On May 16, the CFDA recently issued a consultation paper for "disorganization certification", which is of epoch-making significance in China's clinical research industry. It is said that the cancellation of agency certification indicates that China's clinical research has risen to the level of international integration, and also marks the beginning of a truly specialized clinical study. 

 

Although has always been the CFDA authenticate the pharmacological mechanism and the clinical research in China has trained a large number of qualified researchers and standardize the operating process of clinical research, to improve the quality of Chinese clinical research has made a great contribution, but with the continuous improvement of the clinical research quality, pharmacological mechanism plays a role in clinical research. 

 

For the clinical research industry, the elimination of agency certification presents both opportunities and challenges. But overall, the change is a spring breeze for professional clinical researchers, who seem to be able to see the lush green of the spring breeze. 

 

SMO has huge space 

 

The first to benefit is SMO. The clinical pharmacological institutions of each hospital are actually the SMO of the hospitals themselves. Some of the country's first SMO were built by hospital staff themselves. Even if clinical pharmacies are not certified by the CFDA, clinical pharmacological institutions in hospitals still have a huge advantage over the commercialized version of SMO. 

 

In the market for clinical research, hospitals' pharmacological institutions are the most commercial SMO competitors. Since the birth of China's SMO, it has been able to find a little bit of living space in the seams of pharmacies, and even some SMO has long been semi-legal in operation. After cancel the agency certification, although the SMO stationed outside the court of CRC in each hospital work must still be recognised by the hospital clinical pharmacological mechanism, but the advantage of clinical pharmacology mechanism weakened after cancel the agency certification. At the same time, because of the SMO business development can not be restricted by only in a hospital, can expand the business, and constantly develop new hospitals, SMO reliance on a clinical pharmacological mechanism is also decreased. 

 

To force the development of clinical institutions in hospitals 

 

At the same time, the elimination of agency certification can also promote the development of clinical pharmacological institutions in hospitals. The elimination of certification forces the market for clinical pharmacological institutions in hospitals, and eventually the pharmacological institutions will compete with SMO at the same level in terms of technology and quality. In the past, the certification of pharmacological institutions has been in the form of a lot of forms, and even specialized companies have helped the pharmacological institutions to obtain accreditation and prepare documents for pharmacological institutions. Some organizations have hundreds of sops that they can't even see. 

 

Agencies recognized the cancellation of the forced some hospital clinical pharmacological mechanism and further improve their management level in our business, to use its own relations with our hospital to gain competitive advantage. Well-done clinical pharmacies can also use their technological edge to extend their business to other hospitals, just as commercial SMO does. Pharmacological institutions that do not pay attention to clinical research can gradually reduce their size and ultimately manage some administrative affairs. Some of the largest hospitals in the United States also have institutions, but they do not have much interference in clinical research. 

 

The CRO business has two areas of growth 

 

CRO's business will also grow. For CRO, there will be at least two growth points for feasibility studies and researchers training. 

 

Before because of limited hospital are qualified for clinical research, feasibility study compared with other countries, China's feasibility study was relatively simple, only need to choose from a limited number of qualified hospital is ok. After the cancellation of accreditation, any hospital can become an alternative hospital and the workload has increased significantly. Although the screening of the researchers in the future, in a certain period of time will still be the preferred those who once won the certification institution, but after all, selection scope to expand to those who always do not obtain certification, but the hospital with clinical research experience. 

 

Select really willing to participate in clinical research and is willing to obey the requirements of the clinical research hospital participation in clinical research, is the key to improve the quality of clinical research. Feasibility study in the United States, often need to investigate hundreds or even thousands of hospitals, through the feasibility study found interested in the study researchers, again through the screening of a large number of optional hospital visits to determine the qualified researchers, eventually found both cooperation and qualified researchers. It will also happen in China in the future. 

 

At the same time, there will be a market for researchers training. The certification was released, and the bidders had greater freedom of choice in the choice of hospitals, but the question of whether the researchers were qualified was an outstanding issue. Now the CFDA can send GCP to want to participate in clinical research personnel training certificate, just completed the online training course and pay a fee, you can get a certificate for GCP. 

 

However, the clinical researchers obtain GCP certificate may not truly understand the operation of clinical research, how to make the regulation of GCP in practical application to clinical research work, still need to more specific training. In fact, it is the international pharmaceutical companies and CRO companies that have really trained the researchers since China conducted clinical research. These international pharmaceutical companies and CRO companies have trained researchers in every project in China. Some researchers have become experts in clinical research through the operation of several international multicenter clinical studies. 

 

For the training of researchers, CRO can do it, and SMO can do it, and there will be even some specialized training companies to provide such services. The purpose of this training, not allow researchers to get a certificate, but for the researchers later in real clinical study, can pass from official visit. 

 

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Opportunities also mean challenges. Some colleagues say that after the cancellation of agency certification, the responsibility for the quality of clinical research falls entirely to the bidders. In fact, the main responsibility for the quality of clinical research in the past, before the elimination of agency certification, was ultimately to the bidders, but now more directly. How to do a feasibility study? How to effectively screen clinical research bases? How to do the screening of clinical research? These are the issues facing CRO and the bidders. 

 

Despite the cancellation of agency certification, the bid has been fully liberalized by the clinical research center or the researchers, but not immediately. In the first place, the bidders will still give preference to hospitals that have previously been certified. At the same time, clinical pharmacology institutions in a certain period of time will still play a very important role, clinical research market won't immediately appear "tidy up ca mau, field points really busy".