Stung by widespread criticism of alleged lax standards in conducting clinical trials in the country, clinical research organisations (CROs), which conduct human drug trials on behalf of pharma companies, have resorted to technology to make the process more transparent.
For the first time in India, some CROs and a few pharma companies have begun filming the process of ?informed consent? ? the industry lingo for volunteers in trials being informed of the risks and agreeing to the trial process.
Moreover, the Association of Clinical Research Organisations (ACRO), an apex body of CROs, is creating a national database of volunteers to keep a close watch on those who participate in trials, especially healthy volunteers in BA/BE trials (bio-availability or bio-equivalence trials), to ensure top standards are adhered to in recruiting volunteers for studies. BA/BE studies are conducted on healthy volunteers as part of the FDA?s requirements before a drug is launched in the market.?
?We have started filming the informed consent process in BA/BE studies,? says Apurva Shah, group managing director of Veeda Clinical Research, one of India’s largest CROs, and chairman of ACRO. ?This protects everyone, especially in the context of the negative publicity the industry is being afflicted with ?at present.?
Interestingly, the industry is resorting to the new practice although India?s drug controller does not insist on filming of informed consent. ?The government has to be proactive and issue guidelines for filming consent to make this a success,? Shah adds.
Recently, the Supreme Court asked the government to furnish data on the extent of clinical trials happening in the country, side-effects and compensation to patients after reports of deaths in clinical trails surfaced, with NGOs and some parliamentarians holding pharma companies, CROs and some doctors responsible for the malaise.
This has also sparked an intense public debate on the subject, with pharma companies and top CROs calling for a more balanced view of human trials by the authorities and the courts, since no new drugs can be launched sans trials.
In the meantime, the industry came under pressure, with companies shifting trials to other geographies. While India conducted 505 global and local trials in 2010, it nearly halved to 271 in 2011.
Since informed consent is the most sensitive part in the clinical trial process, the video-recording of the process, where the volunteer or the patient completes a form and puts her signature or thumb impression, is expected to become an important record. ?We have been filming the consent of healthy volunteers in BA/BE studies conducted at our centres in Pune,? says Dhananjay Bakhle, executive VP, medical research at pharma company Lupin.
?This becomes a distinct proof of what we are doing, and helps avoid complaints by volunteers.?
ACRO?s Shah says while filming consent during BA/BE studies is relatively easy since these are done at well-equipped facilities of the CRO or the pharma company, doing so in other trials has its challenges. ?Things would be different in an hospital environment where trials are conducted on patients. Moreover, maintaining confidentiality is paramount, and that could come as a cropper to adopting this technology.?
Arun Bhatt, president of Clininvent Research, a CRO, stressed that patient privacy is a major factor for pharmaceutical companies, and that will create barriers for video-taping consent. Moreover, filming alone cannot be a panacea. ?Recording the consent process surely puts more pressure on doctors to adhere to standards. However, the efforts will be more successful if it comes from India?s drug controller.?
Meanwhile, the national database of volunteers will help prevent those trying to make a quick buck by registering for new trials before the three month mandatory ?washout period?, says ACRO?s Shah. ACRO is in talks with technology vendors to develop the database, which, over a period of time, could even connect various clinics in the country.
