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Introduction: Clinical trials are increasingly supported by industries while previous studies have shown that industry-supported studies have more favorable results than studies with other sources of funding. In the present study, we investigated the association of industrial funding on the results of clinical trials regarding chemotherapy in prostate cancer. Methods: A systematic literature search was performed in the Cochrane Library, MEDLINE, and EMBASE to identify clinical trials comparing chemotherapy with treatments such as hormone therapy, surgery, radiotherapy, and placebo in patients with metastatic or non-metastatic prostate cancer. Data were extracted by two reviewers on the financial resources and the positive or negative results of chemotherapy in each study. The quality of articles was evaluated and compared based on Cochrane Critical Appraisal Tool. The trials were divided into two groups; industry funded and those not funded by industry. Association of industry funding and positive outcome was presented as odds ratio. Results: In this study, out of the 91 studies, 80.2% were funded by pharmaceutical companies and 19.8% were funded by government agencies. The end result of 61.6% of the studies funded by pharmaceutical companies was an increase in survival due to chemotherapy, whereas only 27.8% of the studies sponsored by government agencies reported positive results (P-value=0.010). In fact, industry-funded trials more often presented statistically significant positive results for survival (OR: 4.17; CI, 1.34–12.99). In general, there was no significant difference in the degree of bias between the two groups. Conclusion: According to this study, despite of the similar quality of studies funded by pharmaceutical companies and government agencies, positive results were more common in studies related to pharmaceutical companies. Therefore, this point should be taken into account when making a decision on the best treatment approach.

Objective Assessing safety and immunogenicity of an inactivated whole virus particle vaccine.Design Single-centre, double-blind, randomised, placebo-controlled, phase I (stage I: 18–50, stage II: 51–75 years), phase II (18–75 years) clinical trials.Setting 29 December 2020 to 22 April 2021.Participants Stage I-phase I: 56 participants; stage II-phase I: 32; phase II: 280.Intervention During stage I, participants randomly (3:3:1) received 3 µg, 5 µg vaccine or placebo in a 14-day interval. Participants in stage II received two shots of 5 µg vaccine or placebo (3:1). In phase II, participants received 5 µg vaccine or placebo (4:1) in a 28-day interval.Primary and secondary outcome measures Safety assessment and immunogenicity assessment via antibody response and conventional virus neutralisation test (cVNT).Results All adverse events (AEs) were mild or moderate and transient in both phase I and phase II, and no AEs of special interest were reported. The seroconversion-rate of neutralising, antireceptor binding-domain (RBD) and anti-spike-glycoprotein (anti-S) antibodies 14-days after second dose of 5 µg vaccine in stage I was 70.8% (95% CI 48.9% to 87.4%), 87.5% (95% CI 67.6% to 97.3%), 91.7% (95% CI 73.0% to 99.0%). The antibody titres increased more among 5 µg than 3 µg. The corresponding rates for 3 µg vaccine were 45.8% (95% CI 25.6% to 67.2%), 54.2% (95% CI 32.8% to 74.5%) and 70.8% (95% CI 48.9% to 87.4%), respectively. In stage II, 100% (95% CI 84.6% to 100%), 86.4% (95% CI 65.1% to 97.1%) and 86.4% (95% CI 65.1% to 97.1%) of participants seroconverted for neutralising, anti-RBD and anti-S antibodies. In phase II, the seroconversion rate of neutralising-antibody was 82.8% (95% CI 77.0% to 87.6%), anti-RBD 77.0% (95% CI 70.7% to 82.6%) and anti-S 79.9% (95% CI 73.8% to 85.1%) on day 42. In the cVNT, the sera at 1/64 times dilution would neutralise SARS-CoV-2 among 91.7%, 77.3% and 82.5% of vaccinated participants in phase I-stage I, phase I-stage II and phase II clinical trials, respectively.Conclusions These results support further evaluation of this inactivated whole virus particle vaccine.Trial registration numbers IRCT20201202049567N1 and IRCT20201202049567N2 for phase I and IRCT20201202049567N3 for phase II.