Clinical Trial Medication: Failing to Plan at an Early Stage Could Cost the Entire Trial

Oct. 16, 2008 - PRLog -- While the focus of a clinical trial would seem to be the drug under study this isn’t always the case. Experience has shown that when preparing for a trial, medication is a design, regulatory and logistical challenge which is grossly underestimated and often almost an afterthought. Not taking this crucial part of the study into account early on can cost the investigator credibility of results and even the entire trial.

The manufacture and packaging of investigational medicinal products (IMPs) for use in clinical trials can appear, on the face of it, a fairly straightforward exercise. In reality, increasingly stringent regulations with regards to the preparation of active trial medication and its comparator/placebo used in clinical trials means even the smallest requirements have a long sequence of necessary operations attached to them driving up the complexity and cost of medication supply.  

In the case of non-commercial and academic trials (i.e. where there is no involvement of the pharmaceutical industry in the design of a trial) limited budgets often implies that the investigator is required to undertake complex medication planning tasks that are typically undertaken by pharmaceutical specialist project managers in commercial trials. In practice the lack of resources and awareness about IMP manufacturing options means investigators pursue trials with less than optimal medication solutions. In some cases the true hidden cost of procuring medication means the trial is simply not feasible anymore and has to be abandoned.

modePharma, a company that specialises in the medication supply for clinical trials, has seen an increase in the number of medication enquiries being made by non-commercial Investigators. However, according to modePharma’s Managing Director, Oliver Gupta, the necessity to enquire early in the planning stage is still not being taken seriously enough. “Ideally, we would like to see all non-commercial trial investigators making medication feasibility enquiries before applying for funding.  It is at this stage where there is the most scope to amend the design of the trial and medication and subsequently ensure sufficient funding will be in place.”  

modePharma is an example of the innovative support that is increasingly available to investigators of non-commercial trials.  Focusing entirely on non-commercial trials, modePharma’s specialist project managers assist researchers in optimising the design of the trial medication and help select the most sensible option based on clinical trial variables and commercial manufacturing opportunities.

Oliver Gupta states “It is unrealistic to expect all researchers to possess insight into the broad range of pharmaceutical manufacturing possibilities out there. We help the investigator by using our commercial and IMP expertise to improve the quality of a trial whilst minimising budget outlay at the same time.”

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About modePharma:
modePharma is an independent advisory, sales and project management company, active in various areas of non-commercial clinical trial supplies. modePharma supports customers and manufacturing partners in all issues concerning pharmaceutical contract manufacturing and packaging of investigational medicinal products as well as a broad range of supporting services for clinical trials and studies. modePharma maintains a growing network of high-quality pharmaceutical contract manufacturing companies across the United Kingdom and European Union who bring with them extensive know-how. Through its extensive network modePharma is able to offer its customers the skills, expertise, strengths, capacity and capabilities of industry experts and offer tailor-made solutions for virtually all dosage forms.