We have reviewed the final 2024 FDA guidance on Conducting Clinical Trials with Decentralized Elements (DCTs). While the general concepts are not new, the guidance clarifies many key points that impact the clinical trial experiences for sponsors, investigators, clinical trial industry supporters, and participants. The guidance provides recommendations and best practices for integrating decentralized elements in clinical trials, while ensuring regulatory compliance, maintaining data quality, and supporting participant safety.

The final 2024 guidance updates the Agency’s prior guidances on decentralized clinical trials and digital health technologies (DHTs), clarifying considerations for designing DCTs based on appropriateness of telehealth or in-person visits for trial participants, investigational products, medical conditions of the trial population, and use of DHTs. The current guidance maintains the focus on two overarching principles, participant safety and data integrity by incorporating responsibilities specifically related to DCTs for sponsors, investigators and participants.

The use of decentralized components, such as telehealth or home visits in a clinical trial reinforces prior FDA guidance on patient-focused drug development (PFDD), by allowing trial activities to occur in places where it is convenient for participants. This benefits both participants and trials by reducing participant burden, improving accessibility, and improving retention.

The guidance references participants use of their own digital health technology, often referred to as ‘Bring Your Own Device’ (BYOD), with the caveat that sponsors make provisioned devices available to participants who do not have their own, to ensure that participation is accessible for all potential participants. At times in the past, sponsors have questioned whether the FDA would accept data collected via BYOD when considering regulatory approval. By describing use of a participant’s own DHT in the final guidance, it is clear that the FDA considers data collected via BYOD acceptable (see also the 2023 FDA guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations).

While recognizing that DCTs may risk increased data variability compared to traditional site-based trials, the guidance highlights the need for a strong risk-based monitoring plan to maintain data quality. In a DCT, data integrity can be supported through robust remote trial monitoring plans to ensure compliance with study protocol conventions and best practices for data collection. This may include use of video to supervise remote visits and real-time access to study data and standardized reports/dashboards. While audio/video telehealth interactions do not need to be 21 CFR Part 11 compliant, all study data captured during the virtual visit must conform to these guidelines (Section J). In addition, site and de-identified participant access details (date/time, etc.) should be captured in a robust audit trail (Section J). Critically, participant data privacy and security must be ensured during remote visits/events in decentralized settings.

The guidance also states that training participants on study guidelines is an important element for successful DCT and may be provided by site staff or within the application (Sections A, B, C, D, and J). Furthermore, to improve data consistency and limit variability, protocols for DCTs should include specific instructions for where and how trial activities are to be performed.

Participants must adhere to recommended safety procedures when health/safety issues occur to document potential Adverse Events (AEs) when they are not at the study site. However, the guidance advises that it is helpful to collect real-time information from participants when event-triggering thresholds are exceeded. Safety monitoring plans should ensure that AEs, including those that are identified remotely, are documented, assessed, and addressed. The safety monitoring plan should also detail the type of information specifically collected using DHTs, how it will be monitored, what actions participants should take if something concerning occurs and how trial personnel should respond to electronic alerts (Sections B and I).

The implications for sponsors and vendors have expanded beyond the delivery of enabling technology to include a serious focus on staff training, all quality assurance processes and foundational quality management systems. These are areas where we have focused our attention to ensure compliance not just for audit but for successful trial execution.

Authored on behalf of Clinical ink by Yamamoto, R, Anderson, D, Bowen, C, & Barrasso, B

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In an effort to foster better adoption of eConsent, the European Forum for Good Clinical Practice (EFGCP) has led an eConsent initiative with the intent to harmonize eConsent terminologies, create value models of eConsent for stakeholders, and offer guidance on eConsent processes.

Clinical ink’s Senior Product Manager Liz Goodman co-leads the EFGCP eConsent library workstream with other industry experts. This workstream just released the harmonized eConsent glossary and published an article in Applied Clinical Trials on the their efforts over the past year.

We are pleased to collaborate with key industry leaders on this critical initiative, and look forward to bringing eConsent to the forefront of clinical research software. Reach out today to learn more from our industry experts on how eConsent can work for your research trial!

Read the article and access the EFGCP eConsent glossary.

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This article describes how behavioral science can be applied in cardiometabolic clinical research to augment drug interventions. This combined approach addresses the Health Inequity gap while also increasing patient engagement.

