China Could Play a Leadership Role in Reducing Clinical Research Project Cost
Pharma IQ: What are the challenges in managing global clinical trials data -data compliance & reporting?
N Toraskar: Overall challenges in managing global clinical trials data.
- Ensuring good patient recruitment practice to address sponsor requirements
- Staff training in building a world-class data management center
- FDA requirements and the implications for patient data reporting
- Clinical data standardisation and integration processes
- Organisational structuring for efficient clinical data reporting on a global scale
- Critical clinical form design with balancing needs
- Sensitive clinical operation and process re-engineering
- Continuous technology improvement
- Caution with edit check specifications to minimise bias
Others Specific to use at the sites:
- Site staff not being trained properly, result in entry errors
- Site staff may edit the auto queries to correct values that are incorrect because of their knowledge of the subject
- Impossible values being updated
- Missing values being prompted for
- Extreme values being replaced with acceptable values
- Unexpected data values being removed or modified
Pharma IQ: What is the current regulatory environment & requirements for clinical trial data collection & management?
N Toraskar: For data collected electronically, all data collected for an individual patient will be organized by domain and time and provided as a PDF file. This file should subsequently be handled the same as an imaged CRFs.
Thus for e-CRFs, the following is needed:
The replacement of paper CRFs now scanned into PDF files with PDF files generated by either the EDC implementation from its e-CRFs, or by third party software from the EDC database.
The ability to provide the FDA with “copies of records” in a way that preserves the electronic signature.
The ability to provide the FDA with “copies of records” in such a way that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend Part 11 records, copies provided to the Agency should provide the same capability if it is technically feasible. You should allow inspection, review, and copying of records in a human readable form, on your site, using your hardware and software, following your established procedures and techniques for accessing those records.
N Toraskar: Please elaborate on the role of CRO's in managing patient compliance & data?
Large trials often have several streams or sources of data. These include integrated voice response system data, lab data from central labs, laboratory normal values, electrocardiogram readings, and even electronic patient diary data. All the edit check specifications pertaining to the criteria defined in the protocol relating to the compliance will enable auto queries to get popped up in case of non-compliance of data. Also, the data will be cross-checked against the patient data during the conduct of the trial to identify discrepancies or unusual occurrences.
Bryan Camoens: What sort of role will China play as a data management center for global projects?
N Toraskar: Overall China has huge patient population as well as good infrastructure & skilled manpower which play a main role. As it is well known facts that worldwide pharma research companies are looking for cheap labours cost to reduce huge expenses incurred while conducting clinical trials. Sponsors want additional expertise at lower costs.
- China has handled many global projects for International sponsors in the US and EU. China’s experience of handling CR projects has wide varieties.
- Data management center plays the role of a central collection and processing point for the CRFs that are generated at different parts of the world. The CRFs (paper) are either scanned or physically sent to the centreal office and the study is managed like any other data management study. The same way eCRF can access anywhere from the world site.
- There are already multinational CRO’s working in china in CDM domain.
- Experience in working with international sponsors thus appreciate and understand the work culture in those countries. This ensures a smooth transition and completion of the project.
- China ensures a higher reporting frequency for the global projects.
- China has a very strong Technology providers & IT infrastructure at par with US/EU.
Again overall China can play leadership role to bring down cost in running the clinical research projects in the world.
Bryan Camoens: How does data collection differ in EU than Asia?
N Toraskar: The data collection differs in EU than Asia mainly with respect to regulatory requirement.
Ex1: According to the protocol, if the age limit is set to 18 years - 75 years in US or EU, in India maximum limit is set for most of the studies between 18 years - 65 years.
Ex2: In US and EU, only SUSAR need to be reported. Whereas according to Indian regulatory every SAE needs to be collected and reported.