A 15 Year Review (2006-2020) of Patient-Reported Outcomes (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience

BackgroundDespite wide use of patient reported outcomes (PRO) tools in clinical development, resulting data is rarely incorporated into the US label. This study reviewed oncology product labels approved by the Food and Drug Administration (FDA) between 2006 and 2020 to determine if the rate of PRO inclusion in labeling has meaningfully changed. Sponsors were assessed to identify demographic trends in achieving PRO label success. MethodsFDA-approved drugs were searched utilizing the Drugs@FDA database by month from January 2006 to December 2020 for novel drug and biologic approvals. Labels and product summary basis of approval (SBA) were reviewed for inclusion of PRO data. Sponsor size and experience were determined for each product in the year of initial approval. Results155 oncology products received initial approval between 2006-2020, of which only 7 contained PRO data in the label. More than half (53.5%) of products had PRO data described in the SBA. Over time, PRO information increasingly been included in the product marketing application. Sponsors utilizing PRO data tend to be experienced in oncology development and larger in size. ConclusionsThere has been no meaningful change in inclusion of PRO data in oncology product labeling over the past 15 years. Recent FDA guidance and initiatives may provide additional clarification to support appropriate PRO tools to support label inclusion as well as another forum for distributing PRO data publicly.

Specific Prescribing Information for Geriatric Use in the 2019 Product Labeling for Novel New Drug Approvals

Objectives To review the availability of information specific to older people in the product labeling for novel US Food and Drug Administration drug approvals in 2019. Design Descriptive report. Methods Product labeling for the 48 novel new drugs approved by the US Food and Drug Administration in 2019 were analyzed for the presence of information specific to older people. The “Geriatric Use” section, Section 8.5 in the product labeling, was categorized based on the information available. Each product label was further searched using the terms “geriatric,” “elderly,” “old,” and “year.” Searches of the term “old” and “year” focused on information that mentioned adults 65 years of age or older. The sections of the product label that contained additional information related to older people was identified. Results Information was available in the “Geriatric Use” section (Section 8.5) for 46 of the 48 novel new drugs approved in 2019; 2 did not include a “Geriatric Use” section. Four product labels indicated that the drugs were not used in older people. One of the 2 medications whose labeling omitted the “Geriatric Use” section was also not indicated for use in older people. These labels were excluded from analysis.Of the remaining 42 drugs, there was insufficient numbers of patients 65 years of age and older to determine whether older patients responded differently than younger patients for 18 medications. Labeling for 15 medications indicated that there was no difference in safety and/or efficacy between younger and older persons. Product information for 6 medications indicated that the incidence of adverse events was higher for older people. The product label for 2 medications indicated that no dosage adjustment was required in older patients. One medication’s product labeling indicated that there were insufficient numbers of patients 65 years of age or older for 1 indication but that there was no difference in safety and/or efficacy for the medication’s second indication. Additional sections that referred to people 65 years of age and older included warnings and precautions, clinical trial experience, pharmacokinetics for special populations, and clinical studies. The “Geriatric Use” section of 1 product label referred to the dosage recommendations in patients with renal impairment. Conclusion Despite efforts to increase the enrollment of older people in clinical trials, 43% of the novel new drugs approved in 2019 lacked information on differences in response between older and younger populations because of insufficient numbers of study subjects. This paucity of information translates into therapeutic uncertainty regarding the safety and efficacy of these new medications in older people. An additional concern is that 14% of novel new drug labels indicated that older people are at greater risk for adverse events. Limited information specific to older people is available in other parts of the product labeling. More useful information related to older persons needs to be included in new drug labeling.

