NUMS with 9 affiliated medical colleges, 6 nursing colleges, and 63 teaching hospitals, is focusing on training opportunities and international collaborations-Babar Saeed Khan
Clinical Trials Summit Proceedings-II
By Shaukat Ali Jawaid
KARACHI: Prof. Javed Akram, along with Dr. Mirza Tusawar, chaired the first session on February 18th, the second day of the Clinical Trials Summit jointly organized by Aga Khan University (AKU) and the National University of Medical Sciences (NUMS), Rawalpindi, at the AKU campus from February 17th-18th, 2025.
Dr. Saeed Hamid
Prof. Saeed Hamid, Director of the Clinical Trials Unit at AKU, was the first speaker. He shared that more than 100 clinical trials have been conducted at AKU across various disciplines, including Gastroenterology, Anesthesia, Oncology, Neurology, Cardiovascular Diseases, Endocrinology, Nephrology, and Ophthalmology. The university attracted enough funding from overseas, which helped develop the infrastructure. One of the trials was conducted in collaboration with Novartis, and there were also non-pharma sponsors involved. The World Health Organization (WHO) and the Melinda Gates Foundation sponsored some Phase-3 and Phase-4 studies, many of which were investigator-initiated and supported by AKU and the pharmaceutical industry. Prof.
Dr. Babar Saeed Khan
Hamid emphasized the importance of engaging the local pharmaceutical industry and mentioned ongoing Phase 2, 3, and 4 trials, which have been published in international peer-reviewed journals. During the COVID-19 pandemic, Dr. Saeed Hamid reported that AKU published 19 trial-related articles. He also highlighted a study on Hepatitis D, noting its prevalence in Pakistan is about 16.6%, particularly in districts such as Larkana and adjacent areas of Baluchistan. He discussed therapeutic targets for Hepatitis D and the expected therapies for HDV, including trials for the first oral treatment, with 402 patients enrolled across multiple centers, 56 of whom were from Pakistan.
Speakers in the first session on Second Day of the Clinical Trials Summit held at AKU participating in the panel discussion. Sitting on the dais include Dr. Naseer Amed, Farah Asif, Babar Saeed Khan, Prof. Saeed Hamid, Dr. Ume Sughra,
Dr. Maimoona Siddiqi and Dr. Izhar Hussain.
Dr. Ume Sughra, Director of Research at Al-Shifa Research Centre in Rawalpindi, was the next speaker. She shared that their research center, established two years ago, has completed seven Phase-3 trials, which lasted from a few weeks to a few months. Approved by DRAP in 2021, their studies focused on COVID-19, Rabies, Influenza, COVID-19 booster shots, and malnutrition. In the multi-center COVID-19 trial, they contributed 2,700 patients. She noted the challenges they face, including political instability, regulatory delays, limited infrastructure, lack of public awareness and participation, and funding. She stressed the importance of capacity building, collaboration, and networking and emphasized a patient-centric approach in indigenous research.
Dr. Maimoona Siddiqui, Director of the Shifa Clinical Research Center at Shifa International Hospital in Islamabad, stated that their mission is “Healthcare with Passion for All.” Shifa International Hospital is a 550-bed facility with 52 chief consultants. Their clinical trials team has conducted studies in Maternal and Child Health (MCH), orthopedics, oncology, and gastroenterology, and they are currently collaborating with numerous national and international institutions, including participating in the ASPIRE-AF study. Dr. Siddiqui emphasized the need for greater involvement of the pharmaceutical industry in funding clinical trials and stressed the importance of digitalization.
Dr. Bin Chen responding to the questions during the panel discussion on second day of Clinical Trials Summit held at AKU. Also sitting along
with him is Dr. Camilia Forssten and other panelists.
Dr. Farah Asif, Director of the Clinical Trials Unit at Shaukat Khanum Memorial Cancer Hospital and Research Centre, highlighted that 75% of the patients visiting their institution receive free treatment. SKMT has diagnosed 7,000 new cancer cases and has been conducting clinical trials for over two decades. The hospital has 12 adult oncologists, seven pediatric oncologists, 24/7 emergency care, an ICU, and a dedicated pharmacy team. Dr. Asif discussed the research challenges in Pakistan, noting the lack of coordination between Ethics Committees, Principal Investigators, and study coordinators. She emphasized the need for regulatory reforms, capacity building, and training opportunities.
