Site Optimization and Enhancing Subject Recruitment and Retention in Clinical Trials 2009

David M. Shearer, MD: CMO/ VP of Clinical Operations: ICTS, LLC

I.      INTRODUCTION

The clinical trial process involves many variables which often times jeopardize the successful achievement of study milestones. Approximately 58% of Phase III clinical trials are unsuccessful, with the primary cause for failure being the inability of the trial data to demonstrate efficacy of the tested product against placebo1. This is demonstrative of a severe need in clinical trials for improvement at the site level to maximize performance and ultimately have a positive influence on the quality of study data and results.

There are three major segments of the clinical trial process which can have a direct influence on the timely success of any clinical study: pre-study, active study duration and post-study follow up. Site optimization focuses on efficient transmission of study information between the sponsor and the investigators and coordinators, providing recruitment and enrollment assistance to maximize site performance within the context of their own patient rosters and standardizing the levels of subjective information provided through the collection of study data. The ultimate goal of the site optimization process is to provide enough education and supervision during all three segments of the clinical trial process, therefore providing the sites with the empowerment and tools to conduct a higher quality of research.  This potentially affects their ability to differentiate from placebo, giving the clinical study it’s best chance for success when submitting study results for government review. By “optimizing” site performance in these three areas, studies are far more likely to result in cost-efficient, successful navigation of the clinical trial continuum.

In today’s financial crisis, the cost of clinical trials is significantly impacting decisions to move forward with studies, with many trials described as “nice to have” but not mandatory. This type of thinking may severely impact new drug application submissions if effective communication and confirmation of study requirements is not achieved between the sponsor and Food and Drug Administration. The cost per patient of running Phase 3 clinical studies of new pharmaceuticals exceeds $26,000, on average, according to a new benchmarking report, “Clinical Operations: Accelerating Trials, Allocating Resources and Measuring Performance”2. CMSInfo, Chesam, UK, reports that national spending on clinical trials in the United States was nearly $24 billion in 2005. Results are forthcoming, but the research institute expects this number to rise to $32.1 billion in 2011—growing at an average rate of 4.6% per year3.  This ever rising cost of clinical research is further proof that any investment in clinical studies must be optimized to eliminate the possibility of repeating phase work or eliminating a viable compound from the pipeline.

Site optimization is a comprehensive view towards constant evaluation of study status while incorporating a plan whereby sites are provided with the awareness, education, training and tools necessary to meet the challenges of a more sophisticated clinical trial environment. This paper discusses many of these points, in addition to pre-study, study, and post study activities in order to enhance the objectivity of the reader and also point out those areas in need of further delineation for incorporation into the clinical trial process.

Development of site optimization processes that address today’s economic and quality challenges in clinical trials involve four main functions: (1) evaluation of the protocol and its relationship to site performance, (2) determination of site performance strategy and site solution, (3) implementation of the solution, (4) follow up. These areas are depicted in figure 1 below.

Figure 1: Steps involved with Site Optimization:

Although this process may appear intuitive to the reader, it is a practice that is not being utilized and has significant importance in the establishment of a productive sponsor-site relationship. The incorporation of site optimization into the clinical trial process begins much earlier than post study start. In fact, the intent of this paper is to also delineate how site optimization is incorporated at different levels in a study time line.

I.      PRE-STUDY LEVEL:

A protocol, if not designed accordingly to encompass and address the needs of the study subject, will ultimately yield both recruitment and retention issues. Planning ahead and identifying study needs to better define recruitment and roll out strategies is vital to successfully achieving study timelines. Site selection is crucial in choosing those physicians who can conduct a particular study with quality while also satisfying corporate timelines.  Investigators selected must meet criteria for patient roster counts to fulfill inclusion/exclusion criteria as well as time available to schedule study visits outside of the normal day-to-day requirements of the medical practice.  The best study participants, in terms of recruitment, consent rates, retention and compliance, come from within the site’s current patient rosters as the doctor-patient communication model is already well established.  Providing sites with the tools necessary to maximize study participation performance drastically reduces cost and time of enrollment.  Additionally, effective training and education of both sites and participating subjects enhances compliance and therefore the integrity of the study. Follow up with the sites to assure that study procedures are being conducted properly aids in reducing compliance and regulatory issues. Providing continuous communication of study status to the sponsor results in quick maneuverability to incorporate change and will yield a more positive study outcome.

