Sites need to step up standards to regain lost glory

India has been long back projected to be an emerging hub for clinical trials with great potential and its advantages having mainly, high patient pool. However, the scenario has changed dramatically in the last two years and India has lost the race to other Asia-Pac countries like China and Korea. Now, to regain its lost glory, India has to come back strongly with significant changes in all areas from sites to regulatory environment.

There has been enough learning and everyone today, knows what the problem is and where does it lie. In the last six months we have seen a few good regulations coming up to address them and streamline the CT process in India. These are important amendments with respect to Ethics Committee registration, compensation, audio-video consent, AE/SAE reporting timelines and regulatory timelines for approval.

The question which is still lingering is that what has to be done from now on so that we don’t fall again as the industry is poised for a long term and sustainable growth. There are two specific and important areas which we need to focus ie ‘Study Conduct & Quality at Site level’ and a ‘Balanced regulatory framework for both patient population & healthcare industry’.

What’s needed to be done at and for site level?
The industry collapsed because of the issues that happened at the site level. The sites are the foundation of clinical research and also the epicenter of patient care. So it imperative to strengthen it first. To achieve this, all stakeholders – site institution, sponsor, CRO, SMO, Ethics Committee and regulatory body have to put in great efforts to plug all gaps.

A munificent face-lift

• Centralized database of all sites that has suitable infrastructure for conducting trials
• Registration of all sites across India before conducting trials
• Centralized investigators’ database who are qualified and experienced in conducting trials
• Site needs to maintain good patient database per indications
• Accredited labs at site
• Clinical trial SOPs for sites to function and this has to be same and followed across all sites in India
• Continuous/annual training program for  Investigators, site staff, ethics committee members on GCP, current regulations, audio-video consenting and all practical aspects of Clinical Research
• Prospective investigators & site selection avoiding sites with low standards and know-how to conduct trials
• Ethics committee formulation and proper functioning as per all new guidelines
• Well trained Clinical Research Coordinators (CRC) to support investigators
• Continuous regulatory inspections and audits
• More number of Site Management Organizations to support and work closely with Site, CRO and Sponsor in better management of trials.
• Clinical research awareness programmes to  patients
• Good education to media on clinical research and media further spreading the awareness to the common man.
• Investigators’ strictly limiting to conduct only three trials at a time, to ensure quality site
• Investigators must step up by providing interviews through media regarding their good clinical trials conduct

Regulatory level changes
The regulatory authorities should aim that India conducts clinical trials in highly ethical and transparent manner, which should support the drug development process, which, in turn, benefits the common man in the country.

The steps taken by DCGI Office in the last few months have been greatly appreciated by the industry and all are hoping to see a revival.  There have been significant changes to streamline most of the process yet has to travel few more miles to get India back to one of the best clinical research hub to reach out for supporting medical science.

Recent modulations

• Implementing audio-video consenting process which made more transparent and provided confidence to common man about good clinical trial conduct
• Efficient and swift reporting timeline for AE/SAE reporting.
• Compensation for trial related injuries with help of expert committee investigations.
• Immediate attention to Ethics Committee registration

Looking forward for a revolution

• Reducing the review timeline and fostering a speedy approval process
• Re-ensuring that Ethics Committee is registered after appropriate formulation and SOPs
• Continuous regulatory inspections of sites, sponsor, CRO, SMO & Ethics Committee to ensure proper functioning and to have transparency to common man.
• Creating awareness in the public about the good clinical trial conduct through media support.
• Having user friendly and end-to-end information of clinical research, on-going trials and other healthcare information on Indian regulatory website matching to the standards of US FDA website.
• Attention to site registration before clinical trial conduct
• Centralized database having black listed investigators and sites that followed bad clinical practice and fraudulent conduct.

Conclusion
Clinical research provides the means to tackle the new challenges against new diseases and ill health placing on our society. It also plays a key role in the knowledge economy of our country through its contribution to international competitiveness and economic growth. The overarching purpose of new strategic development of clinical trial process in a developing country like India is to set out a wider change programme to ensure the pragmatic advice and guidance to all those involved in the management of clinical trials - both legal and operational. When the business processes, the people and the technologies in India are aligned, the data and the process transformation into an information and insight on human health will be globally accepted making Indian pharma and clinical research industry more integrated and effective.