Shen Yishuang: "Cooperative problem solving" is the basic concept of clinical research and development of psychotropic drugs.

Introduction: In recent years, the research and development of psychoneurologic drugs has attracted much attention because of the growing prosperity. "We need to work with the industry to launch clinical trials with the goal of a study that answers a single question and eventually brings together a complete chain of evidence to prove the effectiveness and safety of psychotropic substances, to help companies register and market, so that more patients can benefit from it,"
.
perseverance, we can see more successful cases and create greater social and economic value.
" - Shen Yishuang in recent years, psychoneurologic drug research and development because of the growing prosperity and attention.
the Alzheimer's disease (AD) treatment drug GV-971 developed last year in China, which was granted conditional approval by the Fda to go public.
Shanghai Mental Health Center, as the lead agency for phase II and III clinical trials, provides a new treatment option for AD patients.
the agency in the clinical research road quietly worked for more than 20 years, witnessed China's innovative spirit of drug clinical research and development from scratch.
unmet clinical needs, I visited the famous 600 Wanping South Road in Shanghai.
"600" as the exclusive title of Shanghai Mental Health Center, has been passed down by the old Shanghai population for many years.
the beautiful, tree-lined environment here, it is pleasant.
especially the small garden in the courtyard.
on the way to the hospital's office of clinical trials, I saw sculptures by Professor Su Zonghua, a well-known Chinese psychopath, and Professor Xia Zhenyi.
they are the ancestors and founders of chinese psychiatry, they have urged the name of psychiatry to be changed to "psychiatry", which is very humanistic, and at the same time to "mental health center", so that the name of the Shanghai Mental Health Center.
the scale and level of the cause of chinese psychiatry can develop to the present day, and these psychiatric predecessors made contributions are inseparable. Dr. Shen Ifeng, Director of the
Office of The Agency, received my visit.
when he learned that I was going to do an interview with him, he didn't want to talk too much about himself because he was "old enough to want others to remember what he did."
so we went straight to the topic and talked about psychotropic drug research and development.
believes there is a large and unmet clinical need in mental health, and that autism, for example, remains a globally incurable mental disorder.
the great challenges of psychotropic drug research and development come from many aspects: the cause of mental disorders is unknown in general, doctors know very little about the internal causes of their pathogenesis and diagnosis and rehabilitation, research methodology is also limited, the research progress of psychotropic medicine depends on the breakthrough of basic scientific research, and it is difficult to find new candidate stakes.
the development of new drugs why a wide variety of neuropsychiatric disorders, involving more than 600 indications, is a low fatality rate, high disability rate of disease, the global burden of disease is second only to tumors, cardiovascular, chronic respiratory diseases, cirrhosis and endocrine diseases.
antipsychotics are a class of drugs that can relieve psychotic symptoms and prevent the recurrence of psychotic symptoms.
recently, The Analytics times summed up the most searched areas of psychiatry in 2019: including cannabidiol as an auxiliary treatment for schizophrenia, whether immunotherapy can be used as a treatment for schizophrenia, and the path of depression from monoamine to glutamate.
these are a remarkable breakthrough in psychotropic drug research and development.
Although there are more than 10,000 drugs developed worldwide for neuropsychiatric disorders, due to the complexity of the pathogenesis of such diseases, the pathogenesis of many diseases is not clear, so the difficulty of its research and development is very large;
and China is a long-term generic drug-based, according to The Ames China market data, 2019 sales of generic drugs of the Oxana is about 287 million U.S. dollars, accounting for 40.65 percent of the total sales of antipsychotic drugs.
until recently, there are many companies involved in innovative drug research and development, involved in enterprises and scientific research units including Koren Pharmaceuticals, Nanjing Zhongrui, Jiangsu Kangyuan Pharmaceutical, Guangdong Zhongke, Sichuan Haicisco, Shandong Green Leaf, Shanghai Green Valley, Zhejiang Haizheng, Zhejiang Huahai, Guangzhou Magpie, Shanghai Pharmaceutical Research Institute, Guangdong South China New Drug Creation Center and so on. Shen Ifeng,
, believes that there are two reasons for the difficulty of drug research and development.
first, the cause of disease is not clear, because of the limited research methods, research and development personnel on the disease evaluation is more subjective.