Protocol Design:

When considering study design, there are a number of areas which require assessment. Too often, the statistical significance and power of the study is placed as a priority while objectivity is lost in areas such as the frequency of study visits, patient demographics, number and duration of tests per visit, transportation requirements and patient reimbursement. In fact, complex and complicated study designs continue to place a burden on not only the sites conducting the study, but also on the patients4. The protocol and case report form (CRF) design should be reflective of a systematic, easy to follow routine which is not overburdened by a demonstrative number of study procedures and visits. The CRF should also be systematic and time efficient in its design and implementation.

Set up for Success

Anticipating challenges in the patient lifecycle in a clinical trial begins with the design of the protocol.  Too often, the study’s procedures and visit schedule are designed without taking into consideration a likely patient profile.  When considering study design it is essential for the protocol development team to put themselves in the position of the patient candidate and ask themselves whether the procedures, study visit schedule, dosing regimen or other diagnostic and treatment variables will hinder a patient’s willingness to participate and comply with the study requirements. 

Some of the factors that might be considered during protocol development might include the following:

  • What is the patient’s motivation for considering entry into the study?
  • What is the average day like for a patient with this condition?
    • Receiving standard of care?
    • Not receiving any care?
    • What is the level of commitment required by the patient?
      • By a family caregiver?
    • Is the study treatment more painful (irritating) than the condition?
    • How will the study interfere with the patient’s life during the course of the study?

By answering these questions the sponsor can begin to develop solutions to meet challenges in patient enrollment, retention and compliance before the study is initiated.  Proactive development is a major component of the site optimization process.

It is easier for a subject to comply with the demands of a study when patient concerns have already been taken into consideration. A typical example may involve a study whereby a specific test is required and the patient has to drive 15 miles or take a bus to obtain this study measurement and then return for additional study procedures. A few times of “up and back” quickly result in the disillusionment of the study subject and increases the liklihood of early termination. The selection of a facility which offered a higher level of convenience for the study subject may have maintained his/ her interest and study withdrawal would have been avoided.

Designing study materials with the subjects’ best interest in mind as a priority will ultimately yield better regulatory assurance and compliance. Naturally, if study tablets and capsules are oversized due to over-encapsulization, patients will have difficulty taking them. Difficulties also arise with blistering and opening of packages, especially in a geriatric population. Clear labeling with multilingual capacity to enhance understanding and dosing will aid in the reduction of compliance issues. Improving patient compliance in clinical trials via “smart packages and smart design” may aid in addressing issues such as subject embarrassment, losing faith in efficacy, forgetfulness and misinterpretation of prescribing information, not to mention the potential for benefit verses risk7.

By anticipating patient participation challenges the sponsor is far more likely to be able to accurately predict patient discontinuation rates during every step of the process, from consent to study completion.  Building the protocol with the patient in mind ensures that the sponsor can deliver a faster enrolling, more compliant study population.

Defining Study Needs:

Defining study needs begins prior to the start of the study. First, establish the goals and objectives of the study in order to effectively incorporate them into the protocol and CRF. Too many trials have been conducted whereby the question arises midway into the study as to why the study was conducted that way? If the primary and secondary objectives are clear, then the design should follow in support of this.

