Indian CROs are apparently getting into a more proactive mode to deal with the aftermath of a spate of controversial media reports alleging gross ethical violations in clinical trials in recent months.

The way in which human trials are being carried out within the country has become a matter of public debate for some time. Human rights activists and NGO forums have been raising dust arguing that the country is becoming a testing ground for a large number of therapies banned in other parts of the world. Their clamor reached a crescendo soon after a couple of stories made headlines in national and international media.

A shocking expose came out a probe of the death of seven teenage girls who participated in HPV vaccine trials in two different locations of India in 2010. The study was conducted by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the state governments and the Indian Council of Medical Research to assess the feasibility of including the vaccine in the nation’s universal immunization program. It involved 23,500 girls in the 10-14 years age group. A three-member committee, after several months of investigations, found out that a large number of consent forms were not signed by parents.

Then, in an unprecedented act, India’s drug regulator cancelled the licence of Axis Clinicals Limited in June last year. This Hyderabad-based CRO was accused of administering the breast cancer drug exemestane to a group of illiterate women from Guntur in the southern state of Andhra Pradesh. The incident came to public notice as the women under trials started seeking hospitalizations complaining severe body aches and extreme weakness.  The cancellation of licence followed an inquiry that reported several irregularities including recruitments of subjects, laxities in obtaining informed consent and a defunct institutional ethics committee during the trial process.

Safeguarding The Turf
The Drug Controller General of India (DCGI) ordered a thorough audit on all CROs conducting BA/BE studies across the state. Though the HPV controversy is not directly linked to any CRO, these incidents have left many speculating on the ethical nature of clinical studies and the working of CROs in India.

There has been a steady uptick in the number human trials since 2005, when India allowed foreign companies to do clinical trials. And the regulator has started a series of measures to streamline the upcoming industry.

Even as stray incidents and fly-by-night operators continued to generate bad press, legit CROs are getting their act together. “Wouldn’t it be highly unfair to make the whole industry bear the brunt for the misdeeds of one or two errant operators?” ask CROs.

That is the key reason that CROs resorting to several pre-emptive measures these days. Quite a few BA/BE companies have started the practice of keeping video recordings of the informed consent process. “Video recording of the informed consent process would provide an authentic documentary evidence for a CRO in an eventuality where its claims are contested,” said Dr. Arun Bhatt, president, ClinInvent, a clinical development services CRO from Mumbai.

Caring Quality, Caring Subjects
Obtaining informed consent is the most crucial and perhaps the most sensitive aspect in the patient recruitment process. And the ethicality of the process is usually the one that comes under scrutiny after every allegation in India. In that case a video documentation is the most effective measure for the CROs to defend themselves, according to Dr. Bhatt.

The model is well-suited for studies involving healthy volunteers, but videography is difficult to implement for realtime patient studies in hospital settings such.  

CROs have also brought out an online information software for BA/BE studies to check the practice of volunteers getting themselves enrolled to other studies before the wash-out period is over. The Association of Clinical Research Organizations (ACRO), an umbrella body of local CROs, aims to connect all the BA/BE organizations operating in the country through one network registry.

“We have made a broad consensus across all the CROs, including ACRO members, non-members as well as drug makers having captive BA/BE facilities to get themselves to be part of this all India independent data base,” said Apurva Shah, chairman of ACRO. Having 40-plus CROs as members, ACRO hopes to roll out the database before the end of this year. Once in force, the software can effectively track volunteers who try to ‘trick’ CROs before the wash-out period.

This first-of-its-kind online software will bring in more accountability in CRO business. Also, it will go long way toward proving that India cares for the quality of the trials as well as the trial subjects, added Mr. Shah, who is also group managing director and co-founder,Veeda Clinical Research, Ahmedabad, a  service provider for Phase I and IIa clinical research.