Abstract

Challenges of GCP Compliance : Human Protection and Data Integrity

Arun Bhatt, Consultant, Clinical Research & Development

Compliance to GCP, the international ethical and scientific standard for conduct of clinical research, rests on ensuring human protection and data integrity.

Human protection depends on protection rights, safety, and well-being of trial subjects. The rights include: right to 1) safe, considerate and respectful care 2) expect confidentiality  of  all communications and records 3) know the physician responsible for coordinating  care 4) receive complete information about diagnosis, treatment, and prognosis from the physician, in terms that are easily understood by the  patient or legally authorized representative 5)  receive information necessary to give informed consent prior to any procedure or treatment, including a description of the procedure or treatment, any potential risks or benefits, the probable duration of any incapacitation, and any alternatives 6) routine services when hospitalized in connection with research protocol 7) know in advance what appointment times and physicians are available and where to go for continuity of care 8)  receive appropriate assessment of and treatment for medical conditions 9) refuse to participate in research 10) to be informed of the medical consequences of these actions, including possible dismissal from the study and discharge from the Clinical Center. If discharge would jeopardize patient’s health, have the right to remain under care until discharge or transfer is medically advisable. 11) to be transferred to another facility when the patient’s participation in the Clinical Center study is terminated.

This bill of rights should be adapted to Indian conditions with inclusion of some special rights e.g. compensation for trial related injury, special protection and care as vulnerable subjects, ancillary care, and post-trial access. The Ethics Committees and the investigator have prime responsibility for educating the clinical trial participants about their rights and safeguarding these rights during conduct of clinical research.

Data integrity requires quality in clinical trial design, conduct. handled, and stored in a way that allows its accurate reporting, interpretation, and verification. The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data. The sponsor is responsible for ensuring that clinical trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirements.

In India, in the last 5 years the media reports and the court proceedings have highlighted the issues of patient safety and ethical deviations in clinical trials. Compliance to GCP continues to be a challenge in Indian institutions. There is an urgent need to invest in quality initiatives - education, training, certification, accreditation - of key stakeholders to boost quality of clinical trial conduct and to improve compliance to GCP standards.