Clinical Scenario Case Vignette

Years ago, one of us was a young doctor in conversation with a patient regarding enrollment in a Type 2 Diabetes research study. The conversation related to the patient’s high use of basal insulin (>150U/day) and dietary habits around healthy eating. The patient explained that he lived alone and his daughter had repeatedly tried to make him eat healthier by introducing vegetables as a dominant part of his diet, but he couldn’t tolerate the change. He became uncomfortable, dizzy, sweating, fatigued, and hungry – all classical symptoms of hypoglycemia. He stopped the healthy diet and resumed his normal diet. When asked how he had managed to reduce his insulin dose with the healthy diet to anticipate the lower amounts of carbohydrates, he looked baffled.

His understanding of diabetes left him unable to make appropriate health choices and his daughter lived far away and only saw him on occasion. He ate TV dinners and found preparing food for himself an insurmountable challenge. His poor adherence was due to low “Health Capital” or “Health Literacy”, and his resource network wasn’t able to compensate.

Incorporating Patient Behavior into Clinical Guidelines

In clinical treatment guidelines, this is phrased as “Social Determinants of Health” which is presumed to account for 50% of health outcomes. SDoH are equally deemed by the American Heart Association to constitute a major impediment for delivering upon their ambitions of “Goals: to improve cardiovascular health of all Americans by 20% while reducing deaths from CVD and stroke by 20%.”

In clinical trials, we excel in quantifying the biometrics that constitute predictors of poor health outcomes. Zooming in on the cardiometabolic space, we are becoming increasingly diligent in describing the causalities of dysglycemia, dyslipidemia, other markers of atherosclerosis, aspects of hypertension, fatty liver parameters etc. toward adverse Health Outcomes. These are important additions to our scientific understanding of the diseases that together characterize the “Cardiometabolic Pandemic” we see unraveling across the globe with more than 650 million people being obese and 530 million people (10.5% of the world’s population) living with Type 2 diabetes.

In the “non-health related” part of our lives, social media, mainstream media, streaming services, and other outlets have used complex algorithms for years. These approaches have been used to understand consumer preference, direct advertising, and influences on lifestyle behavior, with very high levels of acceptance. For the pharmaceutical industry and investigators, the question now beckons: are there validated methods for how similar approaches can be applied in clinical research to quantify and modify behavioral and psychological factors to augment treatment efficacy and weight loss? And subsequently, is it possible to include a behavioral modification tool to our clinical trial platforms to ensure lifestyle standardization throughout the study? Once the data is available on an individual trial basis it may be possible to obtain a marketing license for a standalone or companion digital therapeutic.

We Suggest the Following General Approaches to Clinical Trial Design:

First, in the context of a clinical trial for diabetes or obesity we need to adhere to FDA recommendations to standardize lifestyle modification – Guidance for Industry Developing Products for Weight Management (fda.gov). But we can take this further by really trying to understand the individual patient and ensuring they get the best possible outcome from the drug and treatment advice.

Second, we can quantify the patient’s personality, mood, and health behavior by screening at baseline. This is important as personality is a known determinant of nonspecific outcomes such as adherence in clinical trials.

Third, we propose using validated behavioral digital tools that are based on principles of cognitive behavioral therapy. This will create a dataset that can characterize and describe these in contexts with the biometrics.

Fourth, we recommend a feedback loop to the patient. We advocate the use of validated behavioral modification modules combined with machine learning. This can provide real-time feedback to clinical trial participants, with the goal of modifying their current behaviors in real time.

Translating General Recommendations to Specific Actions

All of this needs to happen with patient centricity in mind and without increasing the patient burden of a clinical trial. This can only happen if the insights are captured in a seamless site and patient experience solution.

At the patient level this approach will improve the likelihood of therapeutic effectiveness and ensure that activity levels, food intake, and glucose levels are aligned with a putative lifestyle standard for weight loss. Let’s apply digital health technologies in addressing the health inequities of cardio metabolic diseases. After all, it’s not the efficacy obtained in a clinical trial that delivers the promise of a drug, it’s the effectiveness of it observed in the real world. We believe that technology holds the promise of mitigating this gap if we are sufficiently curious to understand how to do it.

