Friday, January 29, 2010

Want to be and Intern or Fellow?

In the past couple of days, two excellent opportunities have come up in my reader that I thought I'd share.

First, The Alternative Scientist wrote about a science writing internship at the Ecological Society of America.

Second, DrugMonkey posted about the Hayre Fellowship in Public Outreach at Americans for Medical Progress.

Have you heard about any programs that would help your fellow New Voices get engaged in science policy, communication, or research?

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Thursday, January 28, 2010

New Voices on the State of the Union

Disclaimer: Today's post includes the opinions of the noted authors, which are not representative of the thoughts, policies, or beliefs of anyone (or any organization) but ourselves.
On Tuesday, we encouraged all U.S. citizens to take the time to listen to (or read) President Obama's first State of the Union. As promised, you can read or watch the speech online if you missed it. (C-SPAN also has a prepared version of the text of the speech, this does not include any ad libs.)

Some of the New Voices regulars share their thoughts on the national address below.

Kimberly's reaction from her apartment.

President Obama reminded me of who he was on the campaign trail. The speech was one of the most humorous presidential speeches that I have ever heard! My favorite line was “and if there’s one thing that has unified Democrats and Republicans, it’s that we all hated the bank bailout. I hated it. You hated it. It was about as popular as a root canal”.

Outside of the humor, Obama tackled the major issues: jobs, the banking industry, expanding the middle class, the economy, and most importantly (to me) health care. As a student of public health, I have been a little disappointed in how the health care bill has been progressing through Congress. I am glad that we have gotten this far in reform, but I hoped that President Obama would have put more involvement in its details. Even though the bill has been passed through partisan lines, I’m pleased that Obama called on both sides of the aisle to stay the course, and not walk away from health care reform.

With sincerity, he acknowledged the problems that his administration has had thus far. Despite the roadblocks, he made it clear that he is laying the foundation for our nation’s “new economy” of research and innovation. I’m looking forward to seeing the fiscal support and policies that will make that statement a reality.

Sarah's take from Local 16 in DC.

In 2008, the majority of U.S. citizens were desperate for change. From soaring unemployment to costly international conflicts, Americans felt the country needed a new course. Obama’s promise of hope for a better tomorrow won him the election and inspired millions. As the election wrapped up, it was clear the American people would be in for a letdown, but not because Obama is not capable of bringing us the things we need. Many people I spoke with seemed to have a poor concept of the time frame such dramatic change would take. And as I expected, in less than a year, people lost hope that things would be any different by 2012.

In the State of the Union address, I was glad that Obama acknowledged the growing lack of faith Americans have in their government and reminded the people that the change they desired is inevitably going to be ‘messy and complicated’. But I was happier that Obama reminded those in government that he needed their help, even though important votes would not necessarily be the popular decision, but were necessary for the future of the country. Obama said, “The only reason we are is because generations of Americans were unafraid to do what was hard; to do what was needed even when success was uncertain…”

With the 2010 elections approaching, our Members of Congress are in a tough spot. However, I think elements of Obama’s speech reminded us of the way he excited the nation, and as a result suggested the best way for the legislative branch to facilitate the process. Congress needs to sell the American people on the changes that are happening. Many of the changes they have put into bills, such as health care reform, will actually improve our lives and security, we just need to hear it from them, because if people truly understood the majority would support these bills and again be hopeful and eager for change.

Heather's impressions from a friend's couch.

I am definitely an oratorical snob, but even so, I felt like the president delivered a decent speech. What I found interesting was how much of the speech was directed at Congress. Though the constitutional function of the SOTU is to address Congress, many presidents address the network television cameras; until the end, President Obama did not. Why does this matter?

The truth is, Congress has the bulk of the responsibility when it comes to getting legislation signed, sealed, and delivered to the American people. As the president mentioned, if Congress doesn't act, he must issue executive orders to get things done. I'm pretty sure this is why Article II, Section 3 is in the Constitution anyway.

Politically, President Obama needed this speech to win him back some popular support; we'll see how long the polling boost lasts. He proposed controversial topics (getting rid of Don't Ask, Don't Tell) and admonished the people who were holding up change (hello, Senators, your president is talking to you). He also made a clear statement in opposition to a recent Supreme Court decision (to allow corporations unlimited contributions to candidates).

