Guest Expert: Dr. Leslie Ford -- On Clinical Trial Accrual: A Little Planning Goes A Long Way
Originally posted by: Ellen Richmond, AccrualNet Co-Moderator, on the former AccrualNet site on Jul 29, 2011.
We are honored to introduce as our guest expert for July, Dr. Leslie G. Ford, M.D. , Associate Director for Clinical Research in the Division of Cancer Prevention at NCI. Dr. Ford, a pioneer in the field of chemoprevention, is an international authority on clinical trials and has been an advocate for clinical trials professionals throughout her career.
Dr. Ford's Post:
After 25 years in the world of cancer clinical trials, I am here to reassure you that although timely completion of patient accrual is difficult, it can be done! While there is not one singular strategy that will be the silver bullet for all trials, I have observed that the combination of several basic strategies increases the likelihood of study completion. First of all, prospective consideration of accrual feasibility and recruitment strategies is paramount. Study sites who plan in advance of opening a trial, based on the characteristics of the targeted patient population are more efficient and more commonly meet their goals (Schroen 2010). In that same vein, judicious study selection is essential. Sites should only open a study after determining that it addresses a need of it's current population (Baer 2010) and/or identifying potential participants to whom they have access. In this era of multiple providers of narrowly-focused services, sites need to think about and involve the multiple points-of-care that patients encounter. A cancer patient may discuss their diagnosis and develop a trusting relationship with medical and nursing personnel in subspecialty areas such as radiology, surgery, primary care, and depending on their disease – gastroenterology, orthopedics, neurology, physical therapy, and more. This means that educating and partnering with these providers could provide opportunities to many otherwise uninformed patients . Finally, sites with engaged PIs and enthusiastic, knowledgeable, well-trained trial managers and staff dedicated to their studies (Mc Donald 2006), are the ones who consistently enroll the most patients. These may seem like obvious factors but until all sites routinely plan and seriously consider recruitment in advance of study start-up, they bear repeating. That said, I know that if you are reading AccrualNet, YOU are the devoted clinical trials professional who is certain to achieve your accrual goals. Please share your approaches to accrual with us.
Leslie G. Ford, M.D.
Schroen AT, Petroni GR, Wang H, Gray R, Wang XF, Cronin W, Sargent DJ, Benedetti J, Wickerham DL, Djulbegovic B, Slingluff CL Jr. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials. Clin Trials. 2010 Aug;7(4):312-21.
Baer AR, Cohen G, Smith DA, Zon R. Implementing clinical trials: a review of the attributes of exemplary clinical trial sites. J Oncol Pract. 2010 Nov;6(6):328-30.
McDonald AM, Knight RC, Campbell MK, et al. What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials 2006; 7: 9.