Access to Medicine

A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and cost-effective use. (WHO framework for health systems). The SARS-CoV-2 had pharmaceutical companies in a foot race to discover a vaccine that was safe for everyone. The efficacy of the vaccine and its safety across all populations became a question. With the global north leading in vaccine production, the global south had to go back to the drawing board and assess where it stands in drug discovery and clinical trials.

What are Clinical Trials?

Clinical trials are a type of research that studies new tests and treatments and evaluate their effects on human health outcomes (WHO). Clinical trials are conducted to collect data regarding the safety and efficacy of a new drug and device development. One can readily access ongoing clinical trials through a data repository at https://trialsearch.who.int. The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in healthcare decision-making. In Kenya, The Pharmacy and Poisons Board will approve protocols for clinical trials for new drugs and establish guidelines for clinical trials involving drugs already registered in Kenya.
The clinical development of a drug involves four key phases, each requiring a different approach to trial design.

• Phase I Studies in this phase are exploratory and conducted in small subject populations who are selected by narrow criteria, leading to a relatively homogeneous population which is closely monitored.
• Phase II studies primary objective is to explore therapeutic efficacy in patients. An important goal for this phase is to determine the dose(s) and regimen for the phase 3 confirmatory trials.
• Phase III studies objective is to confirm therapeutic benefit. These studies carried out in phase 3 are often known as the ‘pivotal’ studies and complete the information required to support the proposed product information for use of the drug in the marketing authorization application (MAA).
• Phase IV studies, often called postmarketing surveillance trials,begins after the approval of the drug. Commonly conducted studies include additional drug–drug interaction, dose-response or safety studies, and studies designed to support the commercial use under the approved indication. (Oxford Handbook of Clinical and Healthcare Research 2016)

#Data Visualization 
 plot1 <- ggplot(data = Phases_data1,
         aes(x =count_a , y =fix_Phase, label = round (count_a, 1)))+
    geom_point()+
    geom_segment(aes(y=fix_Phase, yend=fix_Phase, x=0, xend=count_a),
                 size = 1,
                 color = 'grey')+
    geom_point(
      size = 6,
      color = '#5D3FD3'
    )+
    geom_text(aes(label=count_a),color='white', size = 3.5)+
    theme_light()+
    theme (
      panel.grid.major = element_blank(),
      panel.border = element_blank(),
      axis.ticks.x = element_blank()
    )+
    xlab("")+
    ylab("Phases")+
    ggtitle("Clinical Trials Phases Distribution, Kenya")+
    labs (subtitle = '01-Jan to 30-Sep 2022')+
    scale_x_continuous(breaks = breaks_width(5))
#Data Source: trialsearch.who.int