Challenges in Data Collection and Clinical Trials Management
Bruce Xue, Biostatistical Manager, Medical Affairs Department, Xian-Janssen Pharmaceutical, speaks to Andrea Charles from Pharma IQ, about the challenges of data collection and integration of clinical trials and the practical implications of globalisation.
Pharma IQ: Please could you tell us about your current role and responsibilities?
My current role is biostatistical manager in China R&D and scientific affairs department, Janssen China, in charge of DM, biostatistics and statistical programming for all phase I to phase IV studies. For DM responsibilities, we work as the role overseeing external vendors in conducting our outsourced projects.
Pharma IQ: What is the biggest challenge you face in data collection and integration of clinical trials? How do you seek to overcome it?
The biggest challenge for me is to keep consistent standards (for DM process, quality and database structure etc.) for all projects outsourced to different vendors, which range from local small CROs to global top 10 CROs. My goal will be working out specific standards and internal reviewing process with an internal DM group. Collaboration models with CROs will be also observed to serve this purpose.
Pharma IQ: What do you think are the top 3 practical implications of the globalisation of clinical trials and drug development?
1) Patients around the world will have equal chances to get reasonable/best treatments; 2) Most cost-efficient working models/process can become possible in pharmaceutical R&D in global level; 3) There will be less barrier for R&D talents to move around the world, which may benefit the industry a lot.
Pharma IQ: What are the main differences between China, India and rest of Asia?
Except Japan, China has the strictest regulatory environment for pharmaceutical R&D. More trials and more patients in each trial are needed for drug development in China. SFDA timeline is much longer than any other Asian countries. Based on all of those, the cost will be much higher and the timeline much longer for R&D in China.
Pharma IQ:Do you expect the number of clinical trials in BRIC countries in the next 12 months to increase, decrease or stay the same?
Yes. I do expect there will be more trials in BRIC countries since most pharmaceutical companies are aware of the opportunities for them to grow their business in these countries.
Pharma IQ: What are you most looking forward to about the 2nd Annual Data Collection and Management in Clinical Trials Asia 2011?
Sharing experiences overseeing CROs to assure the data quality and consistency with internal standards/requirements. Collaboration models with CROs to assure a real double win outcome. Main problems/issues we are facing in globalisation of clinical trial conduction (especially in DM) in the whole AP region and AP countries and possible solutions.
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