NOT-CA-18-063: National Cancer Institute (NCI) Request for Information (RFI): Strategies for Matching Patients to Clinical Trials

National Cancer Institute (NCI) Request for Information (RFI): Strategies for Matching Patients to Clinical Trials

Notice Number: NOT-CA-18-063

Key Dates
Release Date: April 11, 2018

Related Announcements
None

Issued by
National Cancer Institute (NCI)

Purpose

Introduction

Through this Request for Information (RFI) Notice, the National Cancer Institute (NCI) seeks public comments on approaches to improve the ease and functionality of searching for cancer clinical trials. These approaches can focus on how to find a cancer clinical trial to participate in, or finding participants for clinical trials. Our goal is to make structured clinical trials information available that could support a variety of efforts relating to clinical trial searching and matching. This structured information could be consumed by a searching (finding trials that meet predefined search criteria) or a matching application where information flows between applications in a mostly automated fashion. It is within this context that NCI seeks to better understand what information about clinical trials is most consequential for clinical trials searching. To improve the convenience, functionality, and success of this activity for patients and others, we seek information on how to structure clinical trial protocol eligibility criteria, and tools and applications that are currently in use to structure these data. We also seek information on searching and automated clinical trials matching applications and implementation models that facilitate identification of appropriate cancer clinical trials. The information received from respondents will be used to inform the planning of a collaborative workshop to inform the NCI-Finding Cancer Trials Collaborative. No grants and/or contract awards will result based on this RFI.

Background

Clinical trials are a critical part of identifying new approaches for preventing and treating cancers, as well as for managing cancer-related side effects. NCI is committed to helping members of the public and their health care providers find cancer clinical trials, and ultimately facilitate the development and implementation of an automated approach to matching patient information to cancer clinical trials information. We hypothesize that by making it easier for patients and physicians to find clinical trials, trials will reach target accrual faster, resulting in more rapid completion of the trials and dissemination of information to advance improvements in prevention and cancer care. Despite recent improvements to NCI’s clinical trials searching capabilities, including standardized disease, intervention, and biomarker terminology available through the NCI Clinical Trials Search application programming interface (API) and enhanced searching of this information on the NCI trials.cancer.gov website, searching and finding appropriate cancer clinical trials remains complex. Search results are suboptimal, and barriers remain to clinical trials searching, matching, and trial accrual. Currently, searches may retrieve too many trials for which a patient is not eligible, and may miss trials for which a patient is indeed eligible, but are somehow excluded. Through the NCI Clinical Trials Search API, third party users have access to NCI-supported clinical trials information, including limited structured elements such as trial status, administrative data required for trial registration, disease, intervention, and biomarkers. Other trial registration elements such as trial description, eligibility criteria, and outcome measures are currently unstructured. NCI seeks input to determine whether structuring eligibility criteria can support improved identification of relevant clinical trials, and, if so, which of those criteria can, and should be, structured, and how should they be made available. Our hypothesis proposes that adding additional structure to clinical trial eligibility criteria will make it easier to find applicable trials. Additionally, we consider structuring eligibility criteria foundational to the development and production of more automated approaches to clinical trials searching. This RFI seeks input on some or all of the elements below.

Information Requested

NCI seeks information on approaches, proof of concepts, and implementation models for the following areas:

Structuring clinical trials information
1. Information in clinical trials eligibility criteria that can, and should, be structured, recommendations for structure, and importance
2. Approaches for implementation and maintenance of structuring clinical trials eligibility criteria, e.g., Natural Language Processing (NLP), Artificial Intelligence (AI), human curation, etc.
Facilitation of cancer clinical trials searching/matching
1. Data elements in clinical trial eligibility criteria that are most meaningful for clinical trials searching
2. Presentation of patient information and the types of information as well as source e.g. human input into a website, Electronic Health Record (EHR) that will narrow clinical trial search/match retrievals to those for which a patient is most likely eligible
3. Approaches for NCI to facilitate cancer clinical trials search/match (e.g. a simple interface on cancer.gov, contact center, etc.)
4. Approaches to automate matching participants to clinical trials (e.g. extensible clinical trials machine learning algorithms)
Technologies and standards that may facilitate capture and transmission of information in structured format
1. Adoption of a shared language (or ontology) of systems interoperability to ensure research and development efforts are sustainable and scalable
2. A simple user interface for searcher data entry, automated based on EHR systems and automated matching, using a standardized Clinical Trials Management System (CTMS) form that is filled out, etc.
Methods for fostering agile interdisciplinary collaboration, and, when applicable, public-private partnerships to advance modern culture of cutting edge research and development
Approaches to facilitating and/or incentivizing structuring eligibility criteria in clinical trials protocols, as well as submission of structured information to the NCI Clinical Trials Reporting Program (CTRP)
Additional information, or factors, that should be considered on how can NCI best support and accelerate the ways in which patients find the appropriate cancer clinical trials and the ways cancer clinical trials may find patients?

Submitting a Response

Comments and relevant citations on any of the above outlined areas should be submitted electronically to FindingCancerTrialsCollaborative@mail.nih.gov, or mailed to: Coordinating Center for Clinical Trials (CCCT) 6W610, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20890. Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. Comments submitted will be compiled for discussion and incorporated into the strategic plan as appropriate. Any personal identifiers (personal names, email addresses, etc.) will be removed when responses are compiled. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any information submitted or for use of that information.

References

NCI Clinical Trials Search API: https://clinicaltrialsapi.cancer.gov/

Inquiries

Please direct all inquiries to:

Coordinating Center for Clinical Trials
National Cancer Institute (NCI)
Telephone: 240-276-6160
Email: FindingCancerTrialsCollaborative@mail.nih.gov