With the increasing number of discoveries in the field of medicine and an increase in number of diseases, causative agents and pollution, it becomes imperative to bring new medicines in the market. More and more CRO’s are emerging, which serve biotechnological, medical and pharmaceutical companies.
Some of the well-known CROs are Covance which has lately given us breakthroughs in cancer treatment and supported development of 25 currently marketed drugs; INC research which is working on phase1-IV trials along with pediatric and women’s health areas; ICON carrying out phase1-IV trials; and the list goes on and on.
Nowadays, Clinical Trails also called Interventional Studies are in question due to the concerns that are associated with them. To go ahead with the trials a lot of pre planning is required by the sponsor as well as the steering committee employed by them. The perspectives and concerns of the sponsor and volunteer personas have interesting differences.
1. Return on Investments
The clinical trial industry is known to have non-trivial costs. Hence the sponsors are more focused on the returns they are going to earn. On the other hand a volunteer is willing get a drug tested on his body (investment in most of the cases) only for monetary gains.
In both the cases, one needs to be sure of his estimation and requirements of the investment before going ahead with it. Also, he should be well prepared for any kind of further investment or losses incurred during the process. Then they must again and evaluate before going ahead with the final step.
2. Brand Image
Considering the high costs in the Clinical Trial industry and challenges in willingness of volunteers to participate, a solid brand can be a great asset to instill confidence in trial volunteers.
3. Time Involved
A trial is a time consuming process which may continue for years. In the meantime a lot of participants might back out; some diseased participants might even die before the results of the trial are complied. Out in the market people might be dying waiting for the treatment of diseases they are suffering through. Until then a trial is just an investment by all in terms of money, time and effort with no guarantee of results.
4. Adverse events/SAE associated with the drugs
Though the anticipated adverse events are pointed out and listed in the investigator brochure, there are still some chances that a volunteer might develop some of them during the trial. Such a situation may worry a sponsor for the consequences, which, in some cases, might lead to a stop in the trials.
At the same time, a volunteer is risking his life and lives in a hope that he will not have such an encounter during the trail. Hence a thoughtful start of the trial based on an intense research work is required before going ahead with the phases of trails.
5. HSP (Human Subject Protection)
The major concern of a volunteer lies in how his rights are protected by the sponsor and regulating authorities. It is the responsibility of the IRB/FDA/Sponsor to keep a control on how and why are vulnerable volunteers appointed. This especially holds true for developing countries where there are more chances of a forced or illegal appointment of a volunteer.
It also has to be made sure that the volunteers are provided with the correct and complete information by ICF(Informed Consent Form) before they sign up for the studies and after their sign up, all the promises made to them are kept up to the mark.
6. Attitude of the volunteer
The most important aspect here is to understand the motive of the participant for the acceptance of the offer. The sponsor fulfills his duties of guarding the rights of a volunteer by appointing CRAs and genuine reporting to the regulatory authorities. However, there is no way to make sure that the volunteer is keeping up to the duties entrusted in him. A Principle Investigator (PI) can keep record of the activities carried out in his clinic and his vicinity but outside these boundaries, a volunteer is at his own discretion.
Taking a pill on time, following the prescribed procedure and being honestly associated with the trial is all dependent on the volunteer’s judgment which in turn has a direct impact on the trial and its result.
7. Use of placebo
Trials are randomized, not even the PI is aware of the original labels of the drugs given to the participants. The motive of a diseased volunteer (patient) might be to join a trial in a hope to benefit from it. But in a case where he is administered a placebo instead of the testing drug, the trial holds no value for him and his efforts and trust is all in vain. Hence, administration of the type of drug (placebo/testing drug) forms a major concern for the patient.
8. Drug Recalling
A drug might get recalled from the market even after it has gone through positively with the clinical trials. This forms the major concern for the sponsor and the investors. FDA makes sure of reporting such recalls to the public and other investors by keeping such events updated on their website. Example: As per the FDA recall reports on the its website some of the recent recalls are as follows:
- a) 4“May 25,2013 Fresenius Kabi USA Initiates Voluntary Recall of single lot of Magnesium Sulphate”
- b) 5“May 15,2013 Pentec Health announces limited voluntary recall of certain compounded prescription therapies for renal patients”
9. Authenticity of the data and the case files
Though a clinical trial is regulated by a lot of authorities like IRB, FDA,DSMB(Data Safety and Monitoring Boards) but still there are a good number of chances that a data can be manipulated somewhere in the loop. The investors or stakeholders of the Trial companies continuously look forward to cut costs and improve productive results.
Profits might become a key driver for the loop members to manipulate the data in some way or the other to bring their so called successful product to the market. Hence, the integrity of the data forms a major concern. 6“The unexpected catastrophic adverse events in a first-in-human-trial involving s drug called TGN1412 highlighted ethical issues in clinical study design and safety monitoring”
10. 3C’s: Commitment, Communication and Co-ordination
The Clinical Trial industry has a comprehensive set of very strict regulations and policies. Sponsors and stakeholders need to be very particular about compliance of the same, to avoid blunders which can turn their huge investments into sunk costs and more. Here the sponsor holds more responsibility of appointing a staff who is diligent enough and is ready to input both time and effort to the best of their abilities and not just work for monetary gains.
Though the roles and responsibilities of each and every member of the trial (Sponsor, PI, CRC, IRB, FDA, CRA) is clearly defined but in some cases duplication or ignorance of these responsibilities can be easily observed. Such a lack of coordination and communication breakdowns can lead to some unanticipated events or outcomes. Detection at a right time is essential for drug to be successful with integrity.
