extract-Transform-Load (ETL) approach, allowing for a seamless payment experience. Sponsors would benefit from on-demand access to comprehensive payment information, detailed reports by country and payee and currency-improved transparency.

Payment notifications would keep site invoice recipients informed and engaged, while global portfolio visibility and robust forecasting capabilities support strong financial management and foster a transparent, efficient payment process.

2.      Provide Complete Oversight

A tech-enabled clinical trial payments solution would offer comprehensive payment oversight and expert management of amendments, budgets and contracting. With user-friendly payment portals, sites would gain 24/7 access to complete payment information, promoting increased visibility and accountability.

The integration of critical clinical data from EDC systems, study budgets, agreements and schedules of events would enable automated invoicing for streamlined efficiency. Site invoice recipients would receive Pro Forma notifications when payable visit activity occurs and would get notified promptly in their preferred language when payments were released.

3.      Enable Just-in-Time Funding

One of the standout features of a tech-enabled payment solution is the provision for Just-in-Time (JIT) funding. This approach would allow online approvals for JIT funding, exceptions, milestones, and more, streamlining the payment process. By integrating JIT funding into the payment system, sponsors and sites could ensure funds were available precisely when needed, enhancing efficiency and reducing the administrative burden.

4.      Enhance Global Portfolio Visibility

A tech-enabled payment service would deliver a comprehensive view of the payment portfolio. Key features such as real-time dashboards would display individual and total payments by country and currency, and advanced forecasting tools would provide better financial management and could cut payment cycle times in half and significantly increase site satisfaction and cash flow. With the ability to handle payments in multiple countries and integration with other systems, such a solution would ensure a seamless payment process, regardless of the geographic diversity of trial sites.

Achieving Better Management of Clinical Trial Payments

The challenges of site payments in clinical trials are multifaceted, but integrating tech-enabled solutions offers a promising pathway to address these complexities. By consolidating payments through innovative methods, sponsors can enhance oversight and efficiency, aligning with the unique demands of modern clinical trials. This approach would streamline the payment process and build a collaborative, transparent relationship between all stakeholders, improving oversight and efficiencies through site payment consolidation.

About the author

Jim DiCesare is passionate about delivering innovative site activation and site payment services to clinical trials. With over 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now IQVIA Technologies, Jim has expertise across the contracting, budgeting, and investigator grant payment management continuum. He is a frequent speaker at industry conferences and has written for a variety of publications. Jim earned a B.S. in Accounting from Kutztown University.

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Decentralised clinical trials technology ecosystem at a glance

The decentralised clinical trials industry is projected to have a compound annual growth rate (CAGR) of between 6.7 and 14.8% until 2027.[1]^,[2] The various digital technologies that support DCTs are projected to experience a staggering CAGR of 26.9% from 2022 to 2030.[3]

Figure 1 illustrates the DCT ecosystem, which, to ensure smooth operations and the proper flow of information, should be customisable, modular, integrated and interoperable. It must also comply with the US Code of Federal Regulations, Title 21, Part 11, Good Clinical Practice (GCP), and the privacy principles of the General Data Protection Regulation (GDPR) in the EU and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the US.

The system design should provide a single interface for trial participants and, of course, be easy for investigators and site staff to use.

Figure 1 | The DCT technology ecosystem

Regulators’ commitment to DHT

The United States Food and Drug Administration (US FDA) published draft guidance on the use of DHTs in traditional and decentralised trials in May 2023, with final guidance expected not later than December 29, 2023.[4] Topics in the draft guidance for DCT include:

• Design
• Conduct of remote clinical trial visits and clinical trial-related activities
• Use of DHTs to remotely acquire data
• Roles and responsibilities of the sponsor and investigators
• Obtaining informed consent and institutional review board oversight of the informed consent process
• Determination of the appropriateness of investigational products for use
• Packaging and shipping of investigational products
• Safety monitoring of trial participants
• Software used to support the conduct

The FDA has created the Digital Health Centre of Excellence (within the Centre for Devices and Radiologic Health) to support the use of decentralised clinical trials in product approvals as well as to maintain an inventory of related guidance.

