Comprehensive Policies & Role of Technology in managing the Clinical Trials

Round Table

Comprehensive Policies & Role of Technology in managing the Clinical Trials

Participants

Context

Clinical Trials is a very significant step in reaching the new inventions in medicines, medical devices, nutraceuticals and cosmeceuticals to the public. With global clinical trials market growing at an approximate 6% CAGR, Indian Clinical Trials market tend to gain substantially. Subject safety being the primary objective, policies and guidelines are becoming more and more stringent and comprehensive from the Regulatory. Rapid changes in technology and improvised systems/devices are playing a key role in enhancing the conduct of the clinical trials.

This Round Table session was organized as part of the BioAsia19 Conference held at Hyderabad, to explore the challenges and opportunities in conducting the clinical trials in India (both for local and global market) and how technology adoption is viewed and supported by the regulatory.

Regulatory View Point

1. Safety of the Patients is the primary focus of the Regulatory Body. The Informed Consent Process needs stringent adherence, especially in the context of the after effects in case of a serious adverse event resulting out of participation in the Trials.
2. After taking the Ethical Committee approvals, it is possible to inform the public about possibility of participating in any given Trial, where the Informed Consent Process is strictly adhered to.
3. There is always a challenge for the Regulatory to maintain a balanced view about the regulatory environment. The expectations from the Public and the Industry vary from time to time and mostly diverse in nature. While the Public and the NGO Groups expect stringent measures and well-defined trial guidelines, Industry seeks certain allowances in the study population requirements and compensation guidelines in-case of adverse events. It is tight rope walk for the Regulatory to keep all the parties happy.
4. Regulatory works relentlessly with multiple agencies such as Indian Society for Clinical Research (ISCR), Indian Council for Medical Research (ICMR), Industry Bodies, Industry Representatives to monitorthe clinical trials environment and provide guidance at a regular interval. With wide variety of trials becoming relevant for the Indian market, it is not easy to release the guidance, without going through adequate due diligence measures.

Knowledge about Clinical Trials Domain

1. Investigator (Doctor) at the Sites are the key personnel who actually execute the trials as per the defined study objectives and the approved protocol. However, many of them have little or no appreciation about the processes to be adopted. Many of the Doctors do not have the Drug Development Life Cycle Process (more specifically the clinical trials process) as part of their curriculum. Even those who completed their Post-Graduation, hardly focus on this topic. Therefore, very few trained or experienced Investigators are available in the market, who can execute the trials.
2. In advanced countries, many doctors focus on research as an integral part of their career, by engaging the research scholars and students. They initiate the research projects on their own, without the need for a Sponsor initiated clinical trials. These research projects immensely help the Pharma Industry and Med-Tech Industry. This culture should be encouraged in India as well.
3. There are no incentives for the Indian Fraternity for undertaking such research projects. The Healthcare Institutions are hard pressed for meeting the demand from the patient-care and it hardly leave any time for their Doctors to focus on research initiatives. However, the research initiatives with large amounts of data accumulated by these institutions, can help improvise their healthcare delivery. The Round Table is of the opinion that there should be a mandate from Medical Council of India, asking the Doctors to allocate certain time for research initiatives.

The Computer (IT) skills are not adequate enough at the Sites, to help use electronic tools for conducting the clinical trials. Even though the initial trainings are conducted by the CROs during the site initiation process, there is a major churn of resources at the sites, putting pressure on the data capture during the trial conduct phase.  Another perspective from the Round Table participants is that the multiple systems from multiple CROs for multiple studies are used at any given site. Even if the Site resources are stable, use of multiple systems throws open the challenge of these resources using the systems effectively, especially when multiple studies are going on at the given site.

Registries for Subject Recruitment

1. Many key trials are afflicted by the non-availability of suitable subjects’ population (patients and healthy volunteers). With out having the right no of subjects, it is difficult to achieve the Study objectives. With minimum subject population mandates from the regulatory bodies, the trials take longer time to complete.
2. The Round Table felt the need for having a national level registry on the Patients who participated in the trails as well as potential candidates that could be contacted to participate in the trials. However, there should be systematic and secure approach to collect this information from various medical research institutions and Hospitals. Hospitals have neither have the incentive nor the authority to share the patients’ profiles for the Pharma Companies. Even if there is a consortium of Hospitals interested in conducting the Clinical Trials, their EHR systems are not uniform and data collection is a challenge. However, an attempt should be made by the industry, to help the growth of Clinical Trials in India.
3. CDSCO suggested that institutions like NASSCOM should spearhead the standardization of EHR systems across the country making use of government agencies such as NeHA and C-DAC and also some of the private institutions working in this space.

Registries for Subject Safety

1. Subject Safety is of paramount interest for the Regulatory Bodies. Cross study participation validation is a mechanism to prevent, uncalled for participation of certain individuals in multiple studies across the country.
2. CDSCO is formulating a plan to build a nation-wide Registry for Patients Participating in the end-point studies and also healthy volunteers in BA/BE Studies. The modalities for technical architecture for a suitable solution and associated commercial implications for the CROs/Sponsors are being finalized.
3. The proposed system should also capture the AE/SAEs linked to the Subjects participating in these studies.

Role of Technology in Clinical Trials

1. Technological advances in IoT and AI are changing the way the Clinical Trials are conducted. While the basic data collection through eCRF remains the main objective during the study conduct, technology can play a significant role in the data collection methods, ease of data collection and quality of data.
2. Use of ePRO in is envisaged for some time, but the adoption levels are very low as it opens up the data access to wider no. of participants, whose data is getting into the study database. The system integration challenges must be considered while implementing the ePRO. Predominant uses cases for ePRO are Prescription Compliance, Adverse Event Reporting and Self-Monitoring Notes.
3. Technology can also play a role in monitoring the Patients who are lost-to-follow-up. It is not clear, why a subject is lost to follow-up: is it due to subjects’ disinterest to participate further in the study or due to adverse events resulting into withdrawal or death. Using Technology solutions, the Sponsors/CROs can do an analysis of all such cases and arrive at steps to prevent frequent drop-outs. This saves a lot of time and money for the Sponsor.
4. Using Artificial Intelligence and Machine Learning algorithms, clinical trial management systems should be able to predict the success of the trial early-on into the study, using the data already collected. It is better to ‘Fail-Fast’ than ‘Fail-Later’.
5. Electronics submissions of trial/study data for approval by Indian regulatory is slowly gaining momentum. CDSCO is focussing on training its staff in evaluating the submissions electronically, but still a long way to go. Industry expressed the challenge of maintaining huge volumes of paper-based source data and printed paper submission for approvals. Regulatory feels that the review of electronic submissions is feasible, if standardized software is available.
6. Technology can also play a role in real time data entry, in lieu of off-line data entry. Many a times, it is difficult for the Regulatory to check the data submitted to them vis-à-vis the source data, through the audit trails. The audit trails data has no meaning and relevance in case of off-line data entry into the systems. Especially in case of an adverse events, examining the sequence of events based on paper-based source data is difficult.

Date

26th Feb 2019

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