Arts & Entertainment Computers & Software Law & Legal Science Technology

Stop the Black Mirror “Joan is Awful” Nightmare with the AI Legalese Decoder


Vancouver, Canada – The highly anticipated return of Black Mirror on Netflix has left viewers questioning the safety of their subscriptions, particularly with the premiere episode, “Joan is Awful.” Known for its gripping portrayal of real-world situations and a grim glimpse into the future, Black Mirror has surpassed expectations once again. In response to rising concerns, the revolutionary AI Legalese Decoder emerges as the ultimate solution, preventing viewers from experiencing the eerie events showcased in the episode.

In “Joan is Awful,” viewers witness Joan’s seemingly ordinary life spiraling into a nightmare after discovering a program titled “Joan is Awful” on her Streamberry account, a fictional counterpart to Netflix. To her horror, the show unfolds like a chilling dramatization of her recent experiences. It is revealed that Streamberry has transformed Joan’s existence into entertainment, exploiting a hidden clause buried deep within the terms and conditions she agreed to when subscribing.

To protect against such unsettling predicaments, the AI Legalese Decoder comes to the rescue. By harnessing the power of cutting-edge artificial intelligence, this groundbreaking tool deciphers and simplifies the intricate legal jargon embedded within terms and conditions agreements. Subscribers can now comprehend the implications and potential risks associated with streaming services, including Netflix, ensuring they make informed decisions before committing to a subscription. With the AI Legalese Decoder, viewers reclaim control over their personal data and shield themselves from potential exploitation.

“Our mission is to empower individuals to navigate the digital landscape with confidence and peace of mind,” said William Tsui, Founder at Legalese Decoder. “The Legalese Decoder serves as a proactive measure, safeguarding viewers from the unsettling possibilities depicted in ‘Joan is Awful’ and other Black Mirror episodes.”

In an era where privacy and data protection have become paramount, the AI Legalese Decoder acts as a crucial ally. By offering a comprehensive understanding of the terms and conditions of streaming services, users can safeguard their personal information and prevent their lives from becoming unwitting sources of entertainment, as portrayed in Black Mirror. With this advanced decoder, individuals can make informed decisions, protecting their privacy and digital well-being.

To experience the benefits of the AI Legalese Decoder and ensure a secure streaming experience, visit Stay one step ahead of the Black Mirror nightmares and take control of your digital engagement.

About AI Legalese Decoder:

AI Legalese Decoder is an innovative AI-powered tool designed to simplify and decode complex legal jargon found within terms and conditions agreements. By providing users with a clear understanding of the implications and potential risks associated with various digital services, AI Legalese Decoder empowers individuals to make informed decisions and protect their privacy in the ever-evolving digital landscape.

Health & Medicine Science Technology U.K U.S

FDA Releases Draft Guidance for Decentralised Clinical Trials; Adoption of DCT is Expected to Increase

The US Food and Drug Administration (FDA) has reportedly released a draft guidance detailing its recommendations on performing decentralised clinical trials (DCTs) for drugs, biological products and medical devices.

With the draft, FDA is committed to providing trial sponsors, researchers, and other stakeholders with guidance on how to accelerate DCT adoption to facilitate drug development, reported European Pharmaceutical Review.

FDA’s New Draft Guidance

The newly issued draft guidance is developed on the recommendations the agency detailed in 2020. With the earlier guidance, FDA aimed to help study teams facilitate trial decentralisation in response to the disruptions (e.g. travel restrictions, site closure, quarantines) and public health emergencies caused by the COVID-19 pandemic. 

“The FDA has long considered the benefits of decentralised clinical trials. Advancements in digital health technologies and the COVID-19 pandemic – when in-person visits were limited or unavailable for many trial participants – have accelerated the broader adoption of these activities,” explained FDA Commissioner Dr. Robert Califf.

This new draft offers recommendations related to the FDA’s conditions for investigations of medicinal products when applied to decentralised studies and meets the requirement outlined in section 3606(a)(1), FDA Omnibus Reform Act (FDORA).

