Andrew Hershey, MD, PhD, and Scott Powers, PhD, who co-direct the Headache Center at Cincinnati Children's will be leading a five-year study to be conducted at up to 40 sites across the United States. The study will be funded by a $12 million grant from the National Institutes of Health. The AHDA asked the study team to talk about the grant here since it relates to AHDA activities to increase NIH research funding. Here are the points they chose to share with us...
(1) How Research Comes Through the NIH:
Research is submitted to the National Institutes of Health (NIH) through many different institutes. Not only are there a variety of institutes, but there are a variety of types of grants that one can pursue. Research comes through the NIH through research training and fellowship grants (T award series), research project grants (R award series), research grant collaborative agreements (U award series), research program project or center grants (P award series), career development awards (K award series), and resource grants (various series of awards). The opportunities are oftentimes limitless, while at the same time, a conundrum of where one should begin. Depending on where an investigator is within their career and what the investigator is hoping to accomplish, the approach taken and grant type chosen will vary.
(2) How Hard it is to get a Grant:
In the current economic climate, while the available funding money at times seems frozen, there is a plethora of pathways and many avenues of research presented through grant submissions. The NIH is presented with thousands of promising grants each year by distinguished investigators and meritorious research teams. Many of these grants go unfunded each year. Earning a grant in today’s economic climate is a difficult task. One with persistence, zeal, and a team of great supports would consider themselves lucky to reach the full-funding, finish line. It is a sincere trial to earn grant funding.
(3) How We Got this Grant:
This grant was originally submitted as an R01 research project in 2010. With a promising score from the NINDS, we were asked to revise and re-submit as a U01 trial, a research grant collaborative agreement with the NINDS. At least 3 years of thought and planning went into making this grant a reality. During the planning stages, such efforts as attending Headache on the Hill in Washington, DC; consulting the top headache specialists in the nation; weekly conference calls between the data coordinating center and the clinical coordinating center; and team development and editing of documents helped to keep us in the running for a successful submission. With the recommendation to revise and resubmit, we diligently worked to respond to reviewers and aim at perfecting our original submission. We had an overall team meeting in Cincinnati connecting both the University of Iowa and the Cincinnati Children’s teams and tackled the grant reviewer’s responses one by one. Following that productive, in-person, meeting, each team assisted one another in preparing our grant re-submissions. The solid and well-concerted efforts within our teams and between our teams were of both promise and hopefulness. We really believed in our finished product. We had faith in the support and guidance of headache specialists across the nation. Paramount was the sentiment that this trial was both necessary and urgent, a true need to help serve the millions of children and adolescents who suffer from headaches not only in the United States, but around the world. The feedback from headache societies, groups, and specialists, even the NINDS, in their review of the initial grant submission, indicated this necessity. Our goal was to develop a grant that would respond to this void in evidence-based practice. Answering this call was the forefront of our work over the last three years. We received this grant by working together between our teams, as well as with headache societies, groups, and specialists, even the NINDS, as we responded to their revision requests for this pivotal project. We were honored to hear that the NINDS study section found merit in our refined approached to this international need to relieve headache and migraine pain in children and adolescents… a hope to help change the outcome and facilitate young headache suffers to develop into fully, functioning healthy adults; not missing out on work and life to deal with on-going migraine pain.
(4) How Big this Grant is:
This grant is an 18 million dollar award ($12 million to the Clinical Coordinating Center at the Headache Center of Cincinnati Children’s Hospital Medical Center and $4 million to the Data Coordinating Center at the Clinical Trials Statistical and Data Management Center of the University of Iowa) from the National Institutes of Health, specifically the National Institute of Neurological Disorders and Stroke. It will be the first grant of its kind; hoping to determine the best medication for preventing migraines in children and adolescents by comparing amitriptyline and topiramate (two medications often prescribed by headache specialists to prevent childhood migraine). With this grant, over five years, Cincinnati Children’s Hospital will train and reach out to 40 research sites across the United States to help answer this question on a national front. Overall, this study will involve 675 children and adolescents between the ages of 8 and 17. With this grant comes the opportunity to lessen the $36 billion national economic impact of migraine, as more than six million children and adolescents suffer from migraine in the United States.
(5) What this Grant may Accomplish:
This grant may elucidate which preventative medication works best to prevent migraine in children and adolescents. It would not only lead to the development of an evidence-based treatment paradigm, but economic relief for society – generating a potential impact within schools, family life, and the overall growth and development of youth dealing with migraine. Since the negative impact of having migraines on quality of life is similar to cancer, heart disease, and rheumatic disease within children, successful completion of this trial could profit today’s youth in many positive ways. Amitriptyline and topiramate have long been used in adults, but there has been little research in children. By comparing these preventative medications within this trial, headache specialists would have a better understanding of their (the medications) effectiveness in achieving relief of migraine pain in children and adolescents.
(6) What this Grant could do for Headache Medicine and for Patients:
This pivotal project could provide a pathway for headache medicine in the treatment of migraine in children and adolescents. Not to mention, the relief for patients and their families. Some patients have a daily, continuous headache that never goes away. If one or both of these preventative medications is found effective in preventing migraine headache, a significant burden would be lifted from the shoulders of this patient and their family. Clinician’s world-wide would have an evidence-based approach in the treatment of pediatric migraine.
(7) What Patients can do to get involved in this Grant:
Our greatest hope is that patients will get involved in this trial. We will need 675 patients between the ages of 8 and 17 to complete this study. Any patient suffering from at least 4 headaches per month is eligible for this research project. There will be 40 sites across the United States where patients can go to be screened for enrollment. If they meet the study criteria and agree to participate, we would be happy for them to be involved. To be involved, they would need to keep a record of their headaches on a daily headache diary, take their study medication each day, answer check-in phone calls and/or come in for study visits (depending on the time-point in the study), and complete questionnaires at their visits. Our overall goal is to get many patients who suffer from migraines across the various research sites within United States involved in this trial.
(8) Receiving this Grant is a Big Step, Headache Still has a Way to Go – How to Bridge Funding Gap:
Bridging the funding gap is just as daunting a task as building that first, well-constructed bridge in history. There are many great research ideas out there, but not all of them will appeal to the funding supporters. Dollars are limited during this time period. Ideas are many. One major focus could be on gleaning which projects would have the most profound impact within the disease populations of society, what teams can develop a proven track record of conducting research within these populations of people, and how can the dollars be divvied out in such a way to support the success of study patients and their families, the progression of the careers of those conducting the trials, and the capabilities of the overall funding sources to thus support the greatest number research projects at any one block of time. A healthy marriage of both economics and health care research could bridge this gap; however, as a body of scientists, no one wants to be floating down-river without toll to the other side. Working as teams of scientists might make bridging this gap achievable and allow for an overall encompassing, solid research project, one of exceptional promise and fortitude to influence the health care community upon completion. Writing economically-friendly grants will also leave funds in the coffers of institutes, societies, and funding bodies to serve other scientists and thus support on-going improvements within medical treatment, health care, the field of science itself, and most importantly, society overall.
Janelle R. Allen, MS,
Andrew D. Hershey, MD, PhD, FAHS,
and Scott W. Powers, PhD, ABPP, FAHS
on behalf of The CHAMP Study team (Childhood and Adolescent Migraine Prevention Study).
MS Allen is a research coordinator, and Drs. Hershey and Powers are Co-Directors of the Headache Center at Cincinnati Children's Hospital.