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- Recommendation
- Resource
Target Health applies CTTI’s Quality by Design recommendations
Bamboo Therapeutics applies CTTI’s Patient Group Engagement recommendations
Horizon and FARA apply CTTI’s Patient Group Engagement recommendations
Pfizer applies CTTI’s Patient Group Engagement recommendations
Northwell Health applies CTTI’s Single IRB recommendations
Genentech applies CTTI’s Informed Consent recommendations
ASCO Improves the Accuracy and Attribution of Serious Adverse Event Reporting in its Clinical Trials
ASCO cites CTTI’s Safety Reporting recommendations
The Feinstein Institutes for Medical Research at Northwell Health applies CTTI’s Investigator Qualification recommendations
The Medicines Company applies CTTI’s Investigator Qualification recommendations
Orikami applies CTTI’s Novel Endpoints recommendations
Genentech applies CTTI’s Digital Health Technologies recommendations
Solutions for addressing barriers in conducting antibacterial drug trials in the pediatric population
Solutions for optimizing DMC conduct
Solutions for designing and conducting a decentralized clinical trial
Recommendations for using digital health technologies intended for outcomes data capture
A figure summarizing the data and supportive information CTTI recommends be made available to FDA inspectors
A figure summarizing the supportive documentation CTTI recommends that sponsors include in their submissions to FDA
A table outlining CTTI recommended strategies for optimizing data quality at the point of collection when using a digital health technology
A table outlining CTTI recommended strategies for promoting and protecting data integrity
A table listing approaches for managing atypical data, including those data captured outside of the intended use of a digital health technology
A list of technical approaches that are being successfully implemented (at the time of recommendation publication)
A checklist for evaluating patient group expertise and assets
A one-page overview on CTTI’s Patient Group Engagement work and solutions
Solutions for maximizing the opportunities of patient group engagement in and around trials
A checklist for assessing patient group internal aspects
Solutions for planning for pregnancy testing in clinical trials
Solutions for building quality into the scientific and operational design and conduct of trials
Solutions for building quality into the scientific and operational design and conduct of trials
Considerations of key stakeholders to include in QbD discussions
A discussion tool for determining what aspects of a trial are critical and what strategies will support quality in these critical areas
A slide outlining the key components of adopting a QbD approach
Recommendations for employing an iterative “Plan – Do – Check – Act” approach to measurement
A list of tips for implementing a QbD process within your organization
Tips for recognizing the team that is championing QbD in your organization
Recommendations outlining considerations that are unique to the use of RWD in planning eligibility criteria and recruitment
Solutions for moving recruitment planning upstream and parallel to the clinical trial design process to ensure a successful trial
A decision tool for engaging stakeholders in study design and development
A tool to assist in considering how to monitor recruitment process and performance
A guide when considering whether and/or how to include PROs in your study
An editable chart that trial designers can use to identify and prioritize the stakeholders they may need to engage to ensure a successful trial
Solutions for assessing and designing registries so that the data meets expectations for FDA review of new products
Recommendations for using an electronic reporting portal to share expedited IND safety information with investigative sites
Recommendations for planning and implementing IND safety assessments
Solutions for addressing the remaining barriers and encouraging implementation of CTTI’s 2017 sIRB recommendations
Recommendations for using an sIRB for multicenter clinical trials
A resource highlighting specifications that sponsors should consider during digital health technology selection for each specific trial
A decision tool for trial designers, working with patients, to determine whether outcomes data should be shared with study participants in real-time via a digital health technology
A list of terms and definitions used in CTTI’s digital health technologies recommendations
An example detailing the verification and validation processes of a digital health technology
An example showing a feasibility study with a cross-over design to support the appropriate selection of digital health technologies for data capture
An example detailing an exploratory observational study to collect a variety of digital data from approximately 150 participants
A discussion tool outlining categories of legal and ethical responsibilities of an institution and an IRB in overseeing the conduct of clinical trials in a sIRB model
An example detailing a study that evaluated the utility of smartphone-based remote assessments to monitor Parkinson’s Disease symptoms
An example outlining a Phase 2a study that used a provisioned handheld technology for data capture and periodically shared data with study participants
A diagram outlining the typical passage(s) of data from its collection by a digital health technology through to the composite analysis dataset
A list of approaches to securing data generated by digital health technologies across its lifecycle
A checklist for investigative sites that are budgeting and contracting for a clinical trial using digital health technology
A checklist for sponsors that are selecting and equipping sites for a clinical trial using digital health technology
How the mPower study successfully interacted with participants during its trial
Resource for implementing CTTI’s Engaging Patients and Sites recommendations
Resource outlining opportunities for patient and site input into a digital health trial
Solutions for engaging patients and sites when planning a digital health trial
Solutions for using digital health technology-derived novel endpoints to support regulatory approval and labeling claims
