Faster, Cheaper, Better – It has been said that you can only have two of the three.
What does this have to do with Parkinson’s Disease and research and finding better treatments, and ultimately a cure? Well, almost everything that patients, clinical trial participants, researchers and advocates have been working at for a while now. The design world’s example of being able to choose only two of the three, rings true with the research world, but I propose a change that involves how clinical trials are funded, from individual grant funders, to the biggest funder of biomedical research in the world, namely the National Institutes of Health. The bottom line is that we all seek the same result, and if we’re totally honest and committed to getting to the ultimate goal, change needs to happen in a transformative way.
For a few years now, I’ve been working at trying to explain and change the mind-set of how much money by way of funded research has been wasted in dollars and time and effort when clinical trials are delayed or even canceled for lack of clinical trial participation. I’ll venture to say that many are delayed because of the chance to seek further federal funding if a good faith effort is shown to recruit and the results are just not there. I must qualify this by saying that there are many researchers in the U.S. and beyond whom are being good stewards of the funds received for the work that they do.
Some background information to highlight what is already being done and to ask why this isn’t being done across the board. Intramural research in Bethesda, Maryland, as part of the budget process requires that funding be available to get participants to them, regardless of the area of the country they live in, thus air travel, hotel, per diem, etc., are not an issue that needs to concern trial participants. I’ve termed the concern about having to worry about trial-related expenses as the “expense cloud”. I’ve experienced the intramural research process and I can vouch for the positive experience that results from the way we are treated, and for which most of us would not have any qualms about getting involved again.
Now to my proposed change. I propose that any patient-involved clinical trial that is funded by federal funds require that a set amount that is solely used for participant trial-related expenses be included in the budget. Can this be done the same way that intramural funding is being handled? I believe so. Can the funding formula be changed? Again, I believe so. The difference is that funding on the intramural side is required to be included in the budget. The extramural funding source, which includes the bulk of federal funding for biomedical research conducted around the country, only encourages applicants to budget an amount to be used for patient-related trial-related expenses. Unfortunately, as a few researchers have shared in the last few months, the first budget amount usually cut is this amount budgeted for travel-related expenses. And… that is if an amount was even included in the budget. This, in turn, causes the issues related to clinical trial recruitment to hit the next level. No volunteers…delayed trials. Delayed trials…request for extra funding from the funding source to keep the trial going.
And now back to whether we can have it all, rather than having to choose two of the three (faster, cheaper, better). I feel we are fighting a losing battle with trial recruitment even before we start trying to help fill the trials. Is there a sense of urgency to completing the trials on time? I’m starting to think that, for some, there isn’t. As we are all aware, research is not cheap by any stretch of the imagination, but rather than adding funding to keep trials going, require those funds to be included up-front, so that the playing field is leveled. No willing clinical trial participant should have to ask if funds are available to them to help cover the costs associated with getting involved in the research process. Only then, will we be able to have it all when it comes to clinical trials completed on time, with quality results out to the community, AND within the budget amount awarded. So..Faster results, Better results, at a Cheaper price are possible, if we are willing to transform the clinical trial process. There is no need to reform the process because much good is being done and credit needs to be given. Also, on the patient side of the process, the numbers of volunteers signing up on the Fox Trial Finder, now reaching 30,000, is a testament to how committed the patient community is to moving research to the next level.
I propose to change the way the funding is handled because, as one of several million people living with Parkinson’s Disease around the world, time is of the essence.