Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

Posted 11 September 2017 By Zachary Brennan


FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective.

Opening with a discussion of the ways in which the gap of time between the discovery of the science behind new treatments and the adoption of such treatments has been shrinking, Gottlieb outlined a few of the ways in which the agency is modernizing its approach to collecting and evaluating clinical information.

And on a day when the discussion of how much it costs to develop a new oncology drug is being hotly debated with the release of a new study, Gottlieb also discussed how the costs of drug development “are also high, and growing.

“There’s been criticism of the various estimates of how much it costs to develop a new drug,” he said, according to the transcript of his speech. “Moreover, on a relative basis, in many cases the costs of early stage drug development has grown at a proportionally faster rate than the cost of late stage drug development. In other words, inflation in early stage drug trials is rising faster than inflation in late stage development.

“By front-loading the cost of drug discovery, the broader biomedical community is making it harder to advance new ideas. It’s economically harder to capitalize the cost of an early stage drug program, relative to funding a later stage project. So frontloading the costs are a recipe for reducing the amount of new ideas that can be advanced.”


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Tips for managing CRO’s

The role of clinical contract research organizations (CRO’s) has come into focus of late, with the burgeoning growth of the outsourced model for business. In the clinical research industry, CRO’s are considered viable alternatives to expensive domestic players. This is because since it is the clinical study process that needs to be outsourced to developing countries; this can happen at a more economical rate than when insourced to clinical contractors in developed economies.

Pros and cons of managing CRO’s

Undoubtedly, the biggest advantage a pharmaceutical company or any other sponsor gains by outsourcing its clinical research is that it saves humungous amounts of money. This is the most obvious no-brainer, because huge cost advantages exist between developed and developing economies.

In addition, there is also the assurance of quality delivery. A CRO is legally contracted to supply the process and results of a remote clinical trial on time with almost no use of resources from the outsourcing organization.

Of course, there are downsides in managing CRO’s, as there are in any business process. CRO’s that outsource their clinical research need to be in control of the whole process, right from start till finish. Unlike say, manufacturing or software, in which the business deals with nonliving products and technologies; sponsors have to constantly be on their toes in monitoring process, results and quality of their outsourced activity, which can vary with the slightest change in input.

So, what do sponsors need to do for managing CRO’s?

First, the aims and objectives of the clinical research need to be very clearly spelt out. All the steps and processes involved in managing CRO’s need to be mentioned very clearly in writing at the beginning of the outsourcing activity, as any ambiguity at any stage will open the way for interpretation and is likely to lead to unpleasantness

Keeping control over the process remotely is a way of managing CRO’s. In a remote, virtual clinical trial, the integrity of data has to be ensured at all stages and approved, so that the next phase is cleared for starting after the previous one has been validated and approved by the sponsor. Putting these steps in place goes a long way in helping sponsors manage CRO’s effectively.

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Understanding clinical compliance

Clinical compliance is a necessary part of a clinician’s profession. Clinical trials are the lifeblood of laboratory experiments and are at the root of drug development. Since clinical trials assume such significance in pharmaceuticals, it is necessary for clinical trials to be compliant with regulations. Regulations are important not only from the perspective of drug development, but also from that of safety, because clinical trials that do not adhere to regulatory compliance have the potential to cause harm and even death to subjects.

Clinical compliance has to be taught

Since the subject of clinical trials requires a high degree of clinical compliance, it is necessary for clinicians to undergo formal training on the subject. They should be aware of not only what procedures go into clinical training, but also how to be compliant with regulations. Like any other regulatory area; clinical compliance is also imparted by regulatory bodies authorized to do so by the FDA. The FDA authorizes accredited bodies to offer clinical compliance training.


Generally, clinical compliance training is offered for a clutch of main subjects. Clinical compliance usually requires the student to choose from among the following subjects:

  • The Drug Development Process
  • Good Clinical Practices (GCP)
  • Adverse Drug Events
  • GCP Audits
  • Ways of Monitoring Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance
  • The EU Clinical Trial Directive

Students can also choose from any of the following when it comes to electives:

  • Medical Writing
  • Writing Effective Standard Operating Procedures and Other Process Documents
  • Biostatistics for Non-Statisticians
  • Computer Systems Validation
  • cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
  • Selecting & Managing CRO’s
  • FDA Inspections of Clinical Data Systems
  • European Regulatory Procedures
  • Best Practices for Clinical Trial Project Management from Phase 1 to Phase 4



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