The adaptive platform trial toolbox

This toolbox aims to collect the accumulated knowledge, experience, & resources from multiple projects and trials into a practical and guided toolbox to facilitate planning & conduct of future APTs in any therapeutic area.

The toolbox has been structured with different categories and subcategories to facilitate the navigation of the over 130 resources. Each tool is presented with a brief explanation indicating the tool's format and level of validation.  The tools can also be searched by their type, year of publication or more generally by keywords. The link to access the outside source is included. If you want to download a list of key references to have on hand you can select them and download them directly. 

Toolbox categories

To begin your search narrow down your key criteria here:

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Functional requirements for a federated network of patient data for cohort building, clinical trial feasibility and recruitment

Category
  • Statistics and data management
  • Data Management

This document explains the feasibility of protocol for patient recruitment using Communication Technology (ICT). This tool enables the reuse of Electronic Health Record (EHR) data, supporting an industry or public platform trial sponsor and contributing research organisations to undertake platform trials. 

Reference : EU-PEARL D3.4 | 2022
Type
Project deliverable
Summary of discussion
Acces tool

Generic process for an EHR-based patient cohort for IRPs

Category
  • Statistics and data management
  • Data Management

Recruiting participants remains crucial to research efficiency in platform trials with more extensive and complicated trial designs. This document describes a proposal for a generic process for gaining an estimate of patient numbers that match the clinical study inclusion criteria at hospitals, based on the analysis of hospitals' Electronic Health Records (EHR)

Reference : EU-PEARL D3.3 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

Global Coalition for Adaptive Research (GCAR) video resource (what is an adaptive platform trial, bringing Bayesian statistics into clinical trials? what do stadiums and adaptive platform trials have in common?)

Category
  • From recent and ongoing trials
  • Other

Global Coalition for Adaptive Research (GCAR) is a non-profit organisation in the US, committed to uniting stakeholders and developing and sponsoring Master Protocols and adaptive platform trials such as GBM AGILE for brain cancer, REMAP CAP US (for COVID) to speed the discovery of treatments for rare and deadly diseases. The website presents several sets of information about platform trials with short video presentations. 

Reference : GCAR | 2023
Type
Website
Trial information
Acces tool

Guidance for supplementary information to the CTR Cover Letter associated with the Master protocol and ISA submission

Category
  • Trial conduct and documents
  • Template / guide for developing document

Guidance for a cover letter outlines the critical point when submitting a platform trial application to the regulatory authority. This guideline applies to the companion protocol templates, Master Protocol Template and Intervention Specific Appendix Template prepared within the EU-PEARL consortium.

Reference : EU-PEARL template 5 | 2023
Type
Project deliverable
Template
Acces tool

Helping alleviate the longer-term consequences of COVID-19 (HEAL-COVID)

Category
  • From recent and ongoing trials
  • COVID

A national platform trial jointly sponsored by Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge. It aims to evaluate the impact of treatments on longer-term morbidity, mortality, re-hospitalisation, symptom burden and quality of life associated with COVID-19.

Reference : Cambridge University Hospitals NHS Foundation Trust 2021 | 2021
Type
Website
Document
Acces tool

How to Use and Interpret the Results of a Platform Trial Users’ Guide to the Medical Literature

Category
  • Trial conduct and documents
  • Reporting

This Users’ Guide is intended to help clinicians and readers understand articles reporting on interventions evaluated using platform trial designs.

Reference : Park et al (b) | 2022
Type
Guide
Journal article
Acces tool

I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design, and operations

Category
  • From recent and ongoing trials
  • COVID

Adaptive platform phase 2 trials family with a Bayesian design to investigate treatments for COVID-19. It is sponsored by QuantumLeap Healthcare Collaborative.

Reference : QuantumLeap Healthcare Collaborative2 | 2021
Type
Website
Trial information
Acces tool

ICH guideline E8 (R1) on general considerations for clinical studies (step 5 8.8.2023)

Category
  • Regulatory
  • International

This document describes internationally accepted principles and practices in conducting individual clinical trials and overall development strategies for new medical products. R1 contains statements for a wide range of study designs (platform trials etc.) and various data sources.

Reference : EMA, CHMP, ICH | 2021
Type
Document
Guide
Acces tool

Implementation of platform trials in the COVID-19 pandemic: A rapid review

Category
  • Introduction and design elements
  • Consideration for particular field

Between 2001 and 2019, 16 platform trials were initiated globally for the COVID-19 pandemic. This review was conducted to quantify and describe platform trials used in COVID-19.