The question is how to take a structured approach to capture and characterize behavior and potentially provide “cognitive behavioral therapy” to modify behavior.

Our Specific Solutions to Capture and Assess Behavior are as Follows:

Clinical ink excels in capturing data directly from patients in clinical trials in a patient-centric manner. We now have an important opportunity to gain insights beyond capture of endpoints into behavioral aspects impacting clinical trial protocols. If patients are unable to adhere to the drug treatments or follow trial protocol procedures, neither they nor the sponsors will have the insights needed to thoroughly evaluate new treatment options for “people like them”, and the patients in the trial will have to be replaced, adding cost and time.

We have thus partnered with Observia, the developer of SPUR, and together we are for the first time bringing a clinically validated digital behavioral assessment into clinical trials for drug development programs.

SPUR stands for “Social, Psychological, Usage, and Rational”, the four overarching dimensions categorizing the drivers of patients’ decision-making processes. SPUR is a dynamic and predictive assessment tool that integrates decades of proven behavioral science into a validated digital solution for detecting a patient’s risk of non-adherence and the drivers of their health behavior.

In our integrated solution, investigators are provided with insights into risk of non-adherence as well as specific underlying drivers of the risk. For example, two people could both present the same high risk of non-adherence, but for one, that might be because they have limited understanding of the benefits of the proposed treatment coupled with a difficult family situation whereas the other person’s risk is primarily driven by more practical difficulties.

Conclusion

Every individual has a unique personality. The best way to ensure their successful participation in a clinical trial is to formally assess their behavior and risk of adherence, and ensure they have the right support.

Having these insights available in real time will provide clinical trial investigators with objective and validated points to consider in the enrollment of patients, and adequately manage the risk of dropout and adherence to drug and protocol.

Authors

Jonathan Goldman, M.D.
CEO
Clinical ink

Christian Born Djurhuus, M.D., PhD, BSc.
Diabetes Advisor to Clinical ink
Owner of Djurhuus Consulting

WATCH ON DEMAND

 

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Our recent blog, published in DIA Global Forum, discusses how technology and human involvement can work together to conduct clinical trials in a compliant and safe manner. In this article, Bill Barrasso, Clinical ink Chief Compliance Officer, refers to the recent guidance from the FDA and EMA on using digital health technologies, software, and electronic data in clinical research. Bill also provides some recommendations and best practices for sites and sponsors to ensure effective planning and communication, as well as patient well-being and safety.

Read Human Interaction: Risk-Mitigation Recommendations When Using Technology in Clinical Trials and learn more about how effective planning and human engagement complement technology use in trials.

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A Burden on Time and Resources

The process of ethics committee review often involves meticulous scrutiny of trial-related documents, with the aim of safeguarding patient rights, welfare, and well-being. However, the existing practice of demanding all translations of eCOA materials as screenshots has come under scrutiny. This practice places a significant burden on study teams, sponsors, and providers of eCOA systems. Additionally, it can lead to unintended delays in study approvals, hampering the timely initiation of clinical trials and, consequently, access to potential therapies for patients.

An Ethical and Efficient Approach

Advocates of change argue that the focus of ethics committee reviews should center on patient rights, welfare, and safety, rather than demanding exhaustive translations of all eCOA materials. This perspective is in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) Guideline for Good Clinical Practice (GCP), which emphasizes patient consent, recruitment, and safety. The key points in favor of this revised approach include:

Contextual Examination: ICH GCP specifies that ethics committees should review written information intended for informed consent and recruitment purposes. This implies that the review of diaries and questionnaires, which serve a scientific purpose in data collection, should be treated differently from consent-related materials.

Scientific Relevance: A thorough examination of the English versions of eCOA materials allows ethics committees to assess the scientific relevance, history of validation, and sensitivity of content.

Patient Burden: Ethical oversight should focus on evaluating the potential burden on trial participants and assessing any incentives that might influence patient participation. 

Quality of Translation: Instead of requiring exhaustive translations of eCOA content, ethics committees can rely on certificates of translation (CoTs) as evidence of rigorous translation processes.

Efficiency: Approaching eCOA review in this way can streamline the ethics committee approval process, reduce administrative burden, and facilitate timely initiation of clinical trials, thus expediting access to potential treatments for patients.

