Tag: Emerging Biotechnology

The Behavioral and Social Clinical Trials Template: A New Resource!

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In May 2017, NIH and FDA released the final version of a template document aimed at assisting NIH-funded investigators in preparing Phase 2 and 3 IND/IDE clinical trial protocols. Additionally, at that time, NIH also released the electronic Protocol Writing Tool (e-Protocol Tool) which was based on the NIH-FDA protocol template. The way we like to describe the e-Protocol Tool is that it is like a Turbo TaxTM for developing clinical trial protocols.   We think it can be safely said that both of these products have been an unmitigated success! In fact, the e-Protocol Writing Tool is one of the most frequently visited pages of the OSP website, drawing on average over 1,000 visitors per month.

Almost immediately, we began to think of how NIH could leverage this platform and expand to other clinical research areas that do not involve a drug or medical device intervention. Taking into consideration the recent NIH policies that have expanded the requirements of clinical trials beyond those that are FDA-regulated, it seemed most appropriate to develop a template specifically aimed at studies involving social and behavioral interventions. Most NIH Institutes and Centers (ICs) fund behavioral and social science clinical trials, so it makes perfect sense to have a resource available that aims to help investigators conducting these types of trials.

Today, the NIH released  a request for public comments on the Draft Behavioral and Social Clinical Trials Template.  This template was created to guide investigators through the systematic development of a comprehensive clinical protocol. The template will be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol. The template retains much of the content and structure of the NIH-FDA Phase 2 and 3 IND/IDE clinical trial protocol template but has been tailored specifically for studies involving a social or behavioral intervention. Given the variations of intervention approaches and designs in the behavioral and social sciences, the NIH wants to encourage comments from a broad and diverse range of investigators on this draft protocol template.

It is important to note that the NIH Clinical Trials policies do not require the use of these protocol templates when submitting a protocol to clinicaltrials.gov or to the NIH Institute that funds the project and provides oversight. For basic or mechanistic studies subject to the clinical trials policies, some components of the template may not be applicable. However, use of the template will help ensure that investigators are writing a protocol consistent with the guidelines outlined in the International Council on Harmonisation (ICH) E6 Guidelines for Good Clinical Practice, which are intended to ensure research integrity and the protection of human research participants.

Comments on the draft protocol template can be made by visiting: Previously Compiled Public Comments. While members of the public are free to comment on any aspect of the template, we are most interested in comments about its utility and the clarity of the instructional text. Comments on the template will be accepted until October 11, 2018.

We have also saved the best news for last. Once NIH has considered all of the comments we receive, we will then integrate the final behavioral and social sciences protocol template into the existing e-Protocol Writing Tool! Investigators will then have a true one-stop (electronic) shop for all of their needs when it comes to preparing Phase 2 and 3 IND/IDE clinical trials documents and comparable behavioral/social science clinical trials.

Please help make the draft behavioral and social clinical trials template the best it can be by reviewing and providing your feedback!

This blog was co-authored by Dr. William Riley, Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). More information about OBSSR can be found at https://obssr.od.nih.gov.

William Riley
Director of the NIH Office of Behavioral and Social Sciences Research
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Recommendations for Moving to a Process for Returning Research Results

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I have become the human subjects police. No, I’m not talking about regulations or compliance. I mean that whenever I hear someone use the term “human subject,” I immediately correct them: “research participant.” This compulsion reflects a larger trend in biomedical research, in which people who volunteer for research studies are considered to be essential partners in the process. As part of this partnership, it is important that we consider the interests and values of our partners, such as the growing recognition that research participants might want the individual results of the research in which they participated returned to them.

Yesterday, the National Academies of Sciences (NAS) released the report of the Committee on Returning Individual-Specific Research Results from Research Laboratories, titled “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” As I wrote last year, NIH, FDA, and CMS collaborated to sponsor this study in recognition of the increasing challenge for the research enterprise posed by determining how and when to provide research participants with their individual-level research results and data, and whether the current regulatory environment is conducive to returning such results.