Planning for the challenges of recruitment, enrollment and retention should be conducted during protocol design.  Establishing budget for recruitment should be based upon the protocol’s difficulty level in the areas of patient identification, patient motivation for entering the study, availability of enough patients within investigator practices to fulfill enrollment goals and the study’s processes and visits as they may impact retention and compliance.  Making sure sites are adequately funded for recruitment stipends is essential to recruitment success.  In the case of extremely difficult studies where many applicants are needed to result in a single, enrolled patient, it is advisable to define a plan for enrollment of patients from outside the practice, a much more time consuming and costly process.

Finally, determining the average number of anticipated post-consent screen fails will help you establish a benchmark reimbursement program for the sites.  This is essential in keeping sites motivated for the duration of the study and operationally maximized in terms of patient processing. 

Establishing a panel of “typical” investigators during protocol design can assist in defining your recruitment and retention strategies and how they will be executed.

Site Selection and Globalization of Clinical Trials

As enrollment in clinical trials in the US has decreased, the pharmaceutical industry has sought out other regions to facilitate the demands of aggressive study timelines while also bringing medications to market more quickly and cost effectively. The globalization of clinical trials should be considered during the site selection process. Since 2002, the number of active Food and Drug Administration (FDA)–regulated investigators based outside the United States has grown by 15% annually, whereas the number of U.S.-based investigators has declined by 5.5%.5,6 Another reason for the decline of studies in the US involves the lack of adjustment by the media and by high tech resources to keep up with the transition required to satisfy interest in US markets. In these days of iPods, BlackBerrys® and high-speed wireless connections, there is a further need to adapt with the technology to further enhance clinical trials.

Geographic site location shifts can have a severe impact on time lines as accommodations need to be taken into account for language translations, packaging requirements, customs, and time zone differences.

A report recently released by the Association of Clinical Research Organizations states that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety6.

Site selection is important in order to achieve quality study results. A great deal of time and effort should go into this selection process with help from field monitors who have established a working relationship with study sites already. If new sites are selected with fresh investigators, site optimization steps should be incorporated to enhance the site’s education, knowledge and awareness of the clinical trial process.

There are many factors which should be taken into consideration when selecting a site such as: past trial performance, number of patients with the illness of concern, available time to conduct the study, number and qualifications of staff, number of ongoing trials, FDA/ Ethics committee black lists, education, geographical location, use of central IRB, cost, audit history, site and data quality from past assessments.

It is important to note that any global clinical trial is going to be confronted with cultural differences in all areas of the clinical trial process.  Recruitment strategies for European operations will differ greatly from those in Asia and those in the USA.  Therefore, approaching enrollment obstacles the same way for all regions is not appropriate due to the ethics committee allowances for clinical recruitment initiatives that not only differ regionally but on a per-country basis.  Additionally, the cultural differences between regions and countries often affect which methods will work and which will not.  Some initiatives that work in the USA would be considered unreasonable and would be denied by ethics committees in other parts of the world.  Development of any patient communication plan must take this into consideration in order to best evaluate which processes work best within the indication in which countries.

II.     STUDY START AND STUDY DURATION

Keeping study communication lines open during the course of the clinical trial is an essential ingredient.  Communication is the key to site motivation and, ultimately, performance. 

Concepts for establishing effective communication between sponsor and sites should be determined prior to study start and introduced at the investigator meetings as well as maintained during the duration and follow up of the study.  The incorporation of communication tools such as webcasts, telecons and reporting mechanisms will aid in maintaining an elevated motivation level and optimal site performance during the course of the study.

Beyond the Investigator Meeting

How many times do an investigator and his staff attend investigator meetings at the beginning of a study, never to see the sponsor again after that point in time? Incorporation of mini-investigator meetings, lunch and learns, webcasts, telecoms, conferences and seminars all aid in providing sites with additional information to aid in their compliance, awareness, education and performance.

