Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘NIH

Science Policy Around the Web – June 7th, 2019

leave a comment »

By: Mary Weston, Ph.D.

Source: Pixabay

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?

Last Tuesday, the Washington Post reported that the biopharmaceutical company Pfizer had hints that their rheumatoid arthritis drug Enbrel might reduce the risk of Alzheimer’s disease, but chose not to report these findings to the public.

In 2015, after analyzing hundreds of thousands of insurance claims, a team of Pfizer researchers observed that their anti-inflammatory drug Enbrel might also decrease the risk for Alzheimer’s by 64%. They recommended that the company conduct a costly clinical trial to prove the link but, after several years of internal debate, the company decided not to pursue the lead.  The question remains: why did Pfizer not release these findings to the scientific community?

Pfizer claims they did not pursue the research due to scientific considerations – they argue that since Enbrel cannot cross the blood-brain barrier and directly reach brain tissue, it is unlikely to prevent the debilitating neurodegenerative disease. Further, Pfizer claimed that they did not to report the research because the statistical findings did meet “rigorous scientific standards” and were concerned about misleading researchers down a false path. However, Pfizer is also losing its patent protection on Enbrel soon, meaning that generics will become available and the drug will be much less profitable, reducing any financial incentive for further research or clinical trials (likely to cost around $80 million).

Some in the scientific community are questioning Pfizer’s justification. Keenan Walker, an assistant professor of medicine at Johns Hopkins, argues that the scientific community benefits when the data is available, stating that ““[w]hether it was positive data or negative data, it gives us more information to make better informed decisions.’’

Several scientists argue that Pfizer’s results should be release because they could provide clues to combating the disease and slowing cognitive decline in its earliest stages. Specifically, recent research is hinting that inflammation may promote Alzheimer’s disease. Further, neurodegenerative research is notoriously challenging and there are no major drugs that treat Alzheimer’s. Even several recent phase 3 clinical trials have been halted because the drugs were not effective. Due to a lack of progress in the field, a couple large pharmaceutical companies, including Pfizer, have just closed their neurology-related research programs.

 (Christopher Rowland, Washington Post)

Trump administration halts fetal-tissue research by government scientists

The Trump administration has announced that government scientists will stop using human fetal tissue for research and is placing new limitations on researchers in academic settings who use federal funding from the NIH.

It is not entirely known how many research projects will be affected by the new regulations. Government scientists will be allowed to continue their current work, but are prohibited from acquiring new tissue samples. Current extramural research at universities and privately funded work can continue but any new grant proposals or renewals of existing projects must be approved by an ethics advisory board that will be formed.

In addition to halting government fetal tissue research, the administration has decided to cancel an ongoing HIV research contract with the University of California San Francisco, effectively ending a 30-year partnership. The project involves using fetal tissue to develop mouse models with human-like immune systems to develop new HIV therapies.

Use of fetal tissue is essential to for studying certain human biological processes, such as kidney development. Often biomedical research uses mice as substitutes of people, but in this case, murine kidney development is too different from their human counterparts to be of use. Some researchers fear that these new restrictions will set back certain research for years to come. Important areas of research that depend on using fetal tissue including HIV, neurodegeneration, human organ growth and regeneration, Zika (determining how/why the virus affects developing fetuses so severely), and certain types of vaccine development.

POLITICO reports that this decision was made after much debate between the White and the Department of Health and Human Services (HHS), which wanted a less restrictive policy. In a statement released Wednesday, HHS said that “promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” HHS is now reviewing whether sufficient alternatives to human fetal tissue exist and will be supporting the development and validation of these models. However, good alternatives for certain fetal tissue research are elusive and many scientists say that the tissue is essential for some fields.

 (Sara Reardon, Nature)

Have an interesting science policy link? Share it in the comments!

