James Gibaldi

A case study focused on the quest for a potential Parkinson’s biomarker highlights the opportunities and challenges in site selection

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) aims to speed clinical research by removing obstacles that stand in the way of drug development. In pursuit of this mission, the Foundation gathers insights from a wide range of stakeholders and uses these perspectives to enhance clinical trial processes from start to finish. In 

Eye on Patient Advocacy series, we will share best practices and lessons learned from the field of Parkinson’s research that can be applied to clinical trials across disease states. In our sixth column in this series, we explore the importance of site selection for study success.	 

	The Systemic Synuclein Sampling Study (S4) was a multicenter, cross-sectional, observational study sponsored by The Michael J. Fox Foundation for Parkinson’s Research. The primary objective of the study was to better understand the progression of Parkinson’s disease (PD) by identifying the optimal biofluids and tissues for measuring the protein alpha-synuclein outside of the brain as a potential biomarker in individuals with PD. The secondary objective of the study was to create standard operating procedures for the collection and assessment of multiple tissues and biofluids to better understand alpha-synuclein’s potential as a biomarker for PD.

	S4 sought to enroll 80 participants meeting the following characteristics (with target enrollment of 20 participants in each category) :

		Individuals with early PD not requiring dopamine replacement therapy.

		Individuals with moderate PD on dopamine replacement therapy without motor fluctuations

		Individuals with advanced PD with motor fluctuations.

	The following section provides a condensed overview of the procedures that study participants underwent as part of S4. For additional information on the procedures and scientific rationale used in the study, please refer to the S4 peer-reviewed publications listed at the end of this article.

		Study staff informed and consented study participants for participation (i.e., study purpose, procedures, potential risks, and benefits were explained, and consent to participate was obtained). Their medical and family histories and any medications were reviewed. Participants’ vital signs were taken, and a general physical and neurological exam were performed. All participants completed MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Hoehn and Yahr scale (H&Y), Montreal Cognitive Assessment (MoCA), Scales for Outcomes in Parkinson’s Disease.

		Autonomic Dysfunction (SCOPA-AUT) and University of Pennsylvania Smell Identification Test (UPSIT). Individuals with PD received Modified Schwab & England Activities of Daily Living Scale and PD stage assignment.

Biofluid collection and skin biopsy visit

		Whole blood, serum, and plasma were collected through routine venipuncture.

		Cerebrospinal fluid was collected through lumbar puncture under local anesthesia.

		Saliva was collected through 20-minute active drool collection.

		Approximately four samples of thigh and upper back/shoulder skin were biopsied using skin punch under local anesthesia.

		Approximately eight samples of colonic tissue were biopsied from study participants using routine clinical procedures.

		Approximately five samples of submandibular (type of salivary) gland tissue were biopsied using a 16-gauge needle inserted through the neck under local anesthesia.

	The number and type of procedures, as well as the variation in recruitment target population, made the S4 research protocol highly complex. The S4 Steering Committee was aware that this was a potential barrier to successful study implementation and determined that careful selection of sites would help to mitigate this issue. To enhance the site-selection process, the S4 Steering Committee: 1) identified and prioritized site-level characteristics necessary for study implementation; 2) developed a checklist to evaluate sites in person; and 3) conducted in-person site visits.

Identified and prioritized site-level characteristics

	The characteristics identified by the S4 team as most critical to study implementation were:

		Site personnel experience in implementing clinical studies that involve collecting biospecimens.

		Access to the population(s) of interest.

	Each of these characteristics addressed an area of complexity in the research protocol. Experienced site personnel provided additional confidence around the ability to conduct study procedures that were both precise and invasive. Strong site infrastructure ensured that samples were collected in a standardized manner and mitigated concerns around data quality. Access to the population(s) of interest ensured greater success in recruitment and reduced trial delays. This information was assessed by asking invited clinical sites to complete a site interest form. The forms were then evaluated and prioritized by the S4 Steering Committee.