In the course of their work, the committee considered the justification for the return of individual-specific research results and found that while no single ethical principle requires the return of results, they assessed the potential benefits of returning individual-specific research results to generally be understated and the harms overstated. True to its title, the report recommends a broad shift in the research enterprise towards greater return of individual-specific research results than is currently common practice. The committee stressed, however, the need for quality in returning research results, and more broadly, for all research results. They conclude that greater return of research results and adoption of enhanced quality control measures would both strengthen the research enterprise by increasing the value for participants while improving scientific rigor and reproducibility.

To achieve this transformation, the report provides a series of recommendations, including specific regulatory and policy changes that would enable greater return of individual-specific research results while promoting greater quality, as well as articulating a process for determining whether and how to return results. Although some of the recommendations are directed at policymakers, they will also be of interest to investigators, institutions, Institutional Review Boards (IRBs), and research participants.

We are grateful to the NAS and the Committee members for their thoughtful treatment of the complex issues they were tasked with addressing. NIH will be reviewing and considering these recommendations with our federal partners and in conversation with the research community.

And as you can probably guess from Recommendation 12G, when it comes to the choice of “subject” or “participant,” this Committee is on trend.

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The Insider’s Guide to Effective Commenting on NIH Policies

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Before I came to NIH, I spent my career working with advocacy groups in the biomedical research community. A big part of my job was writing comment letters in response to proposed policies and rules developed by federal agencies. Now that I’m in a position where I read and consider feedback from stakeholder communities when developing NIH policies, I find myself looking back on my own comment letters and cringe just a little.

Why? Because although those comments may have been beautifully composed (if I do say so myself!) and accurately represented the views of the organizations or constituents that I was representing, I recognize now that they may not have been as effective for NIH or other federal agencies in developing their final policies and rules. So, with that knowledge in hand, what does make feedback on a proposed policy useful? How can you all learn from my experiences to be more effective in shaping biomedical research policy?

Be specific: If you read a lot of comment letters, a common thread is enthusiastic endorsement or opposition to whatever is being proposed. Knowing whether affected stakeholders like or don’t like what you are trying to do is critically important information, but it falls into the category of necessary but not sufficient. Many times such statements tend to be general and sometimes hyperbolic. As a policymaker, what I want to know is: why do you like or not like it? How will it specifically impact you, your organization, or your ability to engage in the mission of the agency? When thinking about where to go next, I want to know if your concerns can be addressed through alterations of the policy (and if so, specific language suggestions about how to alter the policy) or through further guidance or additional resources or, in contrast, whether they represent a deal-breaking obstacle that will send us back to the drawing board. Is this a policy going to have inadvertent negative effects that are important for NIH to be aware of or does dislike represent resistance to change?  Similarly, if you are supportive of a policy provision or proposal, tell us why. Those comments can be helpful to us in navigating the pathway to moving policy forward.

Provide data: There is seldom complete consensus on a proposed policy. It is more common to see some stakeholders strongly in favor, some strongly opposed, and a range of views in between. When considering how to weigh opposing viewpoints or when thinking about how to be responsive to the comments, it is immensely helpful when commenters provide examples and/or data to support their point. For example, a commenter might say a policy will have a great financial impact, either positive or negative, on their organization. What does that mean? Are we talking tens of thousands of dollars, hundreds of thousands of dollars, or millions? What is your evidence, even if there are many built in assumptions, for that estimate? Commenters might say they will have to hire more staff to implement a new policy or that they don’t have the expertise. How many staff are we talking about here?? What kinds of expertise, and how hard is it to find?  When input is unspecific or lacking data, it puts policymakers in the position of having to “read between the lines”, which is not ideal for evidence-based decision making or finding appropriate solutions to make the policy more palatable.

