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Helping clients improve the efficiency of clinical development will continue to be the core competencies of clinical CRO companies in 2018 and in the future. Pharmaceutical companies will unremittingly find new ways to shorten the development cycle and reduce costs. Therefore, CRO companies that rely on professional skills rather than manpower cost will have the greatest benefit. The so-called expertise includes risk-based monitoring, clinical trials adaptive design, and flexible delivery models.

Some CRO companies also use big data to optimize clinical center screening, patient recruitment, health economics assessment, and research results in order to meet key challenges. Even drug companies themselves are consciously investing in this direction.

In addition, there is a great demand for CRO services in the development of orphan drugs and rare disease therapies, because pharmaceutical companies need CRO to provide knowledge in subdivision specialties and global clinical center resources to help them design more reasonable trial solutions for these complex diseases. And recruit patients faster.

Whether it is for submitting a new drug listing application (NDA/BLA) or post-marketing research, the demand for data from drug companies will only increase. These data not only include evidence in pharmacoeconomics, but also include evidence-based data on R&D provided by CRO. This also requires that CROs must keep up with the times, keep up with changing regulatory requirements, and work with organizations that set standards for benchmarking and data compilation systems, such as the International Health Outcome Measurement Coalition (ICHOM).

Patient Challenges: Recruitment and Management

Improving patient’s quality of life is always the top priority of drug development, which means that there are many links that can be optimized in clinical trials, such as quickly identifying patients that fit into a clinical trial through electronic medical records, and adopting advanced statistics. The method was to reduce the number of enrollees in the control group as much as possible and obtain clinical trial results quickly after the patient was in place.

Patient recruitment will still be the main cost of clinical development in the coming years. Industry sources estimate that patient recruitment costs account for more than 30% of the entire clinical trial budget. In addition, patient recruitment is also a major obstacle to the completion of clinical trials. According to Tufts, 11% of clinical centers failed to recruit one patient, and 37% of clinical centers failed to complete their recruitment goals.

Therefore, CRO must continue to look for new ways to cope with this challenge, including reducing the cost of treatment for patients and making them more willing to participate in clinical trials as a treatment option, rational selection of clinical centers so that the clinical trial process and results are more Predictive and more supportive of the clinical center’s training of its physicians, including automatic data collection and analysis of electronic medical records.

Innovation

Needless to say, innovation plays an increasingly important role in improving the efficiency of drug development. Pharmaceutical companies and CROs also need to work together to explore how to integrate new technologies on the basis of existing detection methods and analytical methods to significantly reduce the risks and costs of drug clinical development.

For CRO organizations, it is important to achieve a standardized clinical trial environment through a simplified and streamlined solution on a unified technology platform. At the same time, the use of some cutting-edge technologies may also be indispensable, for example, to give full play to the role of wearable devices and sensors in clinical trials to increase the added value of their development projects.

Adaptive design is not a new, unproven concept. It is after the start of the clinical trial, on the premise of not destroying the integrity and validity of the test, adjust the follow-up test plan based on the partial results obtained from the previous test, so as to discover and correct some unreasonable assumptions at the beginning of the test design in time. The general term for a class of research design methods that reduces research costs and shortens research cycles. The adaptability test provided powerful insights for the subsequent trial design and implementation of the clinical protocol. Only sufficient analysis and response can be made based on the previous adaptive design, in order to continuously design and implement complex adaptive clinical trials, and to recognize the efficacy of the drug in a timely manner. It can even be predicted by machine learning and artificial intelligence. Clinical trial results.

The above initiatives will redefine how pharmaceutical companies use data and adaptive design to accelerate development and open the way for broader indications. Regulators in Europe and the United States also encourage adaptive testing, which can help reduce the cost of clinical trials by about 25%.

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