	The S4 Steering Committee created a checklist that was broken out by the three priority characteristics (experience, site-level infrastructure, and access to the population of interest). Within these categories, specific criteria were listed that provided a measure of how well the site ranked on that characteristic (level of experience, type of equipment, access to storage, etc.).

	S4 Steering Committee members visited each of the sites under consideration based on their responses to the site interest form and, using the checklist, evaluated them on the priority characteristics. Sites were selected to participate in the S4 study if they adequately met the criteria for participation, including documented experience collecting biospecimens from a PD population, site infrastructure requirements (such as collaborations with gastroenterologists and ear nose and throat specialists), and recruitment plans for the population of interest.

	S4 was able to recruit its full target population in a timely manner: 82 individuals were recruited to participate in S4 within 21 months (see Table 1). Although recruitment for the trial took three months longer than originally projected, the S4 Steering Committee considered this to be successful, particularly taking into account the harder-to-reach target population and complex protocol.

	While a comprehensive site-selection process may require a significant investment of time and resources at the outset, the benefits may outweigh the long-term risks (e.g., study delays, additional financial resources, high attrition rates, inability to meet enrollment goals).

 Developing a checklist such as the one used by the S4 Steering Committee can facilitate the site-selection process and lead to more open lines of communication between study sponsors and sites. Sites have an opportunity to share their interest, background, and experience, and sponsors can dig deeper into questions they may have about the ways which the protocol and operating objectives align.

To learn more about the S4 study, see the following peer-reviewed publications:

Chahine LM, Beach TG, Seedorff N, et al. Feasibility and Safety of Multicenter Tissue and Biofluid Sampling for a-Synuclein in Parkinson’s Disease: The Systemic Synuclein Sampling Study (S4). Journal of Parkinson’s Disease, in press. 2018

Beach TG, Serrano GE, Kremer T, et al. Systemic Synuclein Sampling Study (S4). Immunohistochemical Method and Histopathology Judging for the Systemic Synuclein Sampling Study (S4). J Neuropathol Exp Neurol. 2018 Aug 13. doi: 10.1093/jnen/nly056.

Visanji NP, Mollenhauer B, Beach TG, et al. Systemic Synuclein Sampling Study (S4). The Systemic Synuclein Sampling Study: toward a biomarker for Parkinson’s disease. Biomarkers in Medicine. 2017;11(4):359-368.

		Beth Harper and David Zuckerman. “Critical Success Factors for Planning for Site Selection and Patient Recruitment Planning.” 

The MJFF Research Engagement Team includes 

, Research Partnerships Officer; all at The Michael J. Fox Foundation in New York, NY. To contact the MJFF Research Engagement Team, email: 

MJFF would like to acknowledge the following individuals for their contribution to the research presented in this case study: Lana Chahine, MD (Co-PI), Sherri Mosovsky, Brit Mollenhauer, MD, PhD (Co-PI), Danna Jennings, MD (ex oficio), John Seibyl, MD, Vanessa Arnedo, Lindsey Riley, Kuldip Dave, PhD,Tatiana Foroud, PhD, Thomas Beach, MD, Charles Adler, MD, PhD, Chris Coffey, PhD, Dixie Ecklund, RN and the Systemic Synuclein Sampling Study (S4); and Sarah Berk, MPH.

Articles

Case study focused on quest for potential Parkinson’s biomarker highlights opportunities and challenges in site selection.

The Importance of Site Selection

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) aims to speed clinical research by removing obstacles that stand in the way of drug development. In pursuit of this mission, the Foundation gathers insights from a wide range of stakeholders and uses these perspectives to enhance clinical trial processes from start to finish. In

’ Eye on Patient Advocacy series, we will share best practices and lessons learned from the field of Parkinson’s research that can be applied to clinical trials across disease states. In our fifth column in this series, we explore the use of a ride-sharing service to reduce transportation barriers for research participation.