There weren't any big surprises. As far as I know, everything he mentioned were things already passed in the House of Representatives or that have been announced by the White House in recent weeks. However, I think it was a smart play to stick to pre-released news. For one, most Americans have no idea it isn't new news and secondly, because it gave him an opportunity to elaborate personally.

All in all, he re-set his tone. There weren't really any gimics, he was light, he was charming, he was hoping for change. It's a similar story to the one we heard last year around this time. With a year under the administration's belt, will 2010 see some of the big changes in Washington we keep hearing about?

Your thoughts?

Wednesday, January 27, 2010

Welcome Two New Voices

It's time to welcome two New Voices to the blog!

Name: Sarah Gallagher
Position: Research!America Science Policy Fellow
Education: PhD in Chemistry, Columbia University
MA in Chemistry, Columbia University
BA in Chemistry, Franklin & Marshall College
Previous experience: Sarah worked on public lands policy for Rep. Grijalva this past fall and spent considerable time campaigning during the 2008 presidential primary. Her background in chemistry is applicable to both health and environmental studies.
Fun fact: Sarah first started advocating with a letter to the president at age 11 about the destruction of the rainforests.


Name: Kimberly Brown
Position: Research!America Science Policy Intern
Education: Studying Public Health Management and Policy at the University of Florida for an expected MPH in May 2010
BA in Biology, Fisk University
Previous experience: Kimberly worked for the Metro Nashville Health Department educating parents and community members about the importance of check-ups for children.
Fun fact: Kimberly's first journey out of the country was to Jamaica on a trip that her mother won during a showing of The Attack of the 50 foot Woman.

Tuesday, January 26, 2010

State of the Union

Tomorrow night at 9 p.m. Eastern, President Barack Obama is going to give a State of the Union address. I’m not going to speculate on the content, or tell you what I hope he’ll discuss. Rather, I’d like to give you a little history on the State of the Union and tell you why you should be listening tomorrow night.
He shall from time to time give to Congress information of the State of the Union and recommend to their Consideration such measures as he shall judge necessary and expedient.
-Article II, Section 3 of the U.S. Constitution

The first State of the Union address was given by George Washington on January 8, 1790. Since then, every president has either given a speech or written a memo (that was later read aloud to Congress) on an annual basis that detailed where the nation was and where it was going. This may seem a rather dated tradition in an age where almost everyone has access to national news, but the value isn’t in the reporting of the actual state of the union, it is in the framing of the details in the address.

That may not seem clear, so let me explain. There are certain facts about our country. Then there is the interpretation of those facts. Considering the breadth of geography, people, and political opinions – we don't all have the same vision of America. As citizens, we should know our leader’s thoughts on what is important (you can tell he thinks it’s important if he includes it in the speech) and why it is important.

Here at New Voices we do our best to help provide resources that empower you to become better communicators and advocates for research and science. Part of being good at communicating and advocacy is being informed; knowing where our elected officials stand on the issues and what they plan to do (so we can either encourage or discourage it).

I encourage you to take the time to listen to the State of the Union tomorrow night. If you won’t be home or near a radio, record it. If you can’t record it, we’ll have a link to a transcript up on Thursday (and we know you have Internet, or you wouldn’t be reading this). We don’t all have to agree with the president, but we have a duty to know how he sees our nation.

Monday, January 25, 2010

Bringing From Ideas to Treatments Home

Photo credit: Sarah Gallagher

This is the last post in the
From Ideas to Treatments series.

In the last two posts in the series, I highlighted the importance of getting clinical researchers, health care professionals, and patients to think about the importance of diversity in clinical research. But there's more in the works that I think will also have a huge effect in getting the spotlight on this topic.

You've probably heard about the emergence of personalized medicine. What might that mean for you? Imagine one day being prescribed a treatment based on your specific genetic code. Now that's customer service!

Personalized medicine is touted as the health care system of the future, and as we further develop these techniques, diversity in research is going to mean something entirely different. Population-focused medicine will be a thing of the past, and so diversity will take on a whole new meaning. No longer will it refer to African-Americans, Whites, or Asians as entire populations. The focus will be on me, or you, as individuals. The diversity aspect will be unique to my genetic code, not my race or ethnicity.

But until we get there, we need to continue thinking about how best to utilize our clinical research paradigm, and that means continuing to improve the inclusion of diverse populations in clinical research trials.

