Janice Sidorick was working in regulatory affairs for a pharmaceutical company that was starting up a cardiology trial. As Sidorick recalls, there were 250 sites with 500 patients in five countries. Most of the sites were in the U.S., Canada and Eastern Europe, with a smattering in South Africa. Twenty, to be exact.

But when enrollment was finished, says Sidorick, the South African sites blew the rest out of the water. They had each enrolled between 80 and 100 patients, while the sites in other countries lagged far, far behind. Most recruited less than half of that.

Often Overlooked

The experience was eye-opening for Sidorick. Pivotal, even.

In 2004, she launched the Newport Beach, CA-based contract research organization (CRO) Janix, a year later opening an office in Midrand, South Africa, outside Johannesburg, the country’s largest city and the home of the regulatory body that approves trials.

Enrollment Rocks

“Enrollment is amazing,” Sidorick says. “There is very high public awareness about clinical trials there, patients are very compliant, and investigators like to have the opportunity to bring new medicines to their patients.

“And another thing that really impresses me,” adds Sidorick, “is that the [researchers] really do this for the love of the science. Instead of saying, ‘How much are you going to pay me?’ it’s more like, ‘This is an exciting study! I’d love to work on it!’ ”

English Spoken Here

There are plenty of treatment-naive patients in South Africa (unlike the U.S.), as well as Western-trained staff (unlike, say, Russia), reliable communications (unlike India), low cost of doing business (unlike the U.S.) and English is the dominant language (unlike China). While South Africa doesn’t tend to register in sponsors’ minds as a place to consider, several local CROs like Janix are trying to change that.

This year, AAIPharma opened an office in South Africa. Already on the ground are PPD, Quintiles, Parexel, Kendle, Icon, and smaller CROs such as Criterium, TriClinium and Integrium and others. Many came in the mid-2000s. And this fall, ACRO, the first locally and black-owned CRO, was launched in South Africa. Four hundred trials are performed there annually.

First and Third

Therapeutic areas, say those working there, are as varied as anywhere else. More varied, perhaps.

“South Africa has this really ideal mix of First World and Third World diseases,” Sidorick explains. “You can go there and do your HIV studies but you can also do oncology and get the same good data and high enrollment.”

Frequent GCP Retraining

That good, clean data is another upside of doing trials there, adds Nicolette Muller, clinical operations manager in the South Africa office of California-based CRO Integrium. The health department there, she says, requires that all principal investigators and research staff attend a Good Clinical Practice (GCP) course every two years. This is not a requirement in the U.S.

“This results in very high-quality data,”  Muller says.

Plus, the area’s well-developed research infrastructure provides a useful platform for operations on the rest of the continent, said Lindsay Hunter-Dodds, senior director of clinical operations for clinical research services at Parexel. “South Africa provides a good base from which to perform clinical studies for other African countries,” she says.

Parexel has offices in the South African cities of Bloemfontein and George.

Bureaucracy

The only significant stumbling block to conducting trials in the country? The regulatory system, says Quintiles’ Gillian Corken, a native of South Africa. Approval takes between 12 to 14 weeks if all goes smoothly. But sometimes it doesn’t.

“We are a developing country, and a lot of [the regulatory hurdles] have to do with new governments coming into place,” says Corken. “The regulatory authorities are new at the game and sometimes reluctant to give approval.”

Every Eight Weeks

The Ministry of Health Medicines Control Council (MCC), responsible for approving protocols, only meets every eight weeks. If you don’t have your application in at just the right time, you’ll have to wait another eight weeks to even have it considered. And now that South Africa is becoming, slowly but surely, more popular among sponsors, the MCC is getting more and more backed up.

For this reason, says drug-development consultant John Vogel, sponsors who know about the regulatory issues in the country tend to steer clear of South Africa.

Back-Up Plans

“There is a lack of confidence that the regulatory authority is going to move expeditiously, and that the CRO is going to deliver to the sponsor,” Vogel says. “I think CROs [who do business in South Africa] have to have back-up plans in other countries.”

In addition, the MCC is very stringent, adds Sidorick. This may sound like a negative, but is actually a positive, she says. That’s because the MCC asks for so much detailed information up front that it can minimize time-consuming loops of communication later.

Possible Reform

The good news, says Corken, is that the South Africa Clinical Research Association (SACRA) has been meeting with the MCC, as well as the Department of Trade and Industry, to explore how to improve timelines for trial approval. If the bottleneck can be removed, those in South Africa expect to see the clinical trials landscape get a lot more crowded.

Another obstacle to more trials, says Sidorick, is that the country is perceived to be a vast distance from Europe or the U.S. She recalls working with one U.S. client who wanted to take its trial global. When Sidorick mentioned South Africa, the client said, “That’s so far away!” (In fact, getting there from Washington, D.C., takes two flights and 16 hours.) Later, when recruitment didn’t go well for the company in a few other countries, the sponsor asked her if South Africa was still on the table. Sidorick said yes, and enrollment for the trial skyrocketed.

“In today’s global economy, South Africa is just a plane ride away, just like anywhere else,” Sidorick says.

The future of trials in South Africa is unclear. But one thing is certain: more CROs are trickling in and opening up there. And they may just be on the leading edge of the movement to the next hot country for clinical trials. 

“If the regulatory delays can be eliminated, there’s potential for considerable growth in South Africa,” says Vogel.

—by