Answer the questions: When agencies are seeking feedback, whether via part of a Request for Information (RFI) or via the formal rulemaking or policymaking process, it is because there is genuine need of input from the community before a decision is reached. In true Robert Frost fashion, multiple policy options might be possible, and we need guidance from those who know the topic best or have a true on the ground perspective before choosing a way forward. When comments are non-responsive to the question being asked, a decision might be made based on our best judgement and/or input from those stakeholders who did take the time to answer. If you have a reason for not responding – doesn’t apply to me, don’t care about it, don’t have enough data to answer – that can be helpful to know, too.

Include new ideas: Have you and your organization found a creative solution to a problem that we are trying to solve via this policy? Is there something that we haven’t thought of or asked that we should have? One of the reasons I love venturing away from the NIH campus – or welcoming visitors to it! – is because interacting with the biomedical research community, from scientists to research participants to universities to advocates, is where many of the best ideas emerge. Yes, I know I just told you to answer the questions but going beyond the information we are seeking and helping us think outside the box with specific or alternative ideas can also spark innovative and creative approaches to policy.

Emphasize what matters to you most: When reading through a long, complex set of comments, it can be difficult to determine order of magnitude. You might have strong feelings about one policy provision but have a more neutral sense of another. Because you have followed all of the advice above, you may have provided very detailed comments on every piece of the policy being proposed or questions posed. This makes it very difficult to discern the priorities of the commenter. Providing that context will help the agency prioritize the areas that most need to be addressed or retained versus those that may present less of an issue.

At the end of the day, NIH science policy is all about creating the framework that facilitates the mission of the agency: supporting science and improving human health. Understanding the strengths and gaps of that framework, the push and pull tension by which policies incentivize or present barriers to achieving the highest quality, publicly funded research: this is the foundation of sound policy. Nobody understands that framework better than those who live on it and in it, day to day. So keep those comments coming in… and I will look forward to reading them!

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A Match Made in Science Policy Heaven

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Everyone knows someone who has dived fearlessly into the world of online dating and found the perfect match.  But did you know that the American Association for the Advancement of Science (AAAS) plays matchmaker between federal agencies and scientists who are interested in getting their feet wet in the science policy arena?

Here at NIH, we host up to 40 AAAS Science and Technology Policy Fellows each year.  This one-year fellowship provides the opportunity for scientists from a wide range of disciplines and career levels to experience the (science policy) sausage making process à la NIH, while at the same time bringing a wealth of scientific and analytical expertise to the table.  Since this is the time of year when all the action happens, it seemed like an ideal time to tell you about how this program works.

As you can imagine, the whole operation requires considerable coordination, and OSP is responsible for managing NIH’s involvement in the program.  In February and March, the Fellowship cycle begins, and we work to recruit offices from across NIH who are interested in potentially hosting a Fellow. One of the most challenging parts of our job comes next during April’s placement week.  During that week, Fellowship finalists converge on Washington en masse, and dash from agency-to-agency to participate in interviews with potential host offices (think of a cross between speed dating and a steeple chase!).  This all culminates in a matching process, where we work with AAAS to place finalists within NIH host offices.As you might imagine, only the best matches are placed across NIH’s Institutes and Centers, as well as within the Office of the NIH Director.  Fellows find homes in a range of different NIH offices that are engaged in policy, planning, communication, outreach, legislative affairs, program administration, and evaluation, to name but a few.

Once matching has concluded, the real work can then begin.  OSP works with the host offices, AAAS and the incoming Fellows, to begin the onboarding process in preparation for the Fellow’s first day in September.  When the Fellows arrive, OSP provides an NIH orientation to bring everyone up-to speed and then assists throughout the year in making the Fellows and host offices aware of the various AAAS and NIH program requirements.

Having worked closely with many of the AAAS Fellows (as well as having several OSP staff as alumni of the program) I see the Fellowship as a valuable tool in advancing NIH’s mission by fostering productive relationships between federal policy makers and scientific professionals.  I like to look at the OSP role in this as making sure that the relationships forged through this program begin and remain strong!  For more information about our involvement with the program please visit the OSP website.

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