FDA released the guidance a few months after the EU regulators demonstrated their recommendations on DCT to help protect the rights and well-being of the trial participants.

In the draft guidance, FDA provides stakeholders with recommendations on DCT design, conducting remote clinical trial visits and clinical trial-related activities, the adoption of digital health technologies (DHT) as enablers of clinical research, the responsibilities of the involved stakeholders, and how investigational medicine should be administered.

Breaking Down the Recommendations

Providing a framework for DCT design, FDA stresses the importance of having a physical location while conducting DCTs to ensure easy access to participant records and investigators’ care.

The trial protocol should clearly define when a tele-health checkup is required and when a patient needs an in-person visit.

FDA urges investigators to confirm participant identity during each remote visit.

According to the agency, the protocols for using DHTs in a virtual trial to gather data for trial endpoints should be compatible with the draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigation”.

Additionally, in the newly released draft guidance, the FDA has urged sponsors to strive for enhancing participant diversity and inclusiveness in clinical trials. 

FDA stresses the importance of engaging local healthcare providers (HCPs” in trial activities to build trust with at-risk participants, thus improving the inclusion of diverse populations. 

While DCTs and hybrid models can encourage a much higher enrollment rate, FDA suggests investigators recruit only as many participants as they can efficiently manage to provide enough supervision of trial-related activities. 

According to the agency, while taking remote consent from the trial participants, they should be informed about whom to contact in case they face any health issues during the trial period and who can access their personal health information (PHI) acquired during the DCT.

FDA underscores leveraging central IRB in decentralised trials as a key to facilitating the review of the protocol, the informed consent documents, and other pertinent trial data.

In addition, investigational products (IP) should be administered to the participants only under the in-person supervision of the investigator or the supervision of a sub-investigator answerable to the investigator.

It’s recommended for sponsors to take into account the type of an investigational device, its prospective application, and the associated risks to determine its use cases efficiently.

IPs can be directly delivered to the participants’ location and the trial protocol should clearly define the methods of preserving the integrity and stability of the IP.

FDA recommends the use of a centralised distribution system to facilitate the delivery of IP to trial participants.

The sponsor is responsible for thoroughly monitoring the DCT processes while ensuring the trial is being conducted per the general investigational protocols and considerations included in the IND or IDE applications. 

The implemented safety monitoring plan in a trial should be devised considering the decentralised nature of the investigation. It should ensure any adverse events are detected early, correctly captured, and efficiently addressed.

FDA suggests sponsors implement high-end DCT software that can help manage electronic case report forms (eCRFs) and electronic informed consent (eConsent), schedule trial activities, sync data input in DHTs, and more. 

High-end DCT platforms such as ObvioHealth can efficiently address the issues of data inaccuracy and the interoperability essential to produce robust trial outcomes and endpoints.

Wrapping Up

Decentralised and hybrid study models are considered the way forward to decrease the patient burden. Offering participants the support and flexibility they need, DCTs also help improve data quality. 

The result: augmented trial result and accelerated drug development

“As we seek to improve our evidence generation system, decentralised clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility,” commented FDA Commissioner.

Computers & Software Health & Medicine Pharmaceuticals & Biotech Science U.K

The Biggest Compliance Issues Faced by MedTech Companies Transitioning to Data-Enabled Solutions

In April, the UK Medicines and Healthcare Products Regulatory Agency (MHPRA) released a guidance document, called Software and Artificial Intelligence as a Medical Device. This document is a compilation of previous guidance, advice, and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD).

The document covers:

  • How software as a general medical device or an IVD should be classified
  • What the UK regulatory framework is for SaMDs
  • A change programme roadmap for software and AI as a medical device
  • How to qualify and classify one’s SaMD, including how to create an intended use statement
  • Reporting adverse events once the SaMD is in use, and requirements for field safety corrective actions
  • The guiding principles to inform the development of Good Machine Learning Practice (GMLP) for artificial intelligence

This document has been developed keeping in mind the goal of advancing software and AI medical device regulation. With these technologies becoming a growing part of the MedTech industry, this seems like a reasonable next step.

