Article type
Year
Abstract
Background: “Personalised, precision, stratified medicine” is understood as a medical approach in which patients are stratified based on their disease subtype, risk, prognosis, or treatment response, to base medical decisions on individual patient characteristics. The concept of personalised medicine (PM) impacts how treatments are discovered and developed. The current optimism (often hype) on PM is affecting how patients are diagnosed and treated, how healthcare systems allocate their resources and research funding. The European Commission launched the International Consortium for Personalised Medicine and a series of supporting research projects, like the Personalised Medicine Trials (PERMIT https://permit-eu.org/) aimed to investigate various aspects of the methodology used in PM research. Rigorous methodologies applied to clinical trials in PM are critical to correctly select participants and treatments to be tested. However, there are several open questions on the advantages and challenges of different innovative and complex trial designs.
Objectives: To map the methods for clinical trials in PM and identify standards and gaps in methods.
Methods: Scoping reviews have great utility for synthesizing research evidence and mapping existing literature about the nature, features, and volume of a given field. We are conducting a scoping review following the guidance suggested by the Joanna Briggs Institute on the theme of clinical trials in PM. Briefly, we firstly defined the scope and research questions. Relevant articles and reports will be retrieved through rounds of formal literature searches on relevant databases (i.e., Medline, Embase, Cochrane Library) and informal checks of reference lists and institutional websites. Methodological reports and guidance issued by regulatory authorities or agencies for health technology assessment, and examples of published or ongoing trials in personalised medicine will be included. The collected evidence will be assembled, summarized and reported to address the research questions. Results will be discussed in dedicated consultations and workshops with field experts considering gaps in methodology and implications for policy, practice and research. Review protocol under publication (Zenodo https://about.zenodo.org/).
Results: At the time of this submission, the review team defined the scope of the review, turning the key concepts into research questions. Search strategy and screening process are ongoing. The scoping review will be finalised by September 2020.
Conclusions: The results of this scoping review may inform all parties involved in planning, conducting, funding, overseeing, reviewing and publishing PM research.
Patient or healthcare consumer involvement: European Patients’ Forum, member of the PERMIT consortium, participated in topic and scope definition, and were associated to the scoping review protocol definition. They will also be involved in the discussion of the scoping review findings and consultation exercise.
Objectives: To map the methods for clinical trials in PM and identify standards and gaps in methods.
Methods: Scoping reviews have great utility for synthesizing research evidence and mapping existing literature about the nature, features, and volume of a given field. We are conducting a scoping review following the guidance suggested by the Joanna Briggs Institute on the theme of clinical trials in PM. Briefly, we firstly defined the scope and research questions. Relevant articles and reports will be retrieved through rounds of formal literature searches on relevant databases (i.e., Medline, Embase, Cochrane Library) and informal checks of reference lists and institutional websites. Methodological reports and guidance issued by regulatory authorities or agencies for health technology assessment, and examples of published or ongoing trials in personalised medicine will be included. The collected evidence will be assembled, summarized and reported to address the research questions. Results will be discussed in dedicated consultations and workshops with field experts considering gaps in methodology and implications for policy, practice and research. Review protocol under publication (Zenodo https://about.zenodo.org/).
Results: At the time of this submission, the review team defined the scope of the review, turning the key concepts into research questions. Search strategy and screening process are ongoing. The scoping review will be finalised by September 2020.
Conclusions: The results of this scoping review may inform all parties involved in planning, conducting, funding, overseeing, reviewing and publishing PM research.
Patient or healthcare consumer involvement: European Patients’ Forum, member of the PERMIT consortium, participated in topic and scope definition, and were associated to the scoping review protocol definition. They will also be involved in the discussion of the scoping review findings and consultation exercise.