How might America do that?

First, it seems that you can't turn on the news without hearing about health care reform. My purpose here isn't to pass judgment on any of the bills offered thus far, but to highlight how the idea of reform could work to improve inclusion in clinical research trials.

If we can get more people covered by health care, then they will have better access to health care professionals. This has the potential to introduce even more people to the idea of participating in clinical research trials.

Further, we've all heard about the movement to electronic records in the medical industry. Some of these programs are extremely advanced. They have a "smart" feature, that for example, will tell doctors when a drug that they have prescribed is not ideal for the patient. Imagine the capability to enter a patient’s diagnosis and have the system tell the doctor what trials that patient is eligible for.

Finally, one of NIH’s goals, currently in progress, is the formation of research consortiums, which recruit research institutions nationwide to collaborate and share resources, making the clinical research process more productive and efficient.

It takes a lot of time, energy and effort to translate an idea into a treatment and then make it accessible to the populations that need it most.

I hope that this series has helped enhance your interest in the research pipeline - and specifically in clinical research trials. I look forward to any thoughts or questions you may have!


This is Part 13 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Friday, January 22, 2010

Including Minorities in Clinical Trial Research

On Wednesday, I focused on the data about NIH's inclusion of women in trials for 2007. When I asked the same question for minorities, the answer was harder to come by, primarily because NIH doesn't have information on its enrollment for minority-only studies. So, the numbers that I have from them are likely skewed because we can't separate the participation of minorities in diverse studies versus minority-only studies.

My answer to this was to look at the literature again. The vast consensus here, was that we really don't know how much minority participation there is. Most studies Don't report the distribution of races included in their studies; many don't even mention if there was a diverse population participating. So of course, if many aren't reporting this, then you'd expect that there's not much analysis of differences between minority and non-minority populations... and you'd be right.

We know that some minority populations are more prone to certain conditions, so if we want to see the populations that need these therapies most have access to them, minorities need to be involved in the studies. So for my second plea of the week - after asking researchers to start analyzing differences in effect of these treatments between men and women - is for researchers to add minority inclusion and analysis to clinical trial reports.

In order to get great data from these studies, clinical researchers and health care professionals need to consider the importance of diversity. Beyond that, they need to actually ask the questions, what is the difference between these groups, and report the findings... even if the findings are that there are no differences.

As participants, and patients that want to benefit from these drugs, we can also start demanding this. Patient-driven research is on the rise. Organizations like the Cystic Fibrosis Foundation have an excellent network of patients who are not only demanding the research, but are making themselves available to participate when trials arise. We all should be following their lead.


This is Part 12 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Thursday, January 21, 2010

A New Voice at ScienceOnline 2010

Allison sporting her map of the human genome t-shirt (courtesy of AAAS) after returning from ScienceOnline 2010.

For months, I had watched the Facebook event, the #scio10 hashtag on Twitter, and the Wiki. I had my hotel roommate and a Google map of directions to each conference location. But it was a couple days before leaving for ScienceOnline 2010, and I was nervous. I had experienced blogger star-strucked-ness before, and I didn’t want to clam up during such a great opportunity to learn from some of the best science communicators out there.

Fortunately, I had nothing to worry about. ScienceOnline retained the “dinner party” feel you often get on Twitter, where the person sitting next to you, shaking your hand, or leading your session could be a book author, a trained scientist, or someone from one of the many institutions and organizations in the Research Triangle Park area. All forms of participation were welcomed and rewarded, and I left feeling more connected to a community of science bloggers than I had before.

As a communication fellow at Research!America, I look through discussions about science communication through an advocacy lens. During the session “Rebooting Science Journalism in the Age of the Web,” Ed Yong of Not Exactly Rocket Science (I could listen to him talk, er, blog all day) asked whether the publication where science-related content even mattered anymore. “If it’s on the internet, people can find it,” he said.

For me, this raises issues of access: how can we create new advocates for research if the communicators aren’t pushing content to new audiences and instead pull them into a specialized community through blogs and other channels (thanks for BoraZ for this distinction)? I thought this question was answered constructively in David Kroll and Damond Nollan’s session on engaging underrepresented groups in online science media, where the discussion turned to using mobile phones and Facebook at historically black colleges and universities.