The European Medicines Agency (EMA) has published a guidance in 2023 and Q&A document on qualifying novel methodologies. This outlines a pre-approval procedure for the use of a variety of digital tools via an EMA/Committee for Medicinal Products for Human Use (CHMP) qualification opinion. This is similar to the scientific advice procedure in the EU and the Innovative Science and Technology Approaches for New Drugs (STAND) program managed by the FDA. Because gaining pre-approval is a protracted process, sponsors should fully understand what is entailed before proceeding.

A path to equity, inclusion and diversity

One of the technology-enabled value propositions of decentralised clinical trials is enhanced equity, diversity and inclusion within the trial population. This benefit is only realised, however, if the “digital health divide” is considered and all barriers to participation are mitigated, including access to and use of these technologies.

The FDA Reauthorisation Act (FDARA) encourages sponsors to draft development plans that include diversity in clinical trials. In 2022, the FDA issued a draft guidance to industry[5] for developing plans to enrol more participants from underrepresented racial and ethnic populations into clinical trials.

Facilitating consent

Technology can facilitate the informed consent process by providing engaging, accessible information to potential participants, allowing consent to be granted anywhere, and archiving multiple versions of consent forms over the lifecycle of the trial.

The relevant regulations (Figure 2) cover eSignatures, data privacy, retention of materials and the qualification and validation of technology components of any eConsent solution. Regulations are often country specific, and thus it is important to have country-level expertise involved from the design of the solution through to the end of the trial.  Belgium, Denmark, Israel and Sweden have requirements or guidelines specific to eConsent, and it is expected that the EMA will provide more guidance in the future.

The FDA published a comprehensive Q&A document on eConsent in 2016 (Use of Electronic Informed Consent Questions and Answers), which is recommended reading for anyone contemplating using eConsent.

Figure 2 | Aspects of eConsent

Using a bring-your-own-device (BYOD) approach  

Clinical data can now be collected via electronic outcomes assessments (eCOA) via patients’ own mobile devices or computers. The EMA has released final guidance (EMA/INS/GCP/112288/2023) on computerised systems and electronic data in clinical trials. The recent guidance by EMA and FDA are being considered by other countries as the foundation for their requirements.

Sponsors should carefully consider the capabilities of any BYOD technology and confirm that it can support the needed endpoint. This begins with defining the DHT endpoint and then validating it against any existing alternative endpoint. A novel endpoint must be justified in the statistical analysis plan (SAP), showing that it is a statistically meaningful measure of severity or status, explaining how it relates to other effective endpoints for similar conditions, and testing it against a similar endpoint in a licensed drug (if possible).

Practical considerations for using DHTs

Medical grade vs. health/wellness devices

While most sponsors would likely prefer to use consumer grade health and wellness devices as the requirements are less demanding, a device falls into the medical grade category if the manufacturer is making medical claims for it, if it fits within the standard definition of a medical device and if it will aid in clinical decision-making. General wellness devices, however, are those that encourage a healthy lifestyle and are not related to diagnosing, curing, mitigating, preventing or treating a disease or condition.

CE marking

The European Commission CE mark is only obligatory for products for which EU specifications exist and require the affixing of CE marking. When CE marking is required, the product must follow all applicable EU requirements.

Fit-for-purpose

Sponsors must ensure that devices can be used safely and effectively by the user population in the intended environment, and include the information needed to use them safely and properly.

Risk assessment

Once the device’s use is determined and the patient population and use environment are defined, sponsors must perform a safety and security risk assessment. Sponsors must develop a mitigation plan based on the risk assessment.

Data privacy

Given the increasingly complex global privacy legal landscape, the associated scrutiny of large corporations from data protection supervisory authorities, and the risk of large fines for non-compliance, ensuring privacy-by-design principles are embedded in the development and rollout of DCTs is crucial.

The GDPR is widely recognised as one of the most robust regulations for personal data protection. Thus, a rule of thumb is that compliance with GDPR will ensure compliance with every other privacy law.

Conclusion

The DHTs that make decentralised trials possible must be fit for purpose and comply with regulations across all jurisdictions in the trial footprint. Therefore, having in-country regulatory intelligence is critical to successfully applying technology in DCTs. The goal of the expanding array of DHT is to facilitate compliance with study protocol. Prioritising and demonstrating privacy compliance in the design and rollout of DCTs will increase and support wider usage.