Dr. Izhar M. Hussain from Dow University of Health Sciences (DUHS) shared that Pakistan has 106 approved clinical trial sites, with more expected soon, and five functioning bioequivalence centers of which two are functioning at present. He stressed the need for modern healthcare facilities, an increased number of clinical trial units, and better ethical regulatory approval timelines. Dr. Hussain also emphasized the importance of collaboration with new Clinical Research Organizations (CROs) to expand business opportunities and move into the ASEAN clinical research market.
Some of the speakers responding to questions during the panel discussion
at Clinical Trials Conference held at AKU recently.
Dr. Zulfiqar Umrani, Director of the Clinical Trials Unit at Ziauddin University, discussed their unit, established in 2022 and approved by DRAP for Phase 2, 3, and 4 trials. He emphasized the importance of patient and public involvement in clinical trials, stating that such engagement should be a requirement for all Clinical Trial Units. Ziauddin University is collaborating with various national and international institutions and believes that the clinical trials market in Pakistan is currently underdeveloped compared to its potential, particularly in drug discovery.
Dr. Naseer Ahmad, Head of the Clinical Trials Unit at Rehman Medical Institute in Peshawar, shared that their unit, established in 2021, is approved for Phase 3 and 4 trials. Patients come from areas such as Afghanistan, Chitral, and Hazara Division. He mentioned the lack of trained human resources in clinical research and the importance of integrating more institutions into clinical trials. RMI has also begun a Certificate Course in Clinical Trials Management to address this gap.
Panelists in the session on Evolving Role of CROs and Essential Support Services in Pakistan Clinical Trials Landscape responding to questions during the panel discussion on second day of the Summit on Feb. 18th 2025.
Dr. Babar Saeed Khan, Director of the Clinical Trials Unit at the National University of Medical Sciences (NUMS), noted that their unit, which is still in its infancy, has been approved for Phase 2, 3, and 4 trials. NUMS, with its nine affiliated medical colleges, six nursing colleges, and 63 teaching hospitals, is focusing on training opportunities and international collaborations. Dr. Khan emphasized the importance of biotechnology and collaboration for the future of clinical trials in Pakistan.
During the discussion, it was pointed out that Pakistan should not rely on overseas trials, as they often involve limited enrollments of Asian patients. Instead, Pakistan must focus on indigenous research to find solutions to local challenges. DRAP should encourage local research and provide financial support for such initiatives.
Second Session
Prof. Saeed Hamid from AKU, along with Malik Muhammad Asad, Secretary of the Clinical Studies Committee at DRAP, chaired the second session.
Panelists responding to questions during the discussion at Clinical
Trials Summit held at AKU recently.
Dr. Camila Forsten, Principal Clinical Manager at EU Infectious Disease Abbott UK, was the first speaker. She shared her experience with clinical trials in Pakistan and emphasized the importance of proper study preparation and execution, including in-depth study discussions, an experienced clinical study team, clear timelines, and collaboration with CROs. With these factors in place, high-quality data was generated.
Dr. Bin Chen, CEO of Hua Hui Health in China, discussed the approval process with the FDA and Chinese NMPA and mentioned their interest in urology and oncology. He also spoke about the challenges in patient recruitment and retention and shared that they are currently involved in the LIBEVITUG trial in Pakistan, offering protocol design, training, monitoring, and a patient-centric approach to ensure success.
Dr. Salman Kirmani replying to questions during the last session of Clinicals Trials Summit held at AKU recently. Also sitting along with him is Prof. Javed Akram former VC UHS and President of PSIM who was the other speaker in this session devoted to Rare Diseases.
Atika Shaheer discussed the perspectives of people living with obesity, pointing out the high prevalence of overweight individuals in Pakistan, with 28.4% of adults affected. She stressed that obesity is often not recognized as a disease and highlighted the lack of data on diagnosis and treatment. She also shared that they have recruited 5,500 patients in 13 therapeutic areas and are working on BMI studies, with the ACTION APAC multi-country study involving 10,429 patients and 2,765 healthcare professionals.