Reference : Vanderbeek et al | 2022
Type
Journal article
Review
Acces tool

Individualized screening trial of innovative glioblastoma therapy (INSIGhT): a Bayesian adaptive platform trial to develop precision medicines for patients with glioblastoma

Category
  • Statistics and data management
  • Methodology

This journal article presents the Bayesian, adaptive, platform trial INSIGhT to develop precision medicine approaches in glioblastoma. Detailed information on the statistical model, simulations, and randomization algorithm is provided with expected benefits and challenges.

Reference : Alexander et al | 2019
Type
Experience
Journal article
Acces tool

Innovation in clinical trial design: A review of the clinical trial design landscape, A white paper by the EFPIA Clinical Trial Design Taskforce on behalf of the EFPIA Clinical Research Expert Group

Category
  • Introduction and design elements
  • Complex innovative design

European Federation of Pharmaceutical Industries and Associations (EFPIA) Clinical Research Expert Group developed this white paper as a landscape review of innovation in clinical trial design, such as adaptive designs.

Reference : EFPIA | 2020
Type
Document
Review
Acces tool

Integrated platform for designing clinical trials

Category
  • Statistics and data management
  • Statistical software

Clinical Trial Design Software for calculating sample size for basket and platform trials developed by the university of Texas MD Anderson Cancer Center.

Reference : MD Anderson Cancer Center | 2023
Type
Website
Software
Acces tool

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products - Guidance for Industry

Category
  • Regulatory
  • USA

This FDA document guides to sponsors and applicants in interacting with the FDA on complex innovative trial design proposals for drugs or biological products. It also covers some critical aspects of complex trial designs.

Reference : FDA | 2020
Type
Document
Guide
Acces tool

Intervention specific appendix (ISA) template

Category
  • Trial conduct and documents
  • Template / guide for developing document

This intervention-specific appendix (ISA) template for platform trials contains instruction text, common / suggested text, variable text and examples. It is downloadable as a Microsoft Word document for readers' editing. This template is used with the Master Protocol Template, developed within the EU-PEARL project, based on TransCelerate Common Protocol Template CPT V8.0.

Reference : EU-PEARL template 2 | 2023
Type
Project deliverable
Template
Acces tool

Investigation of serial studies to predict your therapeutic response with imaging and molecular analysis (I-SPY) trials

Category
  • From recent and ongoing trials
  • Cancer

Adaptive platform phase 2 trials family with a Bayesian design to investigate treatments for breast cancer. It is sponsored by QuantumLeap Healthcare Collaborative.

Reference : QuantumLeap Healthcare Collaborative1 | 2010
Type
Website
Trial information
Acces tool

IRP integrated sustainability business plan adapted to NASH-PT. EU-PEARL work package (WP6) – Integrated research platform for non-alcoholic steatohepatitis (NASH)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

This deliverable describes the value proposition of the IRP for NASH, the lessons learned during the project duration that affect the options available to fund and set up the IRP, and the proposed plan to implement such lessons in the future. 

Reference : EU-PEARL D6.7 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

IRP- integrated sustainability and business plan adapted to TB. EU-PEARL work package (WP5) - Integrated research platform for tuberculosis (TB)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

This deliverable explains several tools developed by the EU-PEARL project to sustain the integrated research platform (IRP) for TB. Tools are a master protocol template including a design proposal for TB adaptive trials, an operational plan (a community engagement plan),  the Capacity Building and Assessment Handbook for sites to conduct TB drug development trials within the IRP environment, and a systematic review to identify and assess host and bacterial biomarkers able to predict end of treatment outcomes.

Reference : EU-PEARL D5.8 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

Lessons from COVID-19: the first year of the REMAP-CAP global adaptive platform trial

Category
  • Trial conduct and documents
  • Case Study / Lesssons learned

The video with slides discusses the accumulated experience from the REMAP-CAP COVID-19 platform trial, focusing on design, Bayesian statistical model, data management, interpretation of results, funding, and challenges for publication and trial logistics. It was hosted by NIH Collaboratory. 

Reference : NIH Collaboratory | 2021
Type
Experience
Video
Acces tool

Longitudinal natural history study(LNHS) / Readiness cohort protocol for MDD platform. WP4 – Integrated research platform for major depressive disorder (MDD)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

The EU-PEARL project aims to develop an adaptive platform trial for difficult-to-treat depression. This report gives the public information about observational research on difficult-to-treat depression that is a part of this new framework of platform design.  LMHS enables us to recruit a large and continuous number of participants and promote a sustainable model for conducting clinical trials in this field.