Advertisements

Written by sciencepolicyforall

June 7, 2019 at 6:11 pm

Science Policy Around the Web – May 10th, 2019

leave a comment »

By: Caroline Duncombe

Image by Steve Buissinne from Pixabay 

Drug prices will soon appear in many TV Ads

When watching an advertisement for a prescription drug on the television, a new addition will be added to that long list of side-effects: the product’s cost. On Wednesday, the health and human services secretary, Alex Azar, announced that the Trump administration will require pharmaceutical companies to state the priceof prescriptions in television advertisements in “legible” text, similar to the current standard of side effects. This policy will only apply to drugs whose whole-sale-price exceeds $35 per month.

            Such a change in policy has received substantial pushback from the drug industry. They claim that including the list price would confuse consumers who would potentially pay a different amount post-insurance (that is if you have insurance).  In addition, drug companies claim that such a requirement infringed on the companies’ First Amendment Rights. One of the driving forces behind the new policy change are the patient advocacy groups, who have pointed out that televised drug ads direct consumers to the higher priced medications.  The hope of such a policy is to potentially incentivize drug companies to lower their prices. Mr. Azar in a statement points out “If you’re ashamed of your drug prices, change your drug prices.” 

(Glenn Thrush and Katie Thomas, NYT)


Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 10, 2019 at 3:07 pm

Science Policy Around the Web – May 7th, 2019

leave a comment »

By: Allison Cross Ph.D.

Source: Flickr

Shake-up at NIH: Term limits for important positions would open new opportunities for women, minorities

Beginning next year, the NIH will be setting into motion a new policy implementing 12-year term limits for lab and branch chiefs in the NIH intramural program.  Currently, of the 272 chiefs overseeing the NIH intramural program, almost 20% of them have served in their position 20 or more years and, of those, over 5% have held their position for over 30 years.  

Individuals serving as lab and branch chiefs oversee administrative matters, mentoring, and recruitment for several labs or groups at NIH. With the current lack of turnover in chief positions, many feel it is hard to move up to a leadership position within NIH.  The new policy intends to change this, and to increase diversity among NIH leaders.  It is noted that women currently hold 26% of cheif positions, which is comparable to the percentage of women who hold tenured track positions at NIH.  

With implementation of the new policy, as many as half of the currently serving chiefs will be replaced in the next 5 years. The new policy indicates that the positions which become vacant will be filled through “open and transparent processes”.  To increase diversity of those holding these leadership positions, it will be important for NIH to have a diverse field of candidates capable of filling these positions. To help build the pool of candidates, the NIH is relying on the recently launched Distinguished Scholars Program, a program aimed at reducing the barriers to the recruitment and success of tenure-track female and minority faculty.

While some see the policy change as an opportunity to increase diversity in NIH leadership, others feel the change will have little impact, and still others question if leaders doing stellar jobs should really be replaced.  The current term limit policy change intended to take place next year will only affect the midlevel leadership positions, however, these changes may spread to higher level leadership positions in the future.   

(Jocelyn Kaiser, Science)


Senator’s queries prompt NIH and NSF to clarify how they monitor foreign research ties

There has been a recent increase in concern among members of Congress that foreign governments are taking advantage of open nature of the nation’s research enterprise. These concerns prompted senator Chuck Grassley (R–IA), chair of the Senate Committee on Finance, to send letters to the NIH, NSF, and DOD asking each agency to explain the practices they have in place to root out any illegal behavior.

These letters contain several questions for each agency to answer including 1) how the agency conducts background checks before awarding a researcher or institute a grant, 2) how much money is being spent “to identify and investigate potential violations of the rules concerning foreign affiliations and financial support for an investigator’s research, and 3) the number of institutions under investigation by the agencies “for employing individuals who failed to disclose contributions from foreign governments”.

Congress has received responses to these letters from NIH and NSF and is still waiting on a reply from DOD. Though both agencies that responded to the letter failed to answer all the questions from Senator Grassley, they used their responses to highlight changes being made to their grant application processes.  