Clinical ink’s Expertise Aligns with this Approach

1. Streamlined eCOA Review

Clinical ink’s eCOA solutions can significantly streamline the review process by providing comprehensive questionnaires and diaries, allowing ethics committees to focus on the scientific relevance, patient burden, and safety aspects. Clinical ink technology empowers trial sponsors to present these materials in an organized, standardized, and easily accessible manner, reducing administrative complexity and accelerating the review process.

2. Scientific Scrutiny and Patient Welfare

By providing accurate and validated eCOA instruments, Clinical ink helps sponsors uphold the highest quality standards in data collection while ensuring that patients’ needs and well-being are prioritized.

3. Efficient Translation Management

Clinical ink solutions facilitate efficient translation management by enabling accurate and timely translations of eCOA content while maintaining quality and consistency. This feature resonates with the recommendation to provide certificates of translation (CoTs) as evidence of rigorous translation practices.

4. Timely Study Initiation

Clinical ink supports timely study initiation, reducing the time-to-market for potential therapies. This aspect is crucial for both the scientific advancement of treatments and improving patient access to novel interventions.

5. Access to Quality Data

Clinical ink eCOA solutions ensure that high-quality data is collected from patients, addressing the potential compromise on data quality when sponsors resort to paper diaries and questionnaires due to perceived efficiency gains. 

Embracing a New Ethical Standard

The proposed shift in eCOA review practices encourages ethics committees to focus on their core responsibilities while allowing the scientific community to maintain the high standards required for research integrity. By offering comprehensive eCOA solutions, Clinical ink empowers clinical trial stakeholders to navigate the evolving landscape of ethical oversight and operational efficiency while advancing medical research and improving patient care.

Contact us to learn more about how Clinical ink’s eCOA solutions can enhance your trial efficiency.

Bill Barrasso, Chief Compliance Officer at Clinical ink, contributed to a Bloomberg BNA article that highlights the challenges and shift in thinking outlined above.

Read the full article, “Optimizing Electronic Clinical Outcome Assessment Materials Required for IRBIEC,” by submitting our interest form.

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Design for Success: Integrate DCT elements from the start

One of the primary challenges in implementing DCTs is attempting to fit decentralized technologies into a protocol originally designed without their consideration. FDA guidance emphasizes the importance of designing protocols with DCT elements from the outset. Sponsors and investigators need to evaluate whether the study design lends itself to a fully decentralized approach, and if not, consider a hybrid model. Clinical ink experts are available to consult on the protocol design, providing guidance on which DCT technologies might best support study objectives and enhance the patient experience.

Accessible Trials for All: Provide provisioned devices for inclusivity

Ensuring access to technology for all patient populations is crucial for the success of DCTs. FDA guidance suggests providing approximately 15% of the study population with provisioned devices as part of a BYOD solution. This approach addresses patients who lack access to smartphones and caters to those who may not feel comfortable using their own personal devices for clinical trial purposes. Robust user testing and comprehensive translation capabilities can further enhance diversity. Clinical ink recommends user testing to assess accessibility and usability for different patient populations. Our in-app translation tools make it easy to manage multiple translations, ensuring all patient populations can fully engage in the DCT experience.

Empower Sites for Patient Care: Define clear roles for sponsors and investigators

FDA guidance emphasizes the importance of defining distinct roles and responsibilities for sponsors and investigators. In addition, Investigators should have ready access to all patient records generated during the trial to enable informed decisions regarding patient care during the trial and after it has completed.

Meanwhile, sponsors should incentivize sites to meet regulatory requirements regarding patient records.

“Sponsors should assign a final site payment once all patient data has been downloaded to the site servers for ongoing review as needed if a concern arises regarding patient safety. This serves as a reinforcement for sites to prioritize this crucial step.”

Bill Barrasso, Chief Compliance Officer, Clinical ink

By clarifying the roles of each party, sponsors ensure their sites are empowered to provide optimal patient care. Clinical ink technology facilitates connectivity between sites and patients, reducing site burden while providing them the tools and services to meet regulatory requirements.

Prioritize Patient Safety: Implement proactive Adverse Event (AE) reporting

Patient safety remains the top priority in DCTs. The recent FDA guidance advises having a clear plan for AE reporting, including instructions for patients to directly contact site personnel or emergency medical staff if needed. Clinical ink recommends incorporating patient instructions in e-diaries to remind patients to promptly communicate any worsening conditions to their healthcare provider.

