Can Pfizer's Generosity Transform Access to Clinical Trials in Low- And Middle -Income Countries?

Introduction

 

Global health disparities have always existed, with developing countries disadvantaged in clinical research and access to newer medications.

It became painfully clear that these inequities existed during the Coronavirus pandemic as rich countries were the first to receive products to combat the disease while developing countries received the leftovers.

Despite selling the most vaccines in the world during the pandemic, Pfizer's vaccine distribution was criticized for being uneven with the least delivery to low-income countries.

In response, Pfizer's recent announcement that they will donate medications to low- and middle-income countries suggests that they are indeed committed to health equity.

 

The Scope and Nature of Pfizer's Donations

 

In May of 2022, Pfizer launched An Accord for a Healthier World, a transformative initiative focused on reducing significant health disparities between many low-income countries and the rest of the world.

The original goal was to make 23 patented drugs and vaccines available on a non-profit basis in 45 low-income countries. However, to better align its offerings under the Accord with disease burden and unmet patient needs in these countries, Pfizer recently announced that it would include off-patent products, increasing the number of products from 23 to around 500 to benefit 1.2 billion people in 45 countries with low incomes.

That means Pfizer will now contribute patented and unpatented drugs and vaccines that treat or prevent many of the biggest threats from communicable and non-communicable diseases prevalent in low-income countries today.

These include chemotherapy and oral cancer treatments, which have the potential to treat nearly a million new cases of cancer in these poor countries each year. 

It also includes a range of antibiotics that can help manage the increased morbidity, mortality, and costs associated with infections occurring in public health facilities. This will likely prevent an estimated 1.5 million deaths annually in these resource-limited countries.

It doesn't end there.

Pfizer will make its new medicines and vaccines available to these poor countries for a non-profit price as they are launched.

In addition, Pfizer intends to provide medical supplies and support to these countries.

How might this affect clinical trials in these countries?

First, let's briefly summarize what a clinical trial is.

 

An Overview of Clinical Trials 

 

Clinical trials are medical studies with the primary goal of analyzing the effects of new treatments and tests on humans. Most of them take a lot of time to design, review, and complete, and they need approval before they can start.

People voluntarily participate in clinical trials to test medical interventions, such as new drugs, before these products are released to the general public. People of all ages, including children, can participate in clinical trials.

There is also a great need for diversity in clinical trials. This is because people of different ethnicities and races do not respond equally to the same treatment. 

By including diverse subjects in clinical trials, it is necessary to represent the patients in different parts of the world who would need the product.

 

Clinical Trial Participation in Low- and Middle-Income Countries

 

Clinical trials are needed worldwide to reduce the burden of disease by helping to develop new therapies and vaccines that are safe and effective.

There is an urgent need for solutions to noncommunicable diseases like cancer, hypertension, and diabetes, as well as infectious diseases, which are especially prevalent in the poorest regions of the world.

Currently, less than 20% of clinical trials are conducted in developing countries and only 1% of newly discovered drugs are intended to treat tropical diseases. On a continent like Africa, home to 23 of the world's 27 poorest countries and nearly half of the lower-middle-income countries, only 2% of clinical trials are conducted.

One of the most common reasons why developing countries often do not participate in clinical trials is lack of money, or in other words poverty. Funding for clinical trials in developing countries mainly comes from western countries and pharmaceutical companies based there. 

In most low-income countries, research is a luxury due to economic constraints. Scarce resources in developing countries are almost exclusively used for implementing programs, and research funding allocations are barely included in most development plans.

Despite what is currently practiced, the lack of resources makes it even more important that there should be reliable evidence before  directing scarce resources toward healthcare.

Research in developing countries is also underrepresented due to low commercial viability and a lack of trained researchers.

Why Clinical Trials Matter in Developing Nations

 

It is rather paradoxical that there is underrepresentation of developing countries in clinical trials, yet it is in these poorest regions that research-led solutions can have the biggest impact on high mortality rates.

 

Here are 7 major reasons why more  clinical trials should be conducted in developing countries

 

