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Performance of clinical trials has led to major therapeutic developments and substantial improvements in the field of medical oncology. To ensure patient's safety, regulatory aspects for proper clinical trial conduct have been increased over the past two decades but seem to cause information overload and ineffective bureaucracy, possibly even impacting patient safety. To put this in perspective, after the implementation of Directive 2001/20/EC in the European Union, a 90 per cent increase in trial launching time, a 25 per cent decrease in patient participation and a 98 per cent rise in administrative trial costs were reported. The time to initiate a clinical trial has increased from a few months to several years in the past three decades. Moreover, there is a serious risk that information overload with relatively unimportant data endangers the decision-making processes and distracts from essential patient safety information. It is now a critical moment in time to improve efficient clinical trial conduct for our future patients diagnosed with cancer. We are convinced that a reduction of the administrative regulations, information overload, and simplification of the procedures for trial conductance may improve patient safety. In this Current Perspective, we give insight in the current regulatory aspects of clinical research, evaluate the practical consequences of these regulations, and propose specific improvements for optimal clinical trial conduct., (Copyright © 2023. Published by Elsevier Ltd.)

Background: Owing to the rarity and heterogeneity in biology and presentation, there are multiple areas in the diagnosis, treatment and follow-up of soft tissue sarcoma (STS), with no, low-level or conflicting evidence., Methods: During the first Consensus Conference on the State of Science in Sarcoma (CSSS), we used a modified Delphi process to identify areas of controversy in the field of sarcoma, to name topics with limited evidence-based data in which a scientific and knowledge gap may remain and a consensus statement will help to guide patient management. We determined scientific questions which need to be addressed in the future in order to generate evidence and to inform physicians and caregivers in daily clinical practice in order to improve the outcomes of patients with sarcoma. We conducted a vote on STS key questions and controversies prior to the CSSS meeting, which took place in May 2022., Results: Sixty-two European sarcoma experts participated in the survey. Sixteen strong consensus (≥95%) items were identified by the experts, as well as 30 items with a ≥75% consensus on diagnostic and therapeutic questions. Ultimately, many controversy topics remained without consensus., Conclusions: In this manuscript, we summarise the voting results and the discussion during the CSSS meeting. Future scientific questions, priorities for clinical trials, registries, quality assurance, and action by stakeholders are proposed. Platforms and partnerships can support innovative approaches to improve management and clinical research in STS., Competing Interests: Conflict of interest statement The authors declare following conflicts of interest: CR: Consulting or Advisory Role (Payment to Institution): Bayer (Schweiz) AG, Bristol-Myers Squibb, Ipsen, MSD Oncology, Pfizer; Consulting or Advisory Role (Payment to me): Merck (Schweiz) AG; Travel Expenses (Payment to me): PharmaMar; Research Funding (Payment to Institution): Astellas Pharma AG. DA: has received institutional research support from Implantcast GmbH and invited speaker fees from PharmaMar.WGK: served as advisor to Bristol Myers Squibb, unrelated. JYB: grants or research support from AstraZeneca, Bayer, Bristol Myers Squibb, Deciphera, Glaxo SmithKline, Merck Sharp & Dohme, Novartis, PharmaMar, and Roche; has an advisory or board member role in Innate Pharma; and receives honorarium from Bayer, Deciphera, Novartis, and Roche. ID: no COI. PD: Honoraria for consultancy or advisory role: Ayala Pharmaceuticals, Deciphera. RH: no COI. JJ: has received travel expenses or honoraria for participation in advisory boards or invited speaker fees from PharmaMar, Pfizer and Belpharma. LHL: Honoraria and compensation for advisory boards: Boehringer Ingelheim, Novartis, Lilly, Eisai, EL Medconsult, Roche; Travel and research grants: Dr. Sennewald Medizintechnik; Travel grants: PharmaMar; Stockownerships: Thermosome (co-founder) CM: no COI. ABM: Trustee Sarcoma UK, no other conflict of interest. TB: reports personal fees from PharmaMar and Deciphera (lecture fee, advisory board) ABM: Trustee Sarcoma UK, no other conflict of interest. RLJ: Receipt of grants/research support: MSD, GSK. Receipt of consultation fees: Adaptimmune, Astex, Athenex, Bayer, Boehringer Ingelheim, Blueprint, Clinigen, Eisai, Epizyme, Daichii, Deciphera, Immunedesign, Immunicum, Karma Oncology, Lilly, Merck, Mundipharma, Pharmamar, Springworks. SynOx, Tracon, Up to Date. IJ: No conflicts of interest. PR: has received honoraria for participation in advisory boards for Bayer, Novartis, Roche, Deciphera, Mundibiopharma, PharmaMar, Blueprint Medicines, GSK, Boehringer Ingelheim and invited speaker fees from Clinigen, Deciphera, PharmaMar, Boehringer Ingelheim. JS: Participation in advisory boards or invited speaker fees: PharmaMar, Bayer, Roche, Lilly, Amgen; Travel expenses: PharmaMar, Roche, Lilly, Amgen, Bristol Myers Squibb; Research funding: PharmaMar, Roche, Eisai. WvdG: research grant funding from Eli Lilly, advisory board participation Springworks, Bayer, PTC Therapeutics – all to the institute. WJvH: received institutional honoraria for participation in advisory board for Belpharma, invited speaker fees from Amgen andreports expert testimony for Sanofi and MSD and personal travel grant from Novartis and institutional research grant from BMS. EW: has received honoraria for participation in advisory boards or invited speaker fees from Bayer, Roche, Deciphera, Boehringer Ingelheim, Bristol Myers Squibb, PharmaMar. SH: no COI., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: For optimal oncological care, it is recommended to discuss every patient with cancer in a multidisciplinary team meeting (MDTM). This is a time consuming and expensive practice, leading to a growing demand to change the current workflow. We aimed to investigate the number of patients discussed in MDTMs and to identify characteristics associated with not being discussed., Methods: Data of patients with a newly diagnosed solid malignant tumour in 2015 and 2016 were analysed through the nationwide population-based Netherlands Cancer Registry (NCR). We clustered tumour types in groups that were frequently discussed within a tumour-specific MDTM. Tumour types without information about MDTMs in the NCR were excluded. Multivariable logistic regression analyses were used to analyse factors associated with not being discussed., Results: Out of 105.305 patients with cancer, 91% were discussed in a MDTM, varying from 74% to 99% between the different tumour groups. Significantly less frequently discussed were patients aged ≥75 years (odds ratio [OR] = 0.7, 95% confidence interval [CI] = 0.6-0.7), patients diagnosed with disease stage I (OR = 0.5, 95% CI = 0.5-0.6), IV (OR = 0.4, 95% CI = 0.4-0.4) or unknown (OR = 0.2, 95% CI = 0.2-0.2) and patients who received no treatment (OR = 0.3, 95% CI = 0.3-0.3). Patients who received a multidisciplinary treatment were more likely to be discussed in contrary to a monodisciplinary treatment (OR = 4.6, 95% CI = 4.2-5.1)., Conclusion: In general, most patients with cancer were actually discussed in a MDTM, although differences were observed between tumour groups. Factors associated with not being discussed may, at least partially, reflect the absence of a multidisciplinary question. These results form a starting point for debate on a more durable and efficient new MDTM strategy., (Copyright © 2019 Elsevier Ltd. All rights reserved.)