8 Things That Comprise Success Of Investigator Initiated Trial
by Alexander Tolmachev
Along with industry initiated trials in collaboration between pharmaceutical industry and academic community investigator initiated trials (IIT) play significant role. Industry initiated trials are not, and cannot be, designed to determine all the potential uses for a medication. In turn IITs expand product knowledge, including safety. Physician researchers often identify new ways of using existing treatments, thus improving the health of numerous other patients. And there is always greater weight attached to non-industry sources of data. This is the reason why companies need more IIT and continue procedural excellence for the best performance it this area. Below are some considerations that may be helpful in approval and running the IIT.
1. Consider why your company supports (or wants to support) IIT. There are several reasons why your company may want to support investigator-initiated research. The research could provide important benefits to your company in the form of new ideas and valuable clinical data. The research also may advance medical and scientific knowledge of a disease state or an otherwise under-studied patient population. Your company should understand these reasons because they will help the company to define its priorities for investigator-initiated research projects.
2. Remember that the parties involved in the research have mutual goals. Although industry may support investigator-initiated research for a variety of reasons, all parties involved – investigators, clinical sites, and your company – should establish several mutual goals for the research. These goals should include generating quality research that results in publications and high quality data, good partnerships and continuing relationships, and, of course, protecting human subjects and ensuring regulatory compliance. Investigator-initiated research can often complement a company's R&D goals, and in some specialties, a substantial portion of innovation may result from investigator-initiated research projects. As with your company's reasons for supporting the research, these goals should underpin how the research should be structured and conducted.
3. Establish pre-defined criteria for the review and approval of the research. An important part of standardizing company review of and support for investigator-initiated research is defining in advance the types of research a company will support. For example, research may focus on a therapeutic area, disease state, patient population, or other factors. Your company should require written proposals from investigators demonstrating that the proposed research fits within the company's established criteria.
4. Investigate the structure and requirements of internal multi-disciplinary group that will review the proposal. Knowing it will help you to pre-review the proposal and to get prepared better. Usually the companies ensure that research proposals are funneled into a common repository. For example, many companies are implementing an integrated on-line submission system. The research proposals are then reviewed by an internal committee. Most often, this committee will be comprised of medical/R&D personnel. Sales and marketing personnel never can influence the committee's operations.
5. Establish your company's role in and oversight of the research. Your company should think about the role it wants to have in investigator-initiated research. For example, does the company want to comment on the protocol? Require the investigator to submit certain research reports or report adverse events to the company? License the research data? Be able to audit or monitor the research? Review research publications? Train the investigator and others? Although your company's level of participation may vary by the particular research project, the company should think about what level of participation and oversight it wants to have. At the same time, these activities must be balanced with the limitations on regulated industry's interactions with health care professionals and with preserving the investigator's regulatory status as sponsor.
6. Have a written agreement. Quite simply, your company should enter into a written agreement for investigator-initiated research before the research begins. This agreement serves several important purposes, including:
- establishing the elements of the company's participation – such as protocol review/comment, research-reporting obligations, ownership of research data, company auditing and monitoring rights;
- setting forth provisions to protect the company, the investigator, and the research site in case something goes wrong;
- helping to ensure the confidentiality of information a company may provide to an investigator. The agreement also memorializes the key distinction between investigator-initiated research and sponsored research: in investigator-initiated research, the investigator is the regulatory sponsor of the research and must comply with all associated regulatory obligations.
7. Remember the written agreement is different from other clinical research agreements. Your company should be aware that as a general rule, the provisions of an agreement for investigator-initiated research tend to differ from the provisions of industry-sponsored research agreements. For example, investigators often will own the data in investigator-initiated research, whereas in industry-sponsored research, the industry sponsor nearly always requires data ownership.
8. Follow procedures to standardize your company's support of investigator-initiated research. A manufacturer's compliance policies and procedures should include a standard mechanism for tracking review and support of investigator-initiated research.
1. Top Ten Considerations for Industry Support of Investigator-Initiated Research. http://www.ebglaw.com/shownewsletter.aspx?Show=12025