What are the barriers to a wider representation of your region in clinical research?
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Barriers in India
There is a wide capacity for clinical research in India. We have a large, diverse population, large urban hospitals and well-trained specialists. However, for multiple reasons, this capacity is not fully exploited.
One challenge is that only a limited number of centers are formally equipped to conduct clinical trials in ophthalmology. The government of India mandates that centers doing research must be preregistered in the Clinical Trials Registry and undergo the approval of various government agencies. However, access to the ethics committees is limited due to the lack of trained participants, inadequate administrative support and absence of standard operating procedures.
In addition, lack of proper funding discourages clinicians from participating in the demanding setup and conduct of trials, which require extra staff and extra time without providing adequate compensation. There are many well-trained, young retina specialists who would like to engage in research but cannot afford to do this and eventually go back to their regular surgical practice. In India, we traditionally have donations from rich, generous philanthropists, but they are usually destined for health care delivery and not for research.
Another barrier is the patients’ misperceptions of clinical trials. While doctors in the past were seen as godlike, nowadays there is a diffused lack of faith and trust in us and the medical science. Health care has become a consumer good, and whatever we offer is called into question. Patients are afraid of being harmed and exploited. They often say, “No, I won’t let you do experiments on me,” and refuse the opportunity to be included in trials. More awareness programs are needed, but they also require funding, and companies are not always respondent to this need.
Patient enrollment is also limited by the strict eligibility criteria of clinical trials. Patients are usually required to be treatment naive, but most of them are not, and investigators may not even be aware of it because they have been seen and treated in multiple hospitals and have not followed a proper referral pathway. Inefficient trial recruitment has led some clinical trials to fail, producing debt and bad publicity for clinical trials as a whole.
Finally, India has a long history of human transit, migrations and settlements. The diversity of its populations with a large number of genetic variations could also pose challenges and may require a more precise categorization.
Sundaram Natarajan, MD, is with Aditya Jyot Eye Hospital in Mumbai, India.
Misconceptions about Africa
If there is a scarcity of clinical trials conducted in Africa, this is due to a series of misconceptions that ignore how our region, and particularly the East of Africa, has recently evolved.
The first misconception is that we do not have the numbers to satisfy recruitment goals because certain diseases, diabetes for instance, are not highly prevalent. Unfortunately, this is no longer true, and diabetes is on the rise, affecting about 5% of our people, according to the latest survey in Kenya. Half of the people affected are not even aware of having the disease and present when the most severe complications arise. In our department at Kenyatta National Hospital, the largest public hospital in East Africa, we have a long theater list of diabetic vitrectomy cases due to delayed presentation and advanced diabetic retinopathy. We do not have as much macular degeneration as in the West, but we have various forms of polypoidal choroidal vasculopathy. Because the conditions are there, we would like our Black populations to be counted in clinical trials because it is a different subset from Black Americans or Black Caribbeans, and we want our data to learn more and to guide policymakers in taking concrete, targeted actions.
A second barrier is the belief that we do not have enough personnel. Recently, we have been included in the phase 4 Elevatum trial on Vabysmo (faricimab, Genentech), and we have proved that we are ready in terms of workforce. We have had training, a lot of support from the regulatory bodies and local ethics committees, and the capacity, enthusiasm and motivation. Most of us retina specialists have done fellowships in Europe, India or Canada, and we are as well trained and qualified as our colleagues abroad to conduct clinical trials.
We are equipped with the most advanced imaging technologies, surgery platforms, microscopes, slit lamps, tonometers and whatever else is needed, and we have monthly meetings to ensure that we maintain standards. When people come here, they are pleasantly surprised.
We have a health insurance policy paid by the government for basic needs, and nobody misses medical care because they cannot afford it. Therefore, if we have a clinical trial on-site, potential complications would be covered.
Countries in other parts of Africa may not have the same facilities but are coming along, and we are creating networks and professional societies to work together and help raise standards. So, we are ready, the barriers are mainly misconceptions, and we can prove it.
Oscar Muwale Onyango, MD, is with Kenyatta National Hospital in Nairobi, Kenya.
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