Symposium
Proceedings of First Clinical Trials Conference-III
We have 130 functioning IRBs in healthcare
institutes and hospitals abiding to ICH-GCP
Code of Conduct - Dr.Murtaza Hussain
LAHORE: One of the sessions during the First Clinical Trials Conference organized by University of Health Sciences last month was devoted to the role of Clinical Research Organizations (CROs) in Clinical Trials. Mr. R. Arfeen from DRK Pharma Solutions talked about the Role of CRO’s in ensuring Global Standards in Clinical Research. DRK Pharma Solutions he said is a premier solution provider to the pharmaceutical and biopharmaceutical industries in the areas of Product Development, CRO Services having highly experienced professionals and world-class infrastructure. DRK is the first CRO registered by DRAP in Pakistan.
ICH-GCP Compliance Global standards in new drug development can bring about a harmonization that promotes strength for mankind in terms of health solutions. It enables researchers and healthcare professionals to act cohesively instead of separately and open doors to prevent and eliminate illness. CRO, he further stated, plays the major role in ensuring safety of patients and credibility of data generated by strongly adhering to ICH-GCP guidelines whilst conducting clinical studies.. DRK has successfully cleared the Due Diligence of multiple Global CROs, including two of the top five US based CRO. DRK has also been qualified for Pharmaceutical MNCs to provide Clinical Trial Services. Its systems has also been audited by multiple Chinese and Korean CROs. DRK’s experienced team is ICH-GCP certified and recertified to work on global standards of clinical research.
Dr. Murtaza Hussain, Chairman, Metrics Research in his talk on Clinical Trials in Pakistan –Challenging the Status Quo of the Stakeholders said that Key Challenges of Conducting Trials in Asia Pacific are Regulator Complexities, infrastructure and legal issues besides language and cultural hurdles. Interventional Clinical Trials in Pakistan of selected diseases since 2010 to date are on Oncology, Cardiovascular diseases, COVID-19, Respiratory, Neonatal and Hematology.
Talking about opportunities in Pakistan Dr. Murtaza Hussain said that the estimated per patient per visit cost in Pakistan is around $200 which is markedly less than anywhere in the World. Pakistan has delivered quality work for many international sponsors in the past couple of years. Stringent Implementation of S.R.O for ethical practices for local pharmaceutical industry is creating opportunities for more locally initiated Phase-4 trials for studying the dynamics of marketed drugs in Pakistan. Our challenges are that the looming unpredictable law and order situation that can dampen the investors from focusing on Pakistan, Poor visibility of various stakeholders involved in clinical trials for international clientele. Interventional trials require a certain degree of persuasive and practical approach in execution.
Continuing Dr. Murtaza Hussain said that Number of Clinical Trials Registered in DRAP (N=38) not co-relating with the number of clinical trials displayed on International Trail Registry for Pakistan. We need to introduce a system for prioritizing the clinical trials that deserve a fast track approval. More stringent controls required on informed consent process. Independent Data Review and Monitoring Committees to improve the transparency of work. Talking about IRB Scenario in Pakistan Mr. Murtaza said that there are over 130 formally functioning IRBs in healthcare institutes and hospitals across Pakistan abiding to ICH-GCP Code of Conduct. With every passing day, more and more personnel are getting degrees/ certifications in ethical conduct of clinical research. Inconsistent review process” still exists. “Might is right” still applicable! Inexperienced Reviewers” still exist, many IRBs are incapable of reviewing complex protocols. Gradually, with the technology becoming a part of everyone’s daily life, it is to be expected that soon enough the participants will not have to go through extensive hospital stays or frequent hospital visits to take part in a clinical trial, he added.
Mr. M Khurram Zaki Khan, CEO Dimension Research discussed in detail how to establish a Good Research Site. Site selection Criteria is perhaps the most crucial step in initiating a study. Factors involved in investigator site selection are, reputation of the Investigator in the field of his/her expertise, Availability of required resources at site, access to patient population, geographical location of the site, anticipated time to initiate the trial, anticipated time to complete the trial, relationship with individuals at the site besides budgetary factors.
The pharmaceutical industry is experiencing rapid growth, by 2024 the R&D expenditure will reach over US$ 210 bn. The Global CRO Industry is about US$ 38 bn. in 2020, Pakistan Pharma market is US$ 3.2 Billion annually growing at the rate of more than 12% per year. Due to China war tension with India, Chinese drug approval are using Pakistani data by The National Medical Products Administration (NMPA). National Pharma companies are registering new compounds and like to promote them scientifically. It is the right time to prepare oneself for this opportunity and to reap the benefit from clinical research.
Development of site required investment on dedicated personnel that will be the foundation stone. Research coordinator, must be experienced or at least trained in research practices, There must be an ongoing programs of training the research site personnel to keep them up to date with latest developments in this field as well as ongoing studies. Dimension Research , he stated was founded in 2010 and it is the largest CRO of Pakistan providing research services through its 70plus trained personnel in eight major cities of Pakistan covering 19 towns. It is an ISO certified DRAP approved Clinical Research Organization, provide Clinical Research, Site Management, Pharmacovigilance, Trainings and Patient Support Services.