BioGrid has helped many pharmaceutical companies with data which significantly shortened the time preparing TGA submissions. While this may certainly have commercial implications, it also means clinically trialled drugs can be accessed by patients needing them, much sooner.
Pharma can access project specific, real world data through BioGrid as aggregated summary analysis reports, against an agreed protocol.
It’s a unique federated national data connectivity platform enabling access to real-time hospital/ and clinic data across the federation.
Every project that BioGrid undertakes in collaboration with industry is subject to a rigorous review process by the BioGrid Pharmaceutical Advisory Committee. Once a project is approved to proceed, a contract detailing responsibilities and deliverables is executed prior to work commencing.
(Without BioGrid), you would have to employ 2, 3, 4 people to gather the data you would want.
BioGrid works with industry on three types of projects:
Industry donates funding to develop data collection software, or provides data entry support for a clinician-led project, or links databases into the BioGrid platform.
Retrospective Data Request
BioGrid provides a summary report and analysis to an industry client based on retrospective data (only after authorisation from the data custodian/s). This may include information on;
- Trends in medication use in routine practice setting (not clinical trials)
- Variations in routine care: patient attitudes, age, frailty, co-morbidity, chemotherapy dosing
- How are products or devices used?
- What influences product or device use?
Prospective Data Collection
BioGrid, in collaboration with an industry partner, undertakes a project to increase depth and volume of data collection across sites, often with a focus on particular real-world data items being collected. A prospective study enables industry to understand their therapeutic drug or device use and impact in the real patient population.
Real-world data can provide real-world evidence insights to inform clinical trial development, allowing further exploration of optimal treatment of patients by industry
This may include data and information on:
- Analysis of clinician decision making
- Impact on newly available product or device
- Trends over time
Clinicians and researchers have an unrestricted right to present or publish any data that comes out of an industry sponsored research project.
Depending on the project protocol, pharmaceutical companies involved will have the opportunity to review the resultant paper (or abstract) prior to submission within an individual project defined timeframe.
The review prior to submission is to ensure protection of the company’s confidential information. The pharmaceutical company will have no right to influence or change the scientific content or conclusions in the publication.