Domains Challenges Characteristics of the Desired Research Environment Proposed Solutions
Regulatory (government, ethics committees, monitors, auditors) Setting research agenda and standards •  Establishing a national, unified, clinical research mission that balances the needs of industry and the public11
•  Multiple regulatory guidelines
•  Ambiguous definitions13
•  Protection of research participants and integrity of the science
•  Unified and unambiguous guidelines and practices
•  Protection of interests of the patients, public health, and indigenous medical research11
•  Harmony with national and international stakeholders40
1.  Setting standards in consultation with all stakeholders (government, academia, industry, health care providers, media, patients, and public) 2.  Harmonization of research guidelines and practices with other countries
3.  Forging and leading long-term national and international collaborations/partnerships with stakeholders
Evaluation of clinical research applications •   Lengthy turnaround times for approval
•   Limited regulatory and subject-matter experience •  Understaffing/resourcing/training
Review process:
•   Expert review
•   Turnaround time of 1 month
•   Constructive feedback to applicants •  Regular training: keeping staff knowledgeable and up to date
1.  More dedicated staff and resources 2.  Training of regulatory staff
3.  Expert consultants
4.  Working with research sponsors, academicians, and operators to establish efficient review process40
Enforcement of standards at research sites •  Protection of research participants and monitoring sites in a country with 1.2 billion people
•  Multiplicity of regulatory guidelines
Enforcement of standards is:
•  Frequent
•  Educational
•  Proactive
•  Preventative (rather than punitive)
Enforcement of research standards:
1.  Education and routine training of regulatory staff, investigators, and the public41
2.  Regular monitoring and auditing of all research sites
3.  Preventative approach using simulation of challenging non-compliance scenarios34
4.  Empowering the licensing authority to revoke research accreditation of CROs, sites, investigators and ethics committees
Professional (industry, academia, health care: clinicians, investigators, research staff) Compliance with research standards •  Limited exposure to research in medical education
•  Limited experience with clinical trials (especially with treatments not yet approved in humans)
Strong research foundations and regular training in:
•  Therapeutic subject matter (including the latest advances and knowledge gaps)
•  Research ethics, methodology, and operations
1.   Clinical research as part of medical curriculum
2.   Regular training (e.g., CREATE)42 3.   Self-regulation: enforcement of research standards within professional organizations (i.e., academic, health care, industry)
Operations •   Busy clinician-investigators
•   Understaffed research teams
•   Under-resourced sites (e.g., for proper monitoring)
Sufficient time and resources for:
•   Research education and training
•   Active participation in design and implementation of research protocols (not just “supervision”)
•   Original research (investigator-initiated)
1.   Early site contact
2.   Comprehensive site feasibility assessment
3.   Collaborations with established, reliable research institutions
4.   Engagement of regulatory authorities
5.   Cultural and ethnic impact
Public/patients (patient advocacy groups, NGOs, the media) Public awareness •  Recent introduction of clinical research into the public consciousness
•  Little awareness of clinical research and dominant role of clinicians make “informed” consent challenging
•  Limited understanding of patient/participant research information needs
Public and patients are:
•   Aware, informed, participating, advocating and partnering
•   Media disseminates accurate information about the value of clinical research and encourages participation
1.   Public surveys inform research awareness programs (e.g., PARTAKE)37,43
2.   Promotion of research awareness through the media
Public partnership •  Fragmented research environment with poor communication amongst stakeholders • Lack of community representatives and advocates •  Frequent communication with professional stakeholders
•  Collaboration and partnerships with research professionals (e.g., assistance with study design, recruitment, funding, dissemination of results, establishment of national and communal research policies)38
1.   Establish community advocates and representatives = community liaisons with clinical research establishments 2.   Engagement of patient/public representatives in the research process18
Table 1: India clinical research environment: challenges and proposed solutions. CRO: Clinical Research Organization; CREATE: Continuous Research Education and Training Exercises; NGO: Non-Governmental Organization; PARTAKE: Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment.
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