Health Decisions provides insight on industry issues and trends through white papers on a variety of topics in clinical development. Recent white papers are available for download as indicated below.
Health Decisions’ LiveTrial Data Management as a Service
Companies that wish to maintain existing federal contracts or seek new ones must establish compliance with the Federal Information Security Management Act (FISMA). Whether seeking federal contracts or not, organizations conducting clinical trials should recognize that compliance with the rigorous system of FISMA controls increases data security and reduces the risk of embarrassing and damaging security breaches. A Health Decisions white paper, Health Decisions’ LiveTrial Data Management as a Service: A Practical Solution for Achieving FISMA Compliance, Improving Data Security and Maintaining Eligibility for Federal Contracts, describes a straightforward FISMA-compliant data-management solution appropriate for organizations not yet prepared to implement their own FISMA-compliance programs.
Addressing the New Imperative to Include Females in Clinical Trials
Take the guesswork out of meeting your goals for recruitment of women with this new Health Decisions white paper. Addressing the New Imperative to Include Females in Clinical Trials explains how sponsors can efficiently enroll women in studies across the therapeutic spectrum and comply with new NIH and FDA policies. Drawing on experience in more than 300 trials, the white paper:
- discusses key issues in trials involving female subjects;
- reviews the literature on recruitment of women for trials in many indications;
- presents 35 field-proven tips for efficient recruitment and retention of female subjects.
Nine Tips for Success in Precision Medicine: Concise Guidance for Biopharma and Diagnostic Developers
Get a head start on securing your place in development of precision medicines and associated diagnostics by downloading Nine Tips for Success in Precision Medicine: Concise Guidance for Biopharma and Diagnostics Developers. Precision medicine is poised to go mainstream, with precision medicines accounting for more than 1 in 4 new drugs approved by FDA in 2015 and 42% of drugs in the pipeline. However, challenges vary by therapeutic area and indication. Securing your place in precision medicine requires staying abreast of developments in biomarker identification and validation, identification of subgroups in target populations, collection of evidence of clinical utility, and regulatory policy for LDTs and other companion diagnostics. Download Nine Tips for Success in Precision Medicine: Concise Guidance for Biopharma and Diagnostic Developers for tips on nine areas essential to success in the rapidly evolving field of precision medicine.
Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics
This white paper provides tips for successfully establishing the clinical utility of molecular diagnostics in order to ensure healthcare payer reimbursement and clinician adoption. Increasingly, diagnostics developers must demonstrate a link between diagnostic result and improved patient outcome despite the many steps and considerable time that often come between, including treatment decision, treatment and patient compliance or noncompliance. Download Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics – Stepping Stones to Precision Medicine and learn techniques for identifying and executing the optimal strategy for establishing clinical utility, including strategies for determining the need for a clinical trial to assess outcomes and efficiently conducting such a trial if required.
Phase 2c: Expedited Development for All
This white paper proposes a new development pathway that replaces phase 3 trials for most drugs, not just rare and orphan indications, and offers ideas on increasing efficiency and success rates now. The phase 2c development pathway would offer advantages including earlier revenue generation for sponsors, reduced risk vs. phase 3 trials, help covering phase 2c costs, incentives to identify biomarkers, early collection of evidence of reimbursability and earlier patient access to new medicines. Pointers on optimizing programs under current constraints address topics such as making the most of end-of-phase-2a meetings, managing go/no-go decisions, optimizing dose selection and utilizing adaptive design and operations. Download Phase 2c: Expedited Development for All – Accelerating Clinical Development Now and in the Future and learn about a proposed new expedited development pathway and practical steps to address clinical development challenges now.
Perfecting Phase 2: 10 Essential Steps
Utilizing commodity clinical development services in phase 2 is a recipe for disaster. The key to phase 2 success is individualizing every aspect of each trial to meet the specific requirements of the investigational product. Individualization must address key areas such as ensuring collection of data to support future label statements, defining go/no-go decision criteria, identifying optimal doses for phase 3, identifying satisfactory endpoints to demonstrate clinical benefit, performing protocol feasibility for each study, and balancing the selection of the population for each study with the need to support future product acceptance by a commercially viable market. Download Perfecting Phase 2 and learn about 10 essential steps for individualizing phase 2 clinical development and increasing your chances of a successful transition to phase 3.
