{
  "abstract": "Importance Phase 1 clinical trials fall at a critical intersection of translational research and drug development. With a high failure rate at this stage, only enterprises capable of substantial risk tolerance and heavy investment can step into translational medicine. Academic and public sector researchers in India often lack expertise in early-phase clinical trials. This, along with a lack of dedicated infrastructure, poses some unique challenges in the early-phase drug development process. In this paper, the authors explore public-private partnership (PPP) models of pharmaceutical innovation and propose the establishment of national clinical trial networks as a solution to derisk the industry by jointly undertaking translational research of innovations addressing public health priorities.Observations PPPs offer an alternative approach to overcome the challenges associated with early-phase clinical trials. By fostering collaboration between public and private entities, PPPs leverage the strengths of public institutions, which can provide infrastructure, funding and scientific expertise, while private companies contribute their experience in clinical trial management and commercialisation. This is of particular importance in the development of drugs of national health priority.Conclusion and relevance PPPs offer a promising strategy to expedite early-phase clinical trials in India by promoting collaboration, diversification and innovation. By acknowledging and mitigating the inherent risks, public and private stakeholders can work together to develop effective and accessible treatments for patients in need.",
  "authors": [
    {
      "affiliations": [
        "Development Research, Indian Council of Medical Research, New Delhi, India"
      ],
      "name": "Aruvi Poomali"
    },
    {
      "affiliations": [
        "Development Research, Indian Council of Medical Research, New Delhi, India",
        "Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden"
      ],
      "name": "Jerin Jose Cherian"
    },
    {
      "affiliations": [
        "Development Research, Indian Council of Medical Research, New Delhi, India"
      ],
      "name": "Nikhil Benroy Noronha"
    },
    {
      "affiliations": [
        "Development Research, Indian Council of Medical Research, New Delhi, India"
      ],
      "name": "Aparna Mukherjee"
    },
    {
      "affiliations": [
        "Development Research, Indian Council of Medical Research, New Delhi, India"
      ],
      "name": "Taruna Madan Gupta"
    }
  ],
  "title": "Derisking translational research in India through the Indian Council of Medical Research (ICMR) network for phase 1 clinical trials and public-private partnerships",
  "uid": "4ddd01ef-b260-515e-8c99-110302f1973a"
}