To advance excellence in clinical trials in Pakistan, the Clinical Trials Unit organized a two-day symposium “Clinical Trials in Pakistan – Bridging Gaps & Building Networks”. The symposium served as a platform for the stakeholders – i.e. clinicians, researchers, academia, regulators and industry leaders – to connect and collaborate, share experiences, find solutions and pave the way forward for clinical trials in the country. There were speakers from Harvard University, Duke University, University of Sydney, Shaukat Khanum Memorial Cancer Center, SIUT, Pakistan Medical Research Council, Drug Regulatory Authority Pakistan, Provincial Health Secretary, Industry, Trial Patient, AKU Leadership,Department Chairs and Faculty.
The presentations and discussions stretched across ethical challenges, patient centricity (or lack thereof), gaps, strategies to build the gaps, success stories; concluding with the way forward. For the 2 days the participants, that included renowned members of academia, industry, CROs, medical journal & publications, continued to be highly engaged and offered exceptional insight to the discussions.
The highlights of the 2 day deliberations are summarized as follows:
It is our joint responsibility to ensure that we bring no adversity to the communities and population we serve. Clinical trials are an academic pursuit for the benefit of the public. We will all join hands and pool resources to achieve our goal. The Secretary Health committed to add clinical Trial activities and promotion to his portfolio. Member of the Drug Regulatory Authority committed to take the agenda forward at their end. They were very enthusiastic to add a report and presentations to the DRAP website to further the initiative. There is also a pool of funds for research that is contributed by the pharma industry. This funding should be used to promote clinical trials in Pakistan.
The agenda that came forth was:
- Develop national, regional & academic consortia. Though we collaborate with many institutes at all levels however we need to formalize these partnerships through contracts and MOUs.
- Urgent policy development for drug import for clinical trials. Policies exist however stakeholders can assist the government in finalization & implementation.
- Government needs to delineate its role in monitoring and safety of clinical trials. Simple steps would be to register sites conducting clinical trials, make trial registration mandatory, and add clinical trials reporting to the existing adverse event reporting system for the industry & hospitals.
- Research trainings should be formal and mandatory. Again tap in existing resources.
- Public-private relationships should be clearly formed by identifying
problems and then develop partnerships where tasks can be shared.
The agenda will serve as the road map and will be incorporated in the
CTU’s strategic plan. An action plan will be developed and shared at a
larger scale. Some initiatives are already in place like the Clinical
Trials Advocacy group that was founded by Dr. Azizunissa Irumnaz,
Director, CTU-AKU. The group includes members from national institutes
and Industry. The goal is to aggressively pursue this and incorporate
regulatory authority members as well as the CRO. We are also planning to
take the lead in developing formal consortia of institutes.
It is imperative to continue raising awareness about clinical trials among academia, communities, industry and regulatory authorities. The next planned activity is the Clinical Trials Awareness Week which will be celebrated for the second time along with the International Clinical Trials Day on May 21st.