The Asia Pacific Perspective CORPORATE RESPONSIBILITY TOWARDS ETHICAL RESEARCH Aileen Dualan, MD, MS
Disclaimer The speaker is an employee of Novartis, a former employee and stockholder at Abbott, Abbvie, Hospira, former consultant to Merck. The views presented herein represent her own and not that of the entities she represents or formerly represented. Present affiliations APPS Association of Pharmaceutical Physicians in Singapore PCPM Philippine College of Pharmaceutical Medicine Past affiliations
ETHICAL RESEARCH We all have a responsibility
Outline Background and History Current Environment Emerging Challenges In Industry Practices for Ethical Research
Background and history In Industry Practices for Ethical Research
Pharmaceutical Industry and Human Subject Research Why we do it Primary goal: Commercialization of pharmaceutical products Regulatory requirement to perform pre-clinical and clinical studies before product registration US FDA EU EMA
Pharmaceutical Industry and Human Subject Research Why do we have to be ethical? Primarily, for the patients: To make sure drug is efficacious and safe before product registration (marketing authorization) Some terminology: marketing authorization authorization granted by a regulatory authority to a manufacturer or importer to commercialize the product at the time of product registration MAH marketing authorization holder
Pharmaceutical Industry and Human Subject Research Why do we have to be ethical? For patients Human subject safety Assure integrity of efficacy and safety data Improve access to potentially life-saving medications For regulators Acceptance of data submitted for market registration For the scientific community Involvement in developmental (i.e. before product registration) research as well as post-marketing Opportunity to work with peers globally and regionally Opportunity to publish new data
Pharmaceutical Industry and Human Subject Research Why do we have to be ethical? For patients Human subject safety Assure integrity of efficacy and safety data Improve access to potentially life-saving medications For regulators Acceptance of data submitted for market registration For the scientific community Involvement in developmental (i.e. before product registration) research as well as post-marketing Opportunity to work with peers globally and regionally Opportunity to publish new data
Pharmaceutical Industry and Human Subject Research Why do we have to be ethical? For patients Human subject safety Assure integrity of efficacy and safety data Improve access to potentially life-saving medications For regulators Acceptance of data submitted for market registration For the scientific community Involvement in developmental (i.e. before product registration) research as well as post-marketing Opportunity to work with peers globally and regionally Opportunity to publish new data
Pharmaceutical Industry and Human Subject Research Why Asia-Pacific? Historically: Regulatory requirements in some countries: Japan, Taiwan, now Korea and China (ethnic sensitivity analyses, part of ICH guidelines) Improving patient recruitment Decrease R&D costs Now More diverse data more generalizeable Asian footprint: improved drug access once marketing authorization is approved
Pharmaceutical Industry and Human Subject Research Why Asia-Pacific? Historically: Regulatory requirements in some countries: Japan, Taiwan, now Korea and China (ethnic sensitivity analyses, part of ICH guidelines) Improving patient recruitment Decrease R&D costs Now More diverse data more generalizeable Asian footprint: improved drug access once marketing authorization is approved
Current environment In Industry Practices for Ethical Research
Unprecedented number of global studies being done in Asia Pacific 4500 4000 3500 3000 2500 2000 1500 East Asia Japan South Asia Southeast Asia Europe USA 1000 500 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Data from www.clinicaltrials.gov, accessed 2013 Nov. 04
But not without challenges
Unethical conduct of research leads to... Inadequate assurance of patient safety, even death Loss of reputation Commercialization delays Penalties: fines criminal action
The pendulum swings again...
Solutions... Regulators: stricter regulations Industry: independence of development and medical functions from commercial Scientific community: more rigorous ethical reviews
Challenges remain... ERB reviews Do ERBs really know what they are doing? For developmental studies: Technical reviews vs. review of local socio-cultural sensitivities Informed consent process Still not convincing that right thing happens in many sites Study start-up Sometimes, after lobbying to get countries included, site initiation commitments and recruitment numbers are not met
Challenges remain... Monitoring Difficulties in site monitoring seen esp. with certain investigators who are too busy Data analysis and safety reporting Statistical analysis of local data sets still a big challenge for many countries Safety reporting requirements not met Reports and publications Commitments for local data reports and publications are not met
Emerging Challenges and Pearls for ERBs In Industry Practices for Ethical Research
Emerging challenges: Company vs. investigator sponsored Differentiation in studies that are sponsored by the company vs. the investigator NOT clear to many external to industry Sponsorship has a regulatory and industry definition Externally: any form of support is sponsorship Investigators and ERBs must learn to distinguish between company sponsored and investigator sponsored studies
Company sponsored vs. investigator sponsored Company sponsored: (1) development trials fall under this category (i.e. required for regulatory submission to obtain marketing authorization) Science/technical aspects are tight Local review should be primarily for local health environment, ethnic sensitivity, social and cultural context
Company sponsored vs. investigator sponsored Company sponsored: (2) post-marketing studies Sponsored by company (MAH) to monitor how product behaves after MA is granted Usually safety surveillance Most are observational Some are interventional ERBs: must pay attention to design Observational vs. interventional
Company sponsored vs. investigator sponsored Investigator sponsored: - Could be any design (observational or interventional) - Usually studies of new indications (unmet medical needs) - Supported (NOT sponsored!) by company - Obligation to make sure investigator conducts research ethically: everyone s job
Emerging challenges: More real-world studies More interest: Industry, regulators and third party payors Real-world studies may also have different designs A few are interventional (but pragmatic) Mostly observational/registries/cohorts ERBs need more expertise in reviewing these
In Summary Industry has a big role in ethical conduct of research Not just as study sponsors Training: identifying needs, actual training, ongoing monitoring of investigators Final deliverable: results to public Moral obligation to maintain high ethical standards
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