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General information on the pediatric drug clinical trials

As of December 31, 2023, a cumulative total of 722 pediatric drug clinical trials had concluded—either completed or discontinued—in mainland China. The annual trends indicated an increase in the number of completed, discontinued, and overall concluded clinical trials, with average annual growth rates of 21.5%, 89.7%, and 19.7%, respectively (R²=0.486). (Fig. 2). In terms of the trial phases, there were relatively few trials in the early stages such as Phase I and Phase II. The majority of the trials were concentrated in later stages, specifically Phase III (285, 39.5%) and Phase IV (150, 20.1%). Meanwhile, 6.2% of the trials adopted adaptive seamless trial designs such as I/II or II/III. Regarding the types of trial drugs, chemical drugs accounted for the largest proportion (393, 54.4%), while Chinese medicines/natural drugs accounted for the smallest proportion (29, 4.0%). In terms of the age of participants, most trials recruited adolescents (524, 72.6%) and children (429, 59.4%), newborns (124, 17.2%) and infants (274, 40.0%) trials were relatively fewer. From the perspectives of sponsors and trial institutions, the majority of trials were conducted by domestic sponsors (463, 64.1%), and primarily involved investigator-initiated studies (IST) (459, 63.6%). The number of clinical trials conducted in children’s hospitals was relatively low (109, 15.1%), with the majority being conducted in adult hospitals, disease control centres, and other trial institutions (613, 84.9%) (Table 1).

According to the disease classification for trials in ICD-11, as presented in eFig.1 of the supplementary material, the majority of pediatric drug clinical trials in China currently focused on vaccines (134, 18.6%) and respiratory diseases (99, 13.7%). The completion rate was most pronounced in vaccine trials, accounting for 132 trials or 20.5% of the total. Conversely, oncology trials exhibited the highest discontinuation rate, with 22 trials representing 27.2% of the total. At the same time, as shown in Fig. 3, the discontinuation rate of oncology trials involving adolescent subjects is higher, and the completion rate of vaccine trials involving infants and children is higher.

The proportion of diseases system in pediatric clinical trials among different age groups. Coded by International Classification of Diseases (ICD)−11 classification. Because most trials involved multiple age groups, the sum of the proportions for each age group exceeds the total

The Chinese government has successively released two editions of the “Rare Disease Drug List.” Consequently, we utilized this list, along with disease-related information, to screen clinical trials for rare diseases [20, 21]. Among the 722 trials, only 116 were for rare diseases, involving 34 types of rare disease drugs (eTable 1). The distribution of clinical trial leading institutions was shown in Fig. 4, primarily concentrated in the eastern regions of China, Such as North and East China, with 235 (30.3%) and 194 (30.3%) trials respectively. However, the discontinuation rate in these two regions was also high, with 37 (45.7%) and 25 (30.9%) trials discontinued respectively.

Geographical location percentage among Completed and Discontinued pediatric clinical trials. The completion/discontinuation percentage refers to the proportion of the number of completed or discontinued trials in a certain location to the total number of completed or discontinued trials

In terms of trial design, 504 (69.8%) trials adopted randomization, and 384 (53.2%) trials used blinding. The trial sample sizes were mostly in the range of 100–500 participants (259, 35.9%). Most pediatric drug clinical trials were parallel and active-medicine controlled trials, with fewer single-arm and placebo-controlled trials. The proportion of trials with DMCs and MRCT was relatively low (Table 2). This study compared trials with seamless designs such as I/II, II/III with conventionally designed trials such as phase I, II, and III (eTable 2). The results showed that these trials with seamless designs enrolled fewer participants and had stricter data requirements, and a total of 64.4% of the trials had DMCs [22].

A comparative analysis of completed and discontinued trials was presented in Tables 1 and 2, showing significant differences in multiple key dimensions (P < 0.05). In terms of trial phases, completed trials are concentrated in phase III (256, 39.9%) and phase IV trials (146, 22.8%), conducted by non-pediatric hospitals such as adult hospitals and disease control centres. Discontinued trials were primarily in phase III (29, 35.8%) and phase II (13, 16.1%), with a higher proportion conducted by pediatric hospitals. In terms of trial design, completed trials demonstrated higher standards in randomization, parallel design, and active-medicine control (P < 0.05), providing higher levels of evidence. In comparison, the level of evidence for discontinuing trials was lower, the enrollment was smaller, and higher proportions of trials with DMCs and MRCT.