Data-Enabled Solutions in MedTech

Whilst software and AI as a medical device is a growing market which is now at the forefront due to the rapid rise in the use of AI, it’s not a completely new idea.

Technology has been in use in medicine and medical research for a while now. However, as computing grows more sophisticated, so do the devices.

In fact, across the pond, there is a growing concern about regulatory compliance issues surrounding MedTech. 

Earlier this year, an article in Med City News talked about the top five compliance issues faced by MedTech companies transitioning to data-enabled solutions.

Here they are.

Compliance Issues That MedTech Companies Face

Managing How the Data Is Collected, Used, and Shared

Smart MedTech solutions rely on data gathered from the people who use them. That is why the first issue to consider is related to data gathering and storage.

Companies that use MedTech-enabled data platforms are obligated to take appropriate care of any information collected, including,

  • Patient data
  • Drug development data
  • Customer or provider data
  • AI/ML-developed data sets

Any data collected, used, or shared must be prioritised with the following in mind:

  • Legal mandates
  • GDPR
  • Others
  • Ethical values
  • Patient rights and dignity
  • Patient care and care quality
  • Minimising patient risk and burden
  • Data access

Keeping the Changing Interactions Between Patients, Physicians, and Other Stakeholders in Mind

Medical care is shifting from treatment to preventative treatment, which has led to a change in how patients interact with healthcare providers.

This means that not only is the relationship between them changing, but there’s also an increase in the use of technology for patient monitoring and real-time data entry.

This data collection would require greater collaboration with stakeholders, which is something to consider when planning compliant protocols.

Planning New Regulation Regimes for Donation of EHR, Cybersecurity Technology, and Information Blocking

Electronic Health Records (EHR) are replacing the old paper documentation. These EHRs can be shared between health systems and providers for the sake of interoperability. 

However, those donations need to be adequately tracked.

There needs to be a system in place to ensure there is a legitimate need for the adoption and topics such as updates and replacements have been addressed

Additionally, the provider of this information must not engage in “information blocking”, which has been defined as any activity that impedes the exchange or use of the health information.

Addressing Value-Based Care Considerations and the Federal Anti-Kickback Statute Safe Harbours

Data-enabled MedTech has the potential to make patient care much more empathetic, streamlined, and comprehensive. However, these qualities rely on better design and regulations.

At the same time, MedTech companies also need to ensure that their practices align with the regulatory requirements of the federal Anti-Kickback Statute safe harbours.

Balancing the Lack of Advanced Industry Standards Against a Rapidly Growing Technology

MedTech and communication technologies have exploded in the last couple of decades. And, the rise of AI has been even more dramatic. As such, the existing rules and regulations need to evolve with these new developments.

Managing regulatory compliance, especially for an industry like MedTech, can be quite challenging. That is where companies like RegASK can help. Such a service can help one not only maintain compliance but also keep up with any changes.

As is evident from the rise of tools like ChatGPT, the world is going to see more automation through AI. The important thing is to design compliance regulations that are as effective and as scalable as that technology.

Law & Legal Personal Finance Science Services Technology

AI Legalese Decoder Helps General Public Save on Legal Fees


Vancouver, Canada – AI Legalese Decoder, a new technology designed to help individuals decode and understand complex legal documents, is now available free to the general public. The technology, which utilizes the latest advances in artificial intelligence, can help individuals save significant amounts of money on legal fees by enabling them to understand legal documents without the need for expensive lawyers.

The development of AI Legalese Decoder comes at a time when many people are struggling to afford legal representation, and are therefore forced to navigate the complexities of the legal system on their own. According to recent studies, the cost of legal services has risen dramatically over the past decade, making it increasingly difficult for ordinary people to access justice.

