Introduction: 

It has been a general belief in pharmaceutical research that the biggest issue is scientific research itself. When you query the community outside the drugs industry about why it takes so long to find and test new therapies, many people will evoke the image of research and development.

There is another narrative to the story for those of us who work in low resource environments.

The science is difficult, of course. Nobody disputes that. However, in many cases, the question of research is not what will make a project slow. The challenges seem to be coming from somewhere else: getting funding, approval time, equipment maintenance, participant recruitment, and dozens of other issues that simply don't get documented in published papers.

That reality becomes easier to understand when looking at the broader healthcare landscape.

A number of new emerging markets are facing two completely different strains at once. Chronic diseases like diabetes, cardiovascular disease and cancer are becoming more prevalent and infectious diseases are still a burden. Healthcare systems are being called upon to do more than ever. Research institutions are under the same expectations.
The demand for pharmacological research is growing. Resources, however, are not always growing at the same pace.

What's interesting is that a shortage of ideas is rarely the issue.

Visit a university laboratory, teaching hospital, or research institute in many developing regions and you will find no shortage of motivated investigators. Researchers know which diseases are affecting local populations. They know where treatment gaps exist. They often have strong relationships with clinicians and patient communities.

The challenge begins when those ideas need long-term support.

A project might start with enthusiasm and a clear scientific objective. Then practical realities begin to appear. Equipment requires servicing. Funding applications take longer than expected. Recruitment targets become difficult to achieve. Administrative requirements increase. One delay leads to another.

Each of these issues by itself might not be a big deal.

Collectively, they can shape an entire research program.

A rise in small problems becomes a big problem

The talk about infrastructure typically revolves around large-scale investments – be it new laboratories, research parks, or sophisticated technology platforms. Those are important, but a lot of researchers are more likely to speak to the size of the operational irritations.

A freezer fails unexpectedly.

A replacement component takes weeks to arrive.

An internet outage disrupts data uploads.

A supplier changes delivery timelines.

None of these events sounds particularly dramatic. Yet research depends on consistency. Small interruptions have a habit of creating larger consequences.

One delayed shipment can affect laboratory schedules. A postponed maintenance visit can reduce testing capacity. What appears to be a minor operational inconvenience may eventually influence project timelines.

This is one reason why research capacity and scientific talent should not be viewed as the same thing.

Many institutions possess highly capable researchers. Supporting those researchers with reliable systems is often the greater challenge.

Funding Doesn't Just Influence Research. It Shapes It.

Researchers rarely talk about funding as an abstract concept. They experience it through decisions.

At times, it can come down to selecting between two projects when only one can be funded. In some cases, it involves postponing to recruit until more resources are available.

Sometimes it means reducing study scope despite knowing that a larger investigation would generate stronger evidence.

This effect is typically subtle and subtle.

An institution may postpone hiring. Equipment upgrades are pushed into the following year. Opportunities for collaboration are identified but not fully realised.

The more the years go by, the more those decisions pile up.

A tough one is that not always investment priorities reflect health investment priorities. Diseases that affect large populations may still struggle to attract research investment if financial support is directed elsewhere.

Researchers learn to work within those constraints. That does not make the constraints any less significant.

Regulatory Challenges in Drug Development

There is no discussion topic that gets as much discussion as the regulatory review in industry conferences.

The general consensus among scientists, sponsors, and regulators is that supervision is important. Participants are protected by strong regulatory mechanisms and increase trust in research results.

The conversation becomes more complicated when resources are limited.

Regulatory challenges in drug development are often linked to capacity rather than intent. It is possible for agencies to receive more complicated applications from candidates, with limited technical and staff resources.

There are increasing demands on the workload.

So does the complexity of the therapies under review.

New scientific questions have arisen that were not present to many regulators 10 years ago with cell therapies, gene-based treatments and highly specialized biologics. It is essential to have ongoing learning and investment in order to keep up with these developments.

The outcome is a balancing act. The agencies are required to hold high quality standards and face pressure to make the processes more efficient.

This is not so easy to do.

Barriers to Clinical Research in Emerging Markets

One idea that's often mistaken for clinical research is that recruiting large populations is a simple process.

Researchers know otherwise.

There are several clinical research barriers in emerging markets which are not related to the willingness. Recruitment can be impacted by transportation, lack of access to healthcare records, limited access to specialists and geographic barriers.

There's the matter of awareness, too.

Clinical research is not part of everyone's life. Questions are natural. What is the purpose(s) of the study? What will be done with the data? What about if one of the players stops?

These questions are a significant part of a research team's job.

Indeed, some investigators may claim that communication is as important as recruitment itself.

You can't build trust quickly. Time is needed for communities to grasp the significance of the study and how they will be safeguarded. That process may not appear in final study results, but it often plays a major role in determining whether those results are achieved in the first place.