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Objective:This paper aimed to explore the problems and solutions in the management of Investigator-Initiated Trail (IIT) in medical institutions, to provide suggestions particularly in the absence of relevant high-level policy support.Methods:By combining literature review with working practice experiences, this paper analyzed the current situation of IIT’s management and the rationale, put forward suggestions.Results:IIT related problems identified including as the responsible entities of the management, research topics selection, protocol design, continuity, research team construction, ethical review and the cultivation of research management personnel. The centralized management will help the standardized management of such projects, the training of investigators and team building, the review awareness strengthening of the ethics committee, improvement of management ability.Conclusions:IIT plays an important role in promoting the development of medical scientific research. Medical institutions should integrate resources, provide platforms, train investigators assure the quality of IITs.
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60?) in the Huaxi Hospital of Sichuan University. Three cases aged less than 15 years, but the patients or their relatives were informed of and consented the operation scheme. Without rectification, fusion segments were propped open about 5 mm via the upper and lower fixed vertebra, and anterior one was transplanted with fresh-frozen fibular allograft (offered by the donor corpse and excised extremities due to surgical trauma from the Department of Orthopaedics in Huaxi Hospital. The immunogenicity was greatly reduced by routine defat, acellular procedure, soaking sterilization and deep freezing), while rear one was transplanted with costal bone for supporting graft and filling the graft bone intervals with autogenous bone strips. Gypsum (brace) was used to assist external fixation for 8-10 month postoperation. The complications, graft incorporation, neurological function (Frankel grading scale A-E: complete paralysis-normal or no paralysis), back pain (0-3: none-severe), and mobility score (1-4: lying in bed-needing no assistance) before operation and at final follow-up of each patient were collected for analysis. RESULTS: All the patients were available for follow-ups and the mean period was 3.4 years (1.5-5 years).①Apparent fusion was observed in all cases with no graft fracture, only one patient reported mild graft shift and the kyphosis was unchanged.②There was no worsening of the neurological status in any patient. Frankel grades of 3 adult patients were unchanged after operation. All adolescent patients (n =3) had definite neurological improvement and could walk without assistance, while another was adult patient. Complete relief of back pain was observed in all patients. CONCLUSION: Fresh-frozen allograft fibular is a liable graft material for the treatment of severe kyphosis induced by inactive upper thoracic tuberculosis. Anterior decompression and fusion can promote the recovery of motive function and the alleviation of pain, especially is effective for neurological recovery of adolescent.
