Evidence map›Paper›PMID 35629092›Full record

ReviewJournal of personalized medicine2022

A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies.

Victoria Serelli-Lee, Kazumi Ito, Akira Koibuchi, Takahiko Tanigawa, Takayo Ueno, Nobuko Matsushima, Yasuhiko Imai

Abstract readReview
In one paragraph

Review in Journal of personalized medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Targeted nutritional strategies in postoperative care.Anesthesia and pain medicine · 2025
    Review
  5. Article
  6. Review
  7. Review
  8. Unveiling the Paradoxical Nature of Autophagy in Cancer Cell Fate.Cancer control : journal of the Moffitt Cancer Center
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Victoria Serelli-LeeClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.ORCID 0000-0002-4117-4280
Kazumi ItoClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.
Akira KoibuchiClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.
Takahiko TanigawaClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.
Takayo UenoClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.
Nobuko MatsushimaClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.ORCID 0000-0002-6967-6741
Yasuhiko ImaiClinical Evaluation Sub-Committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advances in biotechnology have enabled us to assay human tissue and cells to a depth and resolution that was never possible before, redefining what we know as the "biomarker", and how we define a "disease". This comes along with the shift of focus from a "one-drug-fits-all" to a "personalized approach", placing the drug development industry in a highly dynamic landscape, having to navigate such disruptive trends. In response to this, innovative clinical trial designs have been key in realizing biomarker-driven drug development. Regulatory approvals of cancer genome sequencing panels and associated targeted therapies has brought personalized medicines to the clinic. Increasing availability of sophisticated biotechnologies such as next-generation sequencing (NGS) has also led to a massive outflux of real-world genomic data. This review summarizes the current state of biomarker-driven drug development and highlights examples showing the utility and importance of the application of real-world data in the process. We also propose that all stakeholders in drug development should (1) be conscious of and efficiently utilize real-world evidence and (2) re-vamp the way the industry approaches drug development in this era of personalized medicines.

Indexed as

biomarker-driven drug developmentclinical trial renovationdata ecosystemdisease blueprintecosystem for personalized therapiesgenome medicineJapanpersonalized medicinereal-world data/evidence

Identifiers

PMID35629092
PMCPMC9143954

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.