Transformational growth of clinical trials through improvements in patient recruitment, stratification, monitoring and understanding drug response

DUBLIN, August 17, 2022 /PRNewswire/ — The report “Growth Opportunities for Digital Biomarkers in Drug Development” has been added to from offer.

The study focuses on 3 major therapeutic areas, neurology, oncology and cardiology, on which digital biomarkers have an impact.

Pharmaceutical companies spend billions of dollars on drug development due to expensive and time-consuming clinical trials with low success rates. Frequent clinic visits, manual data processing, and lack of consistent data on the effectiveness of investigational medical products contribute to their low success rate.

Digital biomarkers derived from wearable sensors and advanced algorithms provide the ability to continuously and remotely analyze the response of investigational medical products in clinical trials. Digital biomarkers eliminate the need for frequent clinic visits to monitor patient health.

The shutdown of clinical trials due to the COVID-19 pandemic has fueled the adoption of digital biomarkers for remote patient monitoring in clinical practices and clinical trials. Remote patient monitoring is imperative for pharmaceutical companies to conduct efficient clinical trials, reduce costs, and decide whether to continue or discontinue an investigational drug.

Efforts are underway by market players to turn digital biomarkers into digital measurements or endpoints in clinical trials. Digital biomarkers play an instrumental role in evaluating the efficacy and safety of therapy in DCTs and rapid patient recruitment.

Digital biomarkers offer pharmaceutical companies the opportunity to advance research into complex diseases, such as AD and PD, and find new biomarkers that demonstrate the efficacy of an investigational drug on the disease state of a patient in clinical trials.

Main topics covered:

1. Strategic imperatives

  • Why is it increasingly difficult to grow taller? The Strategic Imperative: Factors Putting Pressure on Growth
  • The strategic imperative
  • The impact of the top 3 strategic imperatives on digital biomarkers for the drug development industry
  • Growth opportunities fuel the growth pipeline engine
  • Research Methodology

2. Analysis of growth opportunities

  • Amid ambiguity among researchers, regulators have provided a numerical biomarker definition for clear expectations
  • Digital biomarkers may explain health variability in humans
  • Digital biomarkers are inexpensive, noninvasive, and relatively new to clinical practice
  • The role of digital biomarkers in accelerating the drug development process will increase dramatically
  • Digital biomarkers can revolutionize pharmaceutical clinical trials by solving major challenges
  • Development of digital biomarkers improves healthcare delivery and patient outcomes
  • Several publications present the use of digital biomarkers to measure health parameters or monitor pathological conditions
  • Digital biomarkers enable the shift from a product-based to a service-based model in the pharmaceutical industry
  • Growth engines
  • Growth constraints
  • Scope of analysis
  • Segmentation of applications (not exhaustive)

3. Growth Opportunities Analysis – Neurology

  • The complexity of neurological disorders and the slow pace of drug development represent a significant burden on the healthcare system
  • Digital biomarkers can accelerate clinical trials through remote patient recruitment and understanding of disease mechanisms
  • Speech activity and biomarkers are the emerging digital biomarkers in neurology clinical trials
  • Gait, speech and sleep are the main biomarkers that digital health devices collect in clinical trials
  • Pharmaceutical companies and universities collaborate to pursue neurology clinical trials with digital biomarkers
  • Smartphone application for data collection to provide digital biomarkers and ongoing monitoring of trial participants

4. Growth Opportunities Analysis – Oncology

  • Cancer leads to significant unmet need due to limited treatment options and understanding of the disease
  • Digital biomarkers help assess the quality of life of cancer patients, which is important in oncology clinical trials
  • Digital biomarkers for oncology are in the nascent stage of adoption for disease management and clinical trials
  • Digital imaging data is the primary digital biomarker that oncology clinical trials collect
  • Main companies involved in clinical trials using digital biomarkers
  • AI Technology for Identifying Digital Biomarkers for Accurate Skin Cancer Diagnosis and Better Treatment Selection
  • Analysis of growth opportunities – Cardiology
  • Cardiology complications result in millions of deaths each year, resulting in significant economic and health losses
  • Digital biomarkers enable remote data collection, improve accuracy of safety signals and eliminate patient inconvenience
  • Digital biomarkers in cardiology can improve the accuracy of disease diagnosis
  • Heart rate, blood pressure and physical activity are crucial digital biomarkers in cardiology clinical trials
  • Main companies involved in clinical trials using digital biomarkers
  • Evaluation of treatment strategy to reduce hospitalization-based digital biomarker collection via remote sensor technology

5. Regulatory landscape

  • FDA guidelines provide framework of evidence to support qualification of new biomarkers
  • Presentation of high quality data, benefits in drug development and evidence are key qualification requirements
  • FDA regulatory initiatives focus on development of digital health technologies and guide developers
  • EMA highlights important considerations for successful qualification of digital biomarkers that support drug approval

6. Industry Assessment and Analysis

  • Most pharmaceutical companies depend on technology development partners to implement digital biomarkers in clinical trials
  • Pharmaceutical companies should assess their reliance on tech developers and wearable devices for clinical trials
  • The NCI and NIA are the main institutes offering grants for digital biomarker research focused on oncology and neurology
  • Private funding focuses on the development of new digital biomarkers and the integration of patient-facing solutions with digital platforms
  • Public funding is focused on evaluating new digital biomarkers for the early diagnosis of diseases, such as cancer and neurological diseases
  • Market players are adopting partnerships and collaborations to accelerate the development of digital biomarkers
  • Established companies and start-ups are developing new digital biomarkers to improve clinical trials or advance research
  • North America is the largest adopter of digital biomarkers due to multiple companies and growing research funding
  • Case Study: Chugai Pharmaceutical Co., Ltd. – Digital biomarker initiatives
  • Case Study: Sanofi – Digital Biomarkers for CNS Clinical Trials
  • Digital biomarkers will play an important role in DCT implementation

7. Patent landscape

  • Digital biomarker innovations focus on developing mobile apps, software and analysis algorithms
  • Neurology and oncology are areas of interest for major digital biomarker patent assignees
  • Key patents

8. Universe of growth opportunities

  • Growth Opportunity 1: Digital Biomarkers for Recruiting Patients into Clinical Trials
  • Growth Opportunity 2: Digital Voice Biomarkers for Remote, Contactless, Continuous and Accurate Patient Monitoring in Clinical Trials
  • Growth Opportunity 3: Development of a new digital biomarker to accurately analyze patient drug response
  • Growth Opportunity 4: Analytical and clinical validation to assess digital biomarkers for use in clinical research

For more information about this report visit

Media Contact:
Research and Markets
Laura Woodsenior
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SOURCE Research and Markets

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