Evidence map›Paper›PMID 32238471›Full record

ReviewJournal for immunotherapy of cancer2020

Master protocols in immuno-oncology: do novel drugs deserve novel designs?

Luca Mazzarella, Stefania Morganti, Antonio Marra, Dario Trapani, Giulia Tini, Piergiuseppe Pelicci, Giuseppe Curigliano

Open access · goldAbstract readReview
In one paragraph

Review in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 32% of its field
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
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 at 2 institutions in 1 country.

Luca MazzarellaDivision of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, Italy luca.mazzarella@ieo.it.ORCID 0000-0002-4043-3279
Stefania MorgantiDivision of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, Italy.
Antonio MarraDivision of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, Italy.
Dario TrapaniDivision of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, Italy.
Giulia TiniExperimental Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy.
Piergiuseppe PelicciExperimental Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy.
Giuseppe CuriglianoDivision of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, Italy.
European Institute of Oncology · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The rapid rise to fame of immuno-oncology (IO) drugs has generated unprecedented interest in the industry, patients and doctors, and has had a major impact in the treatment of most cancers. An interesting aspect in the clinical development of many IO agents is the increasing reliance on nonconventional trial design, including the so-called 'master protocols' that incorporate various adaptive features and often heavily rely on biomarkers to select patient populations most likely to benefit. These novel designs promise to maximize the clinical benefit that can be reaped from clinical research, but are not without costs. Their acceptance as solid evidence basis for use outside of the research context requires profound cultural changes by multiple stakeholders, including regulatory bodies, decision-makers, statisticians, researchers, doctors and, most importantly, patients. Here we review characteristics of recent and ongoing trials testing IO drugs with unconventional design, and we highlight trends and critical aspects.

Indexed as

HumansImmunotherapyMedical OncologyNeoplasmsbiomarkersbiostatisticsclinical trials as topiccombinationdrug therapyimmunotherapytumor

Identifiers

PMID32238471
PMCPMC7174064
OpenAlexW3014458951

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.