Clinical Trials: Millions Around the World Have no Access

Often when a cure for a specific rare disease has yet to be developed, patients have enrolled in clinical trials with positive results. However, FDA-approved trials have developed a reputation for lacking participant diversity.

Lately, it has become apparent that due to a lack of ethnic and racial diversity, millions of people worldwide find the trials to be inaccessible. It appears that the FDA, which is the agency governing U.S. clinical trials, has not been proactive in addressing diversity in the research and development of drugs.

The FDA has had its own problems beginning with political conflicts in connection with external forces angling for control over the nation’s COVID-19 response. The one-year vacancy of the chief commissioner’s position added to a meltdown of reform efforts.

Although the development of drugs is geared to the general population, such political conflicts have caused groups of enrolled trial participants to lack diversity. It is understood that currently, clinical trials are not reflective of the ethnic and racial makeup of people worldwide even though they are significantly affected by the disease being studied.

For example, as of 2021 white, mostly male, affluent adults represented eighty percent of participants in clinical trials.  Trials were generally conducted in white areas throughout the world. Therefore underrepresented minorities and people of color living in low or middle-income areas such as India were denied access to clinical trials investigating both common and rare diseases.

Clinical Trials in India

Although the Indian subcontinent accounts for one-quarter of people in the world, fewer than two percent of worldwide clinical trials maintain study sites in India. In 2020, 18 million persons from India were living outside their country of birth. This includes over four million people living in the United States.

IndoUShare (Indo-US Organization for Rare Diseases) is attempting to remedy this deficit by opening access to orphan therapies. It is building collaborations between the US and India for education, advocacy, and research.


It is apparent that trials that lack diversity are counter-productive. This is especially true in studies that involve rare diseases. Here people affected by the disease are usually widely distributed throughout the world.

Without this base, researchers do not receive accurate data enabling them to compare disease progression or the efficacy of a treatment. Both sides lose. The biopharma industry in the United States often comes up short of its goals when attempting to achieve full enrollment in orphan drug trials.

Note that an orphan drug is one that has not yet been commercially developed due to its anticipated lack of profitability.

Meeting International Standards

India’s Ministry of Health (MOH) and its other regulatory agencies have taken steps to ensure that India’s research facilities are in step with international standards.

Additionally, the National Policy for Rare Diseases (NPRD) was revised in 2021. A Memorandum sent out by the MOH in August 2022 offers up to five million Indian Rupees per patient in financial support for the treatment and management of the disease. In order to qualify the rare disease must be one of the groups listed by the NPRD.

Several units in India’s public sector cover one hundred percent of healthcare costs for approximately one hundred twenty million individuals. This includes treatment costs without preset limits.

Dr.  Harsha Rajasimha, Founder of IndoUShare, has responded to the FDA’s request for comments on the development of networks covering worldwide clinical trials.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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