With the European Medicines Agency (EMEA) announcing its Paediatric Regulations, many developing countries including India will now see an increase in the number of clinical trials carried out in children, according to a section of clinical research organizations (CROs) and hospitals in Karnataka.
The EMEA guidelines have been announced because paediatric trial reports are now part of the labelling process for most drugs. The number of paediatric trials is likely to rise in the European Union, following new legislation that provides drug makers with a valuable financial incentive which is a six-month extension to their exclusive manufacturing license for a drug if children are included in the clinical trials. Similar legislation has been in place in the US for over five years and has led to an increase in drug trials that include children.
To begin with, adequate regulatory guidelines must be in place and India should take a cue from the developing world's paediatric investigation plan, stated a section of principal investigators at the hospitals who did not want to be named.
Clinical drug trials in children are essential for the development of medicines and to provide evidence of the best treatments for specific conditions. But greater safety measures and awareness of the risk is essential. It is important to have a safety monitoring committee for every trial. The number of people required for such a committee is small, but they must have the necessary expertise, stated Dr. Sandhya Ravi, chief of clinical services, Lotus Labs and surgical oncologist.
"It is also important that while a trial is taking place, the investigator examines and monitors other evidences from trials taking place elsewhere to spot at an early stage, the problems that can occur. It is invaluable to have an independent monitor who can swiftly question any adverse drug reactions (ADRs) or differences in illness and death rates between groups taking part in the clinical trials," added Dr Ravi.
During a consent process, it is important that all parents are made aware of the potential for ADRs and the mechanisms that will be used to safeguard their child, stated Dr Sashi Kiran, managing director, D2L Pharma Research Solutions and Surgical Gastroenterologist.
Presently 10 per cent of the total 703 trials in the country are conducted on children. India is becoming a sought after destination because of large pool of patients, faster recruitment at low cost.
According to Dr. Ramananda Nadig, president and deputy dean, Clinical Research Education and Management Academy (CREMA) the country is in demand for conduct of rescue trials when there has been inordinate delay in recruitments or insufficient patient numbers for all therapeutic areas.
The most crucial step in any trial including a study involving children is to strictly adhere to the Protocol Inclusion/Exclusion criteria and closely follow up on any serious adverse events (SAEs). In the event, there are increasing deaths attributable to the trial drug, it is the decision of the Regulatory authority that is final. Most MNC trials have a drug safety monitoring board (DSMB) or Trial safety committee which views and decides on such occurrences. .
Most if not all paediatricians who have conducted trials before are well versed with all the requirements of ICH GCP. Any training for them should only focus on and reiterate the need for strict compliance. "If death of the subject is not causally related to the trial drug we should ensure that undue publicity is not made before we have thoroughly investigated the cause. The 1.18 per cent death in the AIIMS trial could have been an incidental occurrence which in no way is related to the trial and would any case have happened because of childhood pneumonia, added Dr Nadig.