For pharmaceutical companies, contract research organization clinical CRO can shorten the time for pharmaceutical companies by up to 30%, reduce R&D costs by 40%, and become a powerful comrade for pharmaceutical companies to compete with time.
Drug research and development can be roughly divided into two stages: preclinical and clinical trials. Clinical trials refer to systematic research on humans, which usually takes five to seven years. If the capital cost and time cost of developing a new drug are "one billion US dollars in ten years", then "700 million US dollars in seven years" will be spent on clinical trials. With the expiration of patents for global innovative drugs and the fact that only the top three domestic generic drugs of the same variety can be included in the scope of centralized procurement, the sooner or later a new drug is launched is the difference between life and death for pharmaceutical companies. Pharmaceutical companies must race against time.
and FDA have different requirements for conducting trials if they meet the standards. According to the management regulations of GCP, clinical trials in my country must be conducted in tertiary hospitals that are certified as clinical trial institutions. In terms of daily medical treatment for the people, the resources of tertiary hospitals are already tight, and the resources that can be allocated to clinical trials are even more stretched.
Therefore, clinical CRO is the most important segment in the global CRO market. Guoxin Pharmaceutical is a CRO company that focuses on providing clinical research services. It is a national high-tech enterprise and the executive deputy chairman of the CRO branch of the China Pharmaceutical Quality Management Association.
According to data released by the National Health Commission, in 2019, there were 2.77 practicing assistant doctors per 1,000 people in my country and 3.18 registered nurses per 1,000 people, which is only equivalent to the level in the United Kingdom ten years ago and the level in Australia twenty years ago. This means that an average medical practitioner is responsible for the health problems of 361 people, and a nurse is responsible for an average of 314 people, making it difficult to balance clinical trials.
On the one hand, clinical trial resources are tight, but on the other hand, the demand for drug research and development is increasing. In the past five years, China's investment in drug research and development has increased from US$1.05 billion to US$2.11 billion, an annual increase of 19.1%, which is much faster than the construction speed of public hospitals.
In the past, the clinical trial approval cycle was long, with an average of 14 to 20 months from application acceptance to patient enrollment. However, in 2018, the State Food and Drug Administration implemented a tacit approval system for clinical trial applications—within 60 days from the date of acceptance, if the Center for Drug Evaluation does not deny or question the application, the applicant can conduct the trial on its own, and drug research and development has changed from "strict in and out" to "lenient in and strict out".
In drug research and development, hospital beds and doctors have become the scarcest resources. This has also directly led to the development of domestic clinical CRO, which is seriously restricted by the shortage of clinical trial institutions.
What hinders the development of clinical trials is not only the subjective willingness of hospitals to participate, but also the objective shortage of national medical resources . Clinical trial institutions are conducted in tertiary hospitals. The role of researchers is mostly assumed by department directors, assisted by nurses, and the number of full-time researchers is very small.
