Global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators and wide variation in investigative site experience, according to a recently completed assessment by the Tufts Center for the Study of Drug Development.
Although the highest turnover rates are observed among the least active investigators, turnover rates have been getting progressively worse among more active investigators. At the same time, protocol noncompliance, the most common performance deficiency and one that has grown the fastest during the past decade, accounted for 46% of all investigative site deficiencies, Tufts CSDD said.
“Operating conditions for clinical trials have noticeably worsened in recent years,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD. “Most frustrating for drug sponsors and contract research organizations looking to achieve higher levels of predictable performance is the wide variation that exists in the infrastructure, stability, and experience levels of investigative sites conducting clinical trials globally.”
A recent study by HR+ Survey Solutions reveals that merit increase budgets are on the rise in the Global CRO industry. The study found that while the highest reported salary increase budget across the globe for 2013 was 21%, that figure rose to 25% for 2014. The country with the highest average budgeted increase is Argentina with an average increase of 16.1% for 2014. The country with the lowest average budget increase is Portugal with an average increase budget of only 1.8%. This compares to the overall global average budgeted increase for 2014 of 4.1%.
The survey also found that while sixty-percent (60%) of the actual increases for 2013 were less than budgeted, by an average of 0.3%, interestingly, 60% of the budgeted increases for 2014 are larger than actual increases in 2013 by 0.4% The study provides information about planned increases vs actual increases, industry budgets vs global budgets and covered 52 countries globally.
Other findings include:
- The country reporting the largest budget increase from 2013 to 2014 was Indonesia, with an average planned increase that was up 3% from last year.
- The average budgeted increase for the US is 3% for 2014 which is in line with general industry. Most surveys are projecting 2014 salary increase budgets to hover around 3%.
The AVOCA Group has launched its 2014 survey, exploring how outsourcing relationships can contribute to, or interfere with, progress toward more intelligent, data-driven approaches to clinical trial design and execution.
For the past 10 years, The Avoca Group has surveyed industry executives and managers to gain a better understanding of the trends in the outsourcing of clinical research. These insights provide actionable steps to improve the processes and business relationships within our industry.
In responding to continued time, cost, and quality pressures, sponsor companies and CROs are moving increasingly toward the use of novel and “intelligent” approaches to optimizing efficiency and quality in clinical development. Such approaches, often data- and/or technology-driven, include potentially powerful methodologies for optimizing protocol design, development programs, investigator and/or country selection, clinical trial processes, and information sharing, among others.
All contributions to the survey are welcomed. All responses are confidential and individual names are not associated with results. The results will be presented at the Partnerships in Clinical Trials conference in April 2014, and contributors will also receive a summary of the results.
Employees at clinical research organizations (CROs) receive lower annual and long term incentives than their counterparts in other industries, according to the 15th annual CRO Industry Global Compensation and Turnover Survey, conducted by HR+Survey Solutions, Inc.
According to the company’s press announcement, CRO industry executives in the U.S. with salaries of $250,000 were eligible for an average annual incentive of 31% of their salary and a long term incentive (LTI) of 27%. By comparison, similar levels of executives in other industries were eligible for annual incentives of 44% and LTIs of 50%.
Results of the study indicate that CRO pay is heavily weighted toward base salary. Salary represents nearly 50% of the compensation package for executives with annual incentives and LTIs of only 19 and 34%, respectively. At the director level, salary amounts to 86% of total direct compensation with only 13% annual incentives and 1% LTIs.
Although employee turnover dropped from nearly 20% in 2011 to approximately 18%, the rate at which employees leave their jobs in the U.S. CRO industry remained high. Conversely, in countries outside of the U.S., the turnover rate rose to 21% from approximately 18%. In some countries, turnover was more than 30%.
The Health Research Authority (HRA) is launching a call for evidence to identify good practice in identifying potential participants in health research.
Building on their remit to protect and promote the interests of patients and the public in health research, they are asking for examples in the areas in which we are directly involved as well as broader successful participation initiatives.
The revisions to the NHS Constitution have committed the health service to recognising and promoting the value of research, and the Health and Social Care Act 2012 placed obligations on NHS organisations to support this.
People can contribute by completing a brief survey and returning it to email@example.com by 31 January 2014.
