Key barriers in Conducting
clinical trials in India
Ethical issues
A key issue confronting those conducting clinical trials is the highly complex socio and economic structure of Indian society. On the one hand, there are general issues such as vast socioeconomic disparities, various levels of literacy and education, and a multitude of languages. On the other, trial related issues such as the fact that patients often revere the doctor and assume that the latter has his/her interest at heart, and that it may be a family, and not an individual, that takes the decision on whether or not to participate in a trial.The conduct and regulatory compliance of ethics committees, and concerns relating to patient safety, is a principle ethical issue. Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialities has stated that
“fewer than 40 Ethics Committees in India are properly constituted and functioning, which means that the safety of the subjects of clinical trials is on the back burner….it is also worrying that there is no legal requirement for investigators or members of the Ethics Committees to declare a conflict of interest.” Dr Chandra Gulhati, Monthly Index of Medical Specialities
There is no legal requirement for members of ethics committees to declare a conflict of interest and Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialities considers this a particularly serious problem given the increasing number of hospitals now owned by drug companies
Another principle ethical concern is that informed consent given by the research subjects is truly informed i.e. there are concerns that the patients are not given sufficient information about the trial to provide informed consent. In addition given the structure of Indian society there are major concerns as to whether women have the ability to make a decision as to whether they participate or not in a trial.
Lack of experienced investigators
In a country which boasts of a large medical fraternity, only 400-500 investigator sites have taken part in global GCP trials. A large majority of potential clinical investigators lack knowledge of regulations, ethics and GCP, and skills for clinical trial management. The quality of global trials and academic clinical research is not uniform. There are also issues of inadequate permanent research staff and lack of adequate infrastructure for communication, drug/sample storage, archiving. The situation is worse in non-metro cities which have tremendous potential for participation in global trials. In addition, the institutional policies are not yet geared up to support the investigator in managing clinical trials efficiently.Inability to detect and monitor ADRs
A major concern cited by those conducting clinical trials in India is both the lack of experience in recognizing serious adverse drug reactions (ADRs) or if investigators recognize the onset of an adverse event they are afraid to report the event and it is reported that fraudulent clinical trial data is frequently incorporated into the reporting process to disguise both adverse events as well as giving false data about the effectiveness of the drug under clinical trial.Bribery and corruption
There are major concerns over the use of bribery and corruption in gaining clinical trial approval in India. It is recognized that at every stage in the clinical trial process the integrity could be compromised by the practice of bribery amongst officials such as ethics committees who have been known to rubber-stamp pharmaceutical companies proposals and overrule any objections. This practice could have a serious effect undermining confidence of the efficacy and conduct of clinical trials in India.Get Dissertation Help from Mahasagar Publications. Also read Emerging Clinical Trial Locations in India