However, while many lawyers have begun using AI technology like Harvey to save on their own costs, they have not necessarily passed these savings on to their clients. This has left many people feeling frustrated and disempowered, as they are forced to pay high legal fees or go without legal representation altogether.

AI Legalese Decoder seeks to change this by putting the power back in the hands of the people. By using AI technology to decode legal documents, individuals can save significant amounts of money on legal fees, without sacrificing the quality of their legal representation.

According to the developers of AI Legalese Decoder, the technology is designed to be user-friendly and accessible to anyone, regardless of their level of legal expertise. The platform features a simple, intuitive interface that enables users to upload their legal documents and receive a clear, easy-to-understand breakdown of the information contained within them.

The team behind AI Legalese Decoder believes that the technology has the potential to revolutionize the legal industry, and to help level the playing field for individuals who have been historically underserved by the legal system. By putting the power to understand legal documents back in the hands of the people, the team hopes to empower individuals to take control of their legal affairs and to access justice on their own terms.

For more information on AI Legalese Decoder and how it can help you save on legal fees, please visit our website at

Computers & Software Science Technology

Yoti Achieves iBeta ISO PAD Level 2 with 100% Detection Rate: Aims to Strengthen Customer Safety

MyFace®, Yoti’s proprietary passive liveness software, has been declared as fully compliant with ISO/IEC 30107-03. The confirmation came after the product successfully passed a presentation attack detection (PAD) iBeta Level 2 audit with zero attacks getting through, reported Biometric Update.

“We’re very proud that our proprietary liveness technology MyFace has achieved iBeta ISO PAD Level 2,” said Paco Garcia, CTO at Yoti. “It’s a huge achievement for the team, and this milestone demonstrates our commitment to delivering very high standards of security solutions.”

Liveness Check Is Critical for Dodging Spoofing Attacks

With the increasing use of various authentication systems, including biometrics, the risk of “spoofing” attacks is climbing. 

As a result, businesses need to invest in robust technologies as part of a mix of tools to protect users against spoofing attacks while also ensuring a fast verification process. 

As part of the digital ID verification/authentication process, liveness uses motion detection, biometric faceprint add, and face-matching algorithms to affirm that a person is who they claim to be.

Commonly used with other authentication factors, MyFace® locks out bad actors so they cannot spoof real users. 

Unlike facial recognition, liveness does not identify a person by checking their face against records stored in a database. Rather, it’s designed to ensure that the person being verified is a real human.

And unlike active liveness, passive liveness ensures a frictionless user experience and accelerated customer verification process leading to a reduced drop-off rate.

MyFace®: Yoti’s Proprietary Passive Liveness Technology

Built on passive liveness technology, Yoti MyFace® uses a selfie image to catch presentation attacks, requiring no action from the user to prove their “liveness” (like head or hand movements). 

Upon capturing the selfie, the software evaluates whether the face is of a live, real human. It does so by processing the selfie of the user through a series of deep neural networks.

MyFace® ensures a highly accurate and reliable user liveness check by measuring performance in terms of success rates, true positives, false positives, and completion times.

By enabling immediate feedback, ease of use, and ease of access, Yoti’s passive liveness significantly boosts success rates.

“Businesses around the world can use our passive liveness and world-leading facial age estimation to keep their customers safe online,” says Yoti CEO Robin Tombs.

“Naturally, being Yoti, we have tested MyFace® for bias, and the model displays very low bias across age, gender, and skin tone.”

MyFace® Achieving iBeta NIST Level 2

Since passing NIST Level 1 with a 100% attack detection rate in February 2022, Yoti has been upgrading its technology to achieve Level 2 certification. 

Achieving level 1 certification requires a liveness solution to track down each attack and limit false negatives to less than 15%.

Nine-hundred attacks were simulated to test Yoti’s proposed MyFace® which showed zero false positives.

On the other hand, ISO/IEC 30107-3 Level 2 involves testing liveness systems against more sophisticated and specialised attacks such as deepfakes, 3D-printed artefacts, or resin or latex face masks. 