Importance of Education and Awareness

Currently, when a patient is sick in the US, they often times perform a Google™ or Yahoo!® search prior to going to their physician, arrive with a 25-50 page selection of various deferential diagnosis for their doctor to choose from. Yet, this same technology has not followed current clinical trials with the same momentum, leaving a void and a further explanation for the number of subjects in the US who no longer participate in clinical trials due to lack of information and feeling uncomfortable in participating in the study.  Web users are highly conscious of privacy issues regarding their health, identification and finances. Any Internet or new technology solution designed to create study inquiries must acknowledge and overcome the fears of patients when providing private information. Enhancing subject education and awareness creates security and a feeling of engagement in clinical trials, thereby resulting in better compliance, recruitment and retention.

It is the financial responsibility of the sponsor to promote clinical trials. As many clinical trials can be complex, a single recruitment approach may not be thorough enough to satisfy the demands of the study; therefore, complete dependence upon the media to run public service announcements is not a viable option in most cases. Study time lines, especially enrollment periods, are too short to allow for the extensive preplanning required to produce and implement a news or PSA based awareness campaign and, are therefore not able to contribute highly to the success of the enrollment effort. Clinical trial information should maximize each dollar spent by focusing on all four interested audiences; treating physicians, likely patients, caregivers and clinical trial sites (including those sites representing the study). 

Effective targeting of the message is the key to study awareness.  Identify the specific audience most able to act on the information and direct the message to that audience.  Too often a good message is lost in the delivery due to incorrect identification of the action audience or placement of the message in media too general in audience to develop cost efficiencies.

Sites participating in clinical trials want to know the outcome of the study and follow a medication’s process through its research and development pipeline. If sites are not actively engaged in order to feel as though they are part of this process, then their level of participation is oftentimes jeopardized due to loss of interest, enthusiasm, and support and therefore, “other priorities” take over. Topics including, but not limited to regulatory obligations, safety and efficacy parameters, pharmacokinetic and pharmacodynamic medication properties, sponsor requirements and objectives, study procedures and monitoring of the study subject, all aid in establishing a desire for the site to want to engage in an effective working relationship with the sponsor. The educational process for sites as they participate in a clinical trial needs to be embraced with programs for participating sites which offer certifications and continuing education credits, and further enhancing study quality.

Determine Strategy and Site Solutions

After study start, and as sites continue to be initiated, their performance must be monitored on a regular basis. Sites that are performing well should be strengthened and sites that are not performing well, based on enrollment, audit results, sponsor feedback, news media and data quality, should be identified.

Once non-productive sites are identified, a solution as to how the sites’ performance could be improved should be considered. This may not be a single solution as different sites may have different concerns.  Often, a physical visit by a study team manager or contract Medical Science Liaison (MSL) or patient recruitment strategist is required to fully assess the challenges facing enrollment at a specific site.  An on-site evaluation can also involve working with the investigator and coordinator on issues and challenges that may be easily overcome.  This personal attention and communication can often make the difference in a site’s enrollment and data collection.

Potential solutions may involve education for those sites that do not appear to have a firm foundation as to how to accurately conduct a clinical trial.  These sites mayneed to be reassured as to the process and CFR/ ICH guidelines which mandate how trials need to be conducted. Other solutions may include Medical Science Liaisons and their efforts in the field to work with investigators on a doctor to doctor level to enhance how study procedures are conducted.  MSLs also provide a firm understanding of the science behind a protocol which further establishes and builds a stronger working relationship with the sites. Further solutions may involve, but are not limited to, assisting with chart reviews, website development, providing educational and outreach materials, enhancing local advertising budgets and helping the coordinator achieve a level of efficiency in their patient recruitment and consent activities.

Informed Consent

Informed consent is often overlooked in the clinical trial process as a reason for poor recruitment of subjects. More important than the standarization of the material, which is usually accomplished through engaging a central IRB/EC, is the standarization of the delivery of the material.  How the material is presented by each site can vary greatly and have a dramatic affect on the successful enrollment of pre-qualified candidates. Therefore, a unified and consistent delivery of informed consent is essential in enhancing site recruitment performance. 