	In January 2017, The Michael J. Fox Foundation launched a survey to assess the need for transportation infrastructure at clinical trial sites. Using Fox Trial Finder, MJFF’s online clinical trial matching tool, 843 clinical trial sites in the U.S. were contacted to understand how transportation access impacts participant recruitment, and what kind of transportation participants would find most helpful. Of the 49 sites that responded, 95% reported that transportation infrastructure would improve recruitment efforts, and 63% felt it would ensure all studies recruited on time. Eighty-four percent of respondents reported that a taxi, livery, or ride-sharing service partnership would be the preferred transportation infrastructure.

	Data from the survey was used to inform the design of a transportation intervention that was tested via the Parkinson’s Disease Trial Recruitment Innovation (PD-TRI) project, an MJFF-funded pilot study aimed at reducing barriers and enhancing facilitators to clinical trial recruitment.

	To participate in PD-TRI, project sites had to be based in the U.S., be geographically diverse, and have large clinical research portfolios. One of the three selected sites, Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA, elected to implement a partnership with a ride-sharing service. The study principal investigators, Samuel Frank, MD, and David K. Simon, MD, PhD, felt that providing round-trip transportation to research appointments would alleviate stress and logistical challenges for study participants (e.g., finding parking, relying on a care partner for transportation, transportation costs).

	BIDMC used a template to collect data on the cost of the service and the coordinator time required to arrange it, and assess the impact of the transportation service on recruitment. BIDMC also used a study satisfaction survey to gather insights on participants’ experience in the study and use of the transportation service. (To view and download an example of a study satisfaction survey, visit 

	To partner with a ride-sharing service, BIDMC signed a terms-of-service agreement and implemented a payment system. To use the service, coordinators worked with each study participant to determine a pickup location. The coordinator then arranged the ride in advance using a simple web portal. This removed the need for study participants to have a smartphone or online connection. After completing the ride, the ride service could either charge an institutional credit card or send a monthly invoice to the clinical trial site, thereby removing the stress or logistics of reimbursement from the study participant.

	To protect patient privacy, the ride service allows sites to provide an alias or only the patient’s first name when requesting rides. If a site happens to provide a person’s full name, the driver receives only the first name and last initial. Moreover, passenger information disappears from the driver’s phone once the ride is complete. To ensure the ride-sharing service was ethical and compliant with patient privacy regulations, BIDMC developed a protocol describing the service that was approved by its institutional review board (IRB).

	After a preliminary phone screening to determine study eligibility, individuals were offered rides via the ride service. Data on individual acceptance of transportation, cost and timeliness of rides, and coordinator time spent arranging rides were collected via the template. Participants filled out a study satisfaction survey at their baseline visit to assess the impact of transportation on their decision to enroll in the study.

	Data from the BIDMC and ride-sharing partnership are provided in Table 1 and Figure 1. Data from only one BIDMC study are provided, as recruitment for other studies was limited during the PD-TRI study.

	Results provide insights into the impact of providing transportation on clinical trial recruitment efforts:

		Individuals who live farther from the clinical trial site seem more likely to accept rides, indicating that transportation infrastructure may help clinical trial sites engage with harder to reach populations and broaden their recruitment networks.

		While providing transportation may seem expensive, the average round trip cost (two rides) is $96.37. This figure is quite small in comparison to the average total costs of a Phase III clinical trial (between US $11.5 million [dermatology] and US $52.9 million [pain and anesthesia]).

		Coordinators spend a minimal amount of time and effort to coordinate rides, and from the patient satisfaction surveys, this service appears to provide a great amount of benefit to study participants. Providing this service may help mitigate study attrition.

		Although study participants indicated that they likely would have participated in the current clinical study even without being offered transportation, they responded very positively to the service, with all participants reporting that the rides made it easier for them to attend appointments. This suggests that the provision of transportation could improve participant retention in a study. Also, 90% of respondents agreed or strongly agreed that they would be more likely to participate in another study in the future if transportation were provided. This indicates that providing transportation not only helps recruitment, but also is an asset for long-term community engagement.