Who will be the next voice for research? There was so much potential among the ScienceOnline participants. I thought Anil Dash made a convincing case for Expert Labs, a new initiative supported by the American Association for the Advancement of Science which would serve as a filter for policymakers who seek answers from scientists and other experts, but may not know the right questions to ask.

Additionally, Michael Specter, Friday’s keynote speaker and author of Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet, and Threatens Our Lives, ignited the conference with his impatience for misleading information about science, but reminded us throughout the weekend that he was dedicated to promoting scientific interest through his journalism. “Science is much bigger than special interest stories,” he responded to Ed Yong’s question above.

The diversity of the body of ScienceOnline made for lively sessions and informal conversations, and there are many themes not considered here. Based on the amount of content created during ScienceOnline--video, Twitter, blogs, images and Slideshare--I think you could spend a couple days sifting through it and feel as if you experienced the conference firsthand. All content should be marked with the #scio10 hashtag, so keep that in mind in your searching and posting.

Next up: ScienceOnline 2011!


Allison Bland is a communications fellow at Research!America and a graduate of McGill University with degrees in English and history of science. She has previously contributed to New Voices with posts on science education and how-to effectively use Twitter.

Wednesday, January 20, 2010

Breaking News: Women and Men are Different

It's hard to believe, I know. Women and men are different. This is going to be big, and I mean BIG.

Actually, we know it isn't big news, but it took awhile to notice that in clinical research trials. Which is why adoption of the inclusion policies by the National Institutes of Health (NIH) is so important for eliminating health disparities when conducting research trials.

NIH every year publishes its clinical research enrollment demographics for the year. I decided to take a look at the enrollment reports for 2007 and see how NIH is doing in meeting its inclusion policies.

First, I looked at enrollment of males and females in all trials (Phase I-III), and found that, overall, females are very well represented. However, I took this information one step further, and divided it into single-sex and mixed-sex studies.

A single sex study is one in which the researcher focuses on questions that involve either males or females, but not both. For example, they might be interested in treatments for ovarian cancer or testicular cancer, respectively. When I accounted for these trials. I saw that the vast majority of participants in mixed-sex trials were males.

I then looked at Phase III trials alone, because NIH policy focuses on inclusion specifically for this last phase. Again, my initial findings showed a higher proportion of women enrolled than men. When I further divided this into single- and mixed- sex, I found a more equal distribution of males and females in mixed sex studies.

So, it appears NIH is doing a pretty good job of meeting its stated policy goals for enrollment of women. However, I can’t help thinking that this policy may not be good enough.

Not all drugs make it to Phase III trials. What if we are overlooking drugs that might be more effective in women than men, but we don't see it because there aren't enough women in earlier trials? That drug might never make it to Phase III trials, and an entire population might miss out on a therapy that could really help them.

But beyond enrollment, when I looked at some independent publications to see how many clinical trials are actually asking the very obvious question: is there a difference between the reactions in males and females? The consensus: not many.

So either clinical researchers are not asking this question, or they are asking it, finding no differences, and not publishing this information. Either way, we need to know; so researchers, if you're reading this, start reporting!


This is Part 11 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Tuesday, January 19, 2010

A Brief History of Inclusion Policies

When we last visited the From Ideas to Treatments series, we were discussing diversity in clinical trials...

Inclusion of all groups is important, but it's taken some time to get federal policies established to focus on getting women and minorities enrolled in clinical research trials.

In the 1970's an Federal Drug Administration (FDA) policy actually barred women of birthing age from participating in trials. Seems counter-intuitive, huh? Why keep women out, when we know it's important to see their reaction to these drugs? Well, in part, the government was worried that their participation would put any unborn children at risk. Given the recently discovered effects of thalidomide, its difficult to fault them for this.

Thalidomide was a drug used to treat nausea, so of course, it was widely prescribed to pregnant women for morning-sickness. It wasn't until a generation of kids was born that the link between thalidomide and birth defects was discovered. This event played a large role in the reasoning behind the FDA ban.

For minorities, by the 1970s, there was a distrust that existed, particularly in the African-American community. It was a distrust for clinical research trials, and it stemmed from the Tuskegee Syphilis Experiment, a horrible event in clinical research history that took advantage of African American participants in the most unethical way.

In the 1980s, the U.S. government realized its mistake in banning women from trials, and began to adopt policies of inclusion for both women and minority populations. This led to the passage of the NIH revitalization in 1993. This act required both women and minorities to be represented in clinical research trials, and charged NIH with defining the policy.

