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Two frequently cited figures by clinical research insiders and observers – the cost of missing a day to generate prescription drug sales and the cost of a day to conduct a clinical trial – are outdated and based on anecdotal evidence. In late 2023, the Tufts Center for the Study of Drug Development conducted empirical research to gather more accurate and granular estimates and to test whether average sales per day have changed over time. 645 drugs launched since 2000, and 409 clinical trial budgets were drawn from commercially available and proprietary data sets and analyzed. The results indicate that a single day equals approximately $500,000 in lost prescription drug or biologic sales, with daily prescription sales for infectious, hematologic, cardiovascular, and gastrointestinal diseases among the highest. The results also show that each year, the average sales per day of prescription drugs and biologics has decreased by approximately $80,000—$100,000. The estimated direct daily cost to conduct a clinical trial is approximately $40,000 per day for phase II and III clinical trials, with those in respiratory, rheumatology, and dermatology having the highest relative daily direct costs. [ABSTRACT FROM AUTHOR]

The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a follow-up study in 2022 to assess trends in protocol amendment experiences and the impact amendments have had on clinical trial performance, particularly during the COVID-19 pandemic. Sixteen pharmaceutical companies and contract research organizations provided data on 950 protocols and 2188 amendments. The results show that, since 2015, the prevalence of protocols with at least one amendment in phases I–IV has increased substantially (from 57 to 76%) and the mean number of amendments per protocol has increased 60% to 3.3, up from 2.1. Phase I and III protocols saw the highest increases in the mean number of amendments implemented per protocol. A much higher percentage of amendments—77%—were deemed unavoidable with regulatory agency requests and changes to the study strategy as the top reasons cited for amending a protocol. The total average duration to implement an amendment has nearly tripled during the past decade. The time from identifying the need-to-amend to last oversight approval now takes an average of 260 days and the mean duration during which investigative sites operate with different versions of the clinical trial protocol spans 215 days. Protocols that implemented at least one amendment were more effective at increasing patient screening volume and reducing the actual number of patients enrolled relative to plan. Lastly, the prevalence of protocols with at least one amendment and mean number of amendments was significantly higher for protocols conducted during the pandemic. [ABSTRACT FROM AUTHOR]

To better understand the nature of Non-Core procedures and derive new insight into protocol simplification and optimization, Tufts CSDD collaborated with the FDA and sponsor companies to assess alignment on the rationale for collecting, and relevance of, Non-Core protocol data. Twelve sponsor companies classified and rated 700 distinct procedures from 19 pivotal trials supporting new drug and biologics approvals. FDA reviewers classified and rated 80 distinct procedures for three of the 19 pivotal trials. The results of this assessment indicate areas of alignment and misalignment. Sponsors and FDA reviewers agreed on the classification for more than half of endpoints. However, FDA reviewers classified a much higher percentage of procedures as Non-Core (26% vs. 18%) with the largest proportion (50%) of these procedures perceived as Core by sponsor companies. Sponsors indicated that one-out-of-six Non-Core procedures were administered due to perceived regulatory requirement and expectation. The results of this study characterize the challenge in aligning the different—and potentially conflicting—imperatives of sponsors and regulators and speak to the importance of more effective FDA-sponsor communication to help simplify protocol designs. [ABSTRACT FROM AUTHOR]

Consistent implementation and measurement of patient engagement initiatives across the industry have remained aspirational and elusive despite strong interest in adopting patient-centric approaches. One factor contributing to this inertia stems from a lack of standardized implementation of patient engagement activities, which varies widely from company to company, making it difficult to track and measure. Further, empirical evidence mapping the impact of patient engagement capabilities on clinical research outcomes has remained sparse. To address this gap, the Drug Information Association (DIA) and Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine developed and administered an assessment tool that companies can use to not only evaluate their organization's patient engagement capabilities and implementation preparedness but can also measure the impact of such activities on trial outcomes. Results showed that while most organizations are providing logistical support to increase patient engagement in the form of travel stipends, accommodation, and financial incentives, most are not implementing more involved forms of patient engagement such as gathering patient input through patient input panels or patient steering committees. This paper discusses the process for designing and administering this assessment tool, the results of the assessment, and future implications. [ABSTRACT FROM AUTHOR]