In order to consent for research participation, 3 conditions must be met: (1) participant capacity (the participant's understanding of the study, including risks and benefits), (2) voluntariness (freedom from undue coercion), and (3) disclosure (the participant is provided with all information necessary to make a truly informed decision)8.   While these considerations are always on the mind of the presenter, the legal nature of the consent form and the relationship between presenter and potential subject can dramatically affect the level of trust required for consent.  Other considerations to delivery are the manner in which the form is presented, the time available for questions by the potential subject and their caregiver constellation, the tone in which the material is presented as well as myriad of other variables.

Identification of a site’s consent presenter and appropriate delivery training of that person are, at the very least, the essential elements, which will result in an above-average consent rate.  Providing a “guide to consent delivery” will assist in building a better and more consistent delivery of the material.  Reviewing the consent form and creating an FAQ guide for the presenter will help them deliver the consent information more confidently, again resulting in a more successful consent rate. 

Another, more effective, solution is to build a take-home, educational, companion piece to the ICF for the potential patients to review and discuss with loved ones involved in their health decisions.  The companion piece can address the purpose of clinical trials, the goals of the study, the risks associated with participation, study visit schedule, patient responsibilities, common FAQs answered in a positive manner, the patient’s rights to discontinue and other information deemed important.  Since delivery of this type of program is consistent, you will be able to better judge each site’s consent rate and decide more effective courses of action.

Importantly, true consent is considered an ongoing process, not simply the review and signature of a form. Establishing the value of truthful, rather than perceptive, communication between research staff and the patient early on will increase each site’s ability to provide the best study data possible and may decrease placebo response rates.  The subject has the right to withdraw consent at any time. Although a participant's agreement to continue in a study is often implied by the adherence to study visits and protocol, consent should still be confirmed and documented as part of an ongoing process of interaction9.  Effective communication with the patient throughout the study can enhance the patient’s willingness to continue and provide a feeling of value and security.

Implementing Strategy

Once a strategy is developed, a method of implementation should be established in order to achieve efficiency and build on the dynamics of the program itself. For example, those sites that are located in large metropolitan cities may require prioritization, based on the number of potential study participants in that region. Another approach may involve those sites which have a large patient population, independent of site location.

Capturing interim results and amending strategies can enhance the study’s efficiency.  Mini-investigator meetings or webcasts which allow for a smaller, more concentrated and “easy to travel to” location provide a structured and sophisticated presentation of information and are able to satisfy education, quality assurance, safety and protocol topics of discussion. Working with sites, especially those who are poor performers, to establish better trial conduct, recruitment and retention on a one-to- one basis is more time consuming; however, the personalization of the study visit emphasizes sponsor interest in the site. No matter what the solution, a methodical approach towards implementation should always be considered in order to maximize results.

Strategy Follow-up

After implementing a strategy, an evaluation of the effectiveness of the program is invaluable. Many times, a “lessons learned” session occurs following a trial with little incorporation into studies which follow it. As the site optimization process begins in pre-study stages and ends with the evaluation of the data from that site, it should reveal in real time those changes and structure which can should be incorporated into all trials without delay. Process implementation, no matter what stage of the trial, allows for a conscientious change to protocol and CRF design (present and future), study roll out, site initiation, monitoring and close out strategies. The incorporation of information gained from the site optimization process across an entire program could ultimately result in the reduction in the number of clinical trials, which are unsuccessful and fail to differentiate from placebo.

As an important side note for sponsors, the lessons-learned evaluation should be distributed to and discussed with all the therapeutic groups within the organization to best ensure a “best practices” knowledge base within each clinical study team.

Compliance

The propensity of patient compliance to be the weak link in managing and controlling clinical trials will continue to drive the interest of trial designers and managers for electronic packaging, automated data collection and proactive management tools such as intelligent delivery devices11,12. In essence, the clinical trial process must be designed in such a way as to enhance compliance for the sites as well as their patients.  The patient must come first in protocol design, implementation, efficacy and most importantly safety. However, a clinical trial is only as good as the patient participating and their understanding of study requirements.

