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forum background
in the context of globalization, more international clinical studies of psychotropics have been performed. a growing number of multinational pharmaceutical companies lead the early r&d of psychotropic drugs to china. meanwhile, chinese government has called for the development of critical pharmaceutical innovations and novel medical technologies, and launch new policies to fund support activities. the pharmaceutical industry in china has achieved remarkable success in the innovation of psychotropic drugs as a result.
budget, cost control and agreement, are the key words in clinical trials. it is generally known that a reasonable budget is necessary to guarantee the smooth implementation of the trial, and help to reach quality requirements as well. a systematic and scientific “clinical trial agreement” can clearly define the rights and responsibilities of both sides, and contributes to better cooperation. but the current situation is not optimistic. there are a few inharmonious opinions from sponsors and sites.
some complains are from sponsors:
- the cost of clinical trials in china is increasing dramatically. it is difficult to promote even with continuous additional budget.
- a number of investigators only focus on budget. they are not willing to have a further discussion if sponsor cannot offer a satisfied price.
- a number of investigators orally promise everything before signing agreement. but the actual situation of enrollment and quality of the ongoing trial are not in line with the expectations.
- the sites, especially leading site, are sometimes in a strong position. sponsor is reluctant to sign unfair terms.
some complains are from sites:
- the budget can not keep up with the rising cost. how do investigators keep doing clinical trials with enthusiasm?
- the design and operation are more and more complicated in clinical trials actually. the subject enrollment is going difficult due to many strict inclusion or exclusion criteria. the quality requirements are getting higher. it is hard to do with money, to say nothing of insufficient budgets.
- sponsor only focuses on how many subjects enrolled. however they totally ignores that investigators make struggling efforts to screen potential patients. what investigators have done for the trials are more than expectations. sponsor always complains that the investigators are far behind the enrollment schedule which is not made by the investigators.
- sponsors are not willing to help the investigators to solve a number of problems which are not in the agreement.
- there are requirements in gcp about insurance for the subjects and legal and economic guarantee for investigators. actually there is seldom insurance and no guarantee at all.
the sponsors and the sites have to bargain for a long time about “budget and agreement” before the implementation of clinical trials. it is not only time and energy wasting but also not conducive to establish a long-term partnership. it indirectly leads to a decline of pharmaceutical r & d and damages the sustainability of entire industry ultimately.
“cooperate to solve problems” is the philosophy of china academic research organization of psychotropic (chinaaro-p). we organize the forum to create opportunities for direct conversation among sponsors, investigators and related professionals. it is believed that an ultimately promotion of the industry will be made through comprehensive communication.
platform background
clinical tech-platform for evaluation of new drug in psychiatry is the leading platform of psychotropic drugs in gcp of national major project for ind. shanghai mental health center irb is the first psychiatric hospital ec certified by who-tdr sidcer in asia-pacific region, and recognized in the international audit for many times. currently, the platform has successfully completed the 11th five-year project acceptance, and wins the 12th five-year rolling funding (2012-2015). chinaaro-p was established in sep 2012 in order to resolve all kinds of academic issues in this field.
the function and mission of the platform are to strengthen communication between the industry, academia, investigator and user over the past years. we have already organized the following forums:
- sponsors consulting about the platform construction (2009)
- international forum in psychiatry-the perspective of industry and academia (2010)
- international forum in psychiatry-the perspective of ethic (2010)
- international forum in psychiatry-challenge and opportunity of cra/crc (2011)
- international forum in psychiatry- the perspective of drug evaluation (2012)
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