Ensure Regulatory Compliance: Meet 21 CFR Part 11 standards

Clinical Ink technology is compliant with 21 CFR Part 11, which is mandatory. Clinical ink employs robust security measures, manages training, and processes to ensure compliance at every stage of the study.

Clinical ink has extensive experience, supporting more than 75 global DCTs. Our technology, services, and clinical expertise align with the regulatory guidance, providing our clients with the tools and support to conduct successful DCTs. It is important to remember that while technology can help facilitate the operational aspects of DCTs, it is the human element, prioritizing patient safety while adhering to regulatory guidelines, that remains key in achieving successful DCT outcomes.

For more information on solutions for DCTs, download our whitepaper, “A Prerequisite for More Flexible Clinical Trial Designs: an Integrated eSource Solution.”

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CGM’s Role in Clinical Trials

CGM devices are wearable sensors that continuously measure glucose levels in the interstitial fluid under the skin, providing a comprehensive picture of glucose fluctuations throughout the day and night. These devices have improved significantly in terms of accuracy, precision, usability, and affordability in recent years. They have also been approved for use in fully closed loop systems that automatically adjust insulin delivery based on CGM data.

Integrating CGM devices into clinical trials however, presents various challenges, such as device connectivity, data synchronization, patient adherence, exercise tracking, food intake recording, and data integration. Recognizing these complexities, Clinical ink simplifies data collection through its seamless integration with the Clinical ink eSource platform.

The Clinical ink CGM Solution Enhances Patient Safety and Data Accuracy

Clinical ink’s integrated solution enables remote data collection, central storage, and analysis of sensor data from FDA-approved CGM devices in diabetes clinical trials. The platform provides centralized access to compliant CGM metrics, behavioral, cognitive, and biometric measures, while also prompting patients to complete electronic patient-reported outcome (ePRO) questionnaires following hypoglycemic events. This real-time data empowers researchers with valuable insights into treatment adherence, exercise patterns, and food intake, facilitating more effective interventions and faster decision-making.

The FDA’s guidance underscores the significance of hypoglycemia as an endpoint in diabetes clinical trials and emphasizes the role of CGM devices in capturing and analyzing blood glucose data. By leveraging CGM devices within Clinical ink solutions, researchers gain near real-time insights into the effects of diabetes treatments on blood glucose levels, behavior, and physiological responses.

This comprehensive data approach leads to more personalized interventions, improved patient outcomes, and accelerated decision-making processes. By harnessing the power of continuous glucose monitoring, researchers can achieve greater accuracy, enhance patient safety, and streamline data analysis, paving the way for advancements in diabetes care and empowering individuals living with the condition to lead healthier lives.

To learn more about the Clinical ink CGM solution and its impact on diabetes clinical trials, visit here.

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by Anna Keil

Senior Software Engineer, Clinical ink

When patients present for treatment at a clinic, physicians are trained to combine the results of objective assessments with their general observations to form a more complete picture of the patient’s health status. In much the same way, by fusing data from different real-world assessments using technology to continually collect and analyze data, we can gain a more complete — and indeed a more accurate — picture of the patient for clinical research.

Defining Continuous Data Collection

Continuous data collection involves tracking various aspects of a patient’s everyday life using wearables and mobile devices equipped with sensors. There are two types of continuous data: active data and passive data.

• Active data involves performing specific tasks within a defined period to provide known data patterns. For example, in Parkinson’s disease studies, patients may be asked to perform instrumented motor tasks to measure steps, gait, and tremors.
   
• Passive data collection occurs naturally in the context of patients’ normal routines, eliminating the need for active participation and providing a comprehensive view of a patient’s behavior and health in real-world settings.

Enhancing Traditional Clinical Measures with Continuous Data

Integrating continuous data with traditional clinical measures enables a more holistic view of patients and their conditions. It provides numerous benefits to studies such as greater objectivity, sensitivity, and more opportunities to detect patient or disease changes. 