		Third-party ride services can be used in a manner that protects participant confidentiality.

Key considerations for sites contemplating transportation partnerships

		Clinical sites seeking to establish a partnership with a transportation service should request contractual materials from the potential partner, share these with internal grants administrators for review, and seek IRB approval.

		Factor in additional time prior to study start-up for contract negotiations and testing any software or processes associated with the partnership. An institution-wide contract with a ride-sharing service may take significantly longer to implement than one for a single study.

		Develop detailed protocols that determine when and how often individuals will be offered rides, and whether they will be offered transportation for visits throughout the full duration of the study.

		Create systems to evaluate your transportation service and determine how it impacts recruitment at your site.

	To learn more about this transportation pilot, read the “Transportation Innovation to Aid Parkinson’s Disease Trial Recruitment” publication in 

Contemporary Clinical Trials Communications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804741/

		Sertkaya, A, et al. “Key cost drivers of pharmaceutical clinical trials in the United States.” 

. 2016 Apr;13(2):117-26. doi: 10.1177/1740774515625964. Epub Feb 8, 2016.

		Frank, S, et al. “Transportation innovation to aid Parkinson disease trial recruitment.” 

. 2019 Sep 10;16:100449. doi: 10.1016/j.conctc.2019.100449. eCollection Dec 2019.

MJFF would like to acknowledge the following individuals for their contribution to the research presented in this case study: Samuel Frank, MD, David K. Simon, MD, PhD, Laura Hernandez, Holly Shill, MD, Penelope Hogarth, MD, and Sarah Berk, MPH.

Recruitment study tests the use of a ride-sharing service.

Overcoming Transportation Barriers to Trial Participation

’ Eye on Patient Advocacy series, we will share best practices and lessons learned from the field of Parkinson’s research that can be applied to clinical trials across disease states. In our fourth column in this series, we explore retention strategies used in a landmark longitudinal Parkinson’s disease (PD) study.

	To complete a study, it is critical to retain study participants. Participant attrition has the potential to interfere with the scientific validity of a study and distort data designed to measure drug efficacy and safety. According to Forte Research:

		Eighty-five percent of clinical trials fail to retain enough participants.

		The average dropout rate across all clinical trials is 30%.

Patient retention is an important element of the Parkinson’s Progression Markers Initiative (PPMI), a landmark, longitudinal, observational study sponsored by The Michael J. Fox Foundation. PPMI (ppmi-info.org) aims to find reliable and consistent biomarkers for PD progression by studying cohorts of Parkinson’s patients (de novo idiopathic PD and PD-manifesting genetic mutation carriers), populations at risk for PD (non-manifesting genetic mutation carriers and subjects at risk due to REM sleep behavior disorder or hyposmia), and controls without PD.

	Participants in PPMI commit to long-term participation, providing biospecimens (e.g., blood, urine, spinal fluid), and undergoing multiple neuroimaging, clinical and behavioral procedures, and assessments over a period of at least five years.

	The study launched in 2010, and since then, approximately 1,500 individuals have enrolled. PPMI’s retention rate has consistently held strong, year after year, at about 86%.

	To ensure steady participation and to prevent attrition, PPMI weaves together four key tenets of retention, cultivated and refined since study launch: 1) facilitate participation; 2) communicate study progress; 3) express appreciation; and 4) inform participants of study results.

Facilitate participation through travel concierge services, reimbursement, and remote visits. 

PPMI study leadership prioritized and simplified long-term participation in large part because individuals carrying specific PD-linked genetic mutations live across a wide geographical area. To facilitate volunteers’ continued participation, PPMI cultivated a boutique experience for them and their care partners. Prospective and enrolled PPMI participants are given the option for complimentary roundtrip transportation between their home and appointments at two “super sites” that have the capacity to handle a high volume of study volunteers.

