Plan the Clinical Trial Design – The Cloudbyz Way

Clinical trials are research investigations in which people volunteer to evaluate medical, surgical, or behavioral intervention. The trial confirms a new treatment, less side effects and helps to make a better life for people with a chronic health problem. The U.S. Food and Drug Administration(FDA) typically requires Phase I, II, and III trials to determine a drug to be approved.

Current Scenario of the clinical trial design adaptability

Clinical trial planning and design play a critical role in reducing the overall time for getting trials ready for study execution across the clinical sites. Critical increasing of costs in drug development is directly impacted by a larger portion of improper clinical trial planning.

The current scenario demands customized clinical trial design adaptability to the changing dynamic business models in drug discovery development.

Key technology trends to enhance Clinical trial planning and design

Clinical trials are incorporating data from many sources and the sponsors need to be able to incorporate financial data, operational data and real-world evidence of their R&D investments. Clinical research requires a technology platform to ingest and integrate data collected from all sources. The key trends that are impacting clinical trials:

1.Advancements in Adaptive clinical trial takes over traditional methods:

The adaptive trial design allows for modifications to key components of the trial. This innovative trial approach has the potential to reduce resource use, decrease time to trial completion, limit allocation of participants to inferior interventions, and improve the likelihood. The method promotes design modifications or statistical analysis procedures of an on-going trial and data generated. Simulated statistical models are the need of the hour with the ever-changing clinical research model.  

The new draft guidelines by the FDA indicates the increased risk of false positives (type -1 ) errors. The FDA in the new guidelines issues in 2018, recommends sponsors to determine appropriate statistical thresholds for interim and final analysis, to keep the type-1 errors below 2.5.

2.Automation to reduce time to study execution in clinical trial design management

The significant changes are executed in clinical trials moving towards eClinical technology-based solutions being used widely for automation drive. The latest recommended trend is the use of industry data standards and CDISC-based messaging format for storing and communicating. The storage of study components and easy-to-build eCRFs drives efficiencies of all clinical trial stakeholders – sponsors, CROs, and eClinical vendors.

3.Big data analytics and AI modeling is the next big bet on investment 

Enhanced data analytics and data mining applied around clinical trials will help CROs in cost-effective decision making. Increased agility for organizations with advancements in translational medicine, will require companies now to focus on artificial intelligence and adapt to the new business process. Artificial intelligence is now being used for predicting cancer treatment type based on the combination of genes in the planning stage. Projects in clinical trial registers can be decided in the planning stage by all relevant publications available.

Unmet Needs in Clinical trial design

  1. The industry faces a major challenge in planning the documentation with the ever-increasing complexity of new clinical trial products such as biologics, biosimilars and IoT connected medical devices.
  2. Delays in authoring and review exist in protocol development with ad-hoc use of standards and templates.
  3. Repeat process in developing each protocol from scratch-to-end delays process in developing eCRFs.
  4. Protocol amendment issues leading to a complex review process of multiple resources challenges the tracking of trial management documentation.
  5. Discrete storage of metadata repositories in different formats and limited access to data exchange as documents adds complexity.

Cloudbyz CTMS

Cloudbyz offers its end-to-end solution which eases the above challenges. The comprehensive features help the CROs to systematically track trial document from start to end, reduce delays avoiding unnecessary repeat processes. The solution helps to perform a feasibility survey via Portal, provides a centralized location for accessing and sharing all study-level information in a single one-stop solution. Study library serves as a repository for study-related training tools and documents reducing complexity. Cloudbyz CTMS is 100% compliant with 21 CFR Part 11 and other regulatory industry standards.

References

Abbreviations:

  • FDA: U.S. Food and Drug Administration
  • CRO: Clinical Research Organisation
  • APAC: Asia-Pacific
  • CTMS: Clinical Trial Management Solution
  • EHR: Electronic Health Record
  • EMR: Electronic Medical Record
  • R&D: Research and Development
  • AI:Artificial Intelligence
  • CDISC: Clinical Data Interchange Standards Consortium
  • eCRF: Electronic Case Report Form
  • IoT: Internet of Things
  • CFR: Code for Federal Regulations

By Rupam Debnath


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