Sponsors Often Compromise Ethics For Cost Efficiency With Trial Outsourcing
As drug sponsors opt to cut costs by outsourcing clinical trials to emerging nations such as India, incomplete patient consent forms are one of several rising ethical concerns linked to such demand.
"Part of the problem is also the cultural environment in India, for example there are several languages as well as dialects depending on the area of the country," posing challenges for consent, Hazel Aranha, president of the consulting and regulatory firm GAEA Resources, told a recent Regulatory Affairs Professionals Webcast. "In rural areas, not only family, but the local government body may even have some impact on participation ... in the clinical trial."
Additionally, patient reimbursement costs should be included in patient consent forms submitted to Institutional Review Boards for approval, U.S.-based Excel Life Sciences President Vijai Kumar told the RAPS Webcast.
"IRBs are also evolving. In the past IRBs were only approving state funded clinical trials," Kumar said, adding that more policing has occurred since the formation of the Office for Human Research Protections in 2000. "We need to educate the IRBs because clinical trial approvals is a relatively new concept. We need to really tell them what their role is."
Outsourcing clinical trials results in a cost savings of about 30 to 35 percent over a similar study performed in the U.S. or Europe because recruiting patients, nurses and investigators is less expensive in emerging nations.
Though patient recruitment is one area enticing sponsors to conduct trials in countries where costs are significantly lower, in some cases investigators downplay product risks and provide participants incomplete or inaccurate information before testing, Aranha said.
Ethics committees in India, intended to monitor the trials, also currently lack an accreditation process. Panelists said implementing accreditation for such committees is being "aggressively pursued" and that boosting transparency in drug studies is a rising government priority.
Despite remaining ethical concerns, emerging nations often demonstrate strength in technology-related research and development. Companies less willing to outsource entire product trials may choose to send some data abroad for analysis, according to a 2006 McKinsey report: Pharma Leaps Offshore.
"As innovative processes become routine, they can be outsourced to suppliers so that the company can concentrate on the next wave of innovation," according to the report. "At least half of the top ten pharma companies have outsourced their basic finance and IT activities."
Wyeth is among pharmaceutical companies outsourcing studies to accelerate drug development. In 2006, the company aimed to have 30 percent of its trials conducted in the U.S. and 70 percent in other areas of the world - an increase from the 50 percent outsourced in 2004 ("The Pink Sheet" July 3, 2006, p. 18).
Indian chemists are generally more educated, willing to work longer hours and will work at 7 percent of the salary of their U.S. counterparts; additionally a large portion of scientific R&D staff speak English, said Ranbaxy Chief Mentor Brian Tempest at a September 2006 London Biotechnology conference. GlaxoSmithKline has an agreement with Ranbaxy to pursue R&D research in Delhi ("The Pink Sheet" Oct. 2, 2006, p. 14).
But as demand grows, scientists are expressing concerns regarding the ability to maintain trained staff needed to keep pace with outsourced trials, such as principle investigators.
"These investigators are largely concentrated in major towns," Kumar said. "What's likely to happen in the future if we do not find new investigators is we are going to create high cost islands where there will be a lot of competing studies and your study could be delayed."
Approximately two million, or 20 percent, of participants in global clinical trials are expected to come from India by 2010, with clinical spending estimated at $1 billion or more. In 2006 about 35,000 patients were enrolled in India, Kumar said.
"To get two million patients we need at least 40,000 clinical principle investigators, each enrolling 50 patients a year, which is a very, very huge number compared to the U.S. and Europe," Kumar said. "To manage 40,000 PIs we need 200,000 clinical research professors - impossible."
Trial documentation and record keeping is "less than perfect" because of the increasing patient load, Kumar said. "The job is to convert these excellent physicians into competent investigators, and this is where training is extremely important."
To accommodate more studies, Kumar suggests focusing on category A trials, which have a shorter regulatory approval period (12-14 weeks) than those classified as category B (14-20 weeks). In category A trials India is one of several participating trial sites, while it is the only site in category B, and therefore has tighter regulations.
Panelists also said sponsors should more closely monitor trial sites with full-time site coordinators and service providers for patients in place to facilitate the process.
"Service providers are also an evolving breed; it's still in infancy," Kumar said, stressing the importance of achieving a balanced ratio between patient databases and set standards of care, as well as the patient screening, enrollment and completion process.
However, some are not convinced efforts abroad to improve trial safety are enough to facilitate outsourced trials, even with lower cost incentives. Consumer Union Senior Analyst Bill Vaughan said more FDA oversight is needed for domestic clinical trials before studies are conducted abroad.
"We certainly want safe new drugs approved ... but we need to make sure [the U.S.] FDA is doing enough sampling to ensure integrity of this process," Vaughan said of outsourced trials. "We need to do a better job domestically before going all over the world."
This article is reprinted from "The Pink Sheet" – Dec. 6, 2007
Click here to start your 30-day, risk-free trial of "The Pink Sheet" – Top down, comprehensive weekly industry insight and analysis.
© FDC Reports 2007 - All Rights Reserved