	A third-party vendor manages all logistical planning, including participants’ accommodations, meals, and travel to and from study visits. This door-to-door service reflects the value PPMI study leadership puts on participation and participants. For participants who choose not to travel to a super site, travel and hotel expenses are reimbursed through Greenphire/ClinCard. PPMI leadership is always looking for ways to reduce participant burden and is currently exploring the possibility of remote (video and enhanced phone) and home visits.

Communicate study progress through newsletters, update calls, and a centralized webpage. 

Reminding participants of the bigger picture is a meaningful way to engage them in the collective success of a study. According to a 2017 report by The Center for Information and Study on Clinical Research Participation,

 the number one reason individuals choose to participate in clinical research is to help advance science or the treatment of a disease or condition. Given this initial motivation, updates on study progress and contributions to the field will facilitate continued engagement. In PPMI, study progress is communicated in several ways:

		PPMI newsletters provide high-level updates on the study (e.g., study enrollment progress, how the data and samples collected are being used for research) as well as interviews or profiles of study participants and/or study staff.

		PPMI update calls, which are scheduled throughout the year, feature presentations and Q&A sessions with study researchers and study team members.

		A PPMI participant webpage allows centralized access to digital versions of the participant newsletters and recordings of study update calls.

		PPMI blog provides regular news about the study, including recent findings that have emerged from the data.

Express appreciation through a thank-you booklet. 

Letters from members of the Parkinson’s community, researchers, MJFF staff, statisticians, and study coordinators were published in a print and digital booklet to thank and honor volunteers for their participation. Collecting the personal reflections of the many individuals involved in or impacted by PPMI is a meaningful way to empower participants and remind them of the larger cause they are tied to.

Inform participants of study results through newsletters, update calls, and a webpage. 

volunteers (90%) want to receive results from the clinical trial in which they participated.

 Because there is ongoing analysis of PPMI data and continued follow up of participants, study results are shared on a rolling basis. Using familiar channels to communicate study progress is a great way to close the loop with study participants.

	PPMI staff and study leadership also show their commitment to the study’s success, and their appreciation for participants, by hosting annual study update luncheons and dinners that incorporate all the tenets of retention. Having an in-person get together gives participants the chance to meet other volunteers and share experiences of living with PD and taking part in PPMI. During these events, local site staff present study progress and provide relevant results from ongoing data analysis. Michael J. Fox Foundation staff also attend and, together, all study stakeholders thank participants for their time and commitment.

Data used in the preparation of this article were obtained from the Parkinson’s Progression Markers Initiative (PPMI) database (

). For up-to-date information on the study, visit 

PPMI-a public-private partnership-is funded by The Michael J. Fox Foundation for Parkinson’s Research and funding partners, including AbbVie, Allergan, Avid Radiopharmaceuticals, Biogen, BioLegend, Bristol-Myers Squibb, Celgene, Denali, GE Healthcare, Genentech, GlaxoSmithKline, Lilly, Lundbeck, Merck & Co., Meso Scale Discovery, Pfizer, Piramal, Prevail Therapeutics, Roche, Sanofi Genzyme, Servier, Takeda, Teva, UCB, Verily, and Voyager Therapeutics.

		Lopienski, Kristina. “Retention in Clinical Trials – Keeping Patients on Protocols.” Forte Research. June 1, 2015. https://forteresearch.com/news/infographic/infographic-retention-in-clinical-trials-keeping-patients-on-protocols	

		The Center for Information and Study on Clinical Research Participation (CISCRP). “2017 Perceptions & Insights Study: Public and Patient Perceptions of Clinical Research.” https://www.ciscrp.org/wp-content/uploads/2019/06/2017-CISCRP-Perceptions-and-Insights-Study-Participation-Experience.pdf	

		Getz, Kenneth. “Events That Have Shaped Study Participant Protection.” The Gift of Participation: a Guide to Making Informed Decisions about Volunteering for a Clinical Trial, 2nd ed., CISCRP, Center for Information & Study On Clinical Research Participation, 2014, pp. 158–158.

