India will need to adhere to international standards in conducting global clinical trials. Right now, several studies are being conducted in the country. But there is clear indication for the need for a set of assessment methods supported with statistically strong evidence and quality data, stated Dr S Mukerjee, senior director, clinical research Pfizer.

The country's clinical research organizations will have to enhance their monitoring standards and drug accountability and compliance protocol. There is also a need for rationalization of records and consistency in the data, explained Dr Mukerjee in his presentation he made on the concluding day of the IPC 2006 at Mumbai.

The documentation of the clinical trials should be complete and easily accessible. There should also be accountability for the documentation.

In terms of ethics to be maintained during the conduct of a trial, informed consent is mandatory. There should be clear cut parameters during an injury and compensation to be met thereafter. Also if a patient is recovering after a trail, the sponsors should ensure that the availability for the drug is made to the patients.

Some of the basic requirements for the trial are expertise of the study design team, training of monitors and staff, hospital documentation practices, standards of care for the trial volunteers and audits or inspections.

India needs a comprehensive data base of clinical standards. These include a single point of contact with the sponsor or the CRO is vital. The database of reported adverse drug reactions are a must along with access to epidemiological database. There should be a Pharmacovigilance expertise within the CDSCO. The medical institution conducting the trial should be accredited and standards of care should be taken into account for site approval. Further there should be enhancement of informed consent procedure. A set of rational guidelines should be in place to assess alleged injury, pointed out Dr Mukerjee, Unless and until India adopts and adheres to these parameters, it will be way behind in the clinical trial business despite being a recognized base for its vast availability of patient pool and cost effective parameters for the conduct of trials by global majors, he said.