This article was authored by Jo Hulbert, Executive Director, Global Regulatory Clinical Services with contributions from Arwa Shurrab, Senior Director, Global Regulatory Affairs and Priti Prasad, Senior Manager, Global Regulatory Affairs, all at ICON.

References

[1] Decentralized Clinical Trials (DCTs) Market 2022-2028: Share, Trend, Industry News, Demand, Business Growth, Top Key Players Update, Business Statistics and Research Methodology. Globe Newswire, April 2022

[2] Virtual Clinical Trials Market Size to Reach US$ 21.5 Bn by 2030. Biospace, May 2022

[3] U.S. Digital Health Market Size, Share & Trends Analysis Report by Technology, by Component and Segment Forecasts, 2022 – 2030. Globe Newswire, March 2022

[4] FDA Draft Guidance for Industry, Investigators, and Other Stakeholders Decentralized Clinical Trials for Drugs, Biological Products, and Devices, May 2023

[5] FDA Draft Guidance for Industry: Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials, April 2022

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In the late summer, Arriello commissioned a comprehensive survey of European and US pharma companies’ initial experiences of the EMA’s new centralised clinical trials information system (CTIS). The new platform and portal are designed to streamline the submission, assessment and approval of trials across EU markets, under the new Clinical Trials Regulation (CTR)[1], applicable since the end of January 2022 and mandatory for all new trials from January 31, 2023.

The August 2022 survey, conducted by Censuswide, took place at roughly the halfway point between the CTR go-live and the mandatory date for compliance with CTIS for new studies. The survey findings have proved remarkably upbeat.

Teething troubles

The first surprise was the level of activity already taking place through CTIS by August, given that CTIS use isn’t mandatory until after the end of January 2023. Over 90 per cent of respondents claimed to be already registered in the new centralised system; 40 per cent had used it to submit a clinical trial application (CTA), and just over 17 per cent had applications pending. Overall, 92 per cent of survey participants said their organisation was planning a clinical trial through the centralised EMA system over the coming six months.

Of those that had already registered a trial through the CTIS, more than a third (37 per cent) had found the experience faster/shorter than expected, and 31 per cent said the process had been easier than expected. Biotechs were most likely to be impressed with the speed of using the new system.

Although experiences of the new portal haven’t been pain free, there was no obvious single point of concern. Issues spanned:

• Organisational structure – cited by 38 per cent of all respondents, rising to 43 per cent of US respondents
• Training/information overload – cited by 36 per cent overall, with a contrast between German and Swiss respondents (50 per cent of Germans found this to be a barrier, compared with just 25 per cent of Swiss respondents). CROs were the most likely to have an issue with this.
• Transition point identification – an issue for 35 per cent of all respondents, with Germany, the US and UK more concerned about this than Swiss survey participants (only a quarter of which felt this to be a barrier).
• Fear of the unknown – cited by 33 per cent of all respondents, rising to 38 per cent of German respondents
• A lack of clearly defined process steps – for 33 per cent overall, rising to 39 per cent of German participants.

Traditional pharma organisations were most likely to have encountered issues with organisational structure and transition point identification. Biotechs were not overly concerned with any one pain point.

Intended benefits of the CTIS

All respondents appeared to have a good grasp of the intended benefits of the CTIS, confirmed to include:

• Faster approvals – expected by 35 per cent of all respondents (rising to 40 per cent of US respondents);
• A wider group experience – cited by 33 per cent of all respondents (rising to 50 per cent of consultancies);
• Efficiency of scale – cited by 30 per cent;
• Harmonised processes – 28 per cent;
• Greater transparency – 28 per cent (rising to 40 per cent of US respondents while by contrast falling to 16 per cent of Swiss respondents);
• Fostering of innovation & research – 26 per cent (falling to 16 per cent of Swiss respondents); and
• More uniform decisions – 25 per cent.

Biotechs were most switched on by the potential for accelerated trial approvals. For traditional pharma, harmonised processes, increased transparency, and efficiency of scale were the top three expected benefits.

