Friday, August 21, 2015

Clinical research: Part art, part science, all communication

By Michael A. Martorelli, Fairmount Partners

I’ve followed contract research for twenty years as an investment analyst and banker. I’ve seen the industry fragment and consolidate, shrink and expand and I’ve used these observations to advise CROs and other service providers of the opportunities and pitfalls.

The most important lesson I’ve learned is that having a clear aim from the outset is the key to success in any drug development project.

The goal of clinical research is to provide regulators with the information they need to make informed decisions about the marketability of new therapeutic products as quickly and efficiently as possible.

To conduct such research in the most effective way requires that sponsors understand the tasks they want their outsourcing providers to conduct empower them to carry them out.

For their part, contractors need to understand and complete their assigned tasks as quickly and efficiently as possible, hopefully on time and on budget.


To achieve these aims, sponsors and contractors need to be led by skilled and adaptable management teams that are capable of establishing the correct clinical programme for each investigative compound.

Clinical research is both an art and a science and its effective management requires leaders who strive for optimal success while being able to adjust to unforeseen difficulties.


The other key party in all effective clinical research is the regulator. It is important that regulators are on top of the scientific and medical advances on which new therapies are based.

In addition, regulators must demand that clinical trials are conducted to high standards while keeping in mind the need to assess the potential marketability of drug candidates as rapidly as possible.

It is also vital that regulators provide sponsors and their contractors with consistent guidance that makes clear their expectations.

Equally, drug developers and their outsourcing providers need to communicate effectively with regulators, remembering at all times that failure to so could result in poorly conceived, poorly executed trials that yield unpersuasive results.


Patients are the ultimate beneficiaries of effective clinical research and it is vital that sponsors, outsourcing providers and regulators share information.

PCT-Europe is an excellent forum for such interaction because it offers workers at all levels of all companies the chance to share experiences and find ways of dealing with common challenges.


By Michael A. Martorelli, Fairmount Partners
Mr. Martorelli came to Fairmount after serving as managing director of research and senior health care analyst at Investec Inc. and its predecessor, PMG Capital. Prior to PMG Capital, Mr. Martorelli spent more than ten years at Janney Montgomery Scott as a research analyst covering companies in various segments of the health care industry.


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