Investigator initiated studies (IIS) are clinical studies designed and managed by individual physician-researchers and institutions, and include a wide range, e.g., interventional clinical trials of drugs and observational prospective and retrospective studies. IIS can help in investigating health research questions relevant to medical practice.
Academic IIS are essential for the growth of clinical research. Clinicaltrials.gov registry data show that 58% of the registered trials in the US were funded by non-industry academic sources, while the figures were 62% in Europe and 71% in China. In India, only 39% were funded by academic sources. The number of trials from China was 6.4 times higher as compared to the number from India. India lags in the conduct of such studies due to several challenges —–financial, the availability of trained manpower, expertise in research methodology, time constraints etc. New Drug and Clinical Trial Rules (NDCTR) 2019 are likely to add to these challenges.
As per NDCTR, an academic clinical trial is a trial initiated by any investigator or institution for an approved drug for a new indication, new route, new dose or dosage form, and is conducted solely for academic or research purposes. The results of such trials can’t be used for commercial purposes – including regulatory approval in India or any country – or for promotional purposes to support the marketing of a drug. If IIS is industry-funded, compliance to rules
requires that the agreement between the investigator and the company funding the study has to prohibit any current or future commercial or promotional use of the
results. As such, investigators would need to look for financial support from their institutions or the government, as the industry would be unlikely to support a study without any commercial value.
NDCTR includes both types of IIS under biomedical and health research: interventional clinical trials and observational studies. Such IIS will require approval from an ethics committee registered with the Department of Health Research and should be conducted in accordance with the Indian Council of Medical Research (ICMR) ethical principles and guidelines. The investigator should comply with the principles of essentiality, voluntariness, non-exploitation, social responsibility, privacy and confidentiality, risk minimisation, professional competence, benefits maximisation, institutional arrangement, transparency and accountability, totality of responsibility and environmental protection, and alsoadhere to the provisions of EC approval, voluntary informed consent and protection of vulnerable participants. In case IIS is planned with foreign collaboration, an approval of the health ministry’s screening committee is a must.
The institute should ensure the quality of data and the safety of intervention by monitoring and auditing the IIS and make financial arrangements for the conduct of the study, and consider free medical management and compensation for research-related injury, patient travel/inconvenience, ancillary care and post research access. Such compensation requirements, applicable to participants receiving intervention, or control and/or standard of care, would result in a big financial burden on the institution.
NDCT will make the conduct of IIS arduous and dampen the enthusiasm of some of the investigators/institutions engaged in academic research. Let us hope the regulators and ICMR take pragmatic steps to ease the burden of compliance requirements and to encourage the conduct of innovative academic clinical trials.
Writer is a consultant on clinical research & development from Mumbai.