Attracting sponsors to run clinical studies in Europe

Respondents were asked whether – and to what extent – the new clinical trials review set-up might attract more sponsors to run clinical studies in Europe. The vast majority (81 per cent) of all respondents said they expected a net increase in the volume of sponsored trial activity in Europe, rising to 94 per cent of US respondents.

That so many survey respondents appear to have already registered clinical trials via the new CTIS is surprising, but take-up will undoubtedly increase as the risk of having to transition between systems mid study grows.

The positive initial reception of the CTIS is highly encouraging. Yet, achieving complete harmonisation of clinical trial vetting across Europe’s diverse markets remains a challenge that pharma companies must meet to maximise the potential for clinical studies in Europe.

About the authors

Nicola Kidman is a Principal Consultant, Regulatory Affairs at Arriello and has over 20 years of EU/UK and International regulatory experience gained via positions in pharma, CROs and consultancy companies.

Her expertise spans all aspects of regulatory affairs from early drug development to post marketing support, including clinical trial applications and amendments, clinical development plans, scientific advice, Orphan Drug Applications, Paediatric Investigation Plans, MAAs and life cycle maintenance support.

Kieran O’Donnell is VP of Drug Safety & Principal Consultant for Pharmacovigilance at Arriello, a leading global provider of Regulatory, Quality, Safety/PV and Clinical advisory and managed services.

References

[1] Clinical Trials Regulation, EMA: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation

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At the clinical trial level, directly engaging patients and caregivers in protocol development, study design, recruitment, manuscript or plain language summary writing, and data dissemination is key to conduct a truly patient-centric study. In theory, this approach is promising for improving clinical decision-making and, ultimately, patient outcomes. However, as Sheridan et al. (2017) reported, many researchers, patients, and other stakeholders lack clarity about when and how to engage as partners within the clinical research process.

In addition, Hemphill et al. (2020) reported that, while engaging patients and other stakeholders in research partnerships shows promise for strengthening clinical trial evidence, this requires substantial resources and effort. There are several potential challenges associated with building relationships and communicating with patient and caregiver partners, including ensuring that they feel heard and valued, as well as managing expectations about the project progress or their roles. Geographic considerations also require the need for translation and/or interpretation services in order to maintain communication across the study.

In this article, we will dive into the role of digital technologies and virtual tools for partnering with patients and caregivers during all stages of the clinical trial journey.

Virtual & Decentralized Trials

The COVID-19 pandemic has accelerated the interest in, and uptake of, decentralized and virtual trial designs. These benefit patients by removing or reducing the need to travel to a centralized study site. Digital technologies such as virtual patient diaries, eConsent, telehealth, wearables, and mobile apps have undoubtedly improved the clinical trial experience for patients. They should not, however, be the end all be all. Now is the perfect time to rethink how you involve patients in your trials and assess where there is room for improvement.

Needs assessment

Understanding the lived experiences, needs, and wants of patient and caregiver research partners, particularly their motivations and perceptions of how engaging affects their lives, can help inform strategies for developing and sustaining mutually beneficial research partnerships (Hemphill et al. 2020). There are many ways to do this, and the rise of virtual collaboration and communication platforms has made it easier than ever to engage patients and caregivers in a compliant, convenient manner. Virtual communication also allows normally hard-to-reach populations, such as those living in rural, remote communities or belonging to ethnic minorities, to be engaged more easily. This is crucial since diversity is notably lacking in many clinical trials.

Online advisory boards or small focus groups are ideal for needs assessments, whether with patients, caregivers, or other stakeholders. To ensure an engaging, productive two-way conversation, look beyond basic surveys and phone calls and towards comprehensive virtual solutions that host a wide range of communication and collaboration tools in a single place.

Clinical research protocol co-development

Involving patients and caregivers in protocol development, study design decisions, and recruitment can help optimize the clinical trial experience for participants. Patient partners can help determine which study questions to focus on and which endpoints to include. They can ensure that the logistics around the trial are not going to add an unnecessary burden on the patients or caregivers and hinder participation. They can also help directly with recruitment and raising awareness of the trial among other patients or caregivers in their networks. If done right, this patient-centric, holistic approach can lead to more effective recruitment, higher satisfaction, better adherence, and lower drop-out rates.

