Govt has to create awareness about clinical trials: Experts

MUMBAI: The multi-million dollar outsourced clinical trial business in India is going through a rough patch, as the Contract Research Organisations (CROs) are facing difficulties in recruitment of patients and retaining them for the entire period of trial.

With the expected outsourcing up to $1 bn investment in multi-centric trials in India by 2011, experts said during the international conference on `Patient recruitment and Retention in clinical Trials' that India has to make efforts to create awareness among the public about the cost-benefit ratio of these trials to have affordable medicines in the near future.

The large volume of people makes China and India excellent places conducting clinical trial in Asia but between India and China, India seemed to have an edge as the clinical research, as data management here are well placed, President and CEO of D Anderson & Co Dr Nancy Anderson said.

The twenty year old US company D Anderson has joined recently with Clinical Research Education and Management Academy (CREMA) India and are focusing on patient recruitment as per the international and ICMR guidelines, she told the media.
"Earlier, we used to recruit patients and retain them till the trial is over but currently the number seemed dwindling. Therefore, in this conference, we are planning a strategised approach,"she said.

Recruiting patients and retaining them through trials is a tough exercise especially in the case of multi-centric trials in children as it requires informed parents 'consent and follow up, child specialist and former professor of Grand Medical college Yashwant Krishna Amdekar said.

Amdekar said it was therefore important for the CROs to create awareness among public that with the increasing development of several biotech drugs and vaccines, when they undergo human trials, it would be an affordable drug for many in future.

Citing the example of Hepatitis B vaccine which earlier cost Rs 350 per dose but its current cost is Rs 20 per dose, he said very soon it may be taken up under national immunisation programme.
Human trial is the phase III trial after the efficacy and safety trials carried out on animals and volunteers, he added.

He also suggested that the anti-clincial trial activists (NGOs) should be made party to the decisions on trials by having a tri-partied arrangement with the patients and CROs, so that confidence among the patients could be improved.
Chairman of CREMA Vijay Moza,said one of the biggest hurdles faced by CROs in the country today is the difficulty in getting patients for clinical trials not only in the case of critical diseases like cancer and AIDS, but also in diseases like diabetes and heart ailments".

According to Moza, the factors that may have contributed to the patient recruitment and retention issue include a lack of awareness among masses about the importance of the need to conduct and participate in a clincial trial, lack of adequate communication support to the patients and to assess whether they can be included in clinical trials or not.

Anderson said, eighty per cent of clinical trials, to bring out a drug into the market, are delayed by anywhere between six and twelve months due to a shortage of patients worldwide.