In response to the question regarding background checks for grantees, both NIH and NSF explained that the agencies do no perform background checks.  In the NIH’s response to Senator Grassley, they explained that, in the last year, they reminded grantee institutions about their responsibility to notify NIH if a grantee is found guilty of scientific misconduct. Notably, the NIH currently requires that grantees disclose all “foreign components” of their research. The NSF used their response to explain the development of a web-based discloser form where researchers are to list “all sources current and pending support”. In a recent change by the NSF, they now also require all those applying for NSF grants to disclose if their proposal requests money for a foreign organization and, if so, to justify what the foreign collaborator offers that cannot be done at a US-based institution.   

With the responses from NIH and NSF leaving many of Senator Grassley’s questions unanswered, it is expected that further inquiries from Congress will continue.  

(Jeffrey Mervis, Science) 


Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 7, 2019 at 4:15 pm

Tackling scientific misconduct in academic research

leave a comment »

By: Jenny Kim, Ph.D.

Source: Pixabay

In recent years, scandals surrounding scientific misconduct have gained significant media attention. In 2018, the Washington Post reported the resignation of Dr. Brian Wansink from Cornell University. At Cornell, Wansink headed the Food and Brand lab which examined factors that influence people’s food choices. Following an internal investigation, it was determined that Wansink had encouraged his trainees and collaborators to manipulate data to achieve viral, media-worthy results. According to Retraction Watch, 18 of Wansink’s papers have been retracted and 15 papers corrected. Similarly, last year the New York Times published an exposé on Dr. Piero Anversa, a professor at Harvard Medical School, whose work examined the use of stem cells to repair damaged heart muscle. Anversa’s prolific research was able to secure millions of dollars in federal grant funding and even led to clinical trials. Investigation of Anversa’s scientific misconduct began in 2013 after collaborators accused his research group of falsifying data and photoshopping images in scientific publications. The investigation concluded 31 papers affiliated with Anversa should be retracted. In 2017, Harvard Medical School and Brigham and Women’s Hospital settled to pay $10 million to the federal government following the accusations of data falsification in the Anversa lab. While these cases of scientific misconduct are extreme examples, they highlight a larger problem in academic research: a lack of oversight on research integrity.

The National Institutes of Health (NIH) requires all trainees receiving support from an NIH training, career development, research education, or dissertation research grant to receive education pertaining to the responsible conduct of research (RCR). RCR training covers broad subject matters including conflict of interest, peer review, research misconduct and policies for handling misconduct, and responsible authorship and publication. The National Science Foundation (NSF) has similar RCR requirements for all trainees supported by their grants. While most universities and research institutions provide RCR education for their trainees, RCR instruction can vary greatly across research programs. The most effective RCR curricula tend to focus on real-world ethics cases, use of multiple types of practice exercises, contain more than 9 hours of coursework, and facilitate significant instructor-student interaction. However, not all research institutions are able to offer in-person, intensive RCR instruction, rather opting for online workshops instead. Several factors contribute to this discrepancy in RCR training across research programs. Financial constraints may prevent universities and research institutions from hiring instructors to create and teach RCR curriculum. For some, focus on promoting research integrity may not be a top priority for their program. Regardless, it is clear that significant restructuring and standardization of RCR education must occur across research institutions to enhance research integrity in an effort to prevent scientific misconduct.

In 2017, the National Academies of Science, Engineering, and Medicine (NASEM) published a report recommending the formation of a Research Integrity Advisory Board (RIAB) at the national level. The RIAB would aim to work with stakeholders (e.g. researchers, research institutions, funding agencies, and journals) “to share expertise and approaches for addressing and minimizing research misconduct and detrimental research practices.” If an RIAB were established, it could serve as a central resource that stakeholders could use to develop RCR training at their respective institutions to bolster research integrity. By using resources offered by an RIAB, RCR training can be standardized across universities and research institutions to ensure all trainees receive the same level of high quality RCR education. This is especially crucial given that universities often do not have prior knowledge or exper

ience to efficiently investigate these cases, potentially due to the relatively low incidence of reported gross scientific misconduct. Through consulting on these types of cases, the RIAB could act as a central repository for best practices on handling misconduct allegations; this would enable the promotion of research integrity to be more uniform across all research disciplines.  