Dr. Ahmed Nawaz, Head of Medical Affairs and Complaints at Martin Dow, discussed the economic challenges faced in healthcare, emphasizing the need for indigenous research, particularly on tuberculosis, and pointing out that clinical trials are increasingly shifting to South Africa.
Some of the distinguished speakers participating in the panel discussion
during the Clinical Trials Summit held at AKU recently.
Dr. Masood Jawaid, Director of Medical Affairs at PharmEvo, addressed the issues faced by the pharmaceutical industry in conducting clinical trials in Pakistan, such as ill-equipped ethics committees and the high costs of bioequivalence studies overseas.
Dr. Yousuf Hasan Khan, Medical Director at GSK, shared that despite initially having more studies in Pakistan than in India, GSK’s focus shifted to India due to challenges in Pakistan.
Dr. Nadim Ur Rehman stressed that the Federal Health Ministry needs to be more supportive of clinical trials and that research and development costs should receive tax credits.
Dr. Wajiha Javed, Associate Director of Public Health and Research at Getz Pharma, emphasized the importance of conducting high-quality studies. She announced that Getz Pharma had stopped funding medical conferences and instead redirected funds towards research. She encouraged regulators and healthcare professionals to focus on community-based studies that can make a tangible impact on patients’ lives.
In his concluding remarks, Prof. Saeed Hamid stressed that pharmaceutical companies should strengthen their medical affairs departments and highlighted the importance of good protocol development. He noted that local studies have shown that smaller doses of medications are often needed for Pakistani patients, ensuring fewer side effects.
Dr. Asad remarked that while regulation is often seen as a thankless job, they are committed to promoting best practices and reducing approval delays through better collaboration and coordination.
Dr. Abdullah Abro from DRAP responded to a question by stating that DRAP would now provide funding for research and is moving towards digitalization, which should significantly reduce the time required for protocol approval.
Panel Discussion on Trials Landscape
This session was chaired by Prof. Rashid Jooma, along with Dr. Sharafat Hussain, Deputy Director at DRAP. The panelists included Syed Munawar Ali, Associate Director at RDS-IQVIA; Dr. Murtaza Hussain, CEO of Metrics Research; Syeda Azka Wase from DPK Pharma; Dr. Ahmad Kamal from OrciTrials; Khurram Zaki Khan, CEO of Dimensions Research; and Fahad Hussain, CEO of Praetorian Pakistan.
The panelists emphasized that they were a beacon of hope, having witnessed significant changes in the industry. The pharma industry has gone through many ups and downs, but now there is a more structured regulatory process, and transparency is improving. We have made great strides, and this is the way forward. DRAP should accelerate the approval process, but we must be realistic. Many clinical trial units now have dedicated staff, though we still need more human resources. DRAP and the National Bioethics Committee should increase their staff accordingly. It is also essential that DRAP has medical consultants. Currently, DRAP operates with just two and a half staff members. We need to develop solutions to address these challenges. One of the panelists noted that there are too many expectations placed on CROs and suggested that we need more clinical trial units in major hospitals.
Prof. Rashid Jooma remarked that many developments in the field started before the government was even aware. He emphasized the need for better linkage with the Ministry of Finance, as there is significant potential in this area. One of the panelists discussed the issue of Phase-I trials, noting that it is often said that these trials should be approved in many countries, but there is no requirement for registration before initiating these studies. Another panelist clarified that there is no such restriction. For research purposes, there is no problem importing drugs or equipment from Western countries. During a meeting with authorities in 2008, it was emphasized that a positive image should be conveyed to sponsors of these trials. CROs should collaborate with clinical trial units and work together to secure the necessary resources. The panelists also stressed the importance of educating staff in all clinical trial units. They highlighted their involvement in professional capacity-building, noting that patience is required. At times, some individuals engage in “window shopping” to gauge how serious sponsors are. However, there are many success stories, and sometimes random door-knocking proves helpful.
Engaging Patients and Communities
The next session focused on engaging patients and communities in clinical trials. Dr. Fyezah Jehan from the Pediatric Child Health department at AKU discussed “Bridging Communities and Research: Facilitating Community-Based Clinical Trials.” She emphasized the need to reach the majority of people to conduct community-based trials, which are not easy to execute. Without confidence and understanding, even the best trials fail. She suggested adopting hybrid trials that bridge the gap between community researchers and regulators. Dr. Jehan also referred to the mistrust and misconceptions surrounding trials, including concerns about the side effects of treatment.
