Challenges and Solutions in Drug Development Trials in Pakistan
Drug development trials are essential to bringing innovative therapies, vaccines, medical devices, and biologics to patients. However, conducting clinical research in a developing and evolving healthcare landscape presents both opportunities and obstacles. Understanding the Challenges and Solutions in Drug Development Trials in Pakistan is crucial for sponsors, CROs, investigators, and research institutions aiming to achieve global-standard study outcomes.
At PMCPK Clinical Trials Unit (CTU), we support sponsors throughout the research lifecycle—from feasibility and protocol development to regulatory approvals, monitoring, site coordination, and data management. Pakistan has great potential for high-quality clinical research, but stakeholders must be aware of the unique challenges and how to address them effectively.
1. Regulatory Delays and Compliance Requirements
One of the biggest challenges for drug development trials in Pakistan is regulatory approval. DRAP (Drug Regulatory Authority of Pakistan) ensures safety and compliance, but approval timelines can be longer compared to more established regulatory bodies.
Challenges:
- Lengthy approval processes for clinical trial applications
- Complex documentation requirements
- Limited harmonization with global systems
- Inconsistent timelines for import/export licensing
Solutions:
- Early engagement with regulatory experts
- Complete, GCP-aligned documentation to avoid objections
- Pre-submission review of protocols and IBs
- Using a professional CRO or CTU (such as PMCPK) to manage submissions
- Maintaining continuous communication with DRAP to avoid procedural delays
Our CTU ensures your regulatory packages are flawless and compliant, minimizing delays and improving approval success rates.
2. Ethical Oversight and IRB Challenges
High-quality ethical review is essential for trial integrity. Pakistan has multiple IRBs and ethics committees with varied review timelines.
Challenges:
- Different levels of committee experience
- Variation in turnaround times
- Multiple-site approvals prolonging study initiation
- Need for consistent GCP training
Solutions:
- Harmonization of ethics submission documents
- Using centralized ethics committees where possible
- Ensuring investigator teams are GCP certified
- Early submission of ethics applications
- Continuous communication with IRBs to address queries quickly
PMCPK CTU provides full ethical submission support and ensures all documents meet international standards.
3. Limited Site Infrastructure and Capacity
Not all research sites in Pakistan are equipped for advanced Phase II–IV trials.
Challenges:
- Lack of temperature-controlled storage
- Inadequate lab facilities
- Insufficient research staff
- Limited experience in early-phase trials
Solutions:
- Thorough feasibility assessments before site selection
- Upgrading site infrastructure with sponsor collaboration
- Training site teams in GCP, protocol adherence, and documentation
- Using CTUs with established systems for data and safety management
PMCPK ensures sponsors partner with high-quality, well-equipped sites capable of handling complex trials.
4. Patient Recruitment and Retention Difficulties
Recruitment issues often cause timeline delays, budget increases, and protocol deviations.
Challenges:
- Low patient awareness of clinical research
- Cultural hesitation
- Travel and financial barriers for participants
- Loss to follow-up
Solutions:
- Community engagement and patient education
- Using patient-friendly materials with clear explanations
- Offering travel support where ethical and approved
- Strong retention planning, including reminder systems
- Utilizing digital recruitment strategies
Pakistan’s large, treatment-naïve population is a strong advantage when combined with structured recruitment planning.
5. Data Quality and Monitoring Issues
High-quality data is essential for regulatory approval and scientific credibility.
Challenges:
- Manual or paper-based processes at many sites
- Delays in eCRF completion
- Inconsistent adverse event reporting
- Lack of trained data managers
Solutions:
- Using Electronic Data Capture (EDC) platforms
- Real-time monitoring supported by CTUs
- Training teams in accurate AE/SAE reporting
- Ensuring regular on-site and remote monitoring visits
PMCPK CTU offers data management, biostatistics, and centralized monitoring to ensure data integrity.
6. Financial & Logistical Barriers
Conducting trials requires consistent resources and logistical planning.
Challenges:
- Budget limitations
- High costs of imported study materials
- Storage and cold chain issues
- Slow customs clearance
Solutions:
- Early budgeting with cost forecasting
- Working with local logistics partners who understand DRAP processes
- Strengthening central storage facilities
- Using CTUs that offer complete IP management and cold-chain support
7. Lack of Awareness Among Healthcare Professionals
Many clinicians are interested in research but lack structured training.
Challenges:
- Limited exposure to clinical trial SOPs
- Misunderstanding of regulatory responsibilities
- Inconsistent PI/SI involvement
Solutions:
- Clinical trial training workshops
- GCP certification programs
- Clear delegation of study responsibilities
- Mentorship programs within CTUs
PMCPK routinely trains investigators and site staff to ensure research excellence.
Opportunities for Growth in Pakistan’s Drug Development Sector
Despite challenges, Pakistan is becoming a promising destination for global and local drug development trials due to:
- Large diverse patient population
- Lower trial costs
- Highly skilled medical professionals
- Increasing regulatory maturity
- Growing CRO and CTU capabilities
- Expanding pharmaceutical sector
With the right strategies, Pakistan can become a competitive hub for international clinical research.
Conclusion
Understanding the Challenges and Solutions in Drug Development Trials in Pakistan helps sponsors plan better, reduce delays, maintain compliance, and improve study outcomes. Using the right partners—such as PMC Clinical Trials Unit—ensures consistent quality, reliable data, and full regulatory alignment.
Our CTU provides end-to-end trial support, making it easier for sponsors to overcome challenges and maximize trial success across all phases.