Over the next 5-8 years, the remaining federal agencies sponsoring research followed suit. After receiving a less than stellar report in 2000 by the Government Accountability Office concerning NIH’s implementation of its policies, NIH further revised its policy. This revision specifically called for Phase III trials to include women and minorities in a representative number, and highly recommending analysis of these groups.

In recommending analysis, they also made the point that inclusion, while important, is not the last step. Having the diverse representation is important, but how useful is it if you’re not asking the obvious questions: 1) Do females show a difference in response compared to males? and 2) Do minorities show a difference in response compared to one another or the non-minority population?

In the next two posts in this series, we'll take a look at the answers to both of those questions.


This is Part 10 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Monday, January 18, 2010

Day On


New Voices is officially off today in celebration of Martin Luther King, Jr.

However, we hope you are also out making your day off a "day on."

If you still aren't sure what you can be doing, check out mlkday.gov for a list of projects going on in your area.


You can also try:
  • Picking up trash or litter in your neighborhood

  • Doing some community gardening

  • Going through closets, attics, basements, etc. in search of donateable goods

  • Collecting recycleables that aren't usually picked up in your area to drop off at a local recycling center

  • Recording yourself reading books, short stories, etc. for the blind or children

It's amazing what you can do in a day.

Friday, January 15, 2010

Donate Time

Another way to give back to the community is through donating your time.

Many senior citizens and disabled individuals are able to live on their own, but are physically unable to drive or use public transportation. If you have a car and some free time, consider volunteering to provide rides for seniors and the disabled to doctors’ appointments, the pharmacy, or the grocery store.

A variety of state organizations have programs that connect drivers with people in need of a ride. Being a volunteer driver is a great way for busy people to give back because the programs are typically flexible and work around the driver’s availability. At the same time, it is a very important service opportunity because for riders, the transportation allows them to take care of their health needs while remaining in their homes.

You can also volunteer by delivering hot nutritious meals to people who are homebound in your local community, sign up to volunteer at Meals on Wheels.Your time can also benefit seniors and the disabled by providing them help with minor repairs around their houses including improvements for their safety, such as installing grab bars and railings.

These are just a few ways that you can have a positive impact on the lives of others with just a little spare time. What would you add to this list?

Thursday, January 14, 2010

Contribute to Global Health

Photo credit: Eduardo Munoz, Reuters

We've been spending this week looking at ways you can give back to your community both next Monday during the National Day of Service and throughout the year. In lieu of today's planned post on ways to contribute locally, I'd like to refer everyone to the dire health needs of those suffering in the Caribbean - particularly in Haiti.

By now, I'm sure you've heard about the devastating 7.0 earthquake that has demolished Port-au-Prince and taken thousands of lives. Over at The Big Picture, you can see some of these scenes through the lens of photojournalists on the ground.

A friend of mine works at USAID and expressly said that monetary donations are the most effective at this time (clothes and food are difficult to transport in while the priority is medical supplies).

The Daily Beast* has a pretty comprehensive list of ways to help Haiti. The fastest way to get involved for most of you is also simple: send a text message that results in a donation (it will appear on your phone bill).

Text HAITI to 90999 ($10 to Red Cross)
Text YELE to 501501 ($5 to YĆ©le, Wyclef Jean’s development organization.)


*Hat tip to Clifford for the link.

Wednesday, January 13, 2010

Volunteer for a Clinical Trial

Over the past few weeks, you've probably been reading the From Ideas to Treatments series. In it, Jackie discusses the different stages of research, building up to clinical research trials. While we look forward to reading more in the series next week, today we can reflect on the difficulties of recruitment for clinical trials.

Volunteering to be part of a clinical trial - either as someone in medical need or as a healthy person - is a great way to serve your community.

Visit ClinicalTrials.gov for more information about how you can volunteer.

Be a part of research that saves lives.

Tuesday, January 12, 2010

Donate Blood

Our first suggestion for how to celebrate the National Day of Service is ....


When we think about donating things, we often think about food, clothes, or household items; all of which are incredibly important.

Next time you're thinking about donating as a means of serving your community, you should also consider giving a part of yourself - your blood.

