Happy Holidays from CROs

We will be taking some much needed time off for the holidays. We'd like to thank you for your readership and we encourage you to check back with us next year for more innovative thought, perspective and news surrounding the world of contract research organizations.

We wish you a joyous holiday season!

Outsourcing to India

The St. Petersburg Times recently examined the outsourcing of clinical trials to India. With such a large population, the CROs appear to the population as a way to obtain health care, but with the numbers of companies flooding into India to conduct clinical trials, patients' best interests may be forgotten.

One concern brought up in the article is the difference between the patients of the clinical trial in India and the target patients of the drug in the United States.

"First of all the data must be applicable to the U.S., where the population may differ in clinically significant ways," he said. "And the FDA has to have the capacity to go over and inspect the data. If not, you're asking for trouble."

Another is the lack of oversight from the Indian government on the process of the clinical trials.

Government regulators on both sides of the globe are supposed to be the final backstop on the safety of clinical trials. But that hasn't happened in India. Despite being stung by controversies involving the testing behind drugs like Vioxx, Avandia and popular antidepressants, the FDA inspects fewer than 1 percent of all drug trials in the United States. Its record overseas is even worse.

Read the complete article here.

Partnerships with CROs: Best of 2008

As 2008 draws to a close, we'd like to share the most popular articles of the year.

Enjoy!

India, China, Latin America and CEE as Clinical Trial Destinations
CRO Industry Overview
Accenture has Big Plans For Outsourcing Services
CROs Under Fire
Indian government looking into regulation of Clinical Trials

CRO PharmaNet Development Group Explores Strategic Alternatives

ClinicalTrialsToday reports that PharmaNet Development Group, which is a troubled CRO, is working alongside UBS to explore alternatives, including the potential sale of the company.

The company’s share price has plunged from $39.19 in January to $1.01 in early morning trading Friday. The company has also received some letters of interest regarding the sale, but PharmaNet will not comment any further until a decision is made.

Keep Clinical Trial Participants in the Loop

This article on Outsourcing-pharma.com explains how not informing clinical trials participants of the study results may leave them confused and frustrated, and lacking information that might be important for their health. Currently, clinical researchers are not required to tell participants the results of the study, but they are required to tell them information that might affect their willingness to participate in the study.

When a group of people were informed of the research results via a site call, roughly 90 per cent of participants reported “high or complete satisfaction”, and when they informed of the results through the sponsor’s press release only 50 percent reported “high or complete satisfaction.”

Child Death Rate in Outsourced Clinical Trials in India

This post on InjuryBoard.com highlights how 49 children involved in clinical trials in India have died since 2006. Dr. Vinod K. Paul, the head of pediatrics the All India Institute of Medical Sciences, mentions that all these children have died from serious illnesses and not the nature of the clinical drug trials itself.

Still there is some concern that many illiterate, poor families who do not speak English sign contracts written by foreign lawyers without understanding the nature of the clinical drug trials. Other hazardous problems include the lack of inspections at the factories and fraudulent clinical trial data.

Most companies are turning to foreign countries because of fewer restrictions, and where patients don’t fully understand but sign consenting documents anyway. What are your thoughts?

Tigermed Consulting Announces OCT as a Partner in Russia

PMR reports that Tigermed Consulting, a Chinese CRO, has formed a strategic alliance with OCT, which is a Russian based CRO based in St. Petersburg. Tigermed is trying to create a global clinical trials network with this move. Read the full article here.

Thermal Fisher Opens up New Facility in India

From Clinical Trials Today:

Global laboratory supply giant Thermo Fisher opened a new $17 million clinical services facility in Ahmedabad, India, giving the Waltham, Mass.-based company the largest Indian presence of any company in its industry, according to a company release.

The new 150,000-square-foot facility will support growing demand for biopharma services in the region and serve as a hub for packaging, distribution and logistics management of clinical trial supplies.

“With the added capacity now available to us with this new facility, we can offer our customers a higher level of technology, quality and expertise to facilitate clinical trials that serve the needs of both local and multi-national pharmaceutical companies,” said Thermo Fisher president and CEO Marijn Dekkers at the opening of the new facility.

Read the rest of the article here.

Bilcare Boosts its Clinical Trial Business in India

This article on outsourcing-pharma.com reports that Bilcare has extended its clinical trials business with the opening of new packaging and storage capacity at its facilities in Pune, India.

Ajit Dubhashi, president of Bilcare GCS, Asia Pacific mentions:

"This will significantly enhance the capability of sponsors to conduct clinical trials across the world - inclusive of Asia- with desired alacrity.”

This deal has enhanced their global reach in Argentina, Brazil, Columbia, Chile, Mexico, Peru, Russia and Eastern Europe.

Regulatory Changes in India

Bio-IT World reports that in an attempt to broaden examination of the clinical research process within its borders, “India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS).”

The Indian Council of Medical Research has been regularly working towards establishment of a mandatory clinical trials registry to improve the reliability of data. The growth in clinical research in India continues, and so the importance of clinical monitors and research associates increases. India will have to play close mind to regulations over the next years since CRO growth is expected to increase in rapid numbers.

Clinical Trial Regulations Grow Tighter Overseas

John Carroll explains in this post on FieceBiotech that lately overseas regulators have been tightening their grasp of clinical trials around the world. Polish investigators want to know why two seniors died when they took two experimental bird flu vaccines developed by Novartis, and this is just one case of the tight regulations being put in place.

There is a growing concern that in the developing countries, the citizens are being used to test new drugs which will later be sold to more affluent markets. The Wall Street Journal estimates that roughly 40 percent of all clinical trials take place in lower-income countries.

Read the entire article in the Wall Street Journal