Hardships in Clinical Trials: Pakistan Perspective

Conducting clinical trials is always challenging however these challenges are magnified in low and middle-income countries, said Prof Dr. Faisal Mahmood, Section Head of infectious diseases at Aga Khan University. He shared the many challenges that are particular to LMICs, especially in the context of Pakistan, while speaking at a Media Roundtable on “COVID-19 and the importance of clinical trials.”

Clinical trials have long stood as the cornerstone of medical progress, playing an indispensable role in the development and validation of new treatments, therapies, and medical interventions.
Speaking on Ethical and Regulatory aspects of clinical trials Dr. Sadia Asim, Director Clinical trial site and CRO at Dow University of Health Sciences (DUHS) said, that in Pakistan the trial is controlled through DRAP regulations (Laws) and it’s conducted based on prescribed ethical guidelines, to ensure the rights of human beings during the execution of clinical trials.

Clinical Trials

Purpose for Clinical Trials

Clinical trials have been an essential part of improving healthcare for humans. This research is done in an organised, systematic and ethical way for almost all the drugs we benefit from today, stated Dr. Saima Saeed, a Consultant pulmonologist and Director, Lung Health at Indus Hospital and Health Network. An example is antibiotics for infections. For example, we have learnt about the best treatments for TB using clinical trials and this and other infections were previously lethal. Similarly, trials allowed us to understand how well different Covid treatments work for those people in hospital and there are ongoing trials about how to reduce symptoms in mild and moderate symptoms.

Clinical trials involve the careful monitoring and testing of these interventions in carefully selected groups of participants, following strict protocols designed to ensure the highest standards of safety and ethical practice.

Sharing the various stages of a clinical trial, Dr. Muneeba A. Sayyed, Assistant Professor/Head of Department of Infectious Diseases at Sindh Infectious Diseases Hospital & Research Centre/ DUHS said that a Clinical Trial is a type of research that studies new tests, treatment and procedures and evaluates their safety and effectiveness on human health outcomes.

Before approval, the drug or procedure has to pass through different phases of clinical trials. Phase I assesses the safety and dosage of drugs in a small group of healthy volunteers or patients. Phase II assesses the effectiveness in a larger group while in phase III it is compared with standard treatment in a large population of different regions and countries. Phase IV monitors long-term effects after the drug or procedure has been approved and marketed.

All speakers were of the opinion that Clinical trials not only target life-threatening conditions but also seek to enhance the quality of life for patients living with chronic illnesses.
They also informed the audience that AKUH, DUHS OJHA Campus, Indus Hospital & Healthcare Network, and the SIDH are facilitating the general public by offering free COVID-19 Tests to those who are showing relative symptoms, so that there is early detection of the virus as various different variants are still prevalent in Pakistan.

As the world faces an ever-evolving healthcare landscape, clinical trials remain the bedrock of medical progress. Their impact on patient well-being, scientific knowledge, and the global healthcare system cannot be overstated. Through ongoing support and participation in clinical trials, we collectively advance towards a healthier, more innovative future