Reference : EU-PEARL D4.4 | 2022
Type
Project deliverable
Summary of discussion
Acces tool

Master protocol content development guide

Category
  • Trial conduct and documents
  • Template / guide for developing document

This CTTI website includes a step-by-step tool for developing master protocols. It also contains guides for implementing the protocol and statistical considerations.

Reference : CTTI | 2023
Type
Website
Toolbox
Acces tool

Master protocol template (MPT)

Category
  • Trial conduct and documents
  • Template / guide for developing document

This template of the master protocol (MPT) for the platform trial contains instructional text, common / suggested text, variable text and examples, and it is downloadable as a Microsoft Word document for readers' editing. It is developed within the EU-PEARL project, based on TransCelerate Common Protocol Template CPT V8.0.

Reference : EU-PEARL template 1 | 2023
Type
Project deliverable
Template
Acces tool

Master protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics - Guidance for Industry

Category
  • Regulatory
  • USA

This FDA guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers.

Reference : FDA (a) | 2022
Type
Document
Guide
Acces tool

Methodology and design of platform trials: a meta-epidemiological study

Category
  • Introduction and design elements
  • Complex innovative design

This review summarises published platform trials and examines specific methodological design features among these studies, including the basics of methodological and statistical considerations.

Reference : Pitre et al | 2023
Type
Journal article
Review
Acces tool

Mind the gap? The platform trial as a working environment

Category
  • Trial conduct and documents
  • Case Study / Lesssons learned

In this commentary journal article, trial management and data management teams of STAMPEDE and FOCUS4 trials summarise the operational challenges and personal experiences of individual researchers to enable the broader clinical trials community to learn from their experiences.

Reference : Morrell et al | 2019
Type
Commentary
Journal article
Acces tool

Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trial programme (FOCUS4)

Category
  • From recent and ongoing trials
  • Cancer

FOCUS4 is an adaptive, molecularly stratified trial that aims to improve the efficiency with which new novel agents can be tested in colorectal cancer. It has a multi-arm, multi-stage design with a master protocol. It is sponsored by University College London.

Reference : University College London | 2013
Type
Website
Trial document
Acces tool

Motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease

Category
  • From recent and ongoing trials
  • Other

Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART) aims to evaluate the efficacy of drugs efficiently and definitively in a multi-arm, multi-stage, adaptive trial. The first two drugs selected for evaluation in MND-SMART are trazodone and memantine.

Reference : Wong et al | 2022
Type
Journal article
Summary of protocol
Acces tool

NASH final master protocol for an IRP. EU-PEARL work package (WP6) – Integrated research platform for non-alcoholic steatohepatitis (NASH)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

One of the work packages of the EU-PEARL project developed a master protocol to conduct platform trials (phase 2b) for NASH.

Reference : EU-PEARL D6.3 | 2023
Type
Project deliverable
Summary of protocol
Acces tool

NASH final report on regulatory and ethics consultation. WP6 – Integrated research platform for non-alcoholic steatohepatitis (NASH)

Category
  • Regulatory
  • Document from European project

This document presents the process of eliciting feedback from regulatory (EMA innovation task force) and ethics stakeholders for the master protocol for a NASH platform trial.

Reference : EU-PEARL D6.5 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

NCC: An R-package for analysis and simulation of platform trials with non-concurrent controls

Category
  • Statistics and data management
  • Statistical software

R-package NCC (https://CRAN.R-project.org/package=NCC) is for the design and analysis of platform trials using non-concurrent controls. NCC allow for simulating platform trials and evaluating the properties of analysis methods that use non-concurrent controls in various settings. This paper describes the main NCC functions and shows how to use the package to simulate and analyse platform trials through specific examples.

Reference : Krotka et al | 2023
Type
Journal article
Software
Acces tool

New approaches to clinical trials: adaptive designs

Category
  • Introduction and design elements
  • Patient engagement

The document and attached presentation discuss adaptive design elements for clinical trials, including advantages, disadvantages, rare diseases, and involvement of patients. It was prepared by EUPATI.

Reference : EUPATI | 2015
Type
Website
Toolbox
Acces tool

NF master protocol for IRPs. EU-PEARL work package (WP7) – Integrated research platform for neurofibromatosis (NF)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

The platform trial for NF developed by EU-PEARL will consist of an observational and a treatment phase. In the observational phase, patients will not be treated with an investigational agent and will provide data on the natural course of the disease. If patients need treatment and a drug is available, patients will be randomised to a treatment arm. This deliverable aims to report the finalised master protocol for the platform trial for NF. 

