JAMA network open
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Observational Study
Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
The US Food and Drug Administration (FDA) can use postmarketing requirements to mandate pharmaceutical companies to conduct clinical trials after the approval of novel therapeutics. Pharmaceutical companies can also agree to conduct nonmandated clinical trials as postmarketing commitments. However, when therapeutics are approved by the FDA without postmarketing requirements or postmarketing commitments, it is not well known how often pharmaceutical companies voluntarily conduct trials and report results monitoring safety or efficacy after approval. ⋯ Pharmaceutical companies frequently conducted clinical trials after approval, even when there were no clinical postmarketing requirements or commitments at approval. However, most of these trials evaluated new indications or expanded patient populations rather than monitored approved uses, and nearly half of the trials remained incomplete more than 5 years after original therapeutic approval.
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Randomized Controlled Trial Comparative Study
Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women: The mPED Randomized Clinical Trial.
Mobile phone applications (apps) and activity trackers allow researchers to remotely deliver an intervention and monitor physical activity but have not been rigorously evaluated for longer periods. ⋯ In this trial, the intervention groups substantially increased their physical activity. However, use of both the app and accelerometer for an additional 6 months after the initial 3-month intervention did not help to maintain increases in physical activity compared with continued use of the accelerometer alone.
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Randomized Controlled Trial Multicenter Study
Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth: A Post Hoc Analysis of the FLEX Trial.
The Flexible Lifestyles Empowering Change (FLEX) trial, an 18-month randomized clinical trial testing an adaptive behavioral intervention in adolescents with type 1 diabetes, showed no overall treatment effect for its primary outcome, change in hemoglobin A1c (HbA1c) percentage of total hemoglobin, but demonstrated benefit for quality of life (QoL) as a prespecified secondary outcome. ⋯ The precision medicine approach represents a conceptually and analytically novel approach to post hoc subgroup identification. More work is needed to understand markers of positive response to the FLEX intervention.
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Comparative Study
Naloxone Prescriptions Among Commercially Insured Individuals at High Risk of Opioid Overdose.
As opioid-related mortality continues to increase, naloxone remains a critical intervention in preventing overdose death. Opportunities to expand access through the health care setting should be optimized. ⋯ Patients at high risk of opioid overdose rarely received prescriptions for naloxone despite numerous interactions with the health care system. Prescribing in emergency, inpatient, and outpatient settings represents an opportunity to improve access.
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Use of alternative tobacco products (ATPs) such as electronic cigarettes, chewing tobacco, pipes, cigars, cigarillos, little cigars, and hookah is rapidly increasing. Although marketing restrictions exist for cigarettes, marketing of ATPs is not yet fully regulated, and studies have not assessed the association between ownership of ATP promotional materials and subsequent ATP or cigarette initiation among adolescents and young adults. ⋯ Ownership of ATP promotional materials was associated with subsequent initiation of ATPs. The results of this study are consistent with the suggestion that current marketing restrictions for cigarettes, including restrictions of the distribution of samples, coupons, and other promotional material, should extend to ATPs.