Subgroup analysis of the duration of completed pediatric drug clinical trials

A univariate subgroup analysis was performed on the duration of completed trials, excluding statistically insignificant variables such as sponsor type and trial design (eTable 3). The results of this analysis were presented in Fig. 5. Firstly, the duration of trials in China had gradually decreased over time(1201 days: 2003–2006, 458.5 days: 2019–2023). From the perspective of clinical trial stages, the seamless design trials of phases I/II, II/III, etc., took less time than the conventional trials with separate phases [23]. Additionally, there were significant differences in the trial duration among clinical trials of different diseases, with the duration of oncology clinical trials being the longest (1010 days) and that of vaccine clinical trials being the shortest (358.5 days). At the same time, the duration of trials with blinding, no adult participants, biological products, or domestic sponsors was shorter, and the trial duration of pediatric drug clinical trials with DMCs and MRCT was longer.

Duration of Completed pediatric drug clinical trials. Changes in the duration of trials were compared using time subsets of every four-year periods

Analysis of influencing factors and reasons for discontinued pediatric drug clinical trials

The dependent variable was trial discontinuation or completion, and the independent variable was information related to the inclusion of trials. Following the exclusion of variables with P≥0.05 following univariate analysis (eTable 4), the final model was presented in Table 3. This refined model revealed that the number of enrolled participants, disease, control setting, and the establishment of DMCs are significantly correlated with the discontinued trials. Trials enrolling 0-50 participants had a significantly higher probability of discontinuation compared to trials with over 1,000 participants (OR = 17.286, 95%CI = 3.175-94.119, P = 0.001). The results also demonstrate that, compared with placebo-controlled trials, active-drug-controlled trials (OR = 0.278, 95%CI 0.110–0.707, P = 0.007) and uncontrolled trials (OR = 0.149, 95%CI 0.026–0.859, P = 0.033) are associated with a significantly lower probability of discontinuation. Additionally, trials with DMCs were more prone to discontinuation (OR = 4.054, 95%CI = 2.011–8.172, P < 0.001). Furthermore, the likelihood of discontinuation was significantly greater for respiratory disease trials (P < 0.001) and oncology clinical trials (P = 0.009) compared to trials for other diseases (Table 3).

Considering the reasons for trial discontinuation, we conducted a separate analysis of the significant variables in the previous logistic regression. As demonstrated in Table 4, the primary reasons for the discontinued trials were the safety or efficacy of the trial results (22, 27.2%) and commercial/trial plan adjustment(20, 24.6%). Small trials with fewer than 50 participants were discontinued because of plan adjustments (18, 27.6%). Placebo-controlled trials are more frequently discontinued due to safety or efficacy concerns than active-controlled or single-arm trials. Additionally, pediatric drug clinical trials involving adults were discontinued primarily due to trial results (17, 33.7%). In pediatric drug clinical trials for respiratory diseases and pediatric oncology, plan adjustments were the primary reasons for trial discontinuation, accounting for 4 (21.1%) and 8 (36.4%) respectively.

The MAS uses the exchange rate as its policy tool to curb inflation and support growth, given Singapore’s trade-dependent economy. Separately, Singapore will also release its September nonoil domestic exports data on Friday.

  Malaysia 

  Malaysia will release third-quarter advance GDP figures and September trade data. Economic growth likely slowed to 4.3% in the third quarter from 4.4% in the previous quarter, as leading indicators point to weaker private consumption and softer imports of consumer goods, ANZ economists said. 

  While business approvals rose sharply in the first half, sentiment weakened in the third quarter across manufacturing and services, and slower capital goods imports suggest softer investment growth. Nominal imports fell faster than exports, likely improving net export slightly, though external demand remains subdued, ANZ added. The bank maintained its full-year growth forecast at 4.3%. 

  Malaysia's export growth may remain subdued in September amid global uncertainty and U.S. tariffs imposed in August, said TA Securities analyst Farid Burhanuddin. However, Malaysia's diversified export base, particularly strong trade ties with Asean, China, and other emerging markets, should help offset weaker U.S. demand, he added. 

  India 

  India will release inflation data on Monday, which is widely expected to show that price growth has resumed cooling after an uptick in August. A CPI print below the central bank's target could fuel expectations for more rate cuts ahead. 

  DBS economists forecast headline inflation to have eased to 1.5% on year in September from 2.1% the month before, taking the quarterly average slightly below the RBI's projected 1.8%. 