To achieve NIST Level 2 certification, a liveness service must detect 99% of attacks while restricting false negatives to below 15%.

In February 2023, MyFace® passed the presentation attack detection (PAD) iBeta Level 2 audit with a perfect 100% attack detection rate.

It means that MyFace® can restrict kids from accessing online content using latex masks of adults while also blocking bot attacks.

Business Computers & Software Science Society & Culture World

Introducing Latest News in Artificial Intelligence Developments

April 12th 2023 – San Francisco, CA is a new blog that covers the latest news and trends in artificial intelligence (AI). The blog aims to provide informative, insightful and engaging content for anyone interested in AI, whether they are beginners, enthusiasts or experts. was launched by Jane Doe, a former journalist and AI researcher who has been following the developments of AI for over a decade. She decided to start her own blog after noticing a gap in the market for accessible and reliable AI news.

“I have always been fascinated by AI and how it can transform our lives,” said Jane Doe, founder and editor-in-chief of “But I also realized that there is a lot of misinformation and hype around AI that can confuse or mislead people. I wanted to create a blog that would offer accurate, balanced and easy-to-understand AI news for everyone.” covers a wide range of topics related to AI such as machine learning, natural language processing, computer vision, robotics, ethics, society, business and more. The blog features original articles written by Jane Doe as well as guest posts from other experts and influencers in the field.

Some of the recent articles on include:

  • How GPT-3 Is Changing Content Creation
  • The Rise of Conversational AI: Chatbots vs Voice Assistants
  • How AI Can Help Fight Climate Change
  • The Ethical Challenges of Facial Recognition Technology
  • How AI Is Revolutionizing Healthcare also offers various resources for learning more about AI such as podcasts, books, courses, events and newsletters.

Jane Doe hopes that her blog will inspire more people to learn about AI and its potential impact on our world.

“AI is not just a buzzword or a sci-fi fantasy,” she said. “It is already here and it is changing everything from how we communicate to how we work to how we entertain ourselves. I believe that everyone should be aware of what AI can do and what it cannot do and how it can benefit us or harm us depending on how we use it.”

She added: “My goal with is to make AI news more accessible and enjoyable for everyone and to spark curiosity and conversation about this fascinating topic.”

To learn more about and its content, visit or follow them on Twitter @aiupbeat.

Fitness Health & Medicine Pharmaceuticals & Biotech Science Technology

Cyborgcare Launches as the Ultimate Online Marketplace for Health and Wellness Enthusiasts

Israel, Tel Aviv: Cyborgcare, the ultimate online marketplace for cyborg technology products, smart medical devices, gadgets, and wearables. Our platform offers a comprehensive selection of over 500 items designed to improve your health and wellbeing, covering everything from skin, body, hair, eyes, teeth, and nails to medical equipment for fitness centers, beauty salons, clinics, and hospitals.

We understand that keeping up with the latest advancements in cyborg technology can be overwhelming, which is why we’ve created a transparent and user-friendly ecosystem that empowers you to explore and purchase the products you need with ease. Our platform offers an intuitive shopping experience with a wide range of categories and filters to help you find the right products for your unique needs.

At Cyborgcare, we’re dedicated to providing you with qualified online support. Our team of experts is here to answer your questions, offer product recommendations, and help you make informed decisions about your health and wellbeing. Whether you’re new to the world of cyborg technology or an experienced biohacker, our support team is here to help you every step of the way.

We also provide a directory of local services, doctors, consultants, and technicians. Our platform helps you connect with local experts who can provide personalized guidance and support for your biohacking lifestyle. From finding a qualified technician to install your smart medical device to booking a consultation with a top-rated doctor, our directory is a valuable resource for anyone interested in improving their health and wellbeing with the latest technology.