Background: Utilizing a participation burden algorithm developed in a previous study, Tufts CSDD, in collaboration with ZS, led a workshop among 8 pharmaceutical companies to validate the methodology of benchmarking the participation burden of a set of retrospective protocols and comparing these data to a prospective protocol design. Methods: Eight participating companies collected data for 66 retrospective protocols and participation burden scores were calculated for each. Data from one prospective protocol was provided and prospective burden scores were compared to mean retrospective protocol burden for each company. Participating companies provided feedback on data collection process and final reports. Results: Comparisons between retrospective and prospective burden scores revealed higher comparative burden in lab and blood procedures. Companies were able to gather most requested data, but some variables hypothesized to affect burden were not available to sponsors. Time constraints were reported as a challenge throughout the data collection process. Conclusions: Feedback indicated the need for establishing a larger database to enable comparisons between protocols with the same therapeutic area and indication. Investigating the impact of standard of care burden by indication on overall participation burden and encouraging sponsors to collect more accurate data contributing to participation burden at the site level are also important takeaways from this exercise. [ABSTRACT FROM AUTHOR]

Background: Benchmark data characterizing protocol design practices and performance informs clinical trial design decisions and serves as important baseline measures for assessing protocol design behaviors and their impact during and post-pandemic. Methods: Tufts CSDD, in collaboration with a working group of 20 major and mid-sized pharmaceutical companies and CROs, gathered phase I–III data from protocols completed just prior to the start of the global pandemic. Results: Data for 187 protocols were analyzed to derive benchmarks overall and for two primary subgroups: oncology vs. non-oncology protocols and rare disease vs. non-rare disease protocols. The results show a continuing upward trend across all protocol design variables. Phase II and III protocols average more endpoints, eligibility criteria, protocol pages; investigative sites; countries and datapoints collected. Oncology and rare disease protocols' enrolled-to-completion rates are much lower, involve a much higher average number of countries and investigative sites, require more planned patient visits and generate considerably more clinical research data. As such, oncology and rare disease clinical trial cycle times are longer—most notably at time periods occurring after study startup and prior to database lock—due to intense patient recruitment and retention challenges. Conclusions: The results of this study present valuable design insights and comparative baseline measures. The implications of these results and the expected impact of decentralized clinical trials on protocol design practices and performance is discussed. [ABSTRACT FROM AUTHOR]

Tufts Center for the Study of Drug Development (Tufts CSDD) collected data on trial design elements and clinical trial performance outcomes from 187 protocols provided by 20 companies. 10 design variables were tested for correlations with 11 performance variables, and regression models of each performance variable were tested. Results: Many significant correlations were found (p <.01, p <.05). The number of countries and the number of sites were each positively correlated with amendment frequency, longer screening and study duration as well as study participant dropout rates. The number of internal reviews prior to protocol finalization was also positively correlated with these same performance outcomes. In regression modeling, scientific and operational design characteristics were significant predictors of cycle time, enrollment and retention outcomes, and amendment frequency, even when controlling for phase and therapeutic area. These predictors included the number of endpoints, eligibility criteria, procedures per visit, number of countries, and investigative sites. The results of this analysis suggest practical considerations for optimizing protocol performance. [ABSTRACT FROM AUTHOR]

Interest in patient-centric initiatives to engage patients as partners in clinical research and inform drug development strategy, planning and execution has increased exponentially during the past decade. Adoption, use, organizational approach and infrastructure supporting patient-centric initiatives, however, varies widely from company to company. The Drug Information Association (DIA) in collaboration with the Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine developed and validated an assessment tool that companies can use to evaluate their organization's patient engagement preparedness and capabilities within the context of industry-wide practices. This paper discusses the development of the tool, the assessment experience, and implications for further refinement of the assessment process. Specifically, the team conducted an extensive literature review, compiled and analyzed case studies and gathered input from a working group of 18 biopharmaceutical companies. To validate the assessment tool and demonstrate its feasibility, the DIA-CSDD Tufts team conducted a pilot implementation involving onsite and virtual in-depth interviews among 14 biopharmaceutical companies. A subsequent paper will report on the findings from the 14 companies assessed. [ABSTRACT FROM AUTHOR]

Patient recruitment and retention continue to present challenges in conducting clinical trials. The objectives of the study were to benchmark patient recruitment and retention practices across recent global clinical trials from a working group of biopharmaceutical companies and to re-visit the results from an earlier study published 7 years ago. The data collection focused on patient and site enrollment metrics and recruitment and retention tactics used for studies. Analyses were conducted comparing the results from 2012 and 2019. The results indicated that more studies met or exceeded planned enrollment than the previous research and global differences were observed in the present study for site activation rates and target to actual enrollment rates. Since an updated set of recruitment and retention tactics were evaluated in the present study, no comparisons were made to previous data. Researchers suggest further study that would examine usage and effectiveness of specific recruitment and retention tactics across global studies. [ABSTRACT FROM AUTHOR]

The vendor qualification assessment (VQA) process is regarded as expensive and time consuming but there is no quantitative data characterizing and benchmarking this process. The Tufts Center for the Study of Drug Development (Tufts CSDD)—in collaboration with the Avoca Group and 13 pharmaceutical, biotechnology and contract research organizations—conducted a survey of 120 unique companies to gather baseline data. The study results confirm that companies are investing substantial time and resources to support a high and growing volume of vendor qualifications and re-qualifications each year. The average total time to perform a vendor qualification is almost 5 months for single service providers and nearly 7 months for multi-service providers with wide variation within and between companies observed. Re-qualification cycle times are only marginally faster although, in theory, experience and familiarity with a given vendor should replace some assessment requirements. Significant differences were observed by company size and type. A high percentage of assessments—most notably those conducted by large companies—involve customized assessment areas. CROs are able to perform the VQA process significantly faster with fewer personnel. Based on the data provided, Tufts CSDD estimates that global drug developers spent about $375 million to perform approximately 25,000 new vendor qualifications and re-qualifications in 2018. [ABSTRACT FROM AUTHOR]

A growing number of organizations--including pharmaceutical and biotechnology companies, foundations and associations--are routinely implementing patient advisory boards (PAB) given their high reported value for minimal relative investment. Organizations are typically implementing PABs to solicit patient voices and perspectives on a variety of areas such as protocol designs, clinical trial medicine kit designs, informed consent form designs, technology solutions, and patient communication materials. The Center for Information and Study on Clinical Research Participation (CISCRP) has planned, executed, and facilitated more than 30 PABs. In this article, the authors share lessons learned and best practices with regard to structure, format, and process for organizations wishing to adopt and implement PABs. The authors also provide metrics on the adoption and impact of PABs. [ABSTRACT FROM AUTHOR]

Background. Studies indicate that the prevalence of multidrug-resistant infections, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their complex protocol designs and the difficulty in recruiting and retaining patients. Methods. With input from clinicians, representatives from industry, and the US Food and Drug Administration, we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs; (2) to identify opportunities to lower these costs; and (3) to compare (1) and (2) to endocrine and oncology clinical trials. Benchmark data were gathered from proprietary and commercial databases and used to create a model that calculates the fully loaded (direct and indirect) cost of typical phase 3 HABP/VABP endocrine and oncology clinical trials. Results. Results indicate that the cost per patient for a 200-site, 1000-patient phase 3 HABP/VABP study is $89 600 per patient. The cost of screen failures and screen failure rates are the main cost drivers. Conclusions. Results indicate that biopharmaceutical companies and regulatory agencies should consider strategies to improve screening and recruitment to decrease HABP/VABP clinical trial costs. [ABSTRACT FROM AUTHOR]

The article discusses challenges facing by Sponsor and contract research organization (CRO) companies in operations and logistics. Topics discussed include process to speed up timelines by Pharmaceutical companies, increasing efficiency in therapeutic areas such as oncology and Alzheimer, and study to improve these activities funded by technology solutions company goBalto.

Background: Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with 15 pharmaceutical companies and contract research organizations, gathered data on substantial global protocol amendments to better understand how to manage and to reduce the significant unplanned expense and delays associated with major changes to finalized protocol designs. Methods: Data from 836 phase I-IIB/IV protocols were analyzed to understand amendment prevalence. Impact assessments were based on data from 136 randomly selected amendments. Data from 52 protocols were analyzed to derive estimates of the direct cost to implement amendments. Results: Tufts CSDD found that 57% of protocols had at least one substantial amendment, and nearly half (45%) of these amendments were deemed “avoidable.” Phase II and III protocols had a mean number of 2.2 and 2.3 global amendments, respectively. Protocols with one or more global amendments tended to be larger in scope, with longer patient recruitment durations and overall study durations compared with those without a global amendment. Protocols with at least one substantial amendment had fewer actual screened and enrolled patients relative to the original baseline plan than did those protocols without an amendment. The median direct cost to implement a substantial amendment was US$141,000 for a phase II protocol and $535,000 for a phase III protocol. Conclusions: The study findings provide insights into optimizing development planning, protocol design, and clinical trial management practices. [ABSTRACT FROM AUTHOR]

Background: With the pharmaceutical industry’s increased attention on enhancing patient experiences during their participation in clinical trials, the use of mobile nurse (MN) services to support the conduct of clinical trial assessments in the home (or in alternative locations other than in investigational sites) has been gaining momentum. Methods: Because no quantitative data capturing industry-wide practices are available, in July 2014, Tufts Center for the Study of Drug Development and Hoffman-La Roche conducted an online survey to gather data on the prevalence and utilization of MN services in clinical trials taking into account the following factors: industry perceptions of the business model, risks barriers to adoption, vendor landscape, cost, and prospects for future growth. A total of 113 respondents answered the survey, with 53 respondents answering all questions. Results: The use of MN services in clinical trials is an established and growing business practice. Utilization of MN services has so far been most prevalent in North America, followed by Western Europe. Sponsor companies that have adopted this model have done so mainly to improve patient retention and protocol compliance, as well as improve access to rare patients. Most of the companies surveyed work directly with vendors specializing in home nurse services. Experience with vendors was considered favorable in most cases. Conclusions: Building effective partnerships with 1 to 2 vendors is considered a key factor for long-term success. [ABSTRACT FROM AUTHOR]

Background: The Tufts Center for the Study of Drug Development (Tufts CSDD) collaborated with the Clinical Data Interchange Standards Consortium (CDISC) on a joint working group study with 10 participating companies including biopharmaceutical, CROs, and eClinical technology vendors. The objective of the study was to examine current and projected use of eClinical technology and standards across respondent organizations and in clinical studies and to gather perceptions and attitudes about technology and standards adoption. Methods: The Tufts CSDD study examined the use of eClinical technology and CDISC standards through a comprehensive survey combined with analyses of clinical study data among biopharmaceutical companies and contract research organizations. Results: The results suggest increasing use of specific eClinical technology solutions and standards. The barriers to adoption of eClinical trial tools are addressed as well as the benefits of standards adoption. Differences between respondent perceptions and actual study data are examined, and the survey results are compared with those from prior studies. Conclusions: The results of the study indicate that increasing use of standards could translate into improvements in time, costs, and overall approval rates. The study also observed an uptake in the use of eClinical technologies that could potentially create efficiencies and streamline operational processes. [ABSTRACT FROM AUTHOR]

Purpose: Articles in peer-reviewed journals and the trade press presuppose that strategic outsourcing relationships have been formed to replace preexisting collaborative approaches with contract research organizations. They do not consider that large, fragmented pharmaceutical and biotechnology companies may be supporting competing and conflicting relationship models simultaneously. A recent Tufts Center for the Study of Drug Development study quantifies actual strategic outsourcing practices among drug development companies and sheds new light on why these relationships may be failing. Methods: Tufts Center for the Study of Drug Development conducted an in-depth assessment of 43 Phase II and III clinical studies completed since 2012 to examine the outsourcing relationships used by 9 major pharmaceutical and biotechnology companies to support key functional areas. Descriptive statistics were assessed and t tests were performed to characterize outsourcing practices by function and to determine differences in study performance between transactional and strategic outsourcing relationships. Findings: The results indicate that sponsor companies are using a variety of outsourcing relationship models to support their studies, mixing and matching the use of internal staff, and using traditional transactional and strategic outsourcing relationships simultaneously. Specifically, despite the fact that each sponsor company had entered into several strategic outsourcing relationships, in no instance did a single contract research organization manage all functional areas supporting an individual Phase II or III study. In addition, sponsor companies vary the types of outsourcing relationship models that they use on a study-by-study basis. Implications: The inability of pharmaceutical and biotechnology companies to consistently embrace and coordinate sourcing strategies is creating internal friction and inefficiency. As a result, the expected impact of strategic outsourcing relationships on drug development performance, quality, and cost remains elusive. [ABSTRACT FROM AUTHOR]

The article discusses a study that compares development cycle and regulatory approval times of drugs developed clinically by a single firm with those of drugs whose development were interrupted by a collaborative or shared development activity. Topics discussed include a study on the origin, clinical development and U.S. regulatory approved history of 300 therapeutic new molecular entities and findings of a 1.9-month difference in median and 1.2-month difference in mean regulatory review time.

Background: The translation of basic research knowledge into human testing is widely regarded as an inefficient and lengthy process, yet there is no detailed, quantitative information characterizing this early drug development pathway. The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study to derive a generalizable granular process map of the non-clinical to early clinical drug development pathway and associated duration metrics. Methods: Tufts CSDD constituted a working group of seven small and mid-sized pharmaceutical and biotechnology companies to identify pathway milestones and to provide duration metrics. Tufts CSDD then analysed duration data between each process step in the development pathway. Data for Investigational New Drug (IND) submissions are reported overall and stratified by therapeutic area, phase II transition success and modality. Results: Duration metrics (mean and standard deviation [SD]; median and interquartile range [IQR]) are provided for each milestone along the early drug development and regulatory pathways (e.g. time to IND submission). The overall process from First Synthesis - Medicinal Chemistry to First Patient (Subject) First Dose took on average 151.4 weeks (n= 17; SD=90.0 weeks) and a median duration of 133.0 weeks (IQR = 89.6 weeks) overall. There were no statistically significant differences between stratified data. Key pathway steps, their respective durations and variation across programmes are presented. Discussion: The results of this Tufts CSDD study provide a detailed representative mapping of the early drug development research pathway and baseline duration metrics summarizing the overall process and distinct process stages. To our knowledge, this is the first time such a mapping has been completed. Observed duration areas with wide variation between key steps in the process suggest acceleration opportunities. Large variation in duration data may be due to differences in molecule size and structure, as well as strategic decisions made by management teams. Best practices from faster companies also indicate that they perform many activities in parallel, moving forward even before certain milestones have been achieved, and they tend to have more frequent and substantive cross dialogue across different functional areas earlier in the process. Conclusion: It is hoped that the results of this study will assist research and development professionals in making more informed management decisions and in identifying opportunities to streamline and improve the non-clinical to early-stage clinical process. [ABSTRACT FROM AUTHOR]

Drug development companies frequently amend finalized clinical trial protocols. Yet the incidence, causes, and impact of protocol amendments have never been quantified. Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study, in collaboration with 17 large and midsized pharmaceutical and biotechnology companies, examining more than 3,400 clinical trial protocols across development phases and therapeutic areas. Data on protocol characteristics, the number of amendments, the nature and incidence of changes per amendment, the causes of amendments, and the time and cost to implement amendments were among those analyzed. Tufts CSDD found that more than 40% of protocols were amended prior to the first subject/first visit, and one third of amendments were avoidable. Each amended protocol had an average of 2.3 amendments resulting in 4 months of incremental time to implement. Protocol amendments translate into significant unplanned expense and delays for research sponsors and unexpected burden for investigative sites. These findings underscore the substantial impact of protocol amendments on drug development efficiency and present an opportunity to realize substantial cycle time and cost savings. [ABSTRACT FROM AUTHOR]

The recent volume of merger and acquisition activity in the biopharmaceutical industry has been high and is expected to accelerate in 2009 and 2010 due to global economic conditions. In order to understand changes following merger and acquisition (M&A) in clinical research investment and activity, Tufts Center for the Study of Drug Development analyzed development pipeline and spending data for 24 of the largest independent M&As occurring between 1998 and 2004 that each exceeded $1 billion in transaction value. Organizations that had experienced a merger or acquisition were evaluated across three time periods and compared with industry benchmarks: 2 years prior to an M&A announcement, and 2 years and 4 years after the transaction was announced. The results indicate that following a transaction, companies initially limit R&D spending growth to accommodate integration challenges, uncertainty, and instability, However, 4 years post-transaction M&A companies rapidly increase R&D spending across a significantly consolidated portfolio of late-stage (phase 2 and 3) development projects. Due to resource constraints and integration uncertainty, phase 1 and 3 product attrition rates for M&A companies are higher than the industry average. Statistically significant differences are observed in development pipeline and spending practices between small and large acquirers and between companies undergoing mergers versus acquisitions. The results of the study offer biopharmaceutical executives and financial professionals insights into better forecasting of drug development productivity and resource requirements following M&A transactions. [ABSTRACT FROM AUTHOR]

The article focuses on the applications of the lessons learned from organ donation efforts to the clinical trials industry in the U.S. According to a number of surveys being conducted, public's confidence in the pharmaceutical industry, the National Institutes of Health, and academic research centers has decreased. The lessons are aimed to improve public awareness, trust and engagement in clinical research.

The article focuses on the significance of full-service and niche-services contract research organizations (CRO). As market conditions and the overall pharmaceutical industry operating environment change and evolve, sponsor reliance upon and usage of CRO partners has also changed. For nearly a decade, sponsors have become more nimble and adept at mixing and matching CROs of varying sizes and service offerings. The authors conducted a survey among biopharmaceutical companies to understand how outsourcing practices have further evolved and how they are becoming more efficient.

The authors argues that drug development study designs are challenging clinical trial success. They discuss an investigation conducted by Tufts Center for the Study of Drug Development (Tufts CSDD) to examine study design practices of pharmaceutical and biotechnology companies. They mention how study design drives high levels of drug development risk, cost and inefficiency.

The article informs that pharmaceutical company Medidata Solutions Inc. has sponsored a research study in which several biotechnology companies participated and provided data on 10 Phase II and III protocols targeting diseases throughout multiple therapeutic areas. It informs that the companies classified each protocol procedure during the study according to the objective it supported as defined by the clinical study report (CSR) and the study's specific statistical analysis plan (SAP).

The article focuses on the outsourcing relationships of pharmaceutical companies and CROs (clinical research organizations). It discusses the management of risks involved in transformation of clinical research from pharmaceutical companies to CROs through autonomy, accountability and adoption of innovative practices. It suggests that automation and customization manages the relationships. It also reports on the eClinical solutions introduced by the CROs to optimize project management.

The authors argue on the need to change the paradigm for drug development as it becomes increasingly inefficient, risky and expensive. They believe that an open innovation partnership would transform the drug development process by integrating capabilities and expertise among a diverse collective of internal and external stakeholders. The authors also cite numerous signs that the traditional pharmaceutical research and development is no longer sustainable.

The article focuses on the effort of pharmaceutical industry sponsors to find ways to increase efficiency between trial phase in the U.S. Industry sponsors' effort to improve efficiency is centered on activities within drug development phases which occur as clinical data and operations transition from one research phase to another. The author explains that impact of the improvements in efficiency of between-phase trials are substantial to the pharmaceutical industry.

The article reports on the analysis of the impact of the unplanned incremental cycle time from substantial protocol amendment, by Independent nonprofit group Tufts Center for the Study of Drug Development (Tufts CSDD). The protocols with at least one substantial amendment take an average of three unplanned months as indicated by the analysis, the collecting of amendment data and the result of the majority of the protocols which had the high prevalence and avoidability are mentioned.

The article discusses the efforts to provide outreach and education to inform patients and the public about the clinical research process. The author reveals that the National and international polls conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) and other organizations suggests low level of awareness and public support for clinical research. Also offered are examples of educational materials and appraoch to promote clinical trial.

The article discusses the various aspects of interrupted drug development programs. The author cites that half of the all drugs in clinical testing are interrupted by in-licensing, codevelopment, joint venture and merger and acquisition (M&A) arrangements. Also tackled is the effort the determine the type of risk-sharing arrangement established for each development program.

The article offers information on an online study conducted among a global community of health information seekers and research participants by the non-profit organization Center for Information & Study on Clinical Research Participation (CISCRP). Topics discussed include difficulty faced by participants in understanding the informed consent form, questionnaire designed for the study with the help of representatives from the pharmaceutical industry, and results of the study.

The article reports on the possibility of adaptive trial design to transform success in drug development in several aspects, which include performance, cost, and inefficiency. It says that less than 20% of the drugs which undergone clinical testing has received a regulatory approval. It mentions the study by the Tufts Center for the Study of Drug Development (Tufts CSDD) to 12 major pharmaceutical companies in 2012 which examines the adoption rates and their impact on development of drugs.

The article discusses a survey conducted internationally by the U.S.-based nonprofit organization Center for Information and Study on Clinical Research Participation (CISCRP). It informs that the 2013 survey found positive public attitudes and perception regarding clinical research as compared to the period from 1997 to 2007. As per the survey, only 19 percent of Americans believe that pharmaceutical companies do not offer reliable information while 28 percent of them do not rely on sponsors.

In this article, the author discusses the opportunity of contract research organizations (CROs) to transform themselves following the public companies move into the private equity markets. He argues that CROs have the chance to pursue novel leading strategies that may redefine integrated drug development services in the future. He indicates that pharmaceutical and biotechnology companies have increased their use of and reliance on CROs to secure project-specific niche.

The article offers information on the need for pharmaceutical and biotechnology companies to transform their old research and development paradigm through open innovation. It states that success rates and operating efficiency increased through strategies that improve innovation output. However, it mentions that holding the R&D paradigm formed more than 50 years ago would fall far short of the intended impact.

The article offers insights on the cost needed to enforce protocol amendments for clinical trials in the U.S. It mentions the use of benchmarking for incidence and effect of protocol amendments in mid-sized to large pharmaceutical and biotechnology companies. It highlights cardiovascular and gastrointestinal (GI) protocols as the areas with high incidence on amendments. It discusses the impact of time and economic costs thus involving the Food and Drug Administration (FDA) related products.

In this article the author discusses the trend of sponsor companies in the U.S. to practice 100 percent source data verification (SDV) against case report form data. He notes that this practice has been opposed since it diverts resources from critical researches and its capacity to improve data quality is still unproven. He also contends that sponsors could use more selective and targeted SDV since it offers additional support and provide less frequent and more targeted monitoring visits.

The article focuses on the increase of merger and acquisition (M&A) activity among pharmaceutical and biotechnology companies which is strong and potentially will continue through 2010. However, it mentions that the practice of mergers and acquisitions seem to either fall short of anticipations on the effect of drug development spending and productivity. It notes that a study is depicted which quantifies the effect of M&A deals on portfolio and research and development spending growth.

The article discusses the impact of economic recession on clinical research which is manifested through layoffs, tight financial markets and project postponements and cancellations. PhRMA stated that clinical research personnel growth has increased during the recession period and the research and development (R&D) continued to grow. GlaxoSmithKline has planned to eliminate hundreds of research positions as part of its strategy to respond from recession in pharmaceutical industry.

The author reflects on the regulatory compliance of pharmaceutical companies in the U.S. The author inferred that the handling of Investigational New Drug Safety Reports is a problem facing the industry because a policy requires that institutional review boards involved in a study should be informed on any adverse event. He believed that the added burden of going back to the whole process whenever an amendment is made to the study protocol makes the companies more likely not to comply.

The article focuses on the importance of speed and efficiency as central to all viable drug development strategies in the U.S. Pharmaceutical companies need to optimize product revenue while minimizing development costs to enhance performance. In comparison, the slowest firms display high levels of variability, suggesting that drug development practices may be applied within their own organizations.

The article reports on the concern of biopharmaceutical and CRO companies in understanding the development of managed site networks (SMO) in the U.S. It has cited that sponsors are spending less on managed site networks in favor of individual part-time and dedicated investigative sales. The conceptual benefits offered by SMO includes centralized clinical research operations, standardized contracts and operating procedures, and systematic management of patient recruitment and retention. INSET: Radiant the Outlier.

The article reports that many pharmaceutical and biotechnology companies in the U.S. are using ex-U.S.-based investigative sites for their clinical trials. Some of the reasons for such trials are that trials overseas are less expensive and physicians there are eager to serve as investigators and study coordinators. A study by Tufts Center for the Study of Drug Development has found that the number of ex-U.S. principal investigators has been growing by more than 20 percent annually during that same time period.