Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:


Study shows Phase I cancer findings under-reported


Increased publishing in peer-reviewed journals could impact patient care, outcome; researchers need commitment, set time devoted to effort

Phase I cancer studies, trials that are conducted to determine the safety and maximum dose of a new agent, are under-reported in peer-reviewed journals - a trend that could ultimately delay scientific progress and negatively affect patient care, say researchers at The University of Texas M. D. Anderson Cancer Center in a new study out on Mon., Aug, 22 online in Cancer.

Over the last decade, greater understanding of cancer at the molecular and cellular levels has resulted in a scientific discovery explosion, translating into the development of numerous potential anticancer agents. An excellent indication of this progress, says Luis Camacho, M.D., assistant professor of medicine in M. D. Anderson’s Phase I Clinical Trials Program, is the 10-fold increase in the number of Investigational New Drug (IND) applications for oncology agents filed with the Food and Drug Administration - from 100 compounds in 1980 to over 1,000 in 1998.

"With all this new knowledge, the need to share information is paramount, now more than ever before," says Camacho, the study’s senior author. "We, as clinicians and researchers, have a tremendous responsibility to not only investigate and discover new agents, but also to disseminate our discoveries - good and bad - to the medical community at large, to ensure the safety and well-being of our patients."

Given this acceleration of discovery, scientific meetings have become inundated with study submissions, reports Camacho. Yet, often these results are preliminary and subject to change after final analysis. Therefore, publishing in peer-reviewed scientific journals remains the "gold-standard" for sharing medical information, he says.

To understand the rate at which Phase I trials were being published, Camacho and his team analyzed the 275 Phase I abstracts accepted by the American Society of Clinical Oncology (ASCO) for presentation at its annual meeting in 1997, and determined whether those findings had been published over the next seven and a half years. Through repeated MEDLINE searches and emailed questionnaires, researchers discovered that by February 2001, two-thirds (67 percent) of the Phase I abstracts had been published in peer-reviewed medical journals.

Researchers found that the Phase I ASCO studies of novel (agents not approved by the FDA) and non-novel (studies including at least one FDA-approved agent) drugs were published at an equal rate. Research that was financially supported by the pharmaceutical industry was published at the same rate of those studies not industry-supported. There was no difference in the rate of oral and poster presentations published; however, oral presentations were published more quickly than those presented as posters.

Publishing positive or negative Phase I trial results is critically important in developing new, or modifying existing cancer therapies, Camacho says.

"Obviously, if a Phase I agent proves too toxic, we need to ensure that information is shared within the cancer medical community, so as to not put patients in harms way," Camacho says. "Of course, if Phase I studies are promising, publishing can encourage further investigation of these potential therapeutic agents."

In unique cases, Camacho says, positive Phase I results can have immediate impact on clinical care.

"Phase I studies are not necessarily first-in-human trials - they also can be combinations of already approved drugs," he adds. "If those combinations prove relatively non-toxic and show some effect, that combination can potentially be moved forward to Phase II and, in selected cases, used to treat patients, almost immediately."

The median time to publication - 3.4 years - also is very concerning, Camacho says. "Releasing data after such a lengthy interval may not allow researchers to build on their scientific experience, thereby significantly delaying further investigation with encouraging agents."

From the questionnaire sent to investigators, Camacho and his team learned that lack of time and investigator relocation were the major obstacles of publication. These reasons were unexpected, as researchers expected to learn that negative results, lack of interest in pursuing projects to completion, or the stringent peer-review process would be among the reasons why investigators had not published.

Given the investigators reasons for not publishing, Camacho says that academic institutions should provide academicians more time to concentrate on publishing efforts. In return, clinicians must be committed to reporting Phase I toxicities in peer-review literature.

Laura Sussman | EurekAlert!
Further information:

More articles from Studies and Analyses:

nachricht Diagnoses: When Are Several Opinions Better Than One?
19.07.2016 | Max-Planck-Institut für Bildungsforschung

nachricht High in calories and low in nutrients when adolescents share pictures of food online
07.04.2016 | University of Gothenburg

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Etching Microstructures with Lasers

Ultrafast lasers have introduced new possibilities in engraving ultrafine structures, and scientists are now also investigating how to use them to etch microstructures into thin glass. There are possible applications in analytics (lab on a chip) and especially in electronics and the consumer sector, where great interest has been shown.

This new method was born of a surprising phenomenon: irradiating glass in a particular way with an ultrafast laser has the effect of making the glass up to a...

Im Focus: Light-driven atomic rotations excite magnetic waves

Terahertz excitation of selected crystal vibrations leads to an effective magnetic field that drives coherent spin motion

Controlling functional properties by light is one of the grand goals in modern condensed matter physics and materials science. A new study now demonstrates how...

Im Focus: New 3-D wiring technique brings scalable quantum computers closer to reality

Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.

"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...

Im Focus: Scientists develop a semiconductor nanocomposite material that moves in response to light

In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.

A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...

Im Focus: Diamonds aren't forever: Sandia, Harvard team create first quantum computer bridge

By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.

"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...

All Focus news of the innovation-report >>>



Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

Agricultural Trade Developments and Potentials in Central Asia and the South Caucasus

14.10.2016 | Event News

World Health Summit – Day Three: A Call to Action

12.10.2016 | Event News

Latest News

Ice shelf vibrations cause unusual waves in Antarctic atmosphere

25.10.2016 | Earth Sciences

Fluorescent holography: Upending the world of biological imaging

25.10.2016 | Power and Electrical Engineering

Etching Microstructures with Lasers

25.10.2016 | Process Engineering

More VideoLinks >>>