Cyborgcare is committed to promoting a biohacking lifestyle that helps people stay healthy, confident, and happy. Our mission is to empower you with the tools and resources you need to achieve your health and wellness goals. We’re excited to announce that worldwide sales and distribution will be coming soon, so stay tuned for updates and be sure to check out our website to explore our products and services.

Pharmaceuticals & Biotech Science Technology U.K U.S

ObvioHealth and Sterling IRB Partner to Accelerate Access to Clinical Trials

On February 2, 2023, Sterling IRB and ObvioHelath reportedly declared a collaboration to make clinical trials more accessible and step up the decentralisation of clinical studies.

With this announcement, Sterling IRB has emerged as ObvioHealth’s preferred Institutional Review Board (IRB) to help the virtual trial organisation (VRO) with the regulatory requirements, according to Clinical Trial Arsena.

The Shift to Decentralisation Drives Efficiency

Conducting clinical trials is critical to ensuring the safety and effectiveness of therapeutic interventions. However, several steps associated with data compilation, participant enrollment, and more in on-site clinical trials are suboptimal, thus stymieing the development of new therapeutics.

The requirement for frequent hospital visits, complications with transportation, instructions, scheduling, etc., create friction for patients, thus increasing their likelihood of dropping out.

While around 80% of clinical trials fail to meet the enrollment timeline, 55% terminate because of inadequate enrollment. 

Patient drop-off rates in traditional clinical trials (phase III) can often be substantially high (sometimes even over 30%), causing expensive delays for sponsors. Enrolling one participant can cost roughly $6,533 and the cost of replacing them is even higher. 

However, by streamlining communications while allowing patients to volunteer for clinical studies from the comfort of their homes, DCTs can significantly shift the paradigm to a much higher enrollment and retention rate. 

DCTs and hybrid clinical study models are here to stay, and their long-term benefits outweigh the technical and financial challenges related to on-site trials.

However, despite holding great potential to bring new drugs to the market faster, the adoption of DCTs has been slow. 

Some roadblocks to DCT may be down to patient-physician interaction, immature digital infrastructure, and the regulatory issues facing sponsors when implementing and using data from decentralised trials. 

As a new process, the regulatory reception of DCTs is still not well-defined, thereby creating obscurity regarding the oversight of trial processes and governing regulations. 

While the regulatory landscape is constantly evolving, VROs must ensure they design DCT tools that comply with the latest regulatory guidelines. 

The Collaboration Will Facilitate the Regulatory Review Process

By designing and running patient-centric, end-to-end, and tech-enabled DCTs, ObvioHealth helps sponsors get robust therapeutic evidence. 

As part of its effort to ensure zero trade-offs between data accuracy and reduced patient burden, the VRO implements high-end data capture techniques such as tele-health visits, online patient diaries, sensors, wearables, etc.

ObvioHealth expects its partnership with Sterling IRB will act as a step-change in helping it win regulatory acceptance faster for its trial designs.

Since the onset of the COVID-19 pandemic, Sterling IRB has been helping sponsors navigate the ambiguous regulatory guidelines to support fully or partially decentralised trial designs.

“The flexibility of our DCT platform, combined with our full-service virtual site team, gives us the freedom to build studies that will best deliver on a sponsor’s endpoints. This often means we’re navigating uncharted regulatory terrain. We needed a partner willing to collaborate through regulatory challenges and support our next-generation trial designs,” stated Ivan Jarry, CEO of ObvioHealth.

“Sterling IRB and ObvioHealth are like-minded, both sharing a common goal of building stronger DCTs,” said Kathye Richards, vice president of Client Services, Institutional Official at Sterling IRB. “Flexibility and out-of-the-box thinking are becoming increasingly important for continued decentralised trial success. This partnership will enable earlier involvement to help interpret regulations, work through challenges, and collaborate for solutions, all essential for making DCTs less burdensome for all.”

Computers & Software Pharmaceuticals & Biotech Science Technology

Data Capture in Laboratories: Exploring the Barriers and Ways to Overcome Them

Substantial investments should be made in strategising and combining data from a set of instruments in order to turn a medley of free-floating data points into a coherent, integrated message. 

