Life Science Compliance Update

March 06, 2017

ASCO Removes Restrictions on Researchers’ Conflict of Interest

ASCO_logo

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.

June 17, 2016

PhRMA Members Invested $58.8 Billion in R&D in 2015

In 2015, PhRMA member companies invested $58.8 billion in research and development, up 10.3% from 2014. The new R&D data is based on findings from the 2016 PhRMA annual member survey released in the 2016 Biopharmaceutical Research Industry Profile and the corresponding industry chart pack, Biopharmaceuticals in Perspective, which highlighted the wide-reaching impact of PhRMA member companies on the economy and biopharmaceutical innovation.

In the United States, the biopharmaceutical industry is a driver of economic growth and global competitiveness, and is the most research-intensive sector of the economy. The biopharmaceutical industry invests an average of six times more in R&D as a percentage of sales than all other manufacturing industries. The sector also accounted for approximately 17% of all business R&D spending by U.S. businesses. Overall, PhRMA member companies represented the majority of all biopharmaceutical R&D spending in the United States.

According to Stephen J. Ubl, president and CEO of PhRMA,

Investing more than half a trillion dollars in R&D since 2000, our member companies remain tireless in their commitment to driving innovation and delivering greater value than ever before. It is through this increased R&D that the U.S. biopharmaceutical industry continues to lead the world in the development of new medicines to address unmet medical needs of patients.

The increase in long-term R&D investments made by the biopharmaceutical industry have led to more medicines in clinical development than ever before, more than 7,000 medicines globally. As a sign of how increased R&D can really help, from 2000 to 2015, more than 550 new medicines were approved by the United States Food and Drug Administration (FDA) – including 56 new medicines in 2015 alone. Since only 12% of medicines in clinical trials make it to patients, it is critical that there are pro-innovation policies in place that can help sustain the long-term investments needed to develop tomorrow's cures.

As noted in the recently-released "Medicines in Development for Rare Diseases," the biopharmaceutical industry is currently developing more than 560 medicines for patient with rare diseases. The industry is also working to find cures and other treatments for Alzheimer's, cancer and heart disease, and other devastating conditions. This progress once again makes clear that public policies are needed that maintain a health care system that recognizes the value of medicines and incentivizes researchers to continue to develop new treatments and cures for patients.

Of those 560 medicines currently in development for rare diseases, 151 are for rare cancers and 82 are for rare blood cancers; 1468 are for generic disorders, including cystic fibrosis and spinal muscular atrophy; 38 for neurological disorders, including ALS and seizures; 31 for infectious diseases, including rare bacterial infections and hepatitis; and 25 for autoimmune diseases, including systemic sclerosis and juvenile arthritis.

ALS (also known as Lou Gehrig's disease), is notorious for being a rare disease with no cure. However, new therapies that are currently under development, such as antisense technology against SOD1, are a step toward helping patients and their families manage the disease.

These figures and anecdotes show that the biopharmaceutical industry is delivering true value to Americans by transforming patient's lives, lowering projected health care costs, strengthening the United States economy, and helping to improve the drug review and approval process, all while continuing to invest for the long term health of our country.

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