ArticlePharmaceutical medicine2024
Why Oncology Global Safety Teams Should Develop the Safety Section of the Study's Target Product Profile (TPP).
Article in Pharmaceutical medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed, 0 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Oncology Global Safety Teams (GSTs) are not universally tasked with the development of the risk section of the products target product profile (TPP). This fact makes little sense since the GST is tasked by the company to identify, analyze, and mitigate a product's risks. The TPP, in essence, establishes boundaries for go/no-go decisions around a product or products in combination treatment. Involvement of the Oncology GST in producing a well-researched and evidenced based TPP safety section allows the team to develop knowledge around the drug(s) studied or added to a study arm. The increased use of umbrella and platform studies for early-phase oncology trials allows an excellent resource for the use of clinical data to estimate the risk of developmental drugs combined to treat a given oncology indication. To shorten time to marketing, companies are including developmental products with novel mechanisms early within their development cycles. Antibody drug conjugates (ADCs) and bi-directional antibodies are a few examples of products combined in arms of a platform or umbrella study early and with only immature clinical data available. This article will share a novel analytical approach for safety teams to develop a well thought-out and defendable safety section to the TPP. Strategies to estimate the risks associated with combination therapies will be brought forward. The advantages of having the safety team involved early in the benefit/risk, go/no-go decisions for a study or the addition of a study arm will be detailed. The early development of a well-documented TPP will enhance chances of a successful product submission.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.