Outsourcing-Pharma.com focus on: cutting the cost of clinical trials
What can drug companies do to choose high-quality CROs in India?
make sure they are choosing a contract research organisations (CRO)
that will stick to the rules of ethics when running clinical trials
in poorly-regulated countries such as India.
The presence of over 15 prominent CROs and over ten large multinational pharma companies is fuelling India's contract research business, valued at $100-120m (€78-94m) and growing at a rate of 20-25 per cent each year.
However, recent media reports have alleged that some of the clinical trials being conducted in India often target poor, illiterate and sometimes mentally incapacitated patients, many who are unaware they are even taking part in clinical trials that could be detrimental to their health.
While conducting clinical trials in India and other developing countries may seem attractive to a pharma company's bottom line, it may eventually do more harm than good if continuous reports of ethical concerns continue to surface and create a consumer backlash and it is in the pharma firm's best interest to carefully choose a CRO that they can trust to carry out such sensitive work on their behalf.
"Pharma companies can be as much or as little involved in choosing a CRO as they want, however, a more proactive approach can go a long way to gaining the firm security of the quality of the CRO they are choosing," Dr Faiz Kermani of Chiltern International, the largest independent employee-owned CRO in the world, told Outsourcing-Pharma.com.
"When pharma companies are choosing a CRO there is always a lot of discussion about timelines and costs, however, a lot more focus should also be placed on determining exactly what standards the CRO is working to."
Kermani believes a really important question to ask a candidate CRO is: "have you worked in India before and if so, what was the nature of that work?"
"They should be able to provide a reference for any past work that was done in the region to prove the quality of their work," he said.
Dr Umakanta Sahoo, general manager of Chiltern International, India, told Outsourcing-Pharma.com he believes that the best option for pharma companies is usually to choose a global CRO with a local presence and expertise in the area the trials will be run.
Sahoo also recommends pharma firms conduct an interview and assessment of the team assigned by the CRO to gauge their understanding of good clinical practice (GCP) and the clinical research concepts; as well as a one-day kick off meeting to train the clinical research associates (CRAs) and the team to ensure that everyone involved is on the same wavelength.
Sahoo also strongly advises showing due diligence in the selection process of the investigators, including visiting a few sites before initiation to understand the investigator experience, capability and site facilities for the clinical research.
"Don't pressurise the CROs to miss out pre-site selection visits as that is crucial to understand the reality versus the presentation of the site's operations," said Sahoo.
Sahoo also suggests that the use of a site management organisation (SMO) or dedicated site coordinator to support investigators at sites will also help to improve regulation compliance.
"In addition, a representative from the sponsoring pharmaceutical firm may want to consider a few mentoring visits with the CRAs onsite in order to keep track of what's going on," he said.