Reference : EU-PEARL D7.4 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

NF specific report on regulatory and ethics consultation. WP7 – Integrated research platform for neurofibromatosis (NF)

Category
  • Regulatory
  • Document from European project

This report results from a collaboration between the EU-PEARL clinicians, patients, industry, regulatory experts, and Erasmus Universitair Medisch Centrum Rotterdam (EMC) regulatory and ethics review. It also includes a brief produced for an EMA Innovation Task Force meeting in close collaboration with the Global Coalition for Adaptive Research (GCAR), which is expected to play an essential role in the sustainability of the NF platform trials. 

Reference : EU-PEARL D7.6 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

On model-based time trend adjustments in platform trials with non-concurrent control

Category
  • Introduction and design elements
  • Complex innovative design

This article discusses the use of non-concurrent controls in adaptive platforms. In addition to concurrent controls, non-concurrent controls can improve the trial’s efficiency by increasing power and reducing the required sample size but can introduce bias due to time trends.

Reference : Roig et al | 2022
Type
Journal article
Methodology
Acces tool

Operational plan for the implementation of the NF IRP. EU-PEARL work package (WP7) – Integrated research platform for neurofibromatosis (NF)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

EU-PEARL has designed two platform trials for NF, one for NF1 and the other for Schwannomatosis tumours. This report explains the steps needed to make these trials happen.

Reference : EU-PEARL D7.5 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

Operational plan to implement the NASH IRP. EU-PEARL work package (WP6) – integrated research platform for non-alcoholic steatohepatitis (NASH)

Category
  • Trial conduct and documents
  • Case Study / Lesssons learned

This document serves as a template for a Clinical Operations Plan  to support the proposed integrated research platform (IRP) for NASH. It provides specific details regarding where different sets of instructions can be found, who should take on specific activities, and what information needs to be recorded from the beginning to the end of the trial. 

Reference : EU-PEARL D6.4 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

Operational plan to implement TRD/PRD IRP and LNHS. EU-PEARL work package (WP4) – Integrated research platform for major depressive disorder (MDD)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

EU-PEARL has developed an Integrated Research Platform for Major Depressive Disorder (MDD). This report shows an overview of the stakeholder interaction and consultation, including regulators, ethics committees, the biopharmaceutical Industry, clinicians/academics, and patient or community representatives. 

Reference : EU-PEARL D4.6 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

Outcomes of workshops delivered by European Patient’s Forum (EPF) and Patient representatives, EU-PEARL work package 1 (WP1) – IRP governance, quality management and sustainability

Category
  • Introduction and design elements
  • Patient engagement

Within EU-PEARL, several Patient and Community Engagement workshops and sessions were organised with different aims, evolving as the project progressed. This deliverable informs on the EU-PEARL Platform for Patient and Community Engagement in Platform Trials (PaCEPT) and the outcomes of the patient and community engagement (PCE) workshops delivered together with patient and community representatives. Lastly, it covers the design and development of the PaCEPT platform.

Reference : EU-PEARL D1.13 | 2023
Type
Project deliverable
Report
Acces tool

PANORAMIC (platform adaptive trial of novel antivirals for early treatment of COVID 19 in the community) trial

Category
  • From recent and ongoing trials
  • COVID

PANORAMIC is a NIRH-funded, national priority adaptive platform trial in the UK, designed as a platform clinical trial for the early treatment of the COVID-19 community.

Reference : PANORAMIC | 2021
Type
Website
Trial document
Acces tool

Patient engagement platform, EU-PEARL work package 1 (WP1) – IRP governance, quality management and sustainability

Category
  • Introduction and design elements
  • Patient engagement

This deliverable describes how and why one of the working groups of the EU-PEARL project developed an online repository, the EU-PEARL Platform for Patient and Community Engagement (PaCEPT). PaCEPT enables researchers to learn how to engage with patients and communities in platform trials, explains what platform trials are in lay language to patients and affected communities, and provides resources for Patient and Community Advisors who want to actively shape platform trials.

Reference : EU-PEARL D1.12 | 2023
Type
Project deliverable
Report
Acces tool

Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE)

Category
  • From recent and ongoing trials
  • COVID

This study is a national priority, country-wide  platform, randomised controlled trial in primary care that can rapidly test low-risk treatments for people at higher risk of complications from COVID-19. The intent is to establish an on-going trial infrastructure within a master protocol. It is sponsored by the University of Oxford.

Reference : University of Oxford(b) | 2020
Type
Website
Document
Acces tool

Platform trial best practices tool

Category
  • Trial conduct and documents
  • Trial conduct

The tool contains the main tasks involved in planning a clinical trial, highlighting the special considerations that arise when designing a platform trial on top of those typical for a conventional trial.

