The Challenges in Clinical Trials and Drug/Device Development session called attention to one common message from the conference speakers: The Asia Pacific region is becoming a key player in global clinical trials. Presentations by Dr. Mohanish Anand (Pfizer, USA), Dr. Victoria Elegant (China), Dr. Lee Young Jack (Korea), and Prof. Sam Lim (Singapore) emphasized the resources and infrastructure targeting clinical trials and the large participant pools available. For example, several hospitals in China have more patients with liver disease than any other hospitals in the world, providing great opportunities to test new drugs for diseases like hepatitis. At the same time, Dr. Johan Karlberg from Humanity and Health in Hong Kong warned that while clinical trials are rapidly expanding worldwide, ethics committees (ECs) are struggling to improve in order to keep up with the increased demand and complexity of reviews. He also stressed that prospective participants need to be educated and that in addition to the consent document, participants should be given information, perhaps in brochure form, that explains the basics of participating in research in a culturally appropriate manner. Dr. Karlberg sees accreditation as a way to ensure high quality in human research protection programs.
Representing AAHRPP, Dr. Peter Vasilenko, the Chief Education and Evaluation Officer, moderated and presented at two sessions. The message of his slide reflecting an era of quality improvement for HRPPs was reinforced by seven sessions dealing with aspects of quality improvement.
At the Accreditation Promotes Quality IRB Review session, Dr. Vasilenko examined the AAHRPP requirements that promote quality IRBs and ECs. Dr. Prathbha Pereira from Manipal Clinical Research Centre discussed the ethical issues in India, particularly the prevalent feeling that participants are used as guinea pigs. She stressed how accreditation has changed her hospital’s EC, which organized a comprehensive HRPP and developed a high-quality and respectable program as a result of the accreditation process. Dr. Meixia Wang from Beijing You’An Hospital also described how accreditation has improved her hospital’s HRPP and EC, “Accreditation allowed us to make improvements in policies and procedures and in EC performance. The EC members are now more knowledgeable and more confident in making decisions. Examples of policy changes included enhanced management of conflict of interest and quality improvement. The HRPP concept was promoted throughout the hospital and with investigators involved in daily clinical practice, who discuss with prospective participants the safety of research and their rights as participants. AAHRPP accreditation has improved the quality of both clinical research as well as clinical practice at You’An Hospital.” Dr. Wang indicated that the concept of an HRPP is gaining momentum in China and emphasized that accreditation required the HRPP to meet the AAHRPP standards as well as Chinese laws and regulations. The concept of the HRPP, which was also discussed in several other sessions, has been adopted in the Asian Pacific area.
Other highlights of the conference:
- In his opening keynote, Dr. Ezekiel Emmanuel from the University of Pennsylvania discussed the assessment of risks. He talked about how IRBs and ECs overestimate risk and how the use of more quantitative methods can help determine whether research involves greater than minimal risk.
- Prof. Toshiaki Furukawa from Kyoto University Graduate School of Medicine in Japan spoke about publication bias in clinical trials. Prof. Furukawa provided evidence that publications favor positive results and thus the medical literature gives an overestimation of the effectiveness of new drugs. He said that researchers and the public should have access to the totality of evidence.
- A session on emerging trends toward SBER and epidemiologic research, with speakers from Taiwan, Hong Kong, and Australia, explored both the need to review research in the social sciences and epidemiology and how different countries are approaching the topics.
- A session was dedicated to a common issue worldwide, Informed Consent: Protecting Subjects when Capacity Is Lost, with speakers from Germany and Singapore.
- Another session, Effective Project Management, was led by Dr. June Merwin of Pfizer (USA) with colleagues from Singapore from PAREXEL International and ASEANZ Clinical Management Pharmaceutical Product Development, Inc. The session discussed how clinical trials should be optimally performed and monitored.