行业赞助的肿瘤学临床试验的新闻稿:特征、时间和财务影响

IF 2 Q3 HEALTH POLICY & SERVICES
Anna Amela Valsecchi , Cecilia Conte , Nicola Maria Fiore , Maria Lucia Iacovino , Daniele Ierace , Letizia Galeasso , Eleonora Paganoni , Oriana Ciani , Francesco Perrone , Massimo Di Maio
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引用次数: 0

摘要

新闻稿(pr)预测临床试验的结果,可能没有提供详细的数据。本分析的目的是描述肿瘤pr的特点、结果可得性的延迟以及对金融市场的影响。材料与方法筛选前20家肿瘤制药公司网站上2018 - 2022年发表的实体瘤相关论文。收集公关内容、公关与科学会议之间的时间、论文发表和监管机构批准等信息。我们研究了市场在政策调整日的反应。结果159例pr中,157例符合要求。最具代表性的肿瘤是肺癌(28% %)。在大多数情况下(117,74.5 %),pr宣布研究达到了其主要终点。其中,13 %的pr包含特定结果,而其余102(87 %)仅包含一般句子。85% 的pr包含支持结果临床相关性的句子。从PR到会议演示和全文发表的中位时间分别为3.1个月和8个月。中位随访48个月后,FDA批准了79 %,EMA批准了74 %。从PR到FDA和EMA批准的中位时间分别为10个月和15.9个月。分析的大多数事件没有显示出统计上显著的市场反应,异常回报一般为中性或略为正。大多数pr首先宣布临床试验的积极结果,而没有详细的结果。市场似乎以最小的股价调整吸收了这一信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Press releases of industry-sponsored clinical trials in oncology: Characteristics, timing and financial impact

Background

Press releases (PRs) anticipate the results of a clinical trial, possibly without providing detailed data. The purpose of this analysis was to describe the characteristics of PRs in oncology, delays in the availability of results and the impact on the financial market.

Materials and methods

PRs published between 2018 and 2022 about solid tumors, archived on the websites of the top 20 oncology pharmaceutical companies, were screened. Information about PR content, time between PRs and scientific meeting, paper publication and approval by regulatory agencies were collected. Market reactions on the event days of the PRs were examined.

Results

Out of 159 PRs, 157 were eligible. The most represented tumor was lung cancer (28 %). In most cases (117, 74.5 %), PRs announced that the study met its primary endpoint. Among these, 13 % of PRs included specific results, while the remaining 102 (87 %) contained only generic sentences. 85 % of PRs contained sentences supporting the clinical relevance of the results. Median time from PR to meeting presentation and full paper publication was 3.1 and 8 months, respectively. After a median follow-up of 48 months, 79 % were approved by FDA and 74 % by EMA. Median time from PR to approval by FDA and EMA was 10 and 15.9 months, respectively. Most events analyzed showed no statistically significant market reactions, with abnormal returns generally neutral or slightly positive.

Conclusions

Most PRs announce firstly the positivity of a clinical trial, without detailed results. The market appears to absorb this information with minimal stock price adjustments.
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来源期刊
Journal of Cancer Policy
Journal of Cancer Policy Medicine-Health Policy
CiteScore
2.40
自引率
7.70%
发文量
47
审稿时长
65 days
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