, MA, Associate Director; both with The Michael J. Fox Foundation in New York, NY. To contact the MJFF Recruitment and Retention Team, email: 

MJFF would like to acknowledge the following individuals for their contribution to the research presented in this case study: Vanessa Arnedo, MPH, Sarah Berk, MPH, Sohini Chowdhury, MA, Tara Hastings, MA, Catherine M. Kopil, PhD, and Alyssa Reimer.

A case study of the Parkinson’s Progression Markers Initiative.

Retention Strategies for Keeping Participants Engaged

Physicians play a critical role in facilitating patient participation in clinical research.

 In fact, a poll by Research!America found that 72% of respondents would participate in a trial if their doctor recommended it.

 However, general practitioners often are not involved in the recruitment strategy for clinical trials. Historical barriers have made engagement with physicians challenging. They may fear losing care of patients to clinical trial site providers, be unfamiliar with the trial and principal investigator (PI), or have concerns about jeopardizing the doctor-patient relationship.

 One approach to building trust and overcoming these obstacles is for research institutions and PIs to actively engage with community physicians. Reaching out to local physicians to increase knowledge about trials and generate confidence can facilitate referrals. We explore this theme in our third column in 

	The Institute for Neurodegenerative Disorders (IND) serves as a prime example of how research institutions can better engage with community physicians to build referral networks. Founded in New Haven, Conn., in 2001, IND develops diagnostic tools and treatments for individuals with neurodegenerative disorders. Its founders, Kenneth Marek, MD, and John Seibyl, MD, bucked the traditional research institution model. Foregoing regular clinic hours, they focused instead entirely on clinical research studies. This novel approach meant that trials conducted at IND had to rely heavily on patient referrals from community clinicians.

	Through several years of dedicated outreach to clinicians in the community, IND built a referral network of neurologists located across Connecticut. As a result, the top two referral sources for trials at IND are: 1) new patient referrals from community clinicians, and 2) a database of patients referred to past IND studies. This resource of patient referrals has made IND a top recruiting site for Parkinson’s disease (PD) studies, including the 

Parkinson’s Progression Marker Initiative

, a longitudinal observational study sponsored by The Michael J. Fox Foundation. IND may seem uniquely positioned for success in the development of a physician referral network, but Director of Clinical Research David S. Russell, MD, PhD, believes that traditional research institutions can easily replicate these efforts. Dr. Russell outlines a three-tiered strategy to facilitate engagement and long-term relationship building among community physicians:

Learn about the practices in your community

	To maximize your time and effort, do online research about local practices. Begin with clinics that are most likely to see individuals with the condition you seek. For IND, neurologists historically have provided the most referrals for their neurodegenerative disease studies. Consider connecting with primary care physicians and allied healthcare professionals, but prioritize specialty physicians as they may more frequently engage with your target population.

Understand the needs of community clinicians

	Ask physicians about challenges they may be facing in their practices. For example, a community neurologist may be having difficulties diagnosing a patient. Offer to provide an expert second opinion and send your recommendations. Point out research studies that include procedures and assessments that physicians may find useful to treat their patients. For instance, Dr. Russell has found that community physicians often seek DaTscans for their PD patients. In addition, explain the various patient wellness programs available at your site, such as support groups, education events, and fitness/wellness classes. Patients can learn about recruiting trials at your study site through these programs.

	In addition to sharing the latest in PD research and recruiting trials, remind community physicians that these studies are necessary for the discovery of biomarkers and new and improved treatments. Physicians want the best care for their patients. Reminding them of the importance of clinical research in this process may motivate them to provide referrals. Explain that clinical trials give patients treatment options and access to certain procedures, such as a imaging, at no cost.

	Developing a partnership with community physicians cannot be done overnight. It took years for IND to forge the relationships it has today. At the outset of building a referral network, remember it will take time and effort to be successful.

