Biggest challenge in conducting clinical trials is time frame, limitations: NIPER Director

The eminent panelists present during the session were Prof. Kiran Kalia, Director, NIPER-Ahmedabad, Dr Vijai Kumar, President & Chief Medical Officer, Excel Life Sciences, Dr Manish Rajak, CEO, Innvocept Global Solutions, Dr Sornaraja Thasma, Director - Business & Quality Assurance, ProRelix Research.

While chairing the session, Prof. Kalia mentioned that the biggest challenge in conducting the trails is the time frame and the limitations. She further told that we have the third-largest share in the world and need to focus with regards to support the MSME and ask them to join the clinical trials.

Prof. Kalia also mentioned that the new technology is to be accepted by the regulatory authorities and transparency needs to be created. She further mentioned the industry and Government need to have a transparency to gain the patient's trust and awareness needs to be created through all channels and platforms. She has also mentioned having a short-term training program to be conducted by CROs and It is the responsibility of MSME to support academia for developing human resource which are being fit to their application and we need to strengthen this link.

Dr Vijai Kumar shared a brief presentation about clinical Evaluation of drugs and how these help clinicians in clinical practice. Dr Kumar also shared key Indian metrics about the percentage of global disease burden and global clinicals trails in India. He also mentioned about the latest trends in drug development on Oncology- Biologicals, Regenerative and NCEs. He said only 1.4% of global clinical trials done in India in spite of 17% global population and 26% of the global disease burden. He also mentioned about the perception and challenges of the global biopharma industry. Dr Kumar also talked about the role of digitization in the Research and development and keeping health record of the patients.

Dr Vijay also mentioned that complete transparency and confidentiality of the patient are the main important parameters in the clinical trials. He has also said that every day has been a learning experience during the pandemic, right from making business projections and enrolling the patients in the trails.

Dr Manish Rajak shared a presentation about the current change in the world of Clinical Trials. Dr Rajak said the clinical trials industry continues to face various challenges like Increase in Complexity, Rising Costs and Pressing greater pricing. He also shared some critical challenges faced by the CROs in getting the sponsor companies for the trails. Dr Rajak also mentioned about some new technologies that can change the way of clinicals trials. He said organizations should come forward and explore Artificial Intelligence (AI), machine learning (ML) and other advanced technology for creating a better impact on the trials. He said CROs will definitely become more Instrumental by collaborating and partnering with the Innovators and also by adopting new technologies to make global clinical trials more efficient and effective and to further accelerate the availability of the novel medicine to the patients. He said there's a need for Pharmaceuticals Industry to develop a better relationship with the Health Care Industry.

Dr Manish also mentioned that CRO is also as much responsible as the Pharmaceutical company in the drug development process.

Dr Sornaraja Thasma thanked PHD Chamber for providing a platform to discuss on the futuristic advancements in clinical trials and clinical research through the digital 3D platform.

Dr Thasma mentioned that the Pharma and Bio-Tech companies are consistently evolving and new clinical studies, technologies and advancements in care and treatments have augmented the efficiency and at the same time, the complexity of clinical trials has increased, with tests being carried out in a highly structured and closely coordinated manner. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.

Dr Thasma said this session purely focusses on the global health and clinical trials around the world. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & strategy, outsourcing, vendor management, quality in Trial Conduct, risk-based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations.

He mentioned that today's interaction will definitely provide an opportunity to stimulate the health care scientists/professional on trial design, operations, organizing trials, research computing, regulatory aspects, report on clinical trials and gain a better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial- related ethics and disease treatments. He said the Health & Wellness Expo had provided an invaluable networking opportunity with decision-makers and focus on real case studies, insightful presentations and round tables.

The session concluded with a formal vote of thanks by Mr Vivek Seigell, Principal Director, PHD Chamber and was moderated by Dr Ravi Rathod, Deputy Secretary, PHD Chamber.