Dr Arun Bhatt, Consultant – Clinical Research & Development, advocates the need for collective leadership which focusses on Skills, Attitude, Vision and Ethics (SAVE) to make the Indian clinical trials sector ready to deal with the challenges in a VUCA world
If you want to know your past, look at your present conditions.
If you want to know your future, look at your present actions.
– Chinese Proverb
VUCA, an US Army framework to describe volatility, uncertainty, complexity, and ambiguity, has pervaded all industries. Volatility is a state of dynamic instability brought about by rapid change in environment. This creates a state of uncertainty – lack of clarity about the present situation that hampers managerial ability to visualise the threats and challenges facing the organisations. Complexity is characterised by a situation where multifactorial interplay of threats and opportunities can cloud capacity to make a judgement. Ambiguity brings in lack of clarity about awareness of a situation and predictability of the outcomes.
Since 2013, when the Indian regulatory authorities released new regulations, guidelines new orders in response to Supreme Court directives, the discipline of clinical trials has faced the challenge of VUCA. Rapid introduction of rules, regulations, and orders – compensation, registration of EC, audio-visual recording of consent, sponsor undertaking for marketing new drug in India after completion of clinical trial, restricting number of trials per investigator, serious adverse event reporting requirements – and setting up of three committees for clinical trial review – and expert committee for compensation, and regulatory inspection at clinical trial sites has made the environment volatile, uncertain and unpredictable, complex and ambiguous impacting the growth of discipline of clinical trials in India. These regulatory changes impacted all stake holders. The institutions, investigators and ethics committees lost interest in conduct of clinical trials as the increased burden of regulatory compliance activities far outweighed the perceived benefits of conducting clinical trials. For foreign pharma companies, India lost its attractiveness as a cost effective clinical destination. Indian research and development (R&D) based pharma companies had to consider alternate foreign destinations, which increased development cost. Drastic decrease in number of trials caused loss of jobs. The situation is slowly improving because of some pragmatic changes in regulations. However, the question for the industry is how to prepare for such challenges in future.
Col Eric Gill (Harvard Business review 2010) has recommended several strategies to lead effectively in VUCA environment – clear communication, meaningful usable information, agile leadership, flexibility, collaboration, training, listening and thinking divergently. These strategies would be useful for an individual leader to improve situational awareness and strive for predictable outcome for her organisation and team. However, in the long term, only collective leadership will be effective in managing the challenge of VUCA scenario for the country.
The pharma industry associations – IDMA, OPPI, IPA – the clinical research associations – Indian Society for Clinical Research (ISCR), leading public and private medical institutions, should come together to provide leadership and support long-term growth of discipline of clinical research. The leadership should develop a vision for clinical research which ensures ethical conduct of clinical trials, and should support development of skills, with a proactive attitude.
Conducting quality trials in India
Ethics should be the top priority in the conduct of clinical trials. There should be a common ethics code to conduct quality clinical trials, which ensures protection of rights, safety and well being of subjects. The clinical drug development should focus on unmet medical needs of Indian patients.
Skills include knowledge, education, and awareness. It is vital to develop a training programme for all the stake holders – investigators, site teams, ECs, and industry professionals. The programme’s principle elements should be accreditation and focus on science, ethics and regulations for clinical research. It should provide uniform training to ensure compliance with regulatory laws and guidelines, and to ensure protection of rights of clinical trial participants. Skill development should be reinforced by providing the trained investigators an opportunity to conduct research in epidemiologic observational research studies of relevance to Indian healthcare needs.
The participant is the most important stakeholder in clinical trials. There is an urgent need to create clinical research awareness programmes for patients, patient groups and society. European Patients’ Academy on Therapeutic Innovation (EUPATI) – a consortium project, led by the European Patients’ Forum, with 30 project partners across Europe from patient organisations, academic institutions, and pharma R&D companies – aims to increase public knowledge and understanding of medicines R&D, and to help the public communicate more effectively with health professionals about new medicines. EUPATI has plans to develop a training course which aims to increase patient experts’ capacity to become actively involved in medicines R&D. They are also developing a toolkit for patient advocates to facilitate dissemination of medicines R&D
information to patients, and an online library of medicines R&D information for the public. It would be worth emulating this programme and adapting it to Indian realities.
The Indian patient education programme should create awareness about:
- Clinical research process and its value in improving public health and in developing a new drug
- Regulatory mechanisms for human subject protection
- Clinical trial participants’ rights. These include rights of
- Safe, considerate and respectful, professional medical care
- Protection of privacy and confidentiality
- Adequate information to give voluntary informed consent
- Receiving medical care in case of any medical problem and serious adverse event (SAE)
- Receiving compensation in case of SAE related to clinical trials
- Withdraw from clinical trials without penalty or loss of benefits
- Special protection and care as vulnerable subjects and
- Post-trial access
The leadership would require a proactive attitude to meet the above challenges. This requires serenity to accept things which they cannot change, and the courage to change things that they can change. The leadership should accept that the recruitment of Indian clinical trial participants will always pose challenges literacy and poverty and the government would expect that the rights, safety and well being of such vulnerable participants remain a prime consideration while conducting the trials. Whenever there are safety issues and violation of clinical trial participants’ rights, the government will react by making relevant changes in regulations and guidelines to provide assurance of human protection in clinical trials. However, the leadership can change the negative image about clinical drug development by coming together with the objective of improving knowledge and skills of all stakeholders, of empowering clinical trial participants and improving ethical quality of clinical trial conduct in India. This leadership team can also provide uniform feedback to regulators and policymakers and work with them to create regulatory environment which is robust, transparent, and responsive to global and national expectations of ethical and quality clinical trial conduct.
VUCA in the clinical trial environment require a radical change in leadership approach – from reactive to proactive. A reactive response means stopping trials, downsizing manpower and closing operations. But this response won’t change the state of VUCA in the recent past or won’t reduce the potential for VUCA in future. Only a collective leadership, which focusses on Skills, Attitude, Vision and Ethics (SAVE) can save the discipline of clinical trials, and make it ready to deal with the challenges in a VUCA world!