Improvements in RCR training and the formation of an RIAB will not be as effective without the promotion of scientific rigor and research integrity from research faculty and staff. Trainees interact with their research mentors on a daily basis and use them as a guide to navigate the research environment. If research faculty and staff are not well-informed on current research policies or do not promote discussion of or encourage RCR in the laboratory, this could negatively impact a trainee’s understanding of research integrity. Even after his numerous retractions, Brian Wansink defends his research. He admits to poor record keeping but does not believe he conducted improper statistical methods or misreported his data. An internal review by Cornell confirmed Wansink used problematic statistical techniques. Former trainees of Wansink say he strongly encouraged p-hacking, or analyzing data in multiple different ways to discover a desired result, in the lab. Wansink’s trainees knew for years he used questionable research practices, but, under Wansink’s instruction, they continued to manipulate data and re-run analyses until they reached an interesting story. It is important that universities and research institutions provide assistance in identifying dubious practices and protection to trainees that subsequently report scientific misconduct. It would also be beneficial for universities and research institutions to require research faculty and staff to participate in RCR training and gain knowledge on leading RCR instruction. Preparing senior research personnel to have an open discussion of RCR in the research setting would help promote a culture of ethical research.

As scientific research continues to advance, RCR training will need to adapt to stave off potential threats to the conservation of scientific integrity. The creation of a central organization, like an RIAB, will allow for the development and maintenance of effective, efficient, high quality training in scientific rigor and research integrity for current and future researchers. Furthermore, encouraging the participation of senior researchers in RCR training and instruction will have important implications for improving education and communication with mentees in the research setting. When stories of gross scientific misconduct steal the headlines in mainstream media, the reliability of science falters. If the general public does not have confidence in science research, this can lead to difficulty in implementing science-based public policies. Improving RCR training across multiple disciplines at universities and research institutions can be a possible mechanism to promote research integrity and prevent incidents of scientific misconduct.

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

February 28, 2019 at 8:09 pm

Science Policy Around the Web – January 8, 2019

leave a comment »

By: : Jennifer Patterson-West, Ph.D.

benefitsofopenaccess_cc-by_logo.pd_eng

Source: Wikimedia

The world debates open-access mandates

 Plan S is a European-backed program devised to ‘accelerate the transition to full and immediate Open Access to scientific publications’ that is schedule to take effect on January 1st, 2020.

Open access mandates are not a new concept, 74 research funders in Europe already require that paper be made free at some point. The key difference between these existing mandates, which typically permit a 6- or 12-month delay after publication, and Plan S is that article funded by Plan S will be immediately available.

Shortly after the announcement of the program on September 4th, 2018, DeltaThink, a U.S. based consulting firm, began estimated the market influence of the program.  They released a news post stating that the initial 11 European funding agencies in the program accounted for roughly 3.3% of articles published in 2017, and their funding represent less than 1% of the approximately $2 Trillian spent globally on Research and Development (R&D). These metrics are not adequate to drive a global shift toward immediate Open Access.

Thus far, 16 funders have formally joined the program, including the Bill and Melinda Gates Foundation which was the first participant outside Europe. The program has also drawn support from many scientists that would welcome a transformation of the current system that keeps research publications behind paywalls.

Brian Hitson, the Director of the U.S. Department of Energy (DOE) Office of Scientific and Technical Information which is responsible for the agency’s public access policy has stated, “We don’t anticipate making any changes to our model.”  Current policies implemented by U.S. Federal agencies require that all peer-reviewed paper on funded work be made freely available within 12 months of publications. This policy allows published work to remain behind a paywall after initial publication restricting immediate access to the results.  The U.S. isn’t the only federal research funders that plan to maintain currently policies, both Canada and the Russian Science Foundation have indicated that they do not plan to join Plan S.

