Petition to improve the conduct of clinical trials in India by improving the functioning of the Clinical Trials Registry

We recently sent a petition to the Ministry of Health and Family Welfare, urging them to improve the processes which govern the conduct of clinical trials in India. The setting up of the Clinical Trials Registry in India (“Registry”) in 2007 has lent a degree of transparency to the conduct of clinical trials in India. Since 2019 the registration of clinical trials on the Registry has also been made compulsory. While the mandatory registration is a welcome move, we draw attention to the fact that the records maintained by the Registry are of questionable quality and often do not collect complete information regarding the conduct of a trial.

There have been several public controversies in the past which have acknowledged the lapses in conducting such trials in India. More recently during the COVID pandemic, the DCGI was questioned for the manner in which it approved and conducted trials for drugs like Favipiravir amongst others. The development of Covaxin and the process through which the Emergency Use Authorisation in Clinical Trial Mode was given to Bharat Biotech has been extensively criticised by public health experts.

We argue in the petition that there is a direct relationship between the way data is maintained with the Registry and the effectiveness with which ethical clinical trials are conducted in the country.  The functioning of the Registry is compromised both by the way it is designed and by the way it is governed. The most pressing concern is the inaccurate and incomplete information entered by principal investigators on the Registry. In the current framework, the principal investigators cannot be penalised for such errors.

Additionally, the ICMR and DCGI both share responsibility with regard to the conduct of trials. While ICMR is responsible for maintaining the database it cannot review the quality of the information, similarly the DCGI can approve applications for trials, it cannot however control the Registry. We recommend in the petition that the laws should be amended to make ICMR responsible for the quality of information on the database and the DCGI should be allowed to stop clinical trials if it finds the information to be inaccurate.

Another way to ensure accuracy and sufficiency of information is to redesign the Registry and enable it to capture better information. Currently, the database allows for free text fields, non standardised responses and internally inconsistent responses to be entered into it. We believe that these issues can be effectively dealt with by redesigning the database on the basis of logic rules and by using drop-down menus and mandatory fields. These measures will make data entry less prone to errors and ensure better and more complete collection of relevant data.

We also recommend enabling audit trails in the database which can give useful information about the changes made to the trial data. Currently, the Registry also lacks mechanisms of internal validation which encourage ethical use of the data. We believe that internal validations and controls with a workflow between the Registry and the CDSCO’s review of the application is necessary to facilitate ethical use of the data.

Another key issue which is often ignored is the public sharing of clinical trial information irrespective of the success of the trial. ICMR has signed a MOU with the WHO to comply with the 24 WHO specified data elements in the primary registry including summary results.  The compliance with the provisions remains low as there is no requirement under Indian law to publish this data. We suggest that this position of law be amended to make the publication of such information mandatory. Another important responsibility of the regulator CDSCO is overseeing the functioning of the Institutional Ethics Committees which are mandated to ensure proper conduct of clinical studies. The perfunctory existence of such committees has enabled violations of good clinical practices.  Given that the membership and function of the committees has a bearing on the quality of information being fed in the Registry, we recommend establishing  a one-to-one map between the CDSCO database and the Registry so that only studies that have been approved by the Ethics Committee are entered in the Registry.

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