1. Greater diversity in study participants: Conducting clinical trials in developing countries can increase the diversity of study participants, which can help ensure that the results of the trial apply to a wider population. This is particularly important for medications that may have different effects based on genetic or cultural differences. 
2. Access to New Treatments: Clinical trials give people in poor countries access to new and potentially life-saving treatments they might otherwise not have access to. By participating in clinical trials, people in these countries can receive innovative treatments that may not be available in their home countries.
3. Health Disparities: Many diseases disproportionately affect people in low-income countries. However, the gross under-representation of these countries in global clinical trial platforms contributes to sustained health inequity. Clinical trials can help address these health disparities by aiding to identify treatments that are effective for these populations. 
4. Cost-Effective: Clinical trials conducted in poor countries can be more cost-effective than those conducted in wealthier countries. The availability of large numbers of skilled workers with higher education and a relatively low wage base in these countries reduces the cost of conducting clinical trials. The cost of conducting clinical trials in poor countries is often lower due to lower regulatory and infrastructure costs, which can result in a lower overall cost of the study. Unlocking the enormous research potential in developing countries has a two-fold contribution because it can provide ideas for overcoming some of the challenges faced by conducting clinical trials in developed countries.
5. Building Local Healthcare Capacity: Clinical trials can help build local healthcare capacity in poor countries. By participating in clinical trials, local health professionals can gain experience and knowledge about new treatments and methods that can help improve the overall quality of care in their community. Conducting clinical trials in developing countries can help improve local healthcare infrastructure. This is because clinical trials often require local healthcare providers to be trained and the necessary equipment to be installed, which can leave a lasting impact on the local healthcare system. The Global Health Research Forum report highlights that strengthening research capacity in developing countries is one of the most effective and sustainable ways to advance health and development in these countries and to fill gaps in health research. Scientific capacity building is more than just the transfer of knowledge of science and technology from developed to developing countries. The key to scientific success lies in human resources. Therefore, fair and respectful learning and the development of sustainable long-term partnerships must be at the forefront.
6. Faster recruitment: Subject recruitment is responsible for around 23% of total trial costs, and 87% of US trials fail to meet temporal recruitment and enrolment milestones. Developing countries often have a larger pool of potential participants for clinical trials, which can speed up recruitment and reduce the time to complete trials.
7. Addressing Global Health Challenges: Many of the world's most pressing health challenges, such as HIV/AIDS, malaria, and tuberculosis, are concentrated in poor countries. Clinical trials focused on these diseases can help identify new treatments and prevention strategies that are effective in these populations.

 

How Pfizer's Donations Can Transform Access to Clinical Trials in Low- and Middle-Income Countries

 

To reduce the glaring health equity gap that exists around the world, Pfizer launched the Accord to empower developing country governments and work in collaboration with them and other multi sectoral partners to tackle many of the barriers to better health at a system level.

 

Here are 6 ways that could positively impact clinical trials in these countries:

 

1. Enhanced clinical research capacity: The donations can help build capacity for clinical research in these countries by providing resources such as equipment, training, and infrastructure. This will help develop a stronger clinical research network and increase the number and quality of clinical trials conducted in these countries. For example: in collaboration with the Rwandan Ministry of Health, Pfizer has provided professional healthcare education and training to support delivery of donated medications. They are also collaborating with the Ministries of Health in Malawi, Ghana, and Senegal, as well as several other Accord countries, to better understand the critical health needs and health system strengthening opportunities.
2. Greater diversity in clinical trial populations: Clinical trials are often conducted in developed countries and may not reflect the genetic, cultural, or demographic diversity of the global population. This will likely open up the possibility of more clinical trials taking place in developing countries so that clinical research benefits more people. This is because the populations who are not a part of the trials for developing the medications being donated would be more likely to experience resistance and adverse effects.
3. Increased access to medicines: By making medicines available to developing countries, Pfizer increases access to medicines for patients who may not be able to afford them. This could help increase the number of patients who are willing to enter clinical trials now that they have access to the drugs they need.
4. Increased trust in pharmaceutical companies: By making this donation, Pfizer is demonstrating a commitment to public health and improving access to healthcare. For example, Pfizer works with the governments of these countries and its partners across different industries to jointly develop solutions that help remove systemic barriers to better health. This is done with a focus on finding faster and more efficient delivery routes for medicines and vaccines and empowering resources, skills, and platforms that can provide rapid and more sustainable access to these medicines. This includes technical expertise, training, diagnostic capabilities, innovative financing, and more. These efforts could help build trust with patients and healthcare providers in these countries, which could encourage greater participation in clinical trials
5. Increased knowledge of diseases: By participating in clinical trials, patients and healthcare providers can gain a better understanding of diseases and their treatments. This can help build the capacity to conduct clinical trials in developing countries and help healthcare providers better diagnose and treat patients. They would be further motivated to participate in trials.
6. Addressing unmet medical needs: Many developing countries have high rates of communicable diseases such as malaria and tuberculosis which have been neglected by pharmaceutical companies. By targeting this unmet medical need, Pfizer and other pharmaceutical companies can conduct more trials in these countries to help address significant health challenges in developing countries that can provide long-term public health benefits.

 

 Conclusion 

 

Pfizer's donations to low- and middle-income countries have the potential to transform access to clinical trials in these regions. By providing access to essential medications and supporting capacity building, Pfizer's philanthropic efforts could contribute to building research capacity and closing the global health disparities gap. 

 

It is hoped that other pharmaceutical companies will follow Pfizer's example and work towards creating a more equitable global health system.

CROs like Infiuss Health are extremely important in developing countries, especially in Africa. By partnering with a CRO in these countries, pharmaceutical companies can leverage their expertise and infrastructure to overcome the challenges of conducting clinical trials in developing countries, while ensuring that the trials are conducted by international standards and regulatory requirements. This could lead to more efficient and cost-effective trials, as well as greater access to innovative treatments for patients in Africa and other developing countries.