With that said, failing to automate data collection and standardisation via instrument integration is the biggest bottleneck that causes substantial lag in laboratory operations. 

In a recent article published in European Pharmaceutical Review, Samantha Kanza, a senior enterprise fellow at the University of Southampton, sheds light on the leading challenges of adopting digital technologies in the laboratory data collection process and how to overcome them. 

What Is Data Integration?

Data integration means accumulating datasets from multiple sources and equipment and merging them to get a unified view.

Data integration across the value chain—from discovery all the way through production to commercialisation—is critical to strengthening decision-making. 

Even though the massive troves of data a laboratory generates are a great asset, most of it remains unexploited due to failure to connect data and processes.

Leading Data Integration Challenges

The researcher underscores the lack of data standardisation and data standard saturation as two major roadblocks to laboratory data integration. 

Inconsistent datasets, proprietary data formats, and a lack of compatible instruments are a few of the many barriers worth mentioning.

Let’s dive deeper into the issues with proprietary data formats: 

One of the key aspects of successful data integration is to have all datasets from all sources in the same format (or at least convertible into a single format). 

However, in many cases, data attributes in two different sources may conceptually convey the same information, but the datasets are in two different formats, which are sometimes difficult to convert into a desired format. 

These lexical and structural disparities in datasets may cause unfixable errors or even data loss if data gets integrated without standardising or cleaning.

The Solution

Overcoming data standard issues is paramount to enabling a fully integrated and digitally interconnected laboratory.

The research fellow at the University of Southampton advises laboratories to carefully evaluate the software programs they would leverage while generating data and the file formats these systems support. 

On the other hand, software providers should also ensure their programs don’t use intricate proprietary formats that could hinder data integration, sharing, and reuse.

According to Dr. Kanza, researchers must be provided with specific guidelines on the standard process of data structure to efficiently evade the risk of data inconsistencies. 

On top of that, all datasets generated directly from the instruments should include metadata to ensure effective utilisation.

Electronic Systems Adoption Barriers

For laboratories looking to accelerate their R&D, using Laboratory Information Management Software (LIMS) or Electronic Lab Notebook (ELN) as the core part of their research activities is critical. 

Besides enabling instrument integrations for automatic data capture, ELN or LIMS helps automate workflows and ensure efficient management of samples and associated data. 

The result: streamlined operations and quick recognition of bottlenecks across experiments leading to substantially improved efficiency

Despite all the benefits, the adoption of electronic systems in labs has been slow.

Let’s flesh out the reasons:

First off, transitioning away from familiar methods to use a new system may seem challenging for some researchers.

“Whether rightly or wrongly, researchers don’t necessarily trust ELN systems, particularly if they are in the cloud…While trust is important, some of this comes down to a lack of education and understanding on data security coupled with some learned behaviour that needs to be addressed,” explained Dr. Kanza.

Secondly, the scepticism of lab operators about the security of the stored data in cloud-based LIMS or ELN is another leading reason behind the slow adoption rate of LIMS. 

Thirdly, even though digital systems help labs streamline the data capture and management processes, the greatest concern arises when labs aim to leverage these digital systems in their daily operations. The full ELN/LIMS adoption requires buy-in from everyone involved. For some users, the learning curve may seem steeper. 

Overcoming the Electronic System Adoption Challenges

For laboratories looking to address the above challenges and centralise data once siloed in multiple systems to turbocharge their R&D efforts, cashing in on a high-end digital lab notebook like Sapio Sciences is a sensible decision. 

A class-leading ISO-certified system ensures top-notch data security while also offering easy training so that users can get the hang of it in a short time.

On top of that, some high-end integrated LIMS-ELN systems offer automated data capture from instruments via integration that helps minimise experimental redundancy. 

Plus, these systems foster decision-making by enabling interactive visualisation of all data points.

However, digitally transforming a laboratory needs a complete overhaul of lab culture, a change of attitude, and a willingness to learn. 

