CLINICAL TRIALS PROFILE FOR ANDROID-F

All Clinical Trials for Android-f

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02107014 ↗	Low Dose Naltrexone (LDN) Immune Monitoring	Completed	Stanford University	N/A	2014-03-01	We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.
NCT02107014 ↗	Low Dose Naltrexone (LDN) Immune Monitoring	Completed	University of Alabama at Birmingham	N/A	2014-03-01	We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.
NCT02897934 ↗	CWI and Discharge After Breast Cancer Surgery	Completed	University College Cork		2016-08-01	The objectives of this work are threefold: 1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major breast cancer surgery 2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a 23 hour model of care 3. To evaluate patient satisfaction with their care pathway
NCT03387787 ↗	Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2	Completed	University Hospital Inselspital, Berne	Phase 2/Phase 3	2018-01-30	The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data. The GlucoTab® system was found capable to keep hospitalized diabetic patients in the recommended target range without increasing the risk for hypoglycaemic events. Insulin pharmacokinetic is a critical confounder of glycaemic variability and the main determinant of an algorithm-based decision support-system. GlucoTab® is intended for being used with a basal/bolus insulin regimen. Up to date, feasibility data are limited to the use of insulin glargine. Insulin degludec, an ultra-long acting basal insulin is characterized by a stable pharmacokinetic profile a half-life of ~25 hours. It was found equally effective to insulin glargine with respect to glycaemic control, while the incidence of (nocturnal) hypoglycaemia was smaller in patients treated with insulin degludec. Within the present study, insulin glargine will be replaced by insulin degludec, which is not yet approved for dose titration with GlucoTab®. In the present study, 15 non-critically ill T2DM patients, who were hospitalized at the University Clinic of Neurosurgery for various reasons and require insulin treatment will be recruited. Patients will be treated with insulin Tresiba and insulin Novorapid. For a maximum duration of 21 days, GlucoTab® will calculate the required insulin doses for each patient, depending on fasting plasma glucose and postprandial glucose measurements during the day. After the calculated Insulin dose has been approved by the physician, the nursing staff will give the dose to the respective patient. The present study will analyse the efficacy of GlucoTab® for glycaemic management in T2DM patients using insulin degludec.
NCT03953326 ↗	HeartPhone Cancer Survivors Trial 2019	Terminated	Penn State University	Phase 1/Phase 2	2019-04-23	This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.

Clinical Trial Conditions for Android-f

Condition Name

Condition Name for Android-f
Intervention	Trials
Breast Cancer	2
Occipital Neuralgia	1
Diabetes Mellitus	1
Pain	1

Condition MeSH

Condition MeSH for Android-f
Intervention	Trials
Diabetes Mellitus	3
Postoperative Hemorrhage	1
Pain, Postoperative	1
Renal Insufficiency	1

Clinical Trial Locations for Android-f

Trials by Country

Trials by Country for Android-f
Location	Trials
Canada	4
United States	3
Switzerland	2
Ireland	1

Trials by US State

Trials by US State for Android-f
Location	Trials
Vermont	1
Pennsylvania	1
California	1

Clinical Trial Progress for Android-f

Clinical Trial Phase

Clinical Trial Phase for Android-f
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Android-f
Clinical Trial Phase	Trials
Recruiting	3
Completed	3
Not yet recruiting	2

Clinical Trial Sponsors for Android-f

Sponsor Name

Sponsor Name for Android-f
Sponsor	Trials
Stanford University	2
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	1
University of Calgary	1

Sponsor Type

Sponsor Type for Android-f
Sponsor	Trials
Other	18

Clinical Trials and Market Analysis: Navigating the Future of Drug Development

Introduction to Clinical Trials Modernization

The landscape of clinical trials is undergoing significant transformations, driven by the need for efficiency, innovation, and enhanced patient safety. The U.S. Food and Drug Administration (FDA) has been at the forefront of these changes, introducing new guidelines and frameworks to modernize the clinical trial process.

Modernizing Clinical Trials: FDA's New Guidelines

The FDA has recently announced the availability of a draft guidance updating recommendations for good clinical practices (GCPs), adopting the International Council for Harmonisation’s (ICH) E6(R3) draft guideline. These updates aim to make clinical trials more agile and efficient without compromising data integrity or participant protections. The focus is on incorporating rapidly developing technological and methodological innovations into the clinical trial enterprise[1].

Key Updates in Clinical Trial Design and Conduct

• Innovative Trial Designs: The new guidelines encourage the use of innovative trial designs, such as decentralized clinical trials, which can streamline the trial process and reduce burdens on participants.
• Digital Health Technologies (DHTs): The use of DHTs, including wearable sensors, is promoted to facilitate more agile data collection and improve patient recruitment.
• Participant Safety and Data Integrity: The core principles of GCPs remain intact, ensuring that participant safety and data integrity are not compromised despite the introduction of new technologies and methods[1].