A resource outlining CTTI’s step-by-step recommended approach to novel endpoint development
Chart summarizing the process of developing a novel endpoint, generated by digital health technologies, for use in clinical trials
A case study detailing the development of a novel endpoint for diabetes studies using CGMs as a measure of interstitial glucose values
A case study on the development of a hypothetical endpoint for DMD that measured physical activity level with an accelerometer
A case study describing how a novel physical activity endpoint measured using accelerometer technology could be developed
A case study case exploring the possibility of developing accelerometer-derived endpoints for use in PD studies
A chart for assessing patient groups’ relationships with other groups
A Tufts report outlining recommendationg for variables to input into eNPV models to measure return on patient engagement assessments
A high-level summary of CTTI’s Patient Group Engagement work and solutions
A framework for CROs to identify measures that quantify the outcomes of QbD implementation and guide continuous improvement efforts
A tool for research organizations to assess their current implementation of QbD for clinical trials and to identify a desired future state
A tool for study teams to plan their implementations of QbD for an individual clinical trial
A tool for study teams to capture and communicate decisions about what is critical to quality and how the most important risks will be proactively addressed
Tips and recommendations are to support a QbD workshop facilitator
An example of a cardiology study using a QbD approach
An example of a surgery study using a QbD approach
An example of a pancreatic cancer study using a QbD approach
An example of a schizophrenia study using a QbD approach
An example of a study that used RWD to more quickly and accurately determine the right patient eligibility requirements
An example of a study that used RWD collected during the routine care of patients to determine a study’s eligibility criteria
An example of a study that used RWD to determine if they should expand their eligibility criteria to include a third-line treatment
A resource for planning a successful and patient-centric RWD-supported recruitment approach
Tips for using RWD as a standard process for planning eligibility criteria and recruitment
Considerations for determing whether available RWD sources can be used to support design of eligibility criteria and/or recruitment
A checklist for discussing eligibility criteria over the course of designing a trial
A checklist for discussing eligibility criteria over the course of designing a trial
Recommendations for reporting SAEs to IND investigators
A tool to assist in considering engagement with an institution, per OHRP
Scenarios that illustrate examples of institutional involvement in research that would be considered engaged, as well as not engaged
A list of engagement terms and definitions used in CTTI’s sIRB recommendations
Solutions for conducting successful GCP trainings
A documentation tool for conducting the informed consent process
A documentation tool for informed consent trainings
An example outlining the basic structure of a tiered informed consent model
Solutions for conducting the informed consent process and training
Solutions addressing the high rates of clinical trials investigator turnover at research sites
Solutions for more efficient and effective means of qualifications
A resource illustrating how mentoring programs and knowledge-sharing networks are being implemented
A one-page overview on documenting qualification
A template for investigators and their delegates to maintain a record of qualification activities
A resource of attributes that investigators and their delegates can control and modify through learning
A guide to using CTTI’s various sIRB Institutional Engagement resources
A list of educational resources, templates, and tools to facilitate the use of a sIRB for multicenter clinical trials
CTTI’s recommendations to the NIH on its sIRB Policy evaluation framework
Summary of CTTI’s historical work and deliverables from its sIRB work
A template IAA intended to address an administrative concern about using a sIRB for multicenter clinical trials
A summary report of CTTI’s work leading to the launch of its 2013 sIRB recommendations
Solutions for addressing safety data collection in HABP/VABP trials
Solutions for streamlining protocol elements for HABP/VABP trials
A checklist for evaluating an institutional self-evaluation, an institution/sponsor evaluation of an sIRB, and an sIRB evaluation of an institution
Resource outlining pathways for identifying, initiating, and training site investigators
A list of available resources for investigator training and learning
Alexion applies CTTI’s Quality by Design recommendations
UCB Biosciences applies CTTI’s Patient Group Engagement recommendations
USDRN applies CTTI’s Patient Group Engagement recommendations
Fight CRC applies CTTI’s Patient Group Engagement recommendations
CFF applies CTTI’s Patient Group Engagement recommendations
FasterCures applies CTTI’s Patient Group Engagement recommendations
The Medicines Company (now Novartis) applied CTTI’s Quality by Design recommendations
HPS Network applies CTTI’s Patient Group Engagement recommendations
PFMD applies CTTI’s Patient Group Engagement recommendations
Horizon Therapeutics applies CTTI’s Patient Group Engagement recommendations
MJFF applies CTTI’s Quality by Design recommendations
Be The Match Jason Carter CTSS uses CTTI’s AACT database
DCRI’s PTN applies CTTI’s Pediatric Trials in Antibacterial Drug Development recommendations
T. Symons applies CTTI’s Quality by Design and Recruitment recommendations
DCRI implements CTTI’s Quality by Design principles
DCRI applies CTTI’s Quality by Design recommendations
DCRI uses CTTI’s Patient Group Engagement recommendations to build its ‘Research Together’ program
KUMC applies CTTI’s Quality by Design recommendations
NIH cites CTTI’s Large Simple Trials project in funding announcement
Curebase applies CTTI’s Decentralized Clinical Trials recommendations
PPMD applies CTTI’s Patient Group Engagement recommendations
ACTA applies CTTI’s Patient Group Engagement recommendations
CTTI Novel Endpoints Launch Webinar Slides...