However, statements released last month by China’s largest government research funder and two national science libraries supporting the goals outlined by Plan S came as a surprise to many.  China accounts for 18.6% of articles published globally in 2016, more than any other country.  Therefore, a similar Open Access policy in China could have a profound impact on the publishing industry even if China doesn’t formally join Plan S.

Another impending participant is India, the third biggest producer of scientific paper globally. The Principal Scientific advisor to India’s government, Krishnaswamy VijayRaghavan, stated that they will “very likely” join Plan S.

As more funding agencies consider joining Plan S, others wait to see how other details of the program are settled.  One concern is the cap on Author Charges that funders will pay for Open Access publications, which Plan S has yet to announce.  If Plan S succeeds in gaining enough support then a shift toward a fairer publishing system and a worldwide transition to Open Access will become more probable.

(Tania Rabesandratana, Science)

 

NIH hospital’s pipes harbored uncommon bacteria that infected patients

 

Last month, a publication in the New England Journal of Medicine written by National Institutes of Health (NIH) researchers disclosed that at least 12 patients at the NIH clinical center were infected with Sphingomonas koreensis from 2006 through 2016.

S. koreensis is an uncommon waterborne bacteria previously reported in only two clinical cases. The first report of a S. koreensis as a human pathogen was a case study of a single patient in 2015.

A clustered outbreak of S. Koreensis of six inpatient individuals at the NIH clinical center over a six-month period in 2016 prompted an epidemiological investigation to identify the source of the infection and determine effective intervention strategies.

Isolates from these patients indicated that four patients were infected with multidrug-resistant S.koreensis. Eight additional clinical isolates containing S.koreensis were identified during the investigation dating back to 2006, only one year after the new hospital opened.

Genetic testing of the bacteria indicated that all isolates shared >99.8% identity suggesting a shared reservoir. Extensive testing of facilities found S.koreensis on sink faucets in patient rooms as well as in the water they came out, but not in the municipal water entering the hospital.  To eliminate the reservoir, the free chlorine concentration and hot-water temperature were adjusted resulting in no further infections since December 2016.

Dr. Tara Palmore, one of the NIH researchers, points out that although S. Koreensis is a weak bacterium, it have the potential to cause additional illness in highly immunosuppressed patients.  This outbreak in which three infected patients ultimately died during inpatient treatment demonstrates how even abundant and often nonthreatening bacteria can severely impact the health of immunosuppressed patients.

(Ike Swetlitz, STATnews)

 

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

January 8, 2019 at 12:05 pm

Science Policy Around the Web – July 27, 2018

leave a comment »

By: Emily Petrus, Ph.D.

20180727_Linkpost

source: pixabay

Innovation

Artificial Intelligence Has a Bias Problem, and It’s Our Fault

While computer and data scientists are working to create systems which can reason and perform complex analysis, groups of ethicists, lawyers and human rights advocates express increasing concerns about the impact artificial intelligence will have on life. It is becoming apparent that human bias regarding race, gender and socioeconomic position also influence algorithms and data sets used to train machine learning software.

Most artificial intelligence (AI) systems are trained on data sets culled from the internet. This results in skewed data which over-represents images and language from the United States. For example, a white woman in a white dress results in algorithms labeling a picture as “bride” or “wedding”, while an image of a North Indian bride is labeled as “performance art”. If that seems like a harmless hiccup, think about algorithms designed to detect skin cancer from images. A recently published study did a decent job detecting dark moles on light skin, but only 5% of the data set depicted dark skinned people, and the algorithm wasn’t even tested on that data set. This bias could skew accurate diagnoses for already underserved minority populations in the United States. Finally, AI will have a huge impact on financial markets beyond the replacement of humans to do jobs, particularly in manufacturing. Decisions on loan eligibility and job candidate hiring decisions are being filtered through AI technology, which is guided by data which may be biased.

