Wednesday, December 21, 2016

Managing trials and patient recruitment in emerging markets

With the current high cost of research conducted in the US and EU, researchers have turned to developing countries for research participants for a number of reasons.  First, costs are 30-50% lower. Second, there are large populations of prospects who have not participated in research trials previously.  Third, these countries have poor medical care and as a result, have a higher incidence of advanced diseases. For all the benefits of off-shore recruitment, there are significant hurdles to overcome: Adapting the universal paradigms of research to local cultural norms, language, ideas, and literacy levels can be demanding without local support.

Prospective subjects in developing countries are also vulnerable to patient abuse and exploitation. Poverty, limited health-care services, illiteracy, cultural and linguistic differences, and limited understanding of the nature of scientific research may increase the possibility of such exploitation. Examples of abuse and exploitation are all too common providing enough examples to support this contention, causing concern for more appropriate design and development of future models.

The growth in the lucrative Indian research subject market has all but dried up due to series of discoveries involving the unethical recruitment, inadequate regulatory systems, validity of the data, injury to subjects, and allegations of fraud. Between 2007 and 2010, at least 1,730 people died during or after trials.  These deaths were never investigated.

International attention was brought by activists in 1997 about widespread unethical clinical trials.  One of the studies examined the spread of HIV in Africa, Asia, and the Caribbean from pregnant women to their babies.  The study included a placebo group while 2 other groups received treatment, a practice that would never have been permitted in the US.  As a result, the placebo- treated mothers and babies did not receive appropriate treatment even after the study was concluded.

More than 20 years later, this practice continues as demonstrated in a Lancet article where researchers were testing 2 commercially available vaccines for rotavirus, a life-threatening virus. More than 2,000 children in India were denied treatment and were hospitalized because they served as the placebo group despite the availability of two vaccines that were being tested in the same trial. 

Hundreds of tribal girls were ‘recruited’ for an immunization study without parental consent.  Several girls subsequently died, but no investigation was performed as to the cause of death.

Many studies are carried out according to appropriate guidelines in poor, illiterate subjects, but the few that fail to obtain proper informed consent put a spotlight on the despicable treatment of these people and the lack of oversight.

In light of this reality, the international research community faces two questions: (1) to what medical standards should pharmaceutical trials in developing nations adhere, and (2) how should these standards be overseen and enforced?

Most researchers agree that the standard of care in research trials in developing countries should conform to the Declaration of Helsinki. Emmanuel laid out the basic principles and benchmarks of ethical research in developing countries: Collaboration, social value, scientific validity, fair selection of study population, risk to benefit ratio that benefits volunteers, review by an Institutional Review Board, appropriate informed consent, basic human respect for recruited participants and the affected study communities.

In order to prevent these occurrences, it has been suggested that there be more oversight of these trials by enforcement of existing FDA regulations, international partnerships between regulatory bodies, and private peer to peer partnerships all with the focus of enhancing local enforcement in order to prevent harm to research subjects and eliminate invalid data from clinical trial research.

The above excerpt is from our recent whitepaper  "Is Patient Centricity Truly at the Core of Clinical Trials?" which examines the complexity of clinical research trials, their exorbitant cost, and poor patient recruitment. Access the complete whitepaper here.

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