Additionally, it enhances patient convenience, improves compliance rates (Clinical ink has observed up to a 98.3% compliance rate), and provides real-time situational awareness in clinical studies. By fusing data from wearables, sensors, and other sources, researchers can develop digital endpoints and biomarkers, gaining a deeper understanding of therapy efficacy and its impact on a patient’s quality of life, and enabling more sensitive patient monitoring.

Examples of sensor fusion with continuous data streams include:

• Voice data combined with patient diaries for respiratory studies
   
• Passive data from smartwatches integrated with active movement tasks for movement disorder research
   
• Mobility data from GPS or Geographics Information Systems (GISes) in conjunction with other health-related information to assess a patient’s quality of life across various disease states

Sensor fusion is a key driver of innovation in clinical research. By leveraging advanced technologies alongside sensor fusion, such as disease-focused feature engineering and artificial intelligence, researchers can accurately classify disease status and predict outcomes with better accuracy.

Ensuring Success in Continuous Data Capture and Analysis

Capturing and analyzing continuous data requires expertise in designing data capture processes and selecting the appropriate platforms for ingestion, storage, processing, monitoring, export, and analysis. Without the right skills and tools, managing the volume and complexity of continuous data can become overwhelming.

Partnering with experienced teams, such as the Clinical ink Advanced Technology Team, ensures the successful capture, processing, and analysis of complex eSource data and empowers researchers to make informed decisions and meet study goals effectively.

Read more about the Clinical ink Advanced Technology Team and its goals in this DPHARM interview.

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At the heart of EOM is a patient-centered approach that considers the unique needs of oncology patients. By providing better support, improving patients’ comprehension of diagnosis and prognosis, and enabling them to adhere to their treatment plan, EOM seeks to enhance patients’ care experience. Key to its success is the redesign of activities and the implementation of patient-focused technology, including electronic patient-reported outcomes (ePROs) and health-focused social screening tools. This technology provides valuable data for better decision-making in treatment, as well as increasing patient and caregiver satisfaction.

How will oncology patients benefit from this patient-centric, clinician and technology-driven EOM?

• EOM puts the patient at the center of a care team that provides equitable, high-value, evidence-based care
   
• Patients will have 24/7 access to care, patient navigation, and care planning
   
• EOM increases engagement of patients, oncologists, and other payers in value-based care and quality improvement
   
• Improved care quality, health equity, and health outcomes can be observed, while achieving savings over the course of the model test

By leveraging the benefits of EOM, oncology care can be delivered more efficiently and effectively.

The success of EOM will depend in part on the effective integration of technology. Solutions like Clinical ink ePRO provide a simple and intuitive interface for patients who are already overwhelmed from both disease and treatments, while streamlining the data collection process for physicians and oncology practices offers reliability and accuracy to improve overall patient outcomes.

It is clear that patient-centered care is at the forefront of the oncology community, and the EOM is just one example of this shift in focus. For sponsors and CROs, it is critical to adopt a similar patient-centric approach when designing oncology studies. By considering the unique needs of oncology patients and leveraging technologies like Clinical ink eSource, sponsors and CROs can improve patient experience and safety, clinical data quality and integrity, and the efficiency of healthcare providers and study teams.

To learn more about Clinical ink patient-centered solutions that align with the goals of EOM, download our factsheet Eliminate Barriers to Cancer Research with Clinical ink ePRO or speak to an expert to see how we can help.

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Sponsors considering using data from sensors and wearables in their clinical trials worry about three scenarios: collecting too little data, collecting too much data, and collecting bad data.

Each outcome could likely impact their study or a portion of it with a significant waste of time, money, and patient goodwill.

How can you de-risk the use of directly captured data from patients? How can you ensure that incoming data is properly ingested, stored, consumed, and managed to avoid potential issues?

Consider the specialized expertise required to integrate the right data collection application—a unified data platform—and the most advanced analytical methodologies.

Here is some insight from the Clinical ink Advanced Technology Team:

Solving “Too Little Data”

Sponsors may end up with too little data and insufficient statistical power when a protocol is too taxing for patients. Recruitment falters and adherence drops off. Getting expert consultation on protocol design provides an early and thorough assessment of all the abilities and limitations of the target patient profile.

Understanding patient insights and the use of patient-centered measures and assessments guides the technology strategy that will help prevent situations leading to “too little data.”