All of these discussions and co-creation sessions can be held virtually, either synchronously (in real-time) or asynchronously (over-time, anytime), using innovative online tools such as interactive annotation, ranking, rating, and mapping tools. Benefits of virtual collaboration include that patients and caregivers can remain anonymous, and visibility to their responses can be customized so that some questions are only seen by the study investigators/sponsors, while others are open for all patient and caregiver participants to view. In addition, virtual collaboration removes the need to travel to attend meetings and helps overcome time zone differences, things that have traditionally limited patient and caregiver participation in protocol co-development. If the online platform offers translation and/or interpretation services, potential language barriers can also be effectively removed.

Data dissemination

Another area where investigators and sponsors should partner with patients and caregivers is manuscript writing. In some cases, patients are included as study authors; in others, they might serve in more of a consultant role and simply give input on the manuscript. They can also be engaged in creating plain language summaries, either independently or together with the investigators or a medical writer. Again, leveraging virtual collaboration solutions minimizes potential barriers for patients and allows everyone to have an equal voice in these discussions.

When it comes to sharing the trial results with a greater audience outside of the journal readership, working with patient associations to disseminate the data can be an impactful strategy. However, many patients and caregivers are unlikely to read the full clinical research study, and even the plain language summary may fail to catch their attention. In today’s digital world, alternative formats such as educational webinars, podcasts, videos, and social media posts should be considered. These can feature patients, caregivers, researchers, or health care providers directly involved in the care of the patients.

Benefits for patients and caregivers

It is not just the clinical trial investigators that stand to benefit from these partnerships. Patients and caregivers benefit directly in many different ways. Being actively involved in clinical research empowers patients and caregivers to better advocate for themselves and make better health decisions. It also allows partners to feel as if their contributions are making a difference in other patients’ lives, especially for underserved or underrepresented populations. Some feel that their contributions give them a voice and may impact clinical decision-making in the future. It may also help build new or stronger relationships with investigators and other patients in the disease community, as well as lead to better understanding and knowledge of the research and data dissemination processes (Hemphill et al. 2020).

The concept of patient-centric clinical research trials is not new. However, it is unfortunately not yet standard practice to embed the patient and caregiver perspective into the decision-making and study design process. To change the research paradigm from seeing patients merely as study subjects to partners, sponsors and investigators need to think outside the box and work closely with the people impacted by their research.

By Natalie Yeadon, Co-founder & CEO, Impetus Digital

References

https://www.impetusdigital.com/2020/04/15/working-with-advocating-for-and-empowering-patients/

https://www.impetusdigital.com/2019/03/20/patient-engagement-empowerment/

https://innovations.bmj.com/content/3/2/76

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5348236/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7104645/

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For example, by analysing databases of real-world patient data, synthetic control arms can be generated, drug targets can be identified, clinical researchers can gather insights faster into their research questions, and they can even analyse the performance of drugs after regulatory approval. In turn, this is helping to reduce the time and cost associated with trials, minimise the burden on patients, and ultimately get new drugs to market faster.

The pandemic has without a doubt played a part in accelerating these advancements. Covid-19 has driven the healthcare and life sciences industries to improve patient care and dramatically speed up more inclusive and targeted drug development. It’s probably safe to say that during the pandemic we have seen a collective clinical trials process, prompting global cooperation for vaccine research and distribution for the Covid-19 virus in under a year – a pace never before possible.

This level of innovation has only been made a reality through Artificial Intelligence (AI) and machine learning, which has the capability to collect, analyse and produce insights from vast amounts of real-world patent data at pace – far quicker than could be done manually.

Innovating the clinical trial process in this way will continue to be critical to the pharma and life science industry going forwards, in order to support the process from drug discovery through to trials, post-market approval and drug launch.

Developing synthetic control arms

There are many challenges associated with traditional approaches to clinical trials. Factors such as speed, accuracy, costs, failure rates and diverse patient population recruitment in combination with our lack of understanding the underlying biology of diseases, all hinder the evolution of the process.