An interactive selection tool to discern between two viable novel endpoints for development
A case study on ALCHEMIST, a set of randomized clinical trials operating under an overarching master protocol sponsored by the
Nation Cancer Institute.
A guide for developing the written content of a master protocol and sub-protocols
A list of references and resources for learning about the concepts of master protocol, adaptive platform trials, basket trials, emerging best practices, and regulatory guidance related to master protocols
A case study detailing STAMPEDE, a multi-arm, multi-stage platform trial.
Four emerging best practices, and correlating CTTI resources, for driving multi-stakeholder collaboration and mobilization during a master protocol study
The process for interacting with the CDRH and CDER at the FDA, as it relates to novel endpoint development
A slide deck that walks you through CTTI’s QbD Maturity Model with scoring examples
A tool sponsors can use to help interact with FDA during the pre-planning and planning stages of a master protocol development
A complete guide to the three stages – pre-planning, planning, and execution – of conducting a master protocol study
This tool provides an overview of components of statistical simulation and tips for how to organize presentations of simulated trials to key stakeholder groups
A document outlining key scientifc, operational, and funding considerations that can support early adopters’ efforts to think through the “why” and “how” of developing a master protocol study
A tool that helps sponsors and operations partners to best prepare for executing core operations functions within the master protocol trial
An interactive tool that helps investigators, sponsors, regulators, and others in designing a pregnancy testing plan for a clinical trial by estimating the likelihood of a woman enrolling in the study while pregnant, or becoming pregnant during the study.
A tool that helps patient groups and clinical research sponsors identify high-value opportunities to work together
A repository of feasibility studies using digital health technologies to capture data in clinical trials that helps researchers to better match appropriate technologies to their trial goals
Recommendations for properly assessing the landscape of applicable laws to take the appropriate steps needed to deliver an intervention to digital health trial participants.
Recommendations to guide conversations with regulators during the design and conduct of a digital health trial.
Recommendations for understanding, planning for, and addressing the new challenges associated with using digital health technologies in clinical trials
Recommendations for developing a robust digital health technology management plan for sites
Recommendations for understanding what needs to be considered and measured before selecting a digital health technology
A publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov.
An abbreviated version of CTTI’s full set of recruitment recommendations.
Case Study: The Medicines Company Developed Nimble Protocols to Scale for Global Trials...
Case Study: Emphasis on Protocol Design Helps Alexion with Timeline Adherence...
Case Study: DCRI Streamlines Protocol Using Quality by Design Thinking...
Case Study: University of Oxford CTSU...
Long Shot COVID-19 Treatment Yields Fast, Promising Results Using Decentralized Trial Approach...
Can Patients Moderate Research Panels as Effectively as Clinicians? Yes – And They Might Be Better...
Stakeholder Collaboration Yields Recruitment Success in Traditionally Challenging Vulnerable Populations...
Philips Offers Best Practices for Inclusion of Digital Health Technologies in Trials, Leading to Better-Prepared Sites and Improved Data Outcomes...
Clear Roadmap of Requirements Allows Roche to Speed Multiple Sclerosis App Development...
Quality by Design Helps EMD Serono Streamline its Protocol Through Inclusion of New Perspectives...
University of California Irvine’s Multidisciplinary Trial Design Studios Yield Streamlined, Considered Protocols...
Rho Combines CTTI Resources to Operate with Optimal Efficiency and Data Quality...
Recommendations to sponsors for planning decentralized clinical trials
A resource outlining the steps needed to clear a path forward for decentralized clinical trial implementation
A resource detailing considerations for assessing the landscape and delivering an intervention to trial
participants
Updated recommendations focused on driving novel endpoint use by sponsors and review by regulators for greater acceptance across the clinical trial enterprise
A resource providing sponsors, academics, and operational partners (e.g., technology companies) with
evidentiary considerations to prepare a digitally-derived endpoint for a pivotal trial
A resource of questions to identify measures that enable the development of the right endpoint for the right context
A resource of considerations for using digital technologies in clinical trials that aligns with CTTI’s Digital Health Trials Program.
Accelerating eConsent Adoption During COVID-19...
Recommendations for embedding clinical trial elements into clinical trials to enable evidence-based quality care and reduce clinical trial inefficiencies
A resource providing a case example of embedding clinical trial elements into clinical practice.
A resource providing a case example of embedding clinical trial elements into clinical practice.
A resource providing a case example of embedding clinical trial elements into clinical practice.
A resource providing a case example of embedding clinical trial elements into clinical practice.
A resource providing a case example of embedding clinical trial elements into clinical practice.
Small, But Mighty: How a Rare Disease Foundation Built Natural History Data to Accelerate New Therapies...
From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints...
Increasing Diversity in Clinical Trials...
Bristol Myers Squibb (BMS) Co-Hosts Quality by Design Workshop with CTTI to Achieve Quality Culture Aligned with ICH E8(R1)...
FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers...
PEC Meeting Summary – July 2023...
Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov...
Embedding Trials Feasibility Survey...