For example, in the treatment of diabetes, the least compliant patients are more than twice as likely to be hospitalized compared to those who were most compliant, and their total health-care costs were nearly double. Diabetic subjects who use their diabetes medications as directed are less likely to develop the short-term and long-term health problems that can require expensive care. For diabetes, every additional dollar spent on medication saves $7 in medical costs. The combined drug and medical costs for the most-compliant diabetes patients average $4,570, which is almost 50 percent below the $8,867 cost for the least-compliant group13, 14.

Regulatory and Quality Assurance groups provide valuable information and guidance as to what authorities are expecting in the design, conduct and evaluation of a clinical trial. Audit reports provide input on site and study (CRF) quality. This information can be incorporated into a customized site optimization program intended to address major findings and re-establish a CFR/ ICH compliant day-to-day operation.

Sites need to pay particular attention to the quality of a study subject, in not only satisfying inclusion/ exclusion criteria, but also identifying a genuine interest and willingness to participate and comply with study treatments. As a result, subjects adhering to study visit schedules, procedures and dosing requiremens will yield better study data.

Development of an effective communication model between site personnel and subjects is one of the cornerstones of patient compliance.  The level of patient trust can be enhanced through regular communication and making the patient aware of what is expected, before the consent form is signed.  Taking enough time to explain the importance of following study regimens can help alleviate many of the compliance issues common to clinical research and potentially enhance the quality of the subject’s data.

Site Interaction

Lessons-learned during the course of a study should also be incorporated into the site communication program. Multiple randomized clinical trials in depression and anxiety have failed to separate active drug from placebo. A number of reasons have been advanced to explain this observation, including subject and site interactions, trial design, site–sponsor interactions, and rating scale deficiencies10. Sponsors should begin at the outset of a clinical program by integrating the proposals into their site selection and site staff training to minimize any influence of the placebo response.

Site to subject and sponsor to site interaction are critical in the day to day operation of a clinical trial. It is often times assumed that a site has the ability to maintain and fulfill its obligations to subjects, yet, many sites and physicians are relatively new to the study process and have not been provided the necessary tools to conduct a trial with a high degree of comfort, quality and integrity. As one study is completed, the site receives another without obtaining much of the instruction required to succeed in the proper conduct of the clinical trial process. Even more experienced sites must consistently place an effort on maintaining a working knowledge of changes in the industry and ways that they must adapt their daily operations to accommodate for FDA/ EMEA and corporate changes.

A pre-designed site feedback program can have a dramatic effect on site performance during the course of any clinical study. It is important to deliver constructive feedback to the site in order to maintain quality of data collection and the site’s level of motivation. Too often, a lack of effective communication between sponsor, CRO and the site can result in investigator fatigue and frustration, which causes the investigator to reprioritize and decrease the level of importance of the study. By helping an average site to overcome challenges the sponsor will have a more motivated and higher-quality site to work with on future studies.

III.   POST STUDY EVALUATION AND FOLLOW UP

Post-study evaluation and follow up is an area which is often times forgotten in the clinical trial process. This is an opportunity to determine the success of medical affairs, data management, statistics and clinical operations in conducting the trial as well as to examine sites for quality of data, compliance, recruitment and retention.  It is interesting to note how many clinical study errors continue to be made over and over again secondary to not addressing lessons learned. Protocol and CRF design can be fine tuned, receipt of CRF information and CRA monitoring can be improved, interim analysis can be instituted, and update of the statistical analysis plan can all occur with this process. As previously mentioned, the site optimization process is a real time function whereby solutions can be implemented across programs in a systematic and logical format. Incorporation of this process prior to study start creates a benchmark and platform for further analysis and review during the course of the study and provides the ability and security for sites at study start and throughout the duration of the trial.

