India’s Clinical Trials

India is known for their acceptance of outsourcing in their country. Due to the low costs of financing trials here, big Pharma has also started to look to India for outsourcing clinical trials. Time recently took a look at the business of CROs in India. Typically, it costs $1 billion to bring any particular drug to the market, and most of that money is devoted to the part of testing on humans. In India, not only is it cheaper to conduct the human trial, but there are also less strict regulations when testing the drugs. There are currently 400 clinical trials taking place in India. Although there are numerous doctors who are proficient in English to support the effort, few of those doctors have graduated from world class institutes, and even fewer of the people working on the clinical trials have been properly trained.

One of the allures of participating in clinical trials for Indian citizens is the healthcare that’s involved. Since India has no public health care system, the care given during a clinical trial is often better than not receiving any at all. Sadly, most of the citizens who sign up for the clinical trials are illiterate. And with Pharma pushing for trials to go faster, often times health standards are not the highest. The booming business will lead to medical breakthrough for India, but how will it affect their citizens in the long term?

Proper Steps to Choosing the Correct CRO

In a recent article at Applied Clinical Trials, they took time to look in depth at the correct way to choose an clinical research outsourcer, and what steps should take place after the correct outsourcer is chosen.

The first step to starting a clinical trial is choosing the outsourcer. Gathering information to choose the outsourcer should be done in three steps. The planning phase happens with the biotech company chooses a CRO. There are two models of CROs a biotech company can choose from: one stop shop or full service (they complete every part of the process) functional outsourcing (establishing functions that the CRO can prepare). Protocol is also written during these stages. Next is the conduct phase. This is where the biotech company collaborates with the study sites and the trial sites have to attract the subjects. Should the conduct phase be operated by the CRO, it is necessary that they recruit the subjects in a timely manner and ensure that there are subjects throughout the trial. During the final evaluation phase, there should be a rapid evolution of study results, due to the processes that were planned an carried out in the conduct phase. Both the sponsor medic and the CRO’s medical writer should be in full cooperation in order to ensure a timely write-up and final report.

When it comes to the selection of the CRO, it is important to correlate the size of the CRO with the study you wish to perform. A smaller, new CRO will focus more attention on the project due to the success and recognition they will receive in the future, but a larger CRO will be able to handle larger test subjects and they could be more skilled to deal with the requests of the biotech companies.

As for the relationship with the CRO, the sponsor must maintain the relationship with the CRO and keep an open path of communication through out the process. It is beneficial for the sponsor to choose a CRO that has already developed a relationship with the investigators. It is also advisable to allow the CRO to work according to their own standards. The CRO must always be held accountable for the success of the study. With that said, it is also vital for the relationship between the biotech sponsor and the CRO to be a full partnership.

A structured communication plan should be documented, and each team should be accountable for upholding the plan throughout the clinical trial. There should also be a document that states the deliverables and the dates for the CRO. The CRO should also ensure that staff turnover does not interrupt the collection of data for the study.

The article concludes with this paragraph on finding success in the clinical study:

Outsourcing a clinical study by a biotech sponsor clearly demands a high level of professionalism and care when choosing the CRO partner. The success of the trial and the biotech–CRO relationship depend on a well thought out protocol and study conduct plan. These truths are more evident when the sponsor is a small biotech taking the large first step into clinical research. The importance of this decision must be reflected in management's commitment to allocate sufficient resources and provide ample support to the sponsor study management. Considerable efforts need to be taken to ensure that the trial is conducted using best practices to ensure its successful outcome.