", although there are evaluation tools (such as scales), but highly subjective and prone to questioning.
," he said.
second, the high placebo effect, which remains high and rising year by year, also makes the success rate of research and development low. The high effect of the placebo effect of
psychotropic drugs has been widely seen around the world, with antidepressants, for example, some drugs that have been shown to be safe and effective and marketed for many years have a 46 percent chance of failing to demonstrate better-than-placebo performance in subsequent studies, Shen said, citing literature reports.
a new drug may be effective, but because of the high placebo effect, the study is unlikely to be able to confirm pre-set assumptions.
, why is the high placebo effect? Director Shen analysis that once patients participate in clinical trials, their attention and medical services often exceed the general treatment, even if given a placebo, patients also get the psychological treatment of the feeling.
the increasing effect of placebo has attracted the FDA's attention.
training on "How to Reduce the Effects of High Placebo Effects" has been widely added in clinical trials of placebo-controlled psychotropic drugs.
specific to the challenges of psychotropic drugs in clinical trials, mainly reflects the following aspects: First, the patient's willingness to participate is insufficient, there is a misunderstanding of clinical trials.
Shen Yishuang said that some media reports, the volunteers involved in clinical trials (whether healthy volunteers or patient volunteers) compared to "little white rats", for some of the common misunderstandings and stigmatization;
second, clinical trials of psychotropic drugs require professional lead researchers.
the program design of psychotropic drugs clinical trials often has academic or operability defects, there will be ethical problems, so that clinical research is not smooth.
at the same time, some senior psychiatrists pay little attention to psychotropic drug clinical trials, and rarely use clinical trials as a major industry to study. Third,
, clinical trial institutions are uneven and quality varies greatly.
the research and development of innovative drugs requires more and more clinical trial institutions to participate, with the increase of research centers, the quality differences between the centers and the impact of the test is more obvious.
fourth, the ability and level of the applicant and CRO practitioners needs to be improved.
the rapid development of the biopharmaceutical industry, so that the qualified personnel to carry out clinical trials is obviously insufficient, the first-line staff turnover rate is high.
the quality of clinical trials can be worrying if employees who work on the front line are not trained enough and lack a band.
the fifth and most important, hospital leaders need to understand the clinical trial work from the perspective of discipline construction, personnel training, upgrading grasping hands, quality culture construction, and firmly promote the progress of the project, avoid simply emphasizing the organization's brand and fame and loss.
" the smooth development of clinical trials in our hospital can not be separated from the ethics of The Chairman Xu Yifeng and secretary Xie Bin's full support.
," Shen said.
two key points of mental health ethics review In 2016, the Ethics Committee of the Shanghai Mental Health Center identified the helpers and supervisors of clinical research, and the "Operational Guide to Mental Health Ethics Review" was co-authored by all members and secretaries, which helped to understand the basic principles and important concepts of ethical review by focusing on the key issues of the ethics review of psychiatry, supplemented by the discussion and analysis of practical cases.
According to Shen Yifeng, the mental health ethics review process should strengthen the review of informed consent process.
despite the widemis of misconceptions about people with mental disorders, it is believed that they lose their civil capacity if they become ill.
in fact, only a part of the patient with mental disorders, at some stage of their disease, temporarily appear some problems with the ability to know, so this situation is very rare, usually should let the patient himself informed consent.
the Mental Health Ethics Review Guide, it is
that due to the disease, the subject's ability to give informed consent is volatile, and as the condition improves, the ability to informed consent recovers, it is up to the subject sits on the right to exercise it.
at this point, the researchers need to re-inform the patient himself and have the subject signed it off.