It is apparent that computer scientists must make concerted efforts to un-bias data training sets and increase transparency when they develop new AI systems. Unfortunately, these common-sense suggestions are just that: suggestions. Before Obama left office in Fall 2016, a roadmap was created by the administration to guide research and development of AI systems. There’s no teeth in policy dictating fairness and inclusivity in AI development, but private and academic institutions are making gains in this arena. The Human-Centered AI project at Stanford University and Fairness, Accountability, Transparency, and Ethics (FATE) in AI research group at Microsoft are two examples of these types of efforts. Both groups seek to increase inclusivity in AI algorithms and reduce bias – human and computer generated. AI can also be trained to detect biases in both training data and the models by conducting an AI audit. An effort of developers in academia and private industry will be necessary to produce and prove their AI is unbiased, and it is unlikely that federal regulations would have the power or dexterity to administer any concrete regulations regarding this technology. Like most other scientific advances which bring significant monetary gains, the pace is breakneck but corners should not be cut. Legislation is unlikely to be able to keep up with the technology, but incentives to keep the playing field fair should come from within the AI community itself.

(Ben Dickson, PC Mag)

Scientific oversight

NIH delays controversial clinical trials policy for some studies

How does the brain process images of faces? How do we respond to frustrating situations? What does the mind of a sociopath look like in an MRI? These are all basic science questions in brain research which may discover treatment options for future studies. But for the moment, no drugs or interventions are being tested in many basic research labs funded by the National Institutes of Health (NIH). This means they’re not clinical interventions, or by definition, clinical trials, right? Maybe…

Basic researchers studying the healthy human brain sigh a breath of relief as the NIH decided to delay new rules applying to the classification of human trials. At issue is the re-classification of research which can be considered a clinical trial. The intent of the new guidelines was to increase reproducibility and transparency in government funded human research, for example requiring more rigorous statistical practices.  In practice, investigators will be required to upload their studies to clinicaltrials.gov, take mandatory trainings, and produce significantly more paperwork to continue receiving funding for their basic research. In addition, researchers were concerned that this would create more confusion in the public, as their research would be inaccurately represented as a clinical trial.

After the announcement last year, professional societies and academics sent letters of complaint to NIH, prompting congress to delay the implementation of the requirements to September 2019. This delay also gives leniency to basic researchers who apply to funding opportunity announcements seeking studies labeled as clinical trials, meaning they would not be immediately disqualified from being scored. Although many researchers hoped the NIH would drop all requirements for basic research, the delay is welcome for now. “This delay is progress because it gives them more time to get it right, and in the interim people aren’t going to be in trouble if they get it wrong,” said Jeremy Wolfe, a cognitive psychologist at Harvard Medical School.

(Jocelyn Kaiser, Science)

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

July 27, 2018 at 4:51 pm

Posted in Linkposts

Tagged with , , , ,

Clinical Trials Policy Revision: For Better or Worse

leave a comment »

By: Jenn L. Nguyen, Ph.D., M.P.H.

20180220_Essay

source: pixabay

As the largest public funder of biomedical research in the United States, the NIH wants to ensure that conducted trials are relevant to health priorities of the US, trials are conducted efficiently and are not duplicates of previously conducted trials, and trials contribute to scientific knowledge. In an editorial in 2016, NIH leaders noted a need for quality and efficiency improvements to clinical trials. NIH has introduced several initiatives, to enhance clinical trials stewardship by addressing accountability, transparency, efficiency, and dissemination. However, along with the widely acknowledged improvements some recent changes may hinder the pursuit of scientific knowledge.

To address accountability, all investigators and staff conducting and overseeing clinical trials must take the Good Clinical Practice (GCP) training. The training is mandatory for individuals involved with the design, conduct, oversight, or management of clinical trials. While the training may not be sufficient by itself, it does provide a standard of knowledge, a base of knowledge, standards, and guidelines for all clinical trials.

