The Association of Contract Research Organizations (ACRO) is toying with the idea of introducing video recoding of proceedings while seeking patient consent, stated Dr S P Vasireddi chairman and managing director, Vimta Labs Ltd, a leading Hyderabad-based clinical research organization.
On the sidelines of an event organized by ACRO in Bangalore, Dr Vasireddi said video recording of patient consent would strengthen the stand of the clinical research organizations during a trial. This will particularly be of help with the advent of clinical trial insurance coverage, where detailed documentation about the consent is vital to settle claims.
Puja Kapoor, life science specialist, Marsh India Pvt. Ltd, while explaining the company's indemnity to clinical trial organizations said in her presentation, "Common lawsuits against the parties involved are allegations against sponsors, investigators and Ethics Committees who could be sued for a general failure which stemmed from an allegedly faulty consent process. Video recording will come in handy for the organisations to defend their stand."
In this connection, Marsh had the benchmarking data to analyse insurance programs including limits, premium and retentions. The company provides risk solutions to 80 per cent of large pharmaceutical and biotech companies including GE Healthcare, Aventis, Matrix Labs, Unichem, Jubilant, Dr Reddy's, Roche, Emcure and Johnson &Johnson, she added.
P Balasubramaniam, vice president (technical) Marsh India Pvt. Ltd in his presentation tilted 'Insurance Requirements in Clinical Research' said, "There is a need to have protection from liability in clinical trials. In 2006, the Indian clinical trials market generated revenues of US$ 140million registering 40 per cent growth. The volume of business generated from the sector is a clear indicator that that insurance is crucial".
Dr Saral Thangam, managing director Lotus Labs in her topic 'Beyond FDA Inspection in Clinical Trials' dealt on the deception in clinical trials. "Research methods that deceive subjects are used commonly in social and behavioural research. About 70 per cent deception is practised to maintain the validity of research."