Clinical ink on Solving “Too Little Data”

In one assessment, recommendation against requiring prospective participants to complete a nearly 100-question survey at the start of the study could prevent loss of participation.

Evaluation concluded the process represented a burden that the particular patient population may not overcome.

Managing “Too Much Data”

Can you ever really have too much data? Maybe not, but wearables and sensors generate colossal and continuous streams of data. You can have more data than a particular system can handle or analysts can interpret.

The Clinical ink solution involves using a data platform that can store, process, and analyze any type and volume of data associated such as patient cognition, mobility, and phonation. Technology led by an expert analyst team converts incoming raw data into file formats — and ultimately dashboards — that Sponsors can easily consume (See Fig. 1).

Clinical ink on Managing “Too Much Data”

For instance, one assessment used in studies in Parkinson’s disease and COVID is a verbal phonation exercise in which the patient is asked to sustain a certain sound (such as “ah”). The incoming data is binary — a series of ones and zeros — and readable only by machines.

Converted into human-readable files that contain variables enables data scientists to screen important data for analysis. Getting reports and visualizations for data analysts to query the data is crucial in detecting signal patterns and drawing conclusions.

 

Preventing “Poor Quality Data”

Ensuring that the data collected from sensors and wearables is clean and usable requires a deep understanding of the therapeutic area, a detailed knowledge of industry standards, cutting-edge research analytical practices, and a patient-centered approach.

To ensure that collected data is of the highest integrity, here are few rules:

 

• • Rely on applications and tools that have been evaluated for that specific research purpose. In any therapy area, leverage industry standards and consult with experienced research leaders to determine what signals will be most meaningful.
     

• • Apply patient science, using qualitative and quantitative data collection methods, to ensure that the research approach is centered around the patient rather than the technology.
     

• • Design applications to create an excellent user experience that encourages adherence to the protocol and minimizes the opportunity for “user error.”
     

• • Clean and filter data, at the individual patient level, to maximize usability and efficacy for data analysis and modeling.
     

• • Consult your own quality control dashboards as data points come in and at the conclusion of studies to continuously improve methodologies.
     

Concerns over volume and quality of data generated in a trial are natural and should always be discussed as potential risks. Consider overcoming these challenges as fundamental to the success of any study — particularly those using eSource and more complex streams of patient data gathered from sensors and wearables.

To learn more about how Advanced Technology Teams in our industry operate, and how they prepare some of the most complex datasets for analysis, read “Debunking Complex Data Preparation and Analysis.”

Author

Anna Keil
Senior Software Engineer, Clinical ink

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Joan discusses how adopting technology in clinical trials can expedite the trial process, allowing sponsors to more quickly recover their investments. Technology is transforming the clinical research landscape by streamlining regulatory and compliance processes, study design, monitoring, data management, and retention of participants. Even before the start of the trials, technology through online social platforms can be used to effectively identify the right candidates for a study in the planning and recruitment stages of the trial process.

Combining machine learning algorithms and predictive modeling to analyze data helps to identify patient populations that are likely to be interested in the study and meet eligibility criteria. To maximize the effectiveness of these innovative data sources for clinical trial recruitment, however, it is important to use a targeted approach that identifies the right candidates for the study. This can be achieved by ensuring that the recruitment messaging is clear, culturally sensitive, engaging, and resonates with the target audience.

Joan also delves into how consumer wearables are transforming clinical trials by providing a wealth of real-time, objective data on patients’ health and behavior. Additionally, wearables help reduce patient burden by allowing patients to easily participate in a clinical trial from their homes. This encourages increased patient engagement in trials by providing them with a sense of ownership over their data and allowing them to track their progress, leading to improved compliance and retention. Quality data is captured more frequently which, in conjunction with patient-reported outcomes on mobile apps, give insight to patient health and behavior during the trial to provide a more complete picture of the patient’s experience.

Listen to The Real Chemistry podcast to hear Joan Severson, Chief Innovation Officer, Clinical ink, and other panelists Bryan J. Hansen, Ph.D., Maimah Karmo, and Aaron Strout as they shed light on the challenges of clinical trials and the importance of patient involvement.

Talk to one of our Clinical ink experts to learn how our technology can help with your trial success.

The post From Data to Insight: Leveraging Technology for Clinical Trial Success appeared first on Clinical ink.