  "Global energy prices have also been subdued, offsetting the spillover risks from a weak rupee, while precious metals continue to stay buoyant," they said. 

  Wholesale price index data on Tuesday will round out the inflation picture. On Wednesday, attention will turn to trade figures for September, as India remains in talks with the U.S. over tariffs. DBS economists expect exports to moderate, leaving the trade deficit wide at $24 billion. 

  Any references to days are in local times. 

  Write to Emese Bartha at emese.bartha@wsj.com and Jihye Lee at jihye.lee@wsj.com 

  (END) Dow Jones Newswires

  October 12, 2025 20:14 ET (00:14 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.

LONDON, Oct 13 (Reuters) – Spanish energy company Moeve has become the first external supplier of sustainable aviation fuel to join Shell’s blockchain-based platform for scaling SAF use, the oil major told Reuters after a deal was signed.

Shell’s Avelia platform is a “book and claim” system that aims to connect airlines, fuel suppliers and corporate buyers. Avelia, launched in 2022 with Amex Global Business Travel and Accenture, had facilitated over 41 million gallons of SAF use across 17 airports as of mid-2025.

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Moeve produces SAF from used cooking oil at its La Rábida Energy Park. It plans to expand overall capacity to 800,000 metric tons a year by 2030.

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Investing.com — STAAR Surgical’s (NASDAQ:STAA) largest shareholder, Broadwood Partners, has renewed its criticism of the company’s board ahead of the October 23 vote on its $28-per-share sale to Alcon (NYSE:ALC), accusing directors of “carelessness” after a new proxy report suggested they may have approved the deal without full information.

In a letter Friday, Broadwood blasted the board for reaffirming support for the merger “within twelve hours” of a Glass Lewis report that alleged key executives withheld details about interest from another potential buyer.

“We find the Board’s apparent haste to look past the new developments very troubling,” Broadwood wrote, before launching into a series of questions.

The firm pressed the board to explain how it reaffirmed support so quickly, asking when directors met, whether they re-evaluated the deal’s fairness with advisers, and if previously undisclosed acquisition interest was ever fully discussed before endorsing the Alcon merger.

“At worst, this Board has again given proper process short shrift and, at best, has acted so swiftly as to lack credibility altogether,” Broadwood President Neal Bradsher added.

Broadwood, which owns roughly 27.5% of STAAR’s shares, said the board’s haste raises “grave concerns” about diligence and fiduciary oversight. It urged investors to vote against the merger and push for a “credible reset process.”

In its post–Glass Lewis release, STAAR reaffirmed many of the same rebuttals seen in its October 6 statement. The company again rejected Broadwood’s accusations as “flawed, misleading, and misinformed,” emphasizing that the Alcon deal represents a 59% premium to STAAR’s 90-day average trading price prior to the announcement and followed a year-long strategic review.

STAAR argued that acquisition interest cited by Glass Lewis and Broadwood “was not credible or actionable,” stressing that no competing offers have surfaced despite public speculation. The company said that made Alcon’s $1.5 billion all-cash offer the best available option for shareholders.

In its rebuttal, STAAR also accused Broadwood of attempting to gain control “without paying any premium” and warned that rejecting the deal could “place downward pressure on valuation” and cause “lengthy disruption” for patients, employees, and shareholders.

The renewed exchange follows Glass Lewis’s call for investors to vote against the merger, urging shareholders to “scupper the current arrangement in favor of either a full process reset or the unadulterated pursuit of the company’s standalone potential.”

Adding to STAAR’s challenges, proxy advisory firm Egan-Jones has also recommended that shareholders vote against the Alcon deal, citing valuation and process flaws. While echoing Glass Lewis’s concerns, Egan-Jones went further, saying the merger was “executed hastily,” that the board “fell short of its fiduciary duty,” and that STAAR’s fair value could range between $25 and $57 per share, far above Alcon’s offer at the midpoint.

The firm also flagged CEO Stephen Farrell’s shifting tone between bullish public comments in June and the company’s sudden sale weeks later, calling the contrast “deeply troubling.” It further highlighted Farrell’s potential $23.7 million payout, including a $6.8 million tax gross-up, as evidence of misaligned incentives given management’s limited equity ownership.

Together, the Glass Lewis and Egan-Jones recommendations amplify pressure on STAAR’s board ahead of the October 23 vote, with ISS’s forthcoming guidance potentially decisive.

With less than two weeks to go, the fight over STAAR’s future, and whether the Alcon sale represents prudence or surrender, is entering its final stretch.

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