Blood transfusions save lives, whether it be during routine surgery, as a treatment for a disease or condition, or to help those who have experienced trauma.

Only 3 out of every 100 Americans donate blood.* If you think you may be eligible, sign up for a local blood drive or visit redcrossblood.org to make an appointment to donate near you. If you're not sure of your eligibility, or have previously been turned away, double check the listed eligibility requirements as you may now be able to save up to three lives with a single pint of blood.

If you aren't able to donate for some reason, consider volunteering at a blood drive, encouraging friends to donate their blood, or look for other opportunities (instructing CPR, helping our during disasters, etc.) to volunteer with the American Red Cross.


*Only about 38% of Americans are eligible and only 8% do.

Monday, January 11, 2010

MLK Day of Service


A week from now, Americans from coast to coast will be celebrating the life of Dr. Marting Luther King, Jr. by making their day off a "day on" by participating in a National Day of Service.

In preparation for that, all this week, we'll be sharing ideas about what you can do to give back. To get started, check out mlkday.gov for more details or share your plans for the day of service in the comments!

Friday, January 8, 2010

Health Disparities in Clinical Research

The world is full of diverse populations.

As we round out the week, let's recap what we've discussed so far in the From Ideas to Treatments series.

We now know about basic research, animal research, what clinical research trials are, that recruitment is both extremely important to the success of the trial and difficult to achieve, and that there are regulations in place to insure the safety of participants. But there's one last aspect that we haven't broached yet, and that's the importance of recruiting a diverse population into the trials.

Why is diversity important? Well, think about who takes medications... seniors, adults, kids, all races and ethnicities, and both sexes. So, wouldn't it make sense to make sure that the drug or therapy is being tested on all of these individuals?

This is especially important because of the presence of health disparities. Basically, not everyone in the population has the same access to health care. Generally, when you hear about health disparities, people are referring to minority-based health disparities. Minority populations do not have the same opportunity for access to health care as the non-minority population, and because of this, minorities tend to have a higher instance of disease and death from diseases (like heart disease, diabetes, and cancer).

However, not all health disparities are based on race.

Have you ever watched the reality-TV show The Biggest Loser? Each week, people compete to lose weight, with the women tending to drop less weight than the men in any given episode. A guy might lose 15 pounds over the course of the week, whereas his female counterpart may lose 6-8 pounds (if she’s lucky). A lot of that has to do with the genetic difference between males and females. Females happen to be better at storing fat.

Based on that, and many other differences between women and men, there are sex-based health disparities. Women's bodies respond differently to medications, and they also tend to be more prone to certain diseases; like osteoporosis - which appears in older women frequently - heart disease and depression, among other things.

So, sex-based differences should also be an important consideration for researchers when testing new drugs and treatments in clinical trials. If you don't believe me, believe history:

In the 1980s, there was a trial held to test the effect of aspirin on heart attacks in men. The trial found that the aspirin decreased the chance of heart attacks in men. In 1995, a similar trial was started for women. Much to the surprise of the researchers, aspirin didn't decrease the instance of heart attack in women, but did decrease the chance of stroke. Same drug. Different response.

That means for years, aspirin might have been prescribed falsely for approximately half the population and hadn't been being prescribed members of that same half who might be predisposed to stroke.

Race, sex, age, pre-existing conditions, and environment all influence health, so what has been/is being done to make sure all potential groups are included in clinical research? Come back next week to find out how and why health disparities are playing a role in clinical research today.


This is Part 9 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Thursday, January 7, 2010

Recruitment

Photo credit: pixelens photogaphy

Given the multiple phases of clinical trials, there are thousands of patients needed to carry a drug from Phase I trials to FDA approval. Current estimations show that roughly 2% of our population actually participates in these clinical research trials annually. So, recruitment can be a huge obstacle to getting trials completed, and can stall a trial for years.

The recruitment process has three players. The clinical researcher conducting the trial recruits the health care professionals and the health care professionals recruit the patients. But there are barriers in each phase. Participating in these trials requires time and personnel that health care professionals may not have. For those health care professionals willing to participate, they might have a difficult time finding patients who are eligible, or convincing those who are eligible to enroll.

Previous Research!America polling has shown that public participation in clinical research trials is certainly lacking. Only 15% of people polled have ever participated in a trial. The good news is that the majority of those polled are willing to participate. One obstacle to their participation is that doctors are not talking to their patients about the trials.