By using synthetic control arms, clinical development and drug discovery can be transformed. Pharmaceutical companies can use them to improve clinical trial design and success rates. More specifically, synthetic control arms help overcome patient stratification challenges and reduce the amount of time it takes to develop medical treatments. Beyond that, it can also help to improve patient recruitment by allying patient concerns about receiving a placebo, and enable the management of large diverse trials.

Essentially, synthetic control arms utilise both real-world and historical clinical trial data to model patient control groups, removing the need to administer placebo treatments to patients, which can be detrimental to their health, negatively affect trial enrolment and patient outcomes.  This approach can be particularly useful for rare diseases where patient populations are smaller, and where lifespan is short due to the aggressive nature of the disease.

Deploying this technology throughout clinical trials and taking the step to bring trials closer to the patients can hugely reduce the inconvenience of traveling to research sites and the burden of undertaking consistent medical tests. Time spent on recruiting representative patients during the trial process can therefore be streamlined.

AI and ML to support drug discovery

For clinicians, applying machine learning, and AI in particular, during the clinical trial process means previously collected data sets can be analysed and at a much faster pace, often with greater efficiency and more reliability. At a time when clinical trials, and the whole health industry is undergoing huge amounts of digital transformation, integrating synthetic control arms into medical research offers new and exciting opportunities that can revolutionise drug development.

With the number of available data sources continuing to increase – from electronic medical records, patient reported information, personal devices and health apps – these synthetic control arms could become the fastest and safest way for pharma companies to use real-world data for research into diseases with large enough patient populations.

­Leveraging real-world data to drive synthetic control arms and applying AI and ML technologies to analyse it, offers the promise of more efficient, safe and fast paced trials. It poses the opportunity for researchers to quickly achieve more homogeneous patient populations and gain meaningful insights.

Final thoughts

Without a doubt, there has been mindset shift towards applying advanced technology like AI in the pharma and healthcare sector, partially triggered by the pandemic and the rapid development of the COVID-19 vaccines.

Greater amounts of patient data are now being collected than ever before, and clinical researchers will be able to use this wealth of information to develop drugs and treatments with far more targeted, cost and time effective results. With this, we’re also seeing the development of platforms to gather, sort and analyse these datasets. For example, SENSIGHT which is developed by Sensyne Health, in close collaboration with hospitals and healthcare providers.

The pandemic brought about an urgency to speed up the way we develop vaccines – and clinical trials were a huge part of this. Vaccine uptake in the UK wouldn’t be as high had the clinical trials into SARS-CoV-2 not utilised new and innovative technologies, and sparked the global collaboration between pharma, technology companies and governments we all witnessed. Now, looking to the future, we must continue to innovate and make the whole drug discovery and research process as quick, safe and effective as possible.

Dr Nick Scott Ram, Chief of Data Analytics, Partnerships & Delivery and Commercial Director, SENSIGHT – Life Sciences, Sensyne Health

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Clinical trial recruitment can take years and, globally, more than 85% of clinical trials fail to enroll on time. uMotif and Xperiome are joining forces to address the pain points that contribute to these delays, changing the paradigm in clinical trial recruitment by providing sponsors with the capabilities to match the right patients to the right studies, at the right time.

Specifically, the partnership will leverage Xperiome’s knowledge bank for the lived experience of rare disease to build a deep understanding of hard-to-reach populations. Xperiome combines these insights with a specialized matching engine, to connect research-ready members to clinical and real-world study opportunities. Then, once enrolled, uMotif’s patient-engagement app will capture large volumes of high quality ePRO, eDiary and symptom data in real-time throughout the duration of a clinical study. The easy-to-use uMotif app empowers patients to manage and collect their own data, increasing participants’ engagement in clinical research and understanding of their symptoms and behavior among trial sponsors.

Bruce Hellman, uMotif’s CEO said, “Having access to reliable patient data during clinical trials is crucial and it requires effective patient recruitment and engagement strategies. Xperiome and uMotif share a commitment to eliminating the friction in clinical trial enrollment, reducing the burden on both sites and participating patients. Our partnership is designed with patients in mind, to help sponsors and research professionals capture the best quality data in a way that suits study participants. It’s a win-win for all stakeholders and has the potential to aid in accelerating the delivery of vital therapies to patients who need them.”

