Advancing Clinical Research in Nepal: Urgent Calls for Regulatory Framework Upgrades

In recent days, Nepal has been involved in a number of clinical trials specially after the hit of COVID-19 pandemic. Most of such trials were developed on some other countries, imported and implemented here in Nepal. Rise of COVID-19 has certainly given an opportunity for a burning mind of the country in order to involve in a global movement of developing a new therapy or vaccine. This movement has been facilitated from two major government organization - Nepal Health Research Council (NHRC) and Department of Drug Administration (DDA). But In order to make country self-dependent on developing and implementing new trials, there must be few upgrades in the regulation and infrastructure in both of these organizations. 

Nepal Health Research Council (NHRC) provides both ethical review support for all the trials registered and also acts as implementation body for any new trial conducted by or in collaboration with other organizations. In 2019, NHRC has published 'National Ethical Guideline for Health Research in Nepal' which provides direction to perform clinical trial activities anywhere within the country in the most ethical manner possible. All in one, NHRC works as regulatory body as well as implementation body combinedly. for this purpose, it has made collaborations with many national and international organizations working in the field of human health research such as Indian Council of Medical Research (ICMR), International Vaccine Institute (IVI), Oxford University Clinical Research Unit (OUCRU). 

Similarly, Department of Drugs Administration (DDA) is the national licensing authority of the country which reviews and authenticate the documents submitted by clinical trialist / individual or an institute. Based upon the favorable opinion and round of reviews, it provides certificate for conducting research. DDA approval is needed only if you are conducting trial / research on a specific drug or medications but not for other kind of therapies or observational research. After submitting documents physically to 'Administration' section, it will move to the respective department and reviewal process will start. There are multiple departments within DDA for different activities like registration of pharmaceutical company, a pharmacy, import / export of drugs, approval / registration of a medicine, registration of trial etc. 

Problems and Immediate Changes Needed in DDA 

• A new researcher coming to DDA in order to register his / her trial will demotivated by too many windows to queue, lots of Paperworks, ambiguous comments and lack of clarity among the review members themselves. But actually, review process is much simpler than it seems to be. In short, if review and approval process is made via online platform, all the activities will run smoothly in less time-consuming manner which will ease the whole process itself. Though DDA is the national regulatory authority where national as well as international delegates come for different purpose, DDA functions like any other government offices which should be changed immediately. Adapting online platform is mandatory for any office sooner or later. If appropriate arrangements are made in place needed to implement online registration, reviewal and approval process, research activities will be completed more smoothly. 

• Guideline and regulations should be updated enough to make them relevant with the time. Most of the legal obligation under which we are working currently are older than researcher themselves. Getting an approval and being regulated from those outdated guideline is another frustrating experience for a researcher. As for example, if you register a clinical trial which is adaptive in design, once the trial is approved and implemented, there might be multiple amendments to the protocol based upon current scenarios and the requirements. It is not possible to receive new approval license from DDA each time with the protocol amendment. DDA does not have such regulations in place to regulate such trials whereas adaptive design is the most commonly employed model of clinical trial throughout the world on recent times. Similar experiences are there with trials being conducted on emergency health situations like COVID-19 pandemics. 
• Other changes also carry some importance such as administrative, infrastructure wise and for smooth experience of visitors. Such arrangements may not directly affect much the integrity of the functions of DDA. 

                Immediate Changes Needed at Nepal Health Research Council (NHRC)  

Being a part of organization, I may be biased on reviewing functioning of Nepal Health Research Council (NHRC). If you are an independent researcher or have acquainted with the functions of NHRC from any other organizations, your review and experience will matter more than that of mine. Anyway, these are the changes that 'NHRC' should address at the earliest in order to foster research culture in Nepal. 

• Establishing an independent clinical research unit. A separate unit which is completely dedicated for reviewing new clinical trials proposals, conducting meetings and conferences with other different organizations for collaborations, continuation and daily implementation of the trials on the implementation phase and for capacity building of the clinical trials experts in the country. Such unit should be led by an expert working in relevant field. For clinical trial culture to foster in the country, it demands a lot of discussions, trainings and implementation. NHRC only can and should provide such platform for all the researcher working inside and out of the country. 
• Separating ethical review support from routine activities of NHRC. Since NHRC is working both as ethical review board as well as trial implementation body, there is chances of conflict of interest and functions of one can be hindered by the other. Ethical review board of NHRC should be independent not only on provision but also in physical and real sense. Ethical Review Board (ERB) and its activities must be independent from routine NHRC functions which includes multiple meetings, implementation of an observational trials, training and so on. All those activities will definitely hinder the ERB functions and international communities may not consider its activities with higher integrity. 
• Developing an online central information system. If any researcher working here in Nepal or any part of the world wants to make an query about the current situation of health research status or particular evidence, NHRC should be able to respond them online and such system has to be established available for public domain. All in all, NHRC should function as center of evidence generation and dissemination. 
• Strengthening research activities on other institutes. NHRC cannot and should not function all the health research activities on its own. Only if every medical college and hospitals of Nepal involve in evidence generation by themselves, research culture of the country will be upgraded. NHRC should be center of facilitation for other research institutes as well. 

If you have any other viewpoints about how research and clinical trials should be regulated / promoted in the country, please give your opinion on the comment box below.

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