Melanoma is the most lethal skin cancer with a high propensity to metastasis and conventionally is poorly responsive to non-surgical treatments including chemotherapy and radiotherapy. Considerable advances have been ...Melanoma is the most lethal skin cancer with a high propensity to metastasis and conventionally is poorly responsive to non-surgical treatments including chemotherapy and radiotherapy. Considerable advances have been made recently targeting BRAF mutations and immune regulation and, for the first time, credible options exist for patients with metastatic disease. Angiogenesis, the growth of new blood vessels, is an absolute prerequisite for tumour growth beyond a few millimetres in size. Melanoma neovascularisation is correlated with poor prognosis, reduced overall survival, ulceration and increased rate of relapse. Melanoma cells secrete several proangiogenic cytokines including Vascular Endothelial Growth Factor VEGF-A and raised levels of expression are associated with the switch from indolent radial, to invasive vertical and then metastatic growth phases. Understanding the processes underlying angiogenesis and how it relates to tumour growth broadly and to melanoma specifically is instrumental in the current drive to develop new treatments that target a range of tumour cell receptors and intracellular processes from receptor antagonism to monoclonal antibodies aimed at the disruption of the process of tumour angiogenesis. We discuss recent and current trials for metastatic melanoma therapy, and discuss potential directions of future treatment scheduling considering different treatment scheduling approaches beyond the parameters of standard drug trials.展开更多
Mental disorders are generally characterized by abnormal thoughts, perceptions and emotions. These abnormalities may make an informed consent more difficult to obtain from psychiatric patients. The implementation of d...Mental disorders are generally characterized by abnormal thoughts, perceptions and emotions. These abnormalities may make an informed consent more difficult to obtain from psychiatric patients. The implementation of drug trials is being threatened by the decline in its overall frequency generally, especially in Psychiatry. This foretells a dearth of major breakthroughs in pharmacotherapy for psychiatric patients if they are unwilling to present themselves for drug trials. Insight into patient’s awareness and perception of drug trials will enhance the planning, design and implementation of drug trials among this vulnerable subpopulation. This was a cross-sectional study of one hundred patients attending the follow-up clinic of a tertiary psychiatric hospital. A proforma questionnaire to assess awareness and perception of drug trials was administered to participants. About half (51%) were aware of drug trials and 50% of the participants were not willing to participate in a drug trial. Sixty-five percent considered it highly risky to participate. Females were more likely to be unsure whether informed consent will be needed for drug trials. The married were more likely to be unaware of drug trials in clinical research. The unmarried were more likely to be informed about drug trials through the media. Findings are likely to have been influenced by the socio-cultural environment of this study setting. Drug trials among this population require an approach that will create an initial drug trial disorder—sensitive awareness and a design that will ensure that the consent process will take into cognizance the vulnerability of these patients;especially among females.展开更多
我国的临床研究协调员(clinical research coordinator,CRC)行业正处于快速发展阶段,国内部分药物临床试验机构已有CRC团队,由本院退休的医技和护理人员担任;同时,申办者及合同研究组织(contract research organization,CRO)机构也在培...我国的临床研究协调员(clinical research coordinator,CRC)行业正处于快速发展阶段,国内部分药物临床试验机构已有CRC团队,由本院退休的医技和护理人员担任;同时,申办者及合同研究组织(contract research organization,CRO)机构也在培训自己的CRC团队;还有一部分药物临床试验机构采取与现场管理组织(site management organization,SMO)公司合作来培养管理CRC。苏州大学附属第二医院药物临床试验机构采取与SMO公司合作,共同培养、共同管理CRC,并在实际工作中取得了一定成效,同时也积累了实践经验。现就本院临床试验机构在药物临床试验过程中,CRC的运行机制和具体工作职责进行简要介绍,为各药物临床试验机构的建设和管理提供参考。展开更多
文摘Melanoma is the most lethal skin cancer with a high propensity to metastasis and conventionally is poorly responsive to non-surgical treatments including chemotherapy and radiotherapy. Considerable advances have been made recently targeting BRAF mutations and immune regulation and, for the first time, credible options exist for patients with metastatic disease. Angiogenesis, the growth of new blood vessels, is an absolute prerequisite for tumour growth beyond a few millimetres in size. Melanoma neovascularisation is correlated with poor prognosis, reduced overall survival, ulceration and increased rate of relapse. Melanoma cells secrete several proangiogenic cytokines including Vascular Endothelial Growth Factor VEGF-A and raised levels of expression are associated with the switch from indolent radial, to invasive vertical and then metastatic growth phases. Understanding the processes underlying angiogenesis and how it relates to tumour growth broadly and to melanoma specifically is instrumental in the current drive to develop new treatments that target a range of tumour cell receptors and intracellular processes from receptor antagonism to monoclonal antibodies aimed at the disruption of the process of tumour angiogenesis. We discuss recent and current trials for metastatic melanoma therapy, and discuss potential directions of future treatment scheduling considering different treatment scheduling approaches beyond the parameters of standard drug trials.
文摘Mental disorders are generally characterized by abnormal thoughts, perceptions and emotions. These abnormalities may make an informed consent more difficult to obtain from psychiatric patients. The implementation of drug trials is being threatened by the decline in its overall frequency generally, especially in Psychiatry. This foretells a dearth of major breakthroughs in pharmacotherapy for psychiatric patients if they are unwilling to present themselves for drug trials. Insight into patient’s awareness and perception of drug trials will enhance the planning, design and implementation of drug trials among this vulnerable subpopulation. This was a cross-sectional study of one hundred patients attending the follow-up clinic of a tertiary psychiatric hospital. A proforma questionnaire to assess awareness and perception of drug trials was administered to participants. About half (51%) were aware of drug trials and 50% of the participants were not willing to participate in a drug trial. Sixty-five percent considered it highly risky to participate. Females were more likely to be unsure whether informed consent will be needed for drug trials. The married were more likely to be unaware of drug trials in clinical research. The unmarried were more likely to be informed about drug trials through the media. Findings are likely to have been influenced by the socio-cultural environment of this study setting. Drug trials among this population require an approach that will create an initial drug trial disorder—sensitive awareness and a design that will ensure that the consent process will take into cognizance the vulnerability of these patients;especially among females.
文摘我国的临床研究协调员(clinical research coordinator,CRC)行业正处于快速发展阶段,国内部分药物临床试验机构已有CRC团队,由本院退休的医技和护理人员担任;同时,申办者及合同研究组织(contract research organization,CRO)机构也在培训自己的CRC团队;还有一部分药物临床试验机构采取与现场管理组织(site management organization,SMO)公司合作来培养管理CRC。苏州大学附属第二医院药物临床试验机构采取与SMO公司合作,共同培养、共同管理CRC,并在实际工作中取得了一定成效,同时也积累了实践经验。现就本院临床试验机构在药物临床试验过程中,CRC的运行机制和具体工作职责进行简要介绍,为各药物临床试验机构的建设和管理提供参考。
