Life Science Compliance Update

August 08, 2017

FDA Issues Two Proposed Studies on Disclosures for Advertising


Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for oncology advertising. Both studies have comment periods that end on August 18, 2017.

For both proposals, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

General Advertising

The Food and Drug Administration Office of Prescription Drug Promotion (OPDP) plans to investigate the way repetition and over warning apply to the presentation of risks in promotional prescription drug print pieces. They propose to test two levels of the Important Safety Information (ISI) – short versus long – and the presence of the Brief Summary in two different medical conditions (overactive bladder and rheumatoid arthritis). This will be investigated in DTC print ads for prescription drugs.

OPDP will collect descriptive eye tracking data on adult participants' attention to the following: (1) The important safety information, (2) the brief summary, and (3) the indication and benefit claims.

OPDP will conduct one 60-minute pilot study with 40 participants and two 60-minute studies with 200 participants each (50 participants in each cell), for a total of 400 main study participants. The studies will be conducted in person in at least five different cities across the United States. The pilot study and main studies will have the same design and will follow the same procedure.

Participants who self-identify as having one of the medical conditions of interest will be randomly assigned to one of four test conditions. In Study 1, the ad will be for a fictitious drug to treat rheumatoid arthritis. In Study 2, the ad will be for a fictitious drug to treat overactive bladder. After obtaining consent, they will explain the study procedure to participants and calibrate the eye tracking device. To collect eye tracking data, an unobtrusive glasses-based real-world eye tracker with a minimum speed of 50 Hertz will be used. The test images will be presented on paper and sized similarly to how they would appear in print materials such as magazines. To simulate normal ad viewing, participants will view two ads. One of the ads will be the study ad. The non-study ad will be for a consumer product unrelated to health. Only eye tracking data from the study ad will be analyzed. Next, participants will complete a questionnaire that assesses risk perceptions, risk recall, efficacy perceptions, efficacy recall, and covariates such as demographics and health literacy. In the pilot study, participants will also answer questions as part of a debriefing interview to assess the study design and questionnaire.

Oncology Advertising

FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. The use of disclosures is one method of communicating information to health care professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and decision making, and may affect how and what treatment they prescribe for their patients.

According to the FDA, promotional labeling and advertising for cancer drugs deserve specific attention. Oncology drugs represented 26 percent of the 649 compounds under clinical trial investigation from 2006 to 2011.

Different aspects of disclosures may influence their effectiveness. For example, despite the advanced education of health care providers, in a busy practice they may not be willing or able to process the disclosures thoroughly. The level of technicality in the disclosure may play a role in their use of the disclosure to contextualize the data display. Additionally, the addition of a general summary statement to frame the disclosure may help or hinder the processing of the disclosure and therefore the entire data display.

The proposed study seeks to address the following research questions:

  1. Do disclosures mitigate potentially misleading presentations of preliminary or descriptive data in oncology drug product promotion?
  2. Does the language (technical, non-technical) of the disclosure influence the effectiveness of the disclosure?
  3. Does the presence of a general statement about the clinical utility of the data in addition to a specific disclosure influence processing of claims and disclosures?
  4. Do PCPs, oncologists, and mid-level practitioners (nurse practitioners, physician assistants) differ in their processing of claims and disclosures about preliminary or descriptive data?
  5. Which disclosures do physicians prefer?

To address these questions, the FDA has designed a study that will be conducted in three independent phases, each phase examining a data display in a promotional piece for a unique oncological product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (oncologists, PCPs, mid-level practitioners). 

Outcome variables will focus on the assessment of the data display as well as attention to the disclosure, if present. Specifically, recognition of the clinical endpoint in the data display, comprehension of the data display, perceptions of the exploratory nature of the data, and the perceived credibility of the promotional piece will be examined.

Oncologists, PCPs, and non-oncology mid-level practitioners will be recruited to participate via the Internet, and the study is expected to take approximately 20 minutes. Participants will view professionally developed promotional pieces that mimic currently available promotion and answer questions. The questionnaire is available upon request.

March 06, 2017

ASCO Removes Restrictions on Researchers’ Conflict of Interest


The American Society of Clinical Oncology (ASCO) has removed all restrictions on author relationships previously in the 2013 Policy for Relationships with Companies statement, and all eligible manuscripts and abstracts otherwise will be considered for peer review, regardless of any financial relationships of authors. The decision was announced in the Journal of Clinical Oncology, the official journal of ASCO, in January 2017.

The 2013 policy restricted publication and presentation of research in certain ASCO forums, making abstracts and articles describing company-funded original research to be ineligible for consideration if the first, last, or corresponding author had been a company employee, investor, or paid speaker during the previous two years. ASCO felt that since they are a “leading source of cancer information worldwide,” and therefore, they “have a responsibility to ensure that important new information is disseminated to our members and the larger cancer community.”