Real-World Dosing of OnabotulinumtoxinA and IncobotulinumtoxinA for Cervical Dystonia and Blepharospasm: Results from TRUDOSE and TRUDOSE II

The real-world use of onabotulinumtoxinA and incobotulinumtoxinA for cervical dystonia and blepharospasm treatment was assessed in two separate retrospective studies using identical protocols (TRUDOSE and TRUDOSE II). The studies were conducted in Mexico, Norway, and United Kingdom and designed to evaluate dose utilization of the two botulinum toxins in clinical practice. Eighty-three patients treated with both onabotulinumtoxinA and incobotulinumtoxinA for ≥2 years for each botulinum toxin were included, (52, cervical dystonia; 31, blepharospasm). All patients switched from onabotulinumtoxinA to incobotulinumtoxinA for administrative/financial reasons. A range of dose ratios (incobotulinumtoxinA to onabotulinumtoxinA) was reported; with the majority of dose ratios being >1. The mean dose ratio was >1 regardless of the study site or underlying clinical condition. The inter-injection interval was significantly longer for onabotulinumtoxinA versus incobotulinumtoxinA when assessed for all patients (15.5 vs. 14.3 weeks; p = 0.006), resulting in fewer onabotulinumtoxinA treatments over the study time period. Consistent with product labeling, no single fixed-dose ratio exists between incobotulinumtoxinA and onabotulinumtoxinA. The dosage of each should be individualized based on patient needs and used as per product labeling. These real-world utilization data may have pharmacoeconomic implications.

Protection from ‘Fake News’: The Need for Descriptive Factual Labeling for Online Content

So-called ‘fake news’—deceptive online content that attempts to manipulate readers—is a growing problem. A tool of intelligence agencies, scammers and marketers alike, it has been blamed for election interference, public confusion and other issues in the United States and beyond. This problem is made particularly pronounced as younger generations choose social media sources over journalistic sources for their information. This paper considers the prospective solution of providing consumers with ‘nutrition facts’-style information for online content. To this end, it reviews prior work in product labeling and considers several possible approaches and the arguments for and against such labels. Based on this analysis, a case is made for the need for a nutrition facts-based labeling scheme for online content.

Patient Reported Outcomes in Pediatric Cancer Registration Trials: A U.S. Food and Drug Administration Perspective

Pediatric patient-reported outcome (PRO) data can help inform the U.S. Food and Drug Administration’s (FDA) benefit-risk assessment of cancer therapeutics by quantifying symptom and functional outcomes from the patient’s perspective. This study assessed use of PROs in commercial pediatric oncology trials submitted to FDA for regulatory review. FDA databases were searched to identify pediatric oncology product applications approved between 1997 and 2020. Sponsor-submitted documents were reviewed to determine whether PRO data were collected, which instruments were used, and the quality of collected data (sample size, completion rates, and use of fit-for-purpose instruments). The role of PROs in each trial (endpoint hierarchy) was also recorded, along with whether any PRO endpoints were included in product labeling. Seventeen pediatric oncology applications were reviewed, 4 included PRO data: Denosumab, Tisagenlecleucel, Larotrectinib, and Selumetinib. In these 4 instances, PROs served as exploratory endpoints and were not incorporated in product labeling. Trials collecting PRO data were Phase II or Phase I/II single-arm studies with sample sizes of 28 to 88 patients. Symptomatic Adverse Events were characterized using clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) without additional patient self-report. PROs were infrequently utilized in pediatric cancer registration trials. When used, PRO data were limited by lack of a clear research objective and corresponding prospective statistical analysis plan. Contemporary PRO symptom libraries such as the National Cancer Institute’s Pediatric PRO-CTCAE may provide an opportunity to better evaluate the occurrence and impact of symptomatic Adverse Events, from the patient’s perspective, in pediatric oncology trials.

Pendampingan Dan Pelatihan Desain Grafis Untuk Kewirausahaan Bagi Siswa SMK Muhammadiyah 9 Wagir

The problem faced by students is at the production stage, namely the problem of product labeling. Until now labeling was done simply or without labeling. If students can design their own product labels, of course this will add to the selling value of the product. The existence of labels and brochures also add value to the promotion of student products. The aim of this mentoring activity is to provide training and graphic design assistance to students of SMK. The steps of this community service activities are observations, socialization, graphic design training, assistance in making labels and brochures for student entrepreneurial products, as well as evaluating and reflecting on service activities. The result of this service activity was in the form of training and graphic design assistance for students. All of the activities was well done . This can be seen from the number of students who participated in training and mentoring for three days. In addition, there are positive responses from teachers and students that have an impact on the success of this graphic design training and assistance. This can be seen from the results of student designs that are attractive and can be used as a commercial tool.