BACKGROUND
Cancer continues to be one of the top three killers around the globe: it killed 7.6 million people worldwide in 2005 and is expected to kill 11.4 million annually by 2030. Despite the tremendous advances that have been made in the past decade in understanding the biology of cancer development and progression, we are far from curing most of the cancers. The need of the hour is the translation of these advances into better outcome for patients with cancers through interventions that improve the quality of life as well as treat and potentially cure the disease. Such translation is dependent on carefully designed clinical trials which asks the right questions, studies the right population, and uses the correct methodologies. With only a small fraction of eligible patients generally participating in the clinical studies, today’s investigator needs to be educated not only in the art of conducting clinical trials, but also needs to be skilled in communicating the spirit and objective of clinical trials to patients. The majority of the clinical trials today are conducted in the developed nations mostly related to the availability of resources necessary for successful conduct of trials, whether related to new drug therapies or interventions aimed at improved quality of life. The developed nations have advantage of a well organized system of clinical trial conduct that has been improved over the years through a mixture of academic inputs and mechanisms for legal oversight of the process. However, the scenario is changing rapidly with vastly improved medical care as well as access to modern technology in the developing nations. Patients in these emerging healthcare systems are increasingly aware of the advances in the medical science and expect access to the latest advances and it is imperative that they be allowed the opportunity to participate in clinical trials. In order to maximize the information gleaned from these clinical trials, it is important they conform to the well accepted guidelines and international regulations governing the conduct of clinical trials.
THE CHALLENGES
Recent advances in the understanding of cancer biology have led to development of targeted therapies for various cancers. Although hundreds of oncology drugs are currently being developed, the insufficient capacity in conducting high quality clinical trials is limiting the development of these life-saving drugs. China has a large population of cancer patients and a nationwide network of well equipped cancer hospitals, which forms a solid foundation for China to build up a strong clinical research capability. However, the lack of enough clinical research professionals who are well trained to conduct clinical trials in compliance with the accepted guidelines is restraining China from playing an important role in the clinical development of novel oncology drugs. Development of a program that will enable investigators from various medical institutions in China to observe and learn current methodologies in clinical trials will be of immense benefit in enhancing the evaluation of new drugs through well designed clinical trials, translating into better outcome for patients with cancer.
THE SOLUTION
In order to effectively address the challenge that is limiting the growth of Chinese clinical research capability, NFCR, in partnership with AFCR, has established a new training institute, the Institute for Clinical Research Excellence (ICRE), by working with major cancer hospitals and clinical contract research organizations (CROs) in the US and Europe. ICRE will provide extensive International Conference on Harmonisation (ICH) / WHO Good Clinical Practice standards (ICH-GCP) training course and hospital observation opportunity to a group of selected physicians from China each year. This new initiative will leverage NFCR and AFCR’s extraordinary resources and worldwide network in clinical cancer research to accelerate the development of novel anti-cancer drugs and therapies in China.
THE PROGRAM
ICRE selects trainees from major hospitals in China to participate in the Clinical Training Program. The Program will provide the trainees a unique opportunity for exposure to the clinical practice in a large tertiary hospital, such as Mayo Clinic in the United States, in the context of clinical trials. This program will allow each of the trainees to observe every step in the design and implementation of a clinical trial. The program will be focused on four main aspects of clinical trial conduct: protocol development, patient enrollment, data collection and data management, and quality control.
The training course will introduce the trainees with a set of GCP compliant Standard Operating Procedures (SOPs) as a template so that the trainees can use them to develop their hospital-specific documents. The ultimate goal would be to train them how to develop a comprehensive set of hospital-specific workable documents which would cover the methods for conducting all clinical trials in China.
In July 2007, the inaugural Clinical Training Program was successfully conducted at Mayo Clinic, one of the most prestigious cancer research hospitals in the United States. Oncologists and clinical researchers from five tertiary hospitals in China received intense one-on-one training that was specifically designed to improve the knowledge and skills of each trainee. Over time, ICRE is facilitating the participation of a growing community of appropriately-trained Chinese oncologists in multi-national clinical trials and enable them to collaborate on new drug development at a level not currently possible. Steadily and surely, our continued efforts will lead to improved clinical trial conduct in China, expedite clinical cancer research, and bring more life-saving treatment to cancer patients worldwide.