Reference : EU-PEARL template 6 | 2023
Type
Guide
Project deliverable
Acces tool

Platform trials and the future of evaluating therapeutic behavioural interventions

Category
  • Introduction and design elements
  • Consideration for particular field

This article discusses the platform trials in clinical psychology. It could have a transformative effect by increasing the speed with which treatment effects are estimated, getting effective interventions into clinical care more quickly, and providing much-needed comparisons between different interventions for the same condition.

Reference : Gold et al | 2022
Type
Commentary
Journal article
Acces tool

Platform trials as the way forward in infectious disease clinical research: the case of coronavirus disease 2019

Category
  • Introduction and design elements
  • Consideration for particular field

This commentary reviews the experiences of several platform trials for COVID-19, such as REMAP-CAP, WHO Solidarity, RECOVER, ATTACC, PRINCIPLE, AGILE, COPPS, and OPTIMISE C-19, and focuses on the basic concepts and methodological keys of platform trials using some of the recent developments in COVID-19 treatment to illustrate the potential of these trial designs.

Reference : Pericàs et al (b) | 2023
Type
Commentary
Journal article
Acces tool

Platform trials for anaesthesia and perioperative medicine: a narrative review

Category
  • Introduction and design elements
  • Consideration for particular field

This paper provides an overview of platform trials and discusses the possibility of this design for clinical trials in anaesthesia.

Reference : Myles et al | 2023
Type
Journal article
Review
Acces tool

Platform trials to overcome major shortcomings of traditional clinical trials in non-alcoholic steatohepatitis? Pros and Cons

Category
  • Introduction and design elements
  • Consideration for particular field

Although the pipeline for drug development in NASH, active conventional Phase 3 trials often fail to achieve the endpoints necessary for approval by regulatory agencies. Adaptive trials might be an attractive complement or alternative to conventional clinical trials by using a master protocol that allows evaluation for multiple investigational medicinal products concurrently or sequentially with a single, shared control arm. The possibility of using adaptive platform trials in NASH drug development is discussed.

Reference : Pericàs et al (c) | 2023
Type
Commentary
Journal article
Acces tool

Practical considerations and recommendations for master protocol framework: basket, umbrella and platform trials

Category
  • Introduction and design elements
  • Complex innovative design

This paper provides an overview of the master protocol framework, unifies the definitions with some examples, reviews the statistical methods for the designs and analyses, and focuses its discussions on some practical considerations and recommendations for master protocols to help practitioners better design and implement such studies.

Reference : Lu et al | 2021
Type
Journal article
Review
Acces tool

PrecISE: Precision Medicine in Severe Asthma: An adaptive platform trial with biomarker ascertainment

Category
  • From recent and ongoing trials
  • Other

PrecISE, or Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network, is a network of medical centres, doctors, and scientists sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI) established to design and execute a trial that uses adaptive platform design techniques. This paper systematically evaluates novel interventions in biomarker-defined subgroups of severe asthma.

Reference : Israel et al | 2021
Type
Journal article
Summary of protocol
Acces tool

Protocol for a longitudinal natural history study (LNHS) in NF. EU-PEARL work package (WP7)- Integrated research platform for neurofibromatosis (NF)

Category
  • Trial conduct and documents
  • Trial conduct / specific disease

The EU-PEARL established an Integrated Research Platform (IRP) for Neurofibromatosis, including Neurofibromatosis type 1 (NF1). Patients for the treatment arms of the NF1-IRP will be selected from an underlying longitudinal natural history study (LNHS), forming the backbone of the IRP. This document presents a detail of LNHS.

Reference : EU-PEARL D7.3 | 2023
Type
Project deliverable
Summary of discussion
Acces tool

Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults

Category
  • From recent and ongoing trials
  • COVID

This is a protocol paper for the DISCOVERY trial, a multi-arm randomised controlled trial for COVID-19, developed by the French National Institute for Health and Medical Research (Inserm). The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to the standard of care in patients hospitalised with COVID-19.

Reference : Ader et al | 2020
Type
Journal article
Summary of protocol
Acces tool

RAMPART: An international investigator-led phase III multi arm multi stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse

Category
  • From recent and ongoing trials
  • Cancer

RAMPART (Renal Adjuvant MultiPle Arm Randomised Trial) is an international investigator-led phase III multi-arm multi-stage, multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse.

Reference : RAMPART | 2022
Type
Website
Trial document
Acces tool

The tools have been selected for their relevance and utility, but the views and opinions expressed in the tools may not represent the specific opinions of the EU-RESPONSE and RECOVER consortia. If you would like to provide feedback or gather more information about the rationale and methodology of the toolbox, please contact us.