Clinical trials are an essential part of developing new drugs — but how can we limit or prevent ethical violations? How can we ensure effective governance, checks and balances, amid a proliferation of stakeholders? Part-time PhD fellow Farida Lada gives the background on her research and journey ahead of her defence on 22 June 2016. She explains why she chose the topic and why she felt she needed a PhD to advance her career.
You are about to defend your thesis ‘On guarding the welfare of clinical trial subjects while promoting novel drug innovation’. Living and working in New York, how did you find our part-time PhD programme?
I decided to pursue a PhD degree when I realised that my career in university administration had reached a road block without a doctorate. As I have been working in the realm of policy development and compliance, the area of governance was of particular interest to me. However, I was unable to find any related programmes within the US that would allow me to pursue a doctoral degree alongside my work. Since my reason for obtaining a PhD was to advance my career, taking a break from my career was not an option. While researching options online, I was pleased to discover the GPAC² programme that is designed for mid-career professionals. I applied to the programme and was thrilled to be accepted!
Your research presents a novel perspective by recognising on the one hand that subjects of clinical trials must be protected, but on the other hand that without clinical trials the need for novel drug development may not be fulfilled. How can governance systems support policymakers in achieving these sometimes contradictory objectives?
There are three levels of governance involved in the oversight of clinical trials: i) international standards; ii) national level regulations and oversight; and iii) institutional policy and oversight within the pharmaceutical company and the contract research organisation, and by the ethics committee (or institutional review board).
At the international level, the standards can assist policymakers by clearly identifying the various stakeholders involved in the governance of clinical trials and assigning specific responsibilities to each of the stakeholders. Through my research, I found that this level of responsibility is not completely defined in the international standards. Addressing this gap in governance at the international level would be essential in establishing clear expectations of all stakeholders involved in the clinical trial process.
At the national level, we need a system to identify national priorities for the types of clinical trials necessary to address local healthcare needs. National priorities can guide the industry in bringing clinical trials that are relevant to the local population to the given market, and thereby maximise the possibility of addressing local needs while reducing the potential for exploitation of subjects.
The regulators can also use a framework, such as the one developed through my research, to inform their policy pertaining to the protection of human subjects of clinical trials, while giving consideration to the impact of each policy option on innovation. Finally, the regulators can introduce systems that allow for proactive assessment of institutional policies and procedures, rather than adhering to a responsive regulatory approach, which is the most common approach in regulating clinical trials.
At the institutional level, the pharmaceutical companies can take the lead in establishing a system of governance that takes advantage of the expertise and knowledge of the various stakeholders. This can be done through a system that incorporates feedback mechanisms, such as those identified in the relationship structure proposed in my thesis.
I used concepts from game theory to help develop my framework to structure my analysis from the perspective of the various players, and then to propose government policies and initiatives and institutional strategies along with the trade-offs of each in terms of promoting innovation versus protecting clinical trial subjects.
By using game theory elements to inform my analysis I was able to highlight the need for cooperation among the various stakeholders and to identify the areas of potential conflict. This, in turn, resulted in the proposed relationship structure I mentioned earlier, which is the first finding relevant to industry. Introducing a relationship structure such as this would allow each of the players to participate in the design of clinical trials, participate in prospective and retrospective information sharing, and hence be invested in the success of the trial from both subject protection and innovation perspectives.
Second, industry players, similar to regulators and ethics committees, can utilise the proposed framework to analyse and modify or develop their own institutional policies and procedures. The framework allows them to strategically evaluate their internal policy or strategy options, while considering how some uncertainties, whether intentionally placed within their policy or due to absence of policy, may affect either innovation or protection of subjects. Finally, they can use the proposed strategies, consider their trade-offs in various regulatory environments, and then modify their policies in a manner that allows them to strike a closer balance between subject protection and innovation.
After several years of combining a job with the PhD research, eating up your free time, after June your direct connection to the academic world – at least as researcher in the GPAC2 programme – will be closed. Do you have plans to stay connected with research? How do you think the PhD experience will help you in your further career?
Working in academia, I am very much connected with the research community. Now that I have completed my thesis, I plan to focus a little more on scholarly collaborations, within and outside my place of employment. My goal is to continue to do research and build up a portfolio of publications that will give me a competitive advantage as I advance in my career as a university administrator. As I mentioned earlier, my purpose in obtaining this degree was to further my career and I expect that the degree will open some doors that were previously closed to me.
Flickr / Sanofi Pasteur