The second change requires that all grant applications for clinical trials be submitted under clinical trials specific funding opportunity announcements (FOA). Investigators interested in conducting a clinical trial can no longer submit under parent funding announcements, which made identifying clinical trials more difficult in the past. The FOAs will list specific review criteria for reviewers to consider clinical trials-related information, such as focus on the rationale, design, and operational and analysis plans. This new policy will increase NIH accountability and efficiency, as it will ensure that required information is submitted with each clinical trial application, allow staff to better track clinical trial proposals and study, and allow staff to uniformly apply appropriate review criteria.

A substantial change, however, is the limited eligibility of trainees to conduct interventional social science research, Institutional training (T) awards, which provide money to institutions for workforce training, do not allow money to be given to trainees involved in clinical trials (the exception is for D43s and K12s), Fellowship (F) awards, which support individual trainees,  do not support trainees involved in independently conducted clinical trials, but trainees can propose a research experience with a sponsor/co-sponsor.  For Career Development (K) awards, applicants may apply to either FOAs that specify “clinical trials required” or FOAs that are for “no independent clinical trials.” Scientists are concerned this may limit postdocs and students to get support for their fellowships and adequate career training.

To further address efficiency and accountability, applications must be submitted using a clinical trials protocol template that consolidates information from multiple forms, has structured data fields, and will collect information at the study level. This requirement will ensure that all investigators will submit the same information. In addition, the forms will contain fields forcing investigators to be clear and concise about their analytical and dissemination plans.

Addressing efficiency, NIH now requires use of a single Institutional Review Board (IRB) to review multisite studies. Prior, each institute involved with the study required duplicate or multiple IRB reviews, which involved the redundant assembly of experts to assure that the same proposed study was in line with the rights and protections of human and animal research subjects. Multiple reviews resulted in delays and at times, conflicting reviews. Guidance to establish a single IRB on record has been published.

Finally, there are significant changes for registration and reporting of clinical trials to address accountability, transparency, and dissemination. Investigators are now required to register their clinical trial(s) in the ClinicalTrials.gov database within 21 days of enrollment of the first participant. NIH makes the argument that this effort may help reduce the number of trials that fail, as it will require scientists to disclose their results even if the studies do not support their hypotheses urthermore, all investigators must adhere to the NIH policy on Dissemination of NIH-clinical trials. There have been longstanding concerns that investigators are not reporting all results (especially negative or non-significant results, not reporting results in a timely manner, and even sometimes, deviating from their own research protocol.

Along with these initiatives, The National Institutes of Health (NIH) broadened what was considered a clinical trial: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Adaption of this updated definition did not take effect until earlier this year and has alarmed some scientists. Clinical trials have been traditionally understood as experiments or observations for/in clinical settings to answer three questions: 1) Does the proposed treatment/intervention work? 2) Is the proposed treatment or intervention more effective than other treatments? 3) Are there side effects?

Scientists critical of the new definition first and foremost recognize and appreciate the motivation for NIH to increase transparency and replicability, specifically efforts for pre-registration, data sharing, and protocol sharing of trials. Yet, many scientists who conduct basic and behavioral research disagree agree that their work and studies should now be considered clinical trials. These scientists, and even scientific associations, remarked that the new clinical trials definition is too broad and traditional criteria to evaluate a trial might be inappropriately applied to their proposal. There is also concern that these changes will increase the administrative and bureaucratic burden for many scientists, specifically for exploratory scientists. To address and alleviate concerns, NIH released a set of case studies to help scientists identify and understand what is considered a clinical trial and must adhere to all the changes in the policy. While this effort provided clarification, many scientists are calling for NIH to hold further conversation with the extramural community.

While scientists recognize the need and laud NIH’s effort to address clinical trials stewardship, many of the same scientists are worried that these benchmarks set the wrong standards for success and rigor. Scientists are also worried about the additional administrative burden these changes will bring. As NIH enforces the policies, they have promised to monitor trouble issues and work with the community to find a solution without compromise.

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

February 20, 2018 at 3:52 pm