CollaborationConsultingExternal Partnerships

Best Practices for Unsolicited Interactions with Industry – Digital Health Clinical Trial

By October 25, 2019 December 21st, 2019 No Comments

While there are many types of scenarios and questions you may be asked, below are a few best practices as well as some expert advice for when outside industry solicits your advice in the digital health field.

Scenario

A company asks you to be a PI or participate in a digital health clinical trial at Mass General

Best Practices

  • Ensure that the research, not the funding, is aligned to your interests
  • Collaborate with the company in drafting the protocol
  • Ensure that the study is unbiased
  • Use proper Massachusetts General Hospital or Partners HealthCare channels, which may include Partners HealthCare’s Office for Interactions with Industry (OII) and/or your supervisor

Expert Advice

  • Start to draft a protocol for protection of human subjects to make sure it is plausible. Go to Mass General’s Division of Clinical Research (DCR) for a human subjects consult if you are not clear that it is plausible
  • Develop an agreement through Partners CTO). Then, as soon as possible, begin to engage in review processes including supplemental review, Research Information Security Office (RISO) review, and Vendor Information Security Profile (VISP) processes
  • Contract, the IRB, and supplemental reviews are not formally in sequence, but should be viewed as circular dependences that need to be de-risked in an interactive fashion. Unless you have deep technical knowledge, aim to contract with a clear feasibility, discovery phase up front

Resources

Author Details
Founded in 2018, the Center for Innovation in Digital HealthCare serves as catalyst to promote the entrepreneurial and research-minded digital health ecosystem at Massachusetts General Hospital. It provides operational and advisory support to internal innovators and outside industry seeking to collaborate on digital health initiatives.
×
Founded in 2018, the Center for Innovation in Digital HealthCare serves as catalyst to promote the entrepreneurial and research-minded digital health ecosystem at Massachusetts General Hospital. It provides operational and advisory support to internal innovators and outside industry seeking to collaborate on digital health initiatives.
Latest Posts