	When trying to engage with community clinicians, there is no substitute for a face-to-face meeting. Begin by calling the practices you have identified. Introduce yourself, provide them with background on your research, and let them know that you are trying to generate awareness about research studies at your institution. Invite the clinician(s) to your office for a discussion with other medical providers from the community about the latest advances in research and any trials that are currently recruiting. Maximize your time and the number of physicians you can connect with by hosting the meeting in your office or another location that can accommodate a bigger group. If a physician rejects the invitation, be persistent and ask for times that you can drop by their office.

	Make the process of referring patients as simple as possible. Give local practices study flyers and brochures for patients to read in the waiting room and discuss with their doctor. Provide physicians with pocket cards listing high-level eligibility criteria to quickly reference when examining patients. Avoid presenting community clinicians with eligibility criteria not usually gathered through standard clinical care, such as scales and questionnaires used in clinical trials. Physicians may rule out patients if they are unfamiliar with some eligibility criteria. Supply practices with a fax referral form to easily send contact information and a note about interested patients. Obtain patients’ contact information, with their permission; this is faster and more efficient than waiting for patients to call the research site.

	Assure community clinicians that your intention is to expand awareness about research opportunities and help interested patients find a study that is right for them. To alleviate fears that they may lose patients to healthcare providers at your institution, consider the following language: “We will provide only the care necessary to conduct the trial and to ensure patient safety. We will refer the patient back to you for any clinical issues.”

	Update referring clinicians about their patients on a regular basis. If a patient is not eligible for any recruiting studies at the site, send the referring physician a note expressing your gratitude for the referral and explain why the individual was ineligible. If a referred patient is a study candidate, inform their doctor and make yourself available to answer questions. Upon enrolling a referred patient into a study, send their physician an email or letter explaining any medical precautions or exclusionary medications. After a patient is enrolled, provide the referring physicians with updates around milestones, such as a patient’s test results and study withdrawal and/or completion. Consider organizing a group meeting or webinar to explain study results to all referring physicians.

Reinvigorate your physician referral network

	Building a referral network is an ongoing process. Physicians leave practices and new ones are added. It is important to develop new partnerships and maintain existing relationships. IND invites community clinicians from across Connecticut to dinner twice a year to discuss advances in Parkinson’s research and new treatments or challenges in the field. A biannual webinar also can serve as an alternative to an in-person meeting. Remember to express gratitude to physicians in your network for their continued commitment to advancing research.

	While there is no denying that building a physician referral network takes time and dedication, expanding research awareness to more clinicians and ultimately more patients can help accelerate recruitment for clinical trials.

For more information on the Institute for Neurodegenerative Disorders and its work, visit 

		Getz, Kenneth A. “Enabling Healthcare Providers as Facilitators of Patient Engagement.”

http://www.appliedclinicaltrialsonline.com/print/343713?page=full

		Staff Reports, Research!America. “Poll: Majority of Americans Would Participate in Clinical Trials if Recommended by Doctor.” Elsevier. July 31, 2013, 

https://www.elsevier.com/connect/poll-majority-of-americans-would-participate-in-clinical-trials-if-recommended-by-doctor

		Ramirez, Amelie G. et al. “Early Phase Clinical Trials: Referral Barriers and Promoters among Physicians.” 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3782313/

		Michaels, Margo, et al. “Impact of Primary Care Provider Knowledge, Attitudes, and Beliefs about Cancer Clinical Trials: Implications for Referral, Education and Advocacy.” 

, MA, Associate Director; both with The Michael J. Fox Foundation in New York, NY. To contact the MJFF Recruitment and Retention Team, email: 

MJFF would like to acknowledge the following individuals for their contribution to the research presented in this case study: David S. Russell, MD, PhD; Sarah Berk, MPH; and Catherine M. Kopil, PhD.

Exploring the Institute for Neurodegenerative Disorders’ non-traditional approach to engaging community physicians.

James Gibaldi

Articles

The Importance of Site Selection

Overcoming Transportation Barriers to Trial Participation

Retention Strategies for Keeping Participants Engaged

Building a Physician Referral Network: A Case Study