Market Analysis: Drug Delivery Devices and Clinical Trials

Drug Delivery Devices Market Outlook

The drug delivery devices market is projected to experience substantial growth, driven by advancements in technology and increasing adoption of innovative delivery systems. Here are some key points:

• Market Size and Growth: The market is expected to grow from USD 333.4 billion in 2023 to USD 713.1 billion by 2033, with a compound annual growth rate (CAGR) of 7.9%[2].
• Precision and Targeted Delivery: Advanced drug delivery devices are designed for precise targeting of tissues and cells, maximizing patient benefits and reducing side effects.
• Dominant Segments: Oncology, infectious diseases, respiratory diseases, and diabetes are the main application segments. Diabetes treatment devices held the largest market share in 2023 due to the increasing prevalence of diabetes[2].

Regional Analysis

• North America: This region dominated the market with over 39% revenue share in 2023, driven by the presence of major players and increasing adoption of drug delivery systems.
• Europe and Asia Pacific: Europe accounted for a substantial share and is expected to grow moderately, while the Asia Pacific region is anticipated to have the highest growth rate due to its large patient base and economic growth[2].

U.S. Clinical Trials Market

Market Size and Growth

The U.S. clinical trials market was valued at USD 25.81 billion in 2023 and is expected to grow to USD 41.57 billion by 2033. This growth is driven by the demand for innovative healthcare solutions and ongoing research efforts[3].

Key Drivers

• Regulatory Support: The FDA's stringent protocols and support for innovative trial designs are crucial drivers.
• Collaborations and Approvals: Recent collaborations and FDA approvals, such as the approval of SELARSDI, a biosimilar to Stelara, highlight the dynamic nature of the market[3].

Impact of Modernized Clinical Trials on Drug Development

Efficiency and Innovation

Modernized clinical trials are designed to be more efficient and flexible, incorporating innovative technologies and trial designs. This can lead to:

• Faster Evidence Generation: More agile trials can accelerate the generation of evidence for medical products, helping to bring new treatments to market more quickly.
• Enhanced Patient Safety: The use of DHTs and decentralized trials can improve patient safety by reducing the need for frequent hospital visits and enhancing real-time monitoring[1].

Example: Oncology Drug Development

In the field of oncology, which held a significant 21.7% share in the drug delivery market in 2023, modernized clinical trials are particularly impactful. For instance:

• Liposomal and Albumin Drug Delivery: These devices are used extensively in oncology to deliver drugs directly to cancer cells, reducing side effects and improving efficacy.
• Collaborative Research: Collaborations like the one between Exelixis and Arcus Biosciences to evaluate Zanzalintinib in combination with AB521 for advanced renal cell carcinoma exemplify the innovative approaches being taken in oncology clinical trials[2][3].

Future Trends and Projections

Technological Advancements

The future of clinical trials and drug development will be heavily influenced by technological advancements, including:

• Artificial Intelligence and Machine Learning: These technologies can help in data analysis, patient recruitment, and predicting trial outcomes.
• Telehealth and Decentralized Trials: The adoption of telehealth and decentralized trial designs is expected to continue, making trials more accessible and efficient[1].

Market Growth and Opportunities

The drug delivery devices market and the U.S. clinical trials market are poised for significant growth. Companies developing innovative pharmaceutical drug delivery products or systems have lucrative opportunities ahead. The increasing prevalence of diseases such as diabetes and cancer will drive the demand for advanced drug delivery systems and efficient clinical trials[2][3].

Key Takeaways

• Modernized Clinical Trials: The FDA's new guidelines aim to make clinical trials more agile and efficient while maintaining participant safety and data integrity.
• Drug Delivery Devices Market: The market is expected to grow significantly, driven by technological advancements and increasing adoption of innovative delivery systems.
• U.S. Clinical Trials Market: The market is projected to expand, driven by regulatory support, collaborations, and the demand for innovative healthcare solutions.
• Technological Advancements: Future growth will be influenced by technologies such as AI, ML, telehealth, and decentralized trials.

FAQs

What are the key updates in the FDA's new guidelines for clinical trials?

The FDA's new guidelines update recommendations for good clinical practices (GCPs), adopting the ICH E6(R3) draft guideline, which encourages innovative trial designs, the use of digital health technologies, and streamlined trial processes while ensuring participant safety and data integrity[1].

How is the drug delivery devices market expected to grow?

The drug delivery devices market is expected to grow from USD 333.4 billion in 2023 to USD 713.1 billion by 2033, with a CAGR of 7.9%, driven by advancements in technology and increasing adoption of innovative delivery systems[2].

What are the dominant segments in the drug delivery devices market?

The dominant segments include oncology, infectious diseases, respiratory diseases, and diabetes, with diabetes treatment devices holding the largest market share in 2023 due to the increasing prevalence of diabetes[2].

How is the U.S. clinical trials market projected to grow?

The U.S. clinical trials market is expected to grow from USD 25.81 billion in 2023 to USD 41.57 billion by 2033, driven by regulatory support, collaborations, and the demand for innovative healthcare solutions[3].

What role do digital health technologies play in modernized clinical trials?

Digital health technologies (DHTs), such as wearable sensors, play a crucial role in modernized clinical trials by facilitating more agile data collection, improving patient recruitment, and enhancing real-time monitoring[1].

Sources

1. FDA Announces Additional Steps to Modernize Clinical Trials - FDA Press Announcements, June 6, 2023.
2. Drug Delivery Devices Market Size, Share | CAGR of 7.9% - Market.US Report.
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace, April 26, 2024.