Misinformation fuels refusal and hesitancy. She cautioned against overstating the benefits of treatments and emphasized the importance of providing round-the-clock treatment if possible. People are often willing to participate, but they lack understanding. Cultural and gender biases also influence decisions. For instance, women may need approval from their spouse or an elder, and family members often play a role in decision-making. To address these challenges, their team involved community health workers in the study, utilizing their services for home visits. Missed follow-ups lead to dropouts. She suggested using culturally adaptable messaging and making research more accessible, such as through informative videos. Creating patient advocacy groups and training the local research team are also crucial. Ethical oversight and obtaining informed consent can be difficult, but are essential for ensuring the integrity of trials. Clear guidelines for community-based patient enrollment and strengthening the ethical review process were also recommended.
Dr. Timo Tolppa, a global health researcher, shared an online presentation on making public representatives and patients’ members of ethical review boards, community advisory boards, co-applicants for funding, and collaborators for prioritization. He emphasized that research offers many benefits, including fostering community trust. He also discussed their collaboration with the PPIE initiative at Ziauddin Hospital, where twenty PPIE meetings were held, along with two large gatherings. This initiative led to one poster presentation, seven oral presentations, and the formation of six research groups over the last five years. Public and patient engagement in research trials is both possible and acceptable, and can serve as a solution, he concluded.
An online presentation from Johns Hopkins University focused on malnutrition clinical trials in low- and middle-income countries. The presentation highlighted that 13.7 million children in these countries suffer from wasting, while 22% experience stunted growth. The types of trials discussed included therapeutic, supplementation, bio-fortification, and behavior change interventions. Challenges mentioned included logistics, ethical and regulatory issues, funding, and sustainability. The concept of donor-driven trials was also explored.
Shelly Sedighi from Qcare Health Research Corporation was the next speaker. She highlighted the importance of upscaling human capacity in clinical trials. She discussed workforce groups, investment in talent and expertise, integrated digital tools, collective agreements, and the research ecosystem. Professionals must advance the technology required for trials. Clinical trials drive medical innovations, and the future of these trials depends on human capacity. The number of clinical trials has increased by 30% over the last decade, though 60% of trial sites face staff shortages. Research can focus on different therapies or new drug delivery systems. Building capacity for trial design and capacity-building for trialists is essential, she added.
Shaping the Future of Clinical Trials: Innovations and Advancements
This session on shaping the future of clinical trials included several presentations. Dr. Vasee Moorthy from WHO discussed the WHO-CTU Maturity Framework, while Dr. Iftikhar Khan addressed the application of AI and machine learning in clinical trials of drugs and devices. Dr. Shahlan Beg spoke on decentralized clinical trials in resource-limited settings. Prof. Andrew Pollard’s online presentation from the Oxford Vaccine Group focused on “The Use of Controlled Human Infection Models in Vaccine Development: The Role of CHIM in Typhoid Vaccine Policy.”
Session on Rare Diseases
The final session of the summit focused on rare diseases. Dr. Salman Kirmani presented on the spectrum of rare diseases in Pakistan. He pointed out that the country has a low human development index, and malnutrition and infectious diseases are major burdens. There is a significant amount of unrecognized neonatal and infant mortality, and Pakistan lacks a national newborn screening program. Genetic testing is considered a luxury, and cultural taboos often prevent open discussions about rare diseases. Consanguineous marriages, which are common in Pakistan and some other countries, serve as a hidden driver of both rare and common diseases.
Genetic testing is often outsourced to commercial laboratories. While affordable therapies exist, the ten most expensive drugs in the world are for rare diseases. Dr. Kirmani emphasized the need for public education on rare diseases, noting that while these diseases may be rare globally, they are not rare in Pakistan. Prof. Javed Akram spoke on the high prevalence of deaf and mute children in Pakistan. Recently, the Society for Novel and Rare Diseases was formed to address these issues. Most of these diseases are genetic and require multidisciplinary teams for proper management. He cited reports indicating that there are 7,000 rare diseases, with 30 million people in the United States and 380 million people globally suffering from these conditions.