Besides, before investing in a system, laboratories should evaluate the disparities between the system and their laboratory requirements. Through careful vendor evaluation, they can choose the most profitable compromise between the features offered by a seller and a fully customizable solution. 

Health & Medicine Pharmaceuticals & Biotech Science Technology U.S

Underrepresentation & Overconsumption: Analysing the Diversity Gaps in Clinical Trials

Randomised clinical trials (RCTs) have long been considered the bedrock for evidence-based treatment (EBT). Thus they should be designed to be pragmatic and accumulate data representing the larger population for the disease profile. However, the research output is jeopardised severely by the limited enrollment of social, racial, and ethnic minority groups.

The FDA (US Food and Drug Administration) has reported that only 5% of patients partaking in clinical trials are Black, less than 2% are Asian, and as for Latinos, the percentage is as low as 1%.

This disparity is threatening, as it causes trials to show variance in effectiveness. 

Releasing a draft guidance, the FDA has placed emphasis on enhancing diversity in industry-sponsored clinical trials (iCTs), reported Clinical Leader. 

The agency urges investors and sponsors to devise and present a Race and Ethnicity Diversity Plan early in the trial process as per the framework delineated in the guideline.

Why Does Diversity in Clinical Trials Matter

Even though racial and ethnic populations in the United States have a disproportionate burden for specific ailments, they are most often underrepresented in biomedical studies, said the FDA.

With “underrepresented racial and ethnic populations,” the FDA indicates ethnic groups like “Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of colour.”

Considering the response and exposure of over 20% of drugs vary with racial differences, the FDA marks race and ethnic minority inclusion in iCT as a pressing need.

According to a study, white Americans are predicted to become a minority by 2045. The white demographic decline in the USA makes clinical trial diversification critical to confirm that newly developed drugs are safe and effective for whoever may use them across the country. 

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

Barriers to Improving Patient Participation Diversity in Clinical Trials

According to the FDA, the scepticism of the trial process stemming from several historical events deter ethnic minorities from participating in iCTs.

Other factors include limited access to healthcare for ethnic minorities, socioeconomic conditions, insufficient patient recruitment and retention efforts, time and monetary restraints, etc.

The result: gaps in clinical trial diversity that affects the trial success rate.

How to Fill the Diversity Gaps

What can help bridge the diversity gaps in iCT and accelerate effective products to market?

Decentralised Clinical Trial (DCT) Platforms 

The COVID-19 outbreak has made sponsors realise the significance of DCTs in filling the diversity gaps in healthcare research and accelerating the long-overdue changes in trial design.

Let’s see how:

  • DCTs and hybrid study models allow trial teams to expand their participant pools. 
  • DCT platforms such as ObvioHealth that include ePRO and eConsent enable patients to contribute to clinical trials from the comfort of their homes.
  • By helping overcome barriers to participant recruitment, DCTs and hybrid models have encouraged a much higher enrollment rate.

The result: augmented trial outcomes that represent real-world patient populations.

Ethnically Diverse Workforce

According to research, the lack of workforce diversity in the USA has been highlighted as a leading factor impeding the inclusion of diverse populations and causing disparities in oncology trial results.

The good news? Studies found that 74% of Black and 81% of Latinx people are willing to volunteer for clinical trials if their physicians advise. With that said, engaging the workforce in clinical trials from underrepresented groups can help build trust with at-risk participants. 

On top of that, the NHS recognised workforce diversity as the key factor to bring clinical trials closer to underserved folks. 

Patient Expense Reimbursement

The FDA recognised patient expense reimbursement as an effective way to enhance clinical trial diversity. However, the lack of a consistent approach among CROs and regulators makes the process slow and ineffective. 

Wrapping Up

The FDA sheds light on the significance of global efforts in increasing patient diversity. DCT can be a step change in helping sponsors improve the enrollment of participants from underrepresented racial and ethnic populations in clinical trials.