Top 10 Medical Device Development Trends for 2015
Rapid advances in science and technology, evolving regulatory frameworks in the US and EU and reimbursement challenges that reduce access to venture capital are among the trends that will challenge the medical-device industry in 2015. Next Generation Sequencing, indication-specific molecular diagnostics, companion diagnostics and immunoassays will all drive the diagnostics market. Robust activity in a variety of medical implants and growing use of 3D printing will present new opportunities and challenges. FDA’s new regulatory framework for LDTs and the EU’s new Medical Device Regulation will have substantial and sometimes unpredictable effects. Download Top 10 Medical Device Development Trends for 2015 to prepare for the challenges of 2015.
Top 10 Clinical Development Trends for 2015
Clinical developers will face changes and challenges in 2015 on multiple levels. Patient-focused development, inclusiveness in recruitment and preparations for the EU’s new Clinical Trials Regulation will increasingly demand attention. Utilization of risk-based monitoring, Electronic Health Records, Bayesian statistics and adaptive designs will increase. Immunotherapies in oncology will join targeted therapies and Orphan Drugs as areas of intense activity. In CNS, developers will seek greater clarity in diagnostic criteria and endpoints while infectious-disease developers explore new approaches to existing and emerging challenges. Top 10 Clinical Development Trends for 2015 enables clinical developers to get a head start on a challenging new year.
Mitigating Phase 2 Development Risks
Phase 2 development often leaves projects with issues that prevent progression to phase 3 or later cause NDA delays and denials, including uncertainties about the appropriate dose, unsatisfactory endpoints and inconsistent results across sites and studies. This white paper discusses proven techniques that mitigate phase 2 risks in all therapeutic areas. Case studies provide examples of risk mitigation through adaptive designs and data-driven operations in a variety of indications, including major depressive disorder, acute bacterial skin and skin structure infections, multiple sclerosis, influenza, autism spectrum disorder and Alzheimer’s disease.
Ten Tips for Success in Biotech Development
Biotech development is a race from one decision point to the next where delays are likely and odds are against success. This white paper provides tips on reducing timelines and risk and improving success rates, drawing on direct experience on the front lines of biotech development as well as current information that includes the most comprehensive analysis to date of clinical development success rates by phase and an FDA analysis of reasons for denials and delays of NDA submissions. Download this white paper and increase your chances of success in biotech development.
From Here to Risk-Based Monitoring
Planning the transition to risk-based monitoring requires comparing solutions in several key areas including but not limited to SDV. This new white paper will ensure that you consider all the important issues and choose the right solution and transition strategy for your company.
Essential Tips for Success in Large IVD Clinical Trials
This white paper provides tips for addressing the major challenges that diagnostics companies face in the transition to large IVD clinical trials involving hundreds or thousands of subjects.
10 Steps to Optimize Patient Enrollment in Clinical Studies
Learn about the techniques that enable Health Decisions to enroll more than 83% of its studies on time or early in a variety of therapeutic areas and challenging indications.
Do’s and Don’ts of Adaptive Design in Clinical Trials
This white paper provides tips on getting started with adaptive design for those intrigued by the potential to increase flexibility and efficiency in clinical trials but uncertain about the issues involved.
Ten Developments Medical Device Sponsors Should Watch in 2013
The information in this white paper about developments in 2013 remains relevant for medical device projects today.
Reducing Risk in Biologics Trials: Targeted Trials for Targeted Therapeutics
Clinical testing of biologics trials heightens risks because of differences in fundamental areas such as patient safety and recruitment of highly targeted populations. Read this white paper and learn how to reduce risk and run efficient biologics trials.
Agile Risk-Based Monitoring+: Breakthrough Technology for More Efficient Trials
FDA and EMA openness to risk-based techniques opens new possibilities but also concerns such as ensuring data quality while reducing SDV percentage. Read this white paper and learn best practices for risk-based monitoring.
Agile Clinical Development: Increasing Success Rates, Speed and Efficiency in Clinical Research
Read this white paper and learn about Agile Clinical Development, a comprehensive methodology that increases efficiency in every aspect of clinical development, including not only operational areas such as monitoring and enrollment but also study design.