The policy prompted researchers to voice their concerns of barring “ASCO members and highly qualified scientists from presenting their important original research to the oncology community in a setting where the work could be critically reviewed and discussed.” Following the outpour of such concerns, the restrictions were placed on hold and ASCO collected data for the following two years on the relationships of authors who submitted manuscripts or abstracts.

The collected data showed that potentially restricted submissions amounted to less than two percent of accepted journal articles, and roughly eleven percent of accepted meeting abstracts. The largest number of the abstracts related to developmental therapeutics and tumor biology, and a majority of them were accepted for poster presentation or publication. Turning to the remaining small number of abstracts accepted for oral presentation, ASCO examined the existing conflict of interest management strategies that the organization employs, such as slide review and live audit, when a heightened risk of bias is identified through disclosure.

Chief Medical Officer of ASCO, Richard L. Schilsky, MD, along with his ASCO colleagues, finally decided, “We have reached the conclusion that continued disclosure of commercial relationships, rigorous peer review, and management of potential conflicts of interest for all work submitted to ASCO best support our goals of trust and transparency and providing value to our members as a source for scientifically sound and unbiased original research.”

“ASCO continues to support universal and accessible disclosure of financial relationships with companies by authors, speakers, reviewers and participants in ASCO activities,” Schilsky and colleagues wrote. “ASCO welcomes further research and engagement with audiences on the most effective ways of communicating and managing disclosure information and on the impact of conflict of interest policies on scientific discourse.”

ASCO notes that it is important to point out that the ASCO policy continues to meet (or exceed) standards for accredited continuing medical education providers developed by the Accreditation Council for Continuing Medical Education Standards for Commercial Support as well as the standards for other interactions with companies described in the Council of Medical Specialty Societies Code for Interactions with Companies. Thus, eliminating author restrictions on submissions does not remove the prohibition on some company employees as speakers at ASCO meetings where accredited continuing medical education is offered.

March 02, 2017

CME Outcomes Increase with Local Participation in Content

CME Conference

Teams from Rockpointe and Potomac Center for Medical Education worked together to draft an article recently published in the Alliance Almanac, walking readers through the outcomes-based activity design. Throughout the article, readers learn how they structured their ground rounds courses and the modifications needed to address different audiences. They also illustrate how relying upon expert opinions during a needs assessment could create a disconnect between the content and learners’ true needs.

The article focused on “Type 2 Diabetes Management: A Team Approach to Managing Hypoglycemia, Comorbidities, and Patient Challenges,” a one-hour grand rounds activity series held in community hospitals. The activity was designed to educate clinicians on patient-engagement strategies and guideline-based management of T2DM (type 2 diabetes mellitus), specifically in patients with comorbidities or at a high risk for hypoglycemia. The CME activity was held in thirty hospitals in nineteen different states, over the course of seven months from 2014 to 2015.

According to the article, the most effective strategies for educational design contain a multidimensional approach. As such,  

[t]he content for the series was entirely case-based and tailored to the needs of each hosting venue.

The curriculum included six patient case scenarios, with two cases per learning objective. Each host site selected one of the cases per learning objective (three cases total) at the recommendation of the institution’s department chair or clinicians.

The outcomes methodology relies on assessment of responses to a series of case-vignette questions from a sample of HCPs who participated in the CME activity (participants) as compared to responses from a comparable, demographically matched group of HCPs who did not receive the education (nonparticipants).

Comparing the differences in response patterns between the participant and nonparticipant groups allowed for assessment of the following:

  • whether the therapeutic choices of participants were consistent with the clinical evidence;
  • whether practice choices of participants were different from those of nonparticipants;
  • what barriers exist to the optimal management of T2DM; and
  • which educational needs remain.

According to the article, sixty-five percent of responding participants “indicated that they always or frequently evaluated the risk of hypoglycemia in their patients with T2DM and adjusted management as necessary to avoid hypoglycemic episodes. The education was perceived as very impactful to the participants, successfully addressing their practice needs.”

Additionally, compared to nonparticipants, the activity favorably impacted the clinical decision making of the participants. Participants were more likely to account for the cardiovascular impact of glucose-lowering agents, as well as their effects on weight, their hypoglycemia risk and their contraindications when recommending treatment in a variety of patient scenarios.

The article concluded with the following:

Participation in an interactive, case-based grand rounds activity was associated with increased HCP knowledge and competence in the management of T2DM. It was also associated with a 51 percent increased likelihood that patients would receive evidence-based care from participating physicians, specifically in the context of comorbidities, renal impairment, cardiovascular risk and the need to limit weight gain. Participation in the grand rounds series has the potential to improve T2DM patient care during 92,196 patient visits each month to participating clinicians.


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