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International Clinical Trials

Survival of the Brightest


As the pharmaceutical industry seeks to overcome the economic challenges it currently faces, both large and small companies should look to improve efficiency and management, and consider the possible benefits of strategic alliances and diversification, as Alan Wade at CPS Research suggests

We are currently in a recessionary environment which for the pharmaceutical industry in recent years has been compounded by a steady loss of important patents, pressure from generic competition and downward pressure on prices by government institutions. This has led to the need to make cost savings and improve effi ciency, and has resulted in dramatic changes in the way development programmes and clinical trials are managed.

BIG PHARMA’S RESPONSE

Big Pharma has sought to reduce the number of personnel employed in R&D and have entered into long-term exclusive agreements with international CROs to conduct complete development programmes. Experience of these changes so far at the clinical level has been mixed. Where experienced teams have been working, progress has been smooth; but with complicated studies and inexperienced personnel, the need to constantly refer back to the parent company for decisions simply leads to more delays, confusion and uncertainty.

SMALL PHARMA’S RESPONSE

Small biotech companies, already experiencing diffi culties raising capital for development programmes, are reported to be disappointed with the service received from larger CROs as they, perhaps naturally, prioritise their contracts with Big Pharma. Does this provide an opportunity for smaller clinical trials companies?

THE PROBLEMS IN EUROPE & THE US

Without a doubt, the pressure on funding and the need to contain costs has resulted in a reduction in the overall number of clinical trials being conducted, and a move to locating trials in lower cost countries. While the recession is being blamed for the reduction in European trials, it is important that we face up to the fact that, for many years, trials in both Europe and the US have suffered from poor recruitment, high costs and failure to meet deadlines. The reasons behind these facts need to be examined critically. An easy target in Europe is the increasingly complex and hostile regulatory environment being imposed by the EU commission and individual governments. The principal problem resulting from the regulations appears to have been the delay in initiating studies. This can be minimised by understanding the system, however it does not explain poor recruitment after the trial has been initiated or the excessive cost of running the study itself.

At present, clinical trials are designed by personnel within both companies and CROs – many of whom are divorced from the clinical reality of day-to-day patient contact. Advice is taken mainly from ‘key opinion leaders’, many of whom themselves do not have regular clinical contact with patients. The resulting studies are often more complicated than necessary with unnecessarily rigorous inclusion and exclusion criteria. Not only does this result in failure to achieve the smooth and logical flow of data collection needed by both patients and clinicians, but it also renders the data less useful in assessing how the drug will behave in a normal clinical environment. The more complicated and time-consuming the visits, the less likely it is that doctors and patients will achieve recruitment and retention targets.

DATA COLLECTION AT THE PATIENT INTERFACE

The increasing complexity of studies and the difficulty in complying with regulatory requirements has resulted in many physicians stopping clinical trial work altogether. But for the remainder, and for the smaller clinical research operations, what can be done to survive and indeed thrive in this environment? The pharma companies, the CROs, the data handlers, the statisticians, the regulatory bodies and all others engaged in running clinical trials apparently operate a professional business model. By contrast, the actual collection of data at the patient interface is generally at the level of a cottage industry. We must aim for the effi cient collection of genuine high-quality data, and to achieve this each clinical site must have an effi cient management structure backed by a quality assurance programme that can be audited externally.

It is important to acknowledge that a signifi cant part of the problem is the ‘amateurish’ approach of many clinical investigators, which can make clinical trial work a low priority in relation to other duties. If the situation is to be improved and ‘professionalised’, highly trained staff dedicated to the conduct of clinical trials at the clinic level are required. Addressing this problem will be key to the clinical trials industry thriving in the current economic climate. Production of quality data is dependent on quality staff backed up by investment in training. It is not enough to have a single investigator set-up meeting and assume that all will be well. And the investment should not merely be in frontline doctors, nurses and clinical raters, but also in support management staff, in order to ensure effi cient appointments, patient communication, IMP handling, documentation and general backup. It is important when assessing a potential clinical site that full weight is given not just to the clinical personnel but also to the management, regulatory and backup staff, resulting in clinical input that provides professional, accurate and effi cient data.

While each individual site can improve its operation, unless the interface between the pharma company or CRO and the site is effi cient, quality problems will still arise. The monitor or CRA is the conduit for transfer of information from the clinical site to the sponsoring company and vice versa. He or she must be part of the quality assurance system at each site and it is important that they are genuinely seen as someone who is facilitating recruitment and data collection and not merely as a supervisor fi nding faults and inconsistencies in the data collected by the clinical site.

A smaller site management operation may also employ clinical research nurses who are assigned to regular contracted clinical sites. However, for the nurses to work effi ciently requires investment in almost as many management and backup staff with associated facilities. Regular internal and external training opportunities should be provided for all staff, not just nurses and doctors, and the whole system should be contained within a formal framework of current ISO 9001:2000 Certification.

DIVERSIFICATION

As in any pressurised business situation, diversifi cation, the expansion of business opportunities and the development of strategic alliances will all ease the pressure on clinical trial organisations. Smaller biotech companies may feel more comfortable working with a similarly sized operation and communicating with personnel of similar standing without the hierarchy required by an international CRO. However, these companies require the full range of services provided by a CRO. Today, site management organisations seek to enhance the regulatory and clinical services available in-house by developing alliances with data-handling and statistical services, and professional report writers. The result is trials designed in-house and managed throughout with the emphasis on ease of data collection at the clinical level.

Another area for diversification is to recognise the limitations of randomised clinical trial data – carefully defi ned population, age limitation, no comorbid illnesses and strictly supervised concomitant medication – and the need for ‘real world’ data. Trained clinical trial nurses can supplement a web-based system of collecting information directly from patients about marketed drugs or disease pathways, which can allow expansion from a small, well-defined geographical base to being able to collect data from patients on an international basis.

CONCLUSION

The key to survival is to improve the effi ciency and standard of collecting data at the clinical level. This depends on improved clinical trial design and effi cient management, increased investment in training and the implementation of externally supervised quality assurance systems at site level. Nevertheless, small clinical units should not ignore the possibilities of strategic alliances and diversifi cation, allowing effi cient and innovative clinical trials operations to survive and indeed thrive in the current recessionary environment.


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Alan Wade is one of the two founding Directors of CPS Research, a clinical trials company based in the west of Scotland, with 22 full-time staff. He has formed a second company, Patients Direct with the specific purpose of collecting patient reported naturalistic, real-world data. Patients Direct methodology is currently being employed in areas as diverse as childhood rheumatoid disease, infl uenza vaccination and depression. A recent partnership venture between CPS and Bio-Images group will provide clients with a fully integrated pharmaceutical development package. In addition to his clinical interests, Alan regularly gives presentations at international meetings, publishes in the medical press and is a regular reviewer for medical journals, also serving on the local organising committee for two Collegium Internationale Neuro-Psychopharmacologicum (CINP) congresses. Email: alan@cpsresearch.co.uk
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