second, special emphasis should be placed on the confidentiality and privacy of subjects' personal information.
stigmatization of discrimination in people with mental disorders is a social reality, confidentiality and privacy protection are particularly important for subjects who participate in clinical trials of such drugs.
for example, a patient to a general hospital is not afraid of others to see, and to "600" medical treatment is likely unwilling to let others know.
needto pay special attention to privacy when it comes to disease research and small community studies involving diseases and diseases.
as the electronicization of case records and the operation of data confidentiality become more complex, the Ethics Committee should pay particular attention to the practical data and information confidentiality systems in the programme when reviewing projects.
the mind of eco-psychiatrists who have built innovative drugs to develop them tendto to be strong and optimistic, so despite the difficulties faced by psychotropic drug development and clinical trials, Shen Ifeng still believes that there is no such thing as a bump in the world.
he has put forward the following puzzles that can be solved.
based on the government's continuous investment in basic medical research, with a view to making breakthroughs, optimizing evaluation tools, using more high-tech means, trying to objective lying on subjective psychological phenomena, as far as possible, in cooperation with experienced clinical trial institutions, choose clinical trials as the main industry researchers to lead clinical research and development; New methods of pharmacology, reducing the total number of patients in the group, promoting adult data extrapolation to children, communicating with regulatory authorities, focusing on clinical research planning, scientifically designing the efficacy endpoints and research paths of each program, training relatively stable research teams, working together with pharmaceutical companies in the field of mental health, finding the best combination of academic research and industrial research and development, and gradually forming a sustainable industry ecology, in order to actively await the new golden age of psychotropic substances.
The National Drug Clinical Research Base (now known as clinical trial size) of the Shanghai Mental Health Center was founded in 1998 by Professor Gu Niufan.
established an ethics committee in the same year to conduct an independent review of clinical trials of drugs/medical devices and other human-related clinical studies.
, led by Professor Li Huafang in 2008, the first batch of GCP platform funding to receive major special projects of the National Eleventh Five-Year Plan "Major New Drug Creation" science and technology, is the only psychiatric specialist hospital in 26 hospitals. After the
won the "12th Five-Year Plan" and "13th Five-Year Plan" continuous support, in 2019 to become the first batch of outstanding subject-taking units, by the "drug clinical evaluation demonstration platform" title. in addition,
to help psychotropic drug research and development to provide a full range of academic support, improve the quality of research, enhance public trust and support in psychotropic drug clinical trials.
April 2014, the Shanghai Mental Health Center led the establishment of the Cooperative Network for Clinical Trials of Psychotropic Substances, an academic group composed of a voluntary joint group of units with higher levels of psychiatric diagnosis and treatment and scientific research, with the core of the domestic drug clinical trial institutions (Psychiatry). Professor Zhang Hongyan of the Sixth Academy of Peking University,
, is the head of the collaboration network working group from 2020 to 2021.
" co-operative problem solving is the basic work philosophy left by our agency's founder, Professor Gu Niufan.
it's because of a problem that we need to work with the industry to launch multiple clinical trials, with the goal of a study that answers a single question and eventually converges into a complete chain of evidence that validates the effectiveness and safety of psychotropic substances, helps companies register and market, and lets more patients benefit from it.
I'm persistent, I'll see more successful cases and create greater social and economic value."
" Shen Yiffeng said: "On the occasion of the implementation of this new version of the GCP on July 1, I would like to share with the industry a point of view: the GCP principle only trade-offs without compromise, the adherence of each practitioner will promote the continuous improvement of the industry ecology, we welcome domestic and foreign enterprises to cooperate with us to solve the unmet needs of this big problem."
" after the interview, Professor Shen has been taking me to the hospital door, I can not give up.
I said to him that the encounter between people is like "a period of time", every moment can not be repeated. Shen Yissing, an optimistic psychiatrist
, smiled and said that if you want to miss the "600", meet again to chat.
.