Accelerating Patient Recruitment In Clinical Trials

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

About 2% of the United States population gets involved with clinical research trials each year; among those people who suffer from severe, chronic illnesses (including Alzheimer’s disease), only 6% participate. As a result, an increasing number of clinical trials are delayed because too few people ever know they had an opportunity to get involved. Recruitment strategies consist of effective campaigns that reach the intended population of potential patients. A strategy using several tactics will most likely achieve the best outcome. The art of patient recruitment is to cast a wide net, combining a patient-centric enrollment focus, involving the use of social media and conventional media, coupled with customer-“friendly” protocols. Investigative sites providing a high level of customer satisfaction may result in accelerating enrolment, improving retention and thereby reducing the overall study cost.

Patient recruitment and retention are clearly complex and challenging components of the clinical trials process. In the industry's foremost resource, A Guide to Patient Recruitment and Retention, the authors provide a wealth of practical advice and quantifiable examples on every aspect of patient recruitment. This book builds on the success of the original -- A Guide to Patient Recruitment -- by introducing many innovative, multi-faceted strategies designed to recruit and retain patients in clinical trials. Book jacket.

A step-by-step guide to developing and implementing a strategy for successful patient recruitment. It details practical approaches to preventing or solving the problems that can arise in every phase of the recruitment process. Samples of advertisements, brochures and other materials are included.

The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

Provides ideas for how to improve patient recruitment for clinical trials.

Patient recruitment is key to the success of any clinical trial, as clinical trials cannot be conducted without the willful participation of subjects. However, clinical trial recruitment has always been a great challenge in clinical studies. This practicum project conducted over an eight-month period, compares three different methods of subject recruitment into 2 clinical research studies conducted at the Heart & Lung Transplant and Pulmonary Research Department of Baylor Scott & White Research Institute, Dallas. The three recruitment methods are: Physician Referral, EHR Screening and Online Portals. We hypothesize that Physician referral is a more successful method for enrolling patients into clinical studies of different heart and lung diseases. A total of 333 potential subjects were identified via EHR screening or referred by physicians or signed up on the clinical trial portal to be contacted about the study. 108 patients were referred by physicians, 212 patients were identified via EHR screening and 13 patients signed up on the online clinical trial portal to be contacted for a study. By comparing the method of patient recruitment into clinical studies, we can ascertain what method works best in recruiting patients for clinical trials.