So, take home message, if you're at all interested in participating, ask you doctor and/or do your own research (see resources below). Also, if you have a certain condition, like diabetes or heart disease, be sure to visit the websites of patient advocacy groups for those conditions (for example, the American Diabetes Association and the American Heart Association). And most importantly, you don't have to be sick to participate. There are plenty of clinical trials that need healthy individuals to enroll.

Resources:
Clinicaltrials.gov
Center for Information and Study on Clinical Research
Society for Women’s Health Research
NIH Office on Women’s Health
NIH Office of Minority Health and Research
FDA Information Sheet


This is Part 8 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Wednesday, January 6, 2010

Patient Safety in Clinical Trials: IRB Approval

How safe is it to participate in clinical research trials?

Last week, I talked about the lengthy process for approving protocols for animal research. Well, for humans, it’s a whole new ball game. Not shockingly, there is an even more extensive set of rules regulating the approval of protocols for human research. This approval is overseen by the Institutional Review Board (IRB). Depending on the extent of your research question, IRB-approval can delay the implementation of your research trial for years.

As you might imagine, the regulations for the use of humans in research are quite extensive. There are firm checks in place throughout the entire process that makes it extremely safe for volunteers to participate. And, there are personnel available to talk to you at length about the safety measures in place for each trials.

To learn more about participation, or to search the trials available if you are interested in volunteering, please see the following resources:

Clinicaltrials.gov
Center for Information and Study on Clinical Research
Society for Women’s Health Research
NIH Office on Women’s Health
NIH Office of Minority Health and Research
FDA Information Sheet


This is Part 7 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Tuesday, January 5, 2010

Clinical Research Trials

Getty Images: Mallory Cecil, 2009 NCAA Division I Women's Singles Tennis Champion

When I was in high school, I played tennis competitively. I loved to win, as all athletes do, but it was the games that I lost that taught me the most. Through defeat, I could see what strategies worked, and more importantly, which didn’t. Taking that one step further, I’d ask why that strategy failed, come up with a new and improved way to work that strategy, and try it at the next competition. If it worked, perfect. If it failed, the process repeated, but eventually I won the game. The scientific process works the same way.

Basic research can take years to develop a therapy that shows promise for humans. However, one of the great things about research is that even a failure is a success. Everything we do teaches us something, and advances our understanding of the field we’re interested in.

Once that strategy is perfected at the level of basic research, it’s time to test it on humans. Clinical research trials are exactly that: taking a basic research finding and applying it to a human population while asking a very specific health related question.

There are two types of clinical research trials: observational and interventional. Observational trials are just how they sound; you observe a population and ask a question about them without giving them anything. For example, one might ask what percentage of military veterans are afflicted with post-traumatic stress disorder.

Interventional trials are experiments in which the researcher intervenes with the population, giving them a drug or therapy to test its effectiveness. For example, a researcher might want to test if a new drug designed to decrease panic attacks could be helpful to military veterans with PTSD.

Before a drug can be available to the entire population, it needs to undergo interventional clinical research trials to test both its safety and efficacy. The clinical research paradigm is set up so that this is accomplished in three steps, called Phase I, II, and III.

Each phase has a slightly different question in mind, building on the findings from the previous study. The overall goal is to determine the usefulness and safety of the drug, while determining the proper dose and expected side effects. At the end of the three phases, the collected data is sent to the FDA so they can decide if the drug is safe enough.

Once the drug is approved by the FDA, trials may continue into Phase IV. It is during these trials (often observational) that researchers examine longer-term effects of the drug, as well as its cost effectiveness as compared to other approved treatments (commonly referred to as comparative effectiveness research).

Here's a simple chart that summarizes the differences between these phases:

This is Part 6 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

Monday, January 4, 2010

MMX

Calvin & Hobbes by Bill Watterson

Welcome to 2010 New Voices!

I hope everyone enjoyed the end of the year festivities. In the midst of all the toasting, cheering, and bowl-game watching, I imagine there was also some resolution making.

A couple of my resolutions for 2010 include:
  • Figuring out a more urban-friendly means of composting in my backyard
  • Being a more active commenter in the blogosphere
  • Exposing myself to new (to me) authors and literature
  • Finding advocacy opportunities (both personally and professionally)
What are your resolutions for 2010?