More than 15 years ago, a movement called the International Campaign to Cure Paralysis (ICCP) was inspired and initiated by spinal cord injury (SCI) clinicians, researchers, and funders. The ICCP came together to support the translation of preclinical findings toward clinical trials for promising interventions. Subsequently, five consecutive guideline papers were published for dissemination [1,2,3,4,5]. These were regularly referenced by SCI trialists and regulatory offices in the clinical trials that followed. Not surprisingly, the SCI community continues to encounter many challenges (e.g., enrollment issues which are common to clinical trials in many disease indications), including some daunting experiences (i.e., the relatively high frequency of prematurely terminated trials) that “beg” for a critical appraisal of lessons learned. While these experiences may be perceived by many as continuous failures and unresolvable struggles, an international interdisciplinary group of clinicians, researchers, and funders (many who were also involved with ICCP) accepted again the challenge to search for feasible solutions following a meeting in 2016. With the support of SCI foundations, the group focused their activities around specific topics dedicated to Spinal Trials, Understanding, Design, and Implementation (STUDI), and generated follow-up guideline papers aiming to discuss progress, since the ICCP papers, as well as tackling other areas require attention.
The actual STUDI paper titled “The Challenge of Recruitment for Neurotherapeutic Clinical Trials in Spinal Cord Injury” [6] exemplifies areas where substantial lessons have been learned and valuable progress could be achieved while also pointing to areas of continuous and even novel unsolved challenges. Together, the STUDI papers are intended to facilitate the development of innovative SCI clinical trials by addressing persistent and new barriers to their success.
As we encourage our patients to persevere when facing the distinct struggles of living with SCI, those working in the area of SCI should also heed this advice of perseverance!
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Blight AR, Hsieh J, Curt A, Fawcett JW, Guest JD, Kleitman N, et al. The challenge of recruitment for neurotherapeutic clinical trials in spinal cord injury. Spinal Cord. (2019). https://doi.org/10.1038/s41393-019-0276-2 [Epub ahead of print].
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Curt, A. Perseverance is required!. Spinal Cord 57, 347 (2019). https://doi.org/10.1038/s41393-019-0277-1
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DOI: https://doi.org/10.1038/s41393-019-0277-1