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Current trends in the clinical trial landscape for amyotrophic lateral sclerosis
- Source :
- Current Opinion in Neurology. 33:655-661
- Publication Year :
- 2020
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2020.
-
Abstract
- Purpose of review To review the current developments in the design and conduct of clinical trials for amyotrophic lateral sclerosis (ALS), illustrated by a critical appraisal of ClinicalTrials.gov. Recent findings In total, 63 clinical trials were included in the analysis, of which 13 phase 1, 35 phase 2 and 15 phase 3. Virtually all phase 3 clinical trials can be classified as randomized, placebo controlled, whereas this is only true for 57% of the phase 2 clinical trials. There are promising developments in the routes of drug administration, eligibility criteria, efficacy endpoints and overall trial design. Some of these innovative approaches may, however, not fulfil clinical trial guidelines or regulatory requirements. This could delay the development of effective therapy or hamper our ability to determine whether a treatment is truly (in)effective. The initiation of trial consortia comprising patient organizations, academia, industry and funding bodies may significantly strengthen the future clinical trial landscape for ALS. Summary The ALS clinical trial landscape is currently highly active with several promising innovative developments and therapeutic options. By further refinement of evidence-based guidelines, and alignment of our current endeavours, we may soon be able to positively impact the lives of people living with ALS.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
business.industry
MEDLINE
Phases of clinical research
Drug administration
medicine.disease
Placebo
Clinical trial
03 medical and health sciences
Critical appraisal
030104 developmental biology
0302 clinical medicine
Neurology
Medicine
Neurology (clinical)
Amyotrophic lateral sclerosis
business
Intensive care medicine
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 14736551 and 13507540
- Volume :
- 33
- Database :
- OpenAIRE
- Journal :
- Current Opinion in Neurology
- Accession number :
- edsair.doi...........0973f647e0de8440d684005493bdd7e1