Jeremy Edwards, Xperiome’s CEO said, “Finding and retaining eligible patients for trials is a significant challenge for pharma, especially in orphan drug research where populations are hard to reach and participation in research can add significant burdens for patients and their families. We are committed to providing more opportunity for rare disease patients to participate in clinical studies and our partnership with uMotif will deliver a better trial experience once enrolled. By working together, we will provide an end-to-end patient-focused solution that connects patients to research and supports them throughout their clinical trial journey.”

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Disruption caused by COVID-19 suddenly meant CROs were trying to get operations back up and running – virtually. At the peak of the pandemic, clinical research decreased by around 87%, according to research by University College London^[1]. Restarting trials was an industry-wide priority.

While the pandemic accelerated the adoption of virtual engagements, it also fundamentally changed the way engagement will be undertaken going forward. Life sciences companies will increasingly look to virtual solutions to effectively engage a wider range of stakeholders.

For CROs that had to put short-term digital solutions in place to manage the immediate impact of COVID-19, the long-term conversion to virtual can seem daunting. But setting up a reliable way to do business online isn’t just a short-term solution to immediate needs – it’s a sound investment for the future.

Below are four best practices that will enable your team to make the switch to virtual, seamlessly and permanently.

The familiar may not be the most effective

Video conferences are even more common than traditional phone calls these days. Because of their ease and familiarity, it feels like an easy solution to replace in-person events with video calls. However, video conferences are not the right venue for every type of meeting. Many live meetings don’t translate well to webcasts.

Consider the challenges for different stakeholders:

• HCPs are busier than ever, and might not be available for a one-time event^[2]
• Strong personalities may dominate, meaning some voices won’t be heard – this is amplified on a virtual setting where the option is between addressing everyone or nobody^[3]
• Global meetings present barriers across time zones, language, or variable access to the internet

Simply put, it’s not enough to just convert a live meeting to a video conference. Consider using a platform that allows asynchronous communication – allowing individuals to participate when their schedule allows.

Invest in change management

If a new virtual venue is selected, team leaders should develop a communication plan, so everyone knows what’s involved with changing formats. Similarly, once participants are enlisted for an asynchronous virtual meeting or event, teams should promptly reach out and share adequate information about what to expect.

If you’re unsure about how to communicate these changes, don’t hesitate to ask your virtual engagement platform for guidance. They’ll have lots of experience helping get teams oriented to new workflows.

Maintain everyone’s engagement

Most professionals would be familiar with an all-day event, but these meetings aren’t without interruptions. Sessions are often offered in 45-minute increments, breaks for coffee and lunch, and time set aside for networking. These events keep your interest by changing the topic often and building in time to wind down or regroup.

Virtual meetings should follow the same cadence. A virtual meeting can take place over a period of days or even weeks and include content broken down into shorter sections, with the opportunity to provide focused feedback after each topic. Relying on a single approach for each part of your virtual meeting will be too repetitive.

Platforms designed for maximising virtual engagement offer built-in features such as different question types, surveys, and document annotation or collaboration to keep participants actively engaged. Periodic digest emails are used to remind participants to come back to the meeting and respond to new questions or comments.

Keep what works, lose what doesn’t

Virtual interaction can make us keenly aware of what we can’t have – the opportunity to see one another and feel the energy of our colleagues discussing a common interest. Webcasts can provide some of this personal touch, so if your team prefers a verbal presentation, consider recording a webcast and making it available on-demand to anyone who can’t attend live. Webcasts work in tandem with asynchronous meetings in many situations, including advisory board meetings, steering committees, focus groups, patient appointments and HCP working groups.

Similarly, if one group of stakeholders prefer a webcast and another prefers logging on to review a document in their own time, adapt your engagement strategies accordingly.

Virtual meetings, once considered a nice-to-have, have become an essential tool in keeping trials running. The benefits of a temporary “virtual only” policy may persist as a “virtual first” approach. With thoughtful virtual venue selection, CROs can address the challenges of the present and establish a path for future success.

Article by Lance Hill, CEO of Within3

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