AIthough it cannot be stressed enough that analysis of study processes should be shared within the entire therapeutic area of the sponsor organization, certain lessons-learned should also be shared within the entire clinical organization as well as with the participating investigators.  Post-study follow up can help build a more efficient study process within the organization and can also assist wth building better relationships with sites.

 

IV.  CONCLUSION

The randomized clinical trial has emerged as the principal research tool for developing evidence to inform and influence clinical practice. The practice of clinical trials is built on an understanding of the biology of disease, the structure of medical care delivery, statistical design and analysis, data management, clinical research quality, and scientific and medical integrity. As clinical trials continue to evolve, investigators will be challenged to find the optimum balance among these factors that best evaluates new interventions and places older approaches in the proper context as new technology and practice patterns emerge15.

Financial challenges in current global economies are affecting the pharmaceutical industry and the clinical trial process. Yet, the cost for conducting clinical trials is continuing to increase with little change currently being incorporated.

One possible solution to provide a potential cost saving via enhanced efficiency involves the implementation of a site optimization process. As sponsors run into those situations where site performance does not meet their expectations, they oftentimes reflect on the decision to either terminate the sites which do not perform well, allow the more aggressive sites to enroll more subjects, and open more sites; however, each action may introduce potential bias to the study16. Site Optimization is focused on evaluating potential issues before they happen in order to avoid study delays and the catastrophic possibility of collecting poor study data. Figure 2 summarizes the comprehensive nature of this process during all pre-study, study, and post study periods which include and impact protocol design, define study needs and site selection.

Globalization of trials must be carefully considered and executed in order to prevent difficulties in study conduct. Education, awareness, site follow-up and interaction all aid in facilitating a positive working relationship with clinical sites. Studies designed with the patient’s motivation in mind and implementing smart packaging strategies may enhance compliance and quality assurance. In addition, study designs involving patient friendly visit and procedure schedules which minimize travel costs and the level of inconvenience will aid in the retention of study subjects.

The planning, budgeting and utilization of recruitment and retention tools in clinical trials is often beneficial when applied in a systematic and logical manner. It is necessary to determine a site optimization strategy, plan for implementation and follow up to determine the overall success of the program and fine tune where required for continued benefit. Site interaction and communication is critical in establishing a productive working relationship with the sites. In effect, study costs can be reduced with the enrollment of high quality study subjects and improvement of study conduct efficiency which has an overall impact on study dynamics and results in data which may decrease the number of trials which fail to differentiate themselves from placebo.

VI. SUMMARY:

Site optimization involves many different components which occur at various points in the clinical trial process: pre-study, active study period and post study evaluation. Process integration throughout these various research and development areas and prioritizing the perspective of  the sites will maximize the efficiency of enrollment, adherence to study regimen and assure the best quality  data.  Delivering a higher percentage of volunteers within the site’s practice roster will result in a more successful clinical study. As cost containment of clinical trials continues to be an issue in studies, new solutions are required which ultimately streamline process and improve study results.

About the Author:

David M. Shearer, MD, is Chief Medical Officer and Vice President of Clinical Operations for ICTS (Integrated Clinical Trial Services LLC.) which provides clinical trial sponsors, contract research organizations and site networks with a comprehensive resource for patient enrollment, site optimization, education and medical science liaison expertise. In his position, Dr. Shearer oversees the medical components of ICTS to aid in quality assurance in each of these areas. Dr. Shearer has established a turnkey, highly interactive and flexible medical science liaison program for purposes of educating the healthcare community about pharmaceuticals before, during and after the clinical trial process.

Dr. Shearer has 12 years of experience in the pharmaceutical industry and has performed more than 100 clinical trials at some of America’s largest pharmaceutical companies.  These included trials for Type I and II diabetes mellitus, obesity, myocardial infarction, stroke, gastroenterology, schizophrenia, Alzheimer’s, depression, sleep disorders, hypertension and hyperlipidemia. 

Dr.shearer@icts.us

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