Innovative Trials are passionate about ensuring our diverse population is adequately represented within medical research. Whether it is wanting to see more people from underrepresented communities choosing science as a career and pushing for greater patient diversity in clinical trials or focusing on what we are doing internally to celebrate and promote equality and diversity. Today we celebrate World Malaria Day and the Equality, Diversity and Inclusion Committee at Innovative Trials wrote a blog to raise awareness surrounding the illness, its effects and treatment following a blog on Endometriosis.

World Malaria Day is a global event, which is held annually to address the ongoing struggle against the disease.  The themes for the day change each year and 2023’s will be ‘Ready to Beat Malaria’.

What is it and what are the facts? 

Malaria is a serious infection that results from being bitten by a female Anopheles mosquito infected with Plasmodium parasites. Symptoms usually appear 10-15 days after a bite and the early signs tend to be mild and not do not warn of a serious infection. The number of days before other symptoms appear can vary, and some of the rarer forms of malaria can lie dormant in an infected person for years.

In many regions, the risk of being infected with malaria is increased after rainfall and when humidity is high, as these are the optimal conditions for mosquito numbers to increase.  Any region where mosquitos are common carries an increased risk of people contracting malaria, including:

  • Significant areas of Africa
  • Significant areas of Asia
  • Central America
  • South America
  • Middle East
  • Pacific Islands

Who does it affect?

Globally, there were approximately 247 million cases and 619,000 deaths attributed to Malaria in 2021, with Africa accounting for more than 95% of the reported cases. Anyone can fall ill with malaria, however, the people most susceptible to infection are:

  • Pregnant people
  • Young children
  • People over 65

Immunocompromised people  (such as people diagnosed with HIV, AIDS, cancer, diabetes, malnutrition or a genetic disorder)

  • People with Sickle Cell Disease (SCD) are highly vulnerable to malaria, but those with Sickle Cell Trait actually have an increased resistance. This explains the higher rates of SCD in African countries.

The NHS website outlines details of the wider range of symptoms and who are most at risk. Early symptoms are generally similar to having flu such as: 

  • High temperatures
  • Sweats and chills
  • Headaches and confusion 

How is it treated? 

Treatment depends on which species of parasite a person is infected with and any other medical conditions they might have. The WHO website maintains a database of antimalarial drug policies based on region and origin of the infection. Preventative vaccines are expected to be a cheaper solution than prescribed antimalarial medications, such as Doxycycline and Malarone. A malaria vaccine recently approved in Ghana, has been described as a ‘world changer’.  This is expected to be the first approval ahead of wider use of the vaccine. Clinical trials demonstrated that the R21/Matrix-M vaccine had shown considerable efficacy, reducing the rate of repeat infections in children by up to 80%. 

Other strategies to reduce Malaria impact

Public health theories and policies surrounding infectious diseases, such as surveillance, elimination and eradication, form part of the overall solution to ultimately wiping out the global presence of malaria and the disastrous impact it can have on people’s lives. These same principles were used during the COVID-19 pandemic and can be traced back in history all the way to Smallpox. 

  • Surveillance is tracking the spread of malaria, monitoring response to the preventative measures in place and taking preventative actions accordingly. Poor or minimal surveillance can lead to outbreaks that could be prevented. 
  • Elimination is defined as the interruption of local transmission of a specified malaria parasite species as a result of preventative measures. 
  • Eradication is the end goal of combining all of these strategies to reduce malaria rates to zero. The approval of an effective vaccine such as R21/Matrix-M will be a large step forwards. 

Malaria in Clinical Trials and Health Care

As mentioned, the key focus in the fight against malaria is the development of an effective vaccine. One problem is that many patients with malaria will have other infections that might change their experience of malaria and influence the effectiveness of any therapies. Clinical development in Africa, and finding solutions to potential challenges (particularly in more remote regions), are vital to advancing life-improving treatments. With such large numbers being affected by malaria, any effective efforts will make a big impact. Potential challenges include: 

  • The different species of Plasmodium (treatment of one form over another will simply allow the other to thrive)
  • The long-term effectiveness of any treatment (re-infection risks are often high)
  • Healthcare Infrastructure and Development/improvement
  • Making testing and treatment similar across regions to make it easier to compare strategies

There are currently 97 ongoing clinical trials relating to malaria research, and 66 of these trials are taking place in Africa. Finding more effective tests and preventative treatments would have an incredible impact on the quality of life for people affected by malaria. 

Recruiting patients for clinical trials was significantly impacted by the COVID-19 pandemic. The pandemic has raised awareness about clinical trials, vaccinations, and the potential risks and benefits associated with participating in research studies. The importance of vaccinations is widely understood, but there is also increasing hesitation in taking them. Malaria predominantly affects populations who may already have greater concerns and distrust towards clinical research or modern healthcare. This raises the need for greater awareness of the racial make-up of populations for studies globally.  

Conclusion

Development of an effective vaccine for malaria in Africa requires recruitment in regions where malaria rates are not as traditionally high. Innovative Trials would look to utilise in-country knowledge and the expertise of people with experience within local communities to help benefit this.  With our expertise in the development of patient education materials and through extensive experience of performing community outreach, under-represented populations can be collaboratively approached to directly address their concerns, answer questions, and stress the importance of representation of different populations within a clinical trial. Moreover, working in collaboration with Healthcare Providers and Key Opinion Leaders in these regions would provide a well-rounded approach to helping to recruit more patients, quicker, in the countries where it is most needed. This will ultimately help provide access to these life-improving treatments to the people who need it the most.

References

  1. https://www.nhs.uk/conditions/malaria/
  2. https://www.who.int/news-room/fact-sheets/detail/malaria
  3. https://aho.org/fact-sheets/malaria-fact-sheet/
  4. https://www.dosomething.org/us/facts/11-facts-about-malaria
  5. https://borgenproject.org/10-facts-malaria/
  6. https://www.cdc.gov/malaria/malaria_worldwide/reduction/index.html
  7. https://www.who.int/teams/global-malaria-programme/case-management/treatment/country-antimalarial-drug-policies-by-who-regions
  8. https://ourworldindata.org/malaria
  9. https://www.thelancet.com/action/showPdf?pii=S1473-3099%2822%2900442-X  (Lancet Infect Dis 2022; 22: 1728–36)
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3599886/
  11. https://www.bbc.co.uk/news/health-65252511
  12. https://www.clinicaltrials.gov/ct2/results/map/click?map.x=992&map.y=602&recrs=a&cond=malaria&mapw=1916
  13. https://www.race.ed.ac.uk/fixing-the-underrepresentation-of-bame-participants-in-medical-research/