Run-in periods are occasionally used in randomized clinical trials to exclude patients after inclusion, but before randomization. During a run-in period, all patients receive the same treatment– for example, a placebo, the experimental drug, or observation only. A recent analysis of published trials found that 5% reported a run-in period, which could affect study validity if a large number of patients are excluded. (Dovepress)
“Synthethic control” trial design can save time and money
An innovative approach to collecting control group data in clinical trials called “synthetic control arms” means that, instead of collecting data from a newly-recruited control arm, synthetic control arms model those comparators using real-world data that has been previously collected. This approach reduces the number of participants needed for trials and eliminates participants’ fears that they will end up in a placebo group. (STAT)
Eligibility criteria exclude most ALS patients from clinical trials
According to a recent study, if the eligibility criteria of ALS targeted clinical trials were applied to a population of ALS patients in the Netherlands, nearly 60% of these patients would have been excluded from clinical studies. The authors recommend that we use a prediction model to select patients for clinical trials, rather than standard eligibility approaches. (ALS NEWS TODAY)
FDA provides Guidance on oncology endpoints
This December 2018 guidance from the FDA discusses how different oncology endpoints can serve different purposes depending on the context, and provides the agency’s recommendations on which endpoints are to be considered in several different contexts. (Regulatory Focus)
Multiple expansion cohort clinical trials: a new study design
www.appliedclinicaltrialsonline.com
The rapid rise of targeted drugs and biologics in oncology has led to the creation of a variation to the typical trial design that can include multiple expansion cohorts. A multiple expansion cohort trial allows sponsors who spot positive responses to an investigational drug during early stages of testing to expand the trial using additional single-arm studies; these designs can cut the typical development times for conventional trials in half. (Applied Clinical Trials)
New FDA Guidance on “first-in-human multiple expansion cohort trials”
The FDA has published a draft guidance that provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs. The guidance defines this type of trial as “an FIH trial with a single protocol with an initial dose-escalation phase that also contains three or more additional patient cohorts with cohort-specific objectives.” (Clinical Leader)
National Cancer Institute: We need to modernize cancer clinical trials
According to the director of the National Cancer Institute, an important challenge for cancer research now is modernizing the clinical trial infrastructure. Targeted therapies are changing how clinical trials are conducted, with a shift towards molecularly defined trials, which are more complicated to administer and require next generation sequencing to screen patients for enrollment with narrowly defined inclusion criteria. (BIOPHARMADIVE)
FDA seeks feedback on surrogate endpoints
The U.S. Food and Drug Administration is seeking feedback on a table of surrogate endpoints the agency is developing that may be appropriate for use as primary efficacy clinical trial endpoints for drug or biologic approvals. A critic of this list says that it is done at a high level with little detail, and proposes an alternative. The FDA is welcoming comments concerning the utility of the table. (Regulatory Focus)
Should we be bringing drugs to market quickly?
Disease-free survival is a “surrogate end point”, a measure of a drug’s efficacy that can be used as an alternative to overall survival when testing new treatments. Researchers analyze how long the drug prevents the disease from returning or how long a tumor is prevented from growing, thereby accelerating trials and bringing drugs to market more quickly than if using overall survival as the endpoint. (RACONTEUR)
Lack of communication in clinical trial teams
www.journalofclinicalpathways.com
Less than 2% of adult cancer patients are enrolling in clinical trials. What are the barriers contributing to this crisis that are related to the science of clinical trials? One barrier is “clinical trial procedures and conduct”- the team interactions between clinical and research teams suffered from lack of communication, team rivalries, and other inefficiencies. (J of Clinical Pathways)
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