The HRA are interested to hear about the impact of changing recruitment strategies on recruitment and retention rates, and are particularly keen to hear about examples of patient and public engagement around models of recruitment, and evidence about patient and public expectations relating to the identification of participants.
The outcome will be published on www.hra.nhs.uk to enable the research community to benefit from the best ideas in the NHS.
Experienced project management consultant and general clinical research “guru” Les Rose is exploring his frustrations with project management. In a survey on his website, he reveals his top ten and asks you to share your views on their prevalence and importance. The survey is totally anonymous, and findings will be made available on request and published in a future issue of Clinical Research Focus magazine.
Click here to find out what Les’ top ten “pharma frustrations” are, and to have your say…
In his words, “if you do nothing other than avoid half of them, your company will be way ahead of your competitors”
While lack of commercial viability is the leading cause of Phase I failures for new drug candidates, efficacy issues dominate as the reason for Phase II failures, according to a new analysis from the Tufts Center for the Study of Drug Development.
Based on a study of products that entered clinical development from 2000 through 2009, Tufts CSDD found that commercial reasons accounted for 40.9% of all Phase I failures, but only 27.3% of Phase II failures. Efficacy issues explained 50.9% of Phase II failures.
“It is in the interest of drug developers to have new products fail earlier, rather than later, in development,” said Joseph A. DiMasi, Tufts CSDD director of economic analysis, the principal investigator on the study. “While there is natural resistance to give up on a compound too early, the need to reduce costs and boost productivity is leading developers to establish new approaches to R&D, including the increased use of biomarkers and novel clinical trial designs, with the goal of terminating candidates as early as possible.”
The analysis also found that:
- Safety issues accounted for nearly twice as many Phase III failures as did commercial reasons: 29.5% vs. 15.9%.
- Efficacy issues accounted for 54.3% of respiratory drug failures and 48.3% of drug candidates to treat central nervous system diseases.
- Cardiovascular drugs experienced the highest prevalence of commercial failures (46.7%) among all classes of compounds analyzed.
The study, based on investigational drugs in the pipelines of the top 50 firms in terms of pharmaceutical sales, examined the development histories of 812 compounds, which had 1,369 failed indications, and established reasons for failure by clinical phase for 410 of these compounds and 659 indications.
The EU Patients’ Academy on Therapeutic Innovation (EUPATI) has launched a survey to collect data on patients’ and the public’s information needs regarding pharmaceutical medicines development.
Running until September 30th, this survey is designed to take approximately 15 minutes to complete and sets out to increase insight and strengthen findings already being shared within the project. Translated into the seven Patients’ Academy languages, the aim is to increase survey coverage and enable more people to take part.
To complete the survey, click here and select the appropriate language… If you are in contact with patients or patient advocate groups, please encourage them to contribute to this survey.
Survey responses will be analysed, written up into a report and used to inform the development of the Patients’ Academy training programme for Patient Advocates and Expert Patients. The results will also help to shape our Advocacy toolbox for patient advocates as well as the overall public information campaign.
The member companies of TransCelerate are working together to develop guidance documents/template forms for the following documents, FDA1571, FDA1572 and Delegation of Authority Forms. The objective of this workstream is to develop these documents to build efficiencies for both sponsor companies and sites.
To ensure these documents are developed with end users in mind, they are asking investigators and other site representatives to complete a short survey, which will help identify the most important issues around completing Delegation of responsibility forms.
TransCelerate was formed in September 2012, when ten leading pharmaceutical companies formed the non-profit organization BioPharma Inc. (TransCelerate), with a focus on accelerating the development of new medicines – initially by identifying ways to make the clinical trial process more efficient.
A few days ago, I appeared as a panellist on a webinar discussing the results of a recent survey on patient awareness of clinical trials within the hepatitis C patient community, hosted by Tudor-Reilly. We discussed how to raise awareness of HepC clinical trials, some of the issues around conducting studies in this therapeutic area, and how these findings might be applied to patient engagement in clinical research more generally.
The webinar was led by Peter Coe, Chairman of Tudor-Reilly, and the other panellists were:
- Dr Matthew Foxton, consultant hepatologist
- Andrew Langford, CEO of the British Liver Trust
- Karen Donovan, principal of healthcare consultants Health Business Group
The audio and slides from the webinar are now available [here].