In order to make the clinical trials more transparent and also to improve the public image about the clinical trial activities, the Clinical Trial Organizations (CROs) in the country have started videographing the entire trial process right from subject recruitment to dosing of the drugs.
According to sources, several CROs have already started this new system of videographing as part of the Association of Contract Research Organizations (ACRO)'s efforts to self regulate the entire gamut of clinical trial process to counter the malpractices among the peers. ACRO is the umbrella organisation of hundreds of clinical trial companies spread across the country. Other members of the ACRO are also expected to follow suit to make the system more transparent, sources said.
Industry leaders said that there are a lot of misconceptions and propaganda about the working of the CROs in the country which are affecting the image of the industry in a big way. Even though millions of people are benefited because of clinical trial, without which no drugs can be marketed, the clinical trial companies are painted, both by media and common people, in poor light as that of perpetrators of unethical practices.
There are also misconceptions about the recruitment of volunteers and their consent for the participation in the trials. Even though the volunteers are recruited after counseling and they are provided free medicines and taken care of well during and after the trial, the CROs are blamed for unethical practices, sources said and added that it is to allay this impression that the CROs have decided to begin videographing the entire process.
The CROs in the country have been under pressure for the last some months as the authorities had tightened the noose around the neck of these CROs after the eruption of a couple of negative news reports about the alleged unethical practices in the trial. It all started with the controversy surrounding the Hyderabad-based CRO Axis Clinicals in which the company was alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each. The incident created such a hue and cry in the country over the illegal activities of the CROs that the DCGI ordered auditing of all the CROs in the country.
Ever since the eruption of controversies, the authorities virtually stopped giving clearance to clinical trials including the BA/BE studies. Now, by initiating some self